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  1. Development and validation of stability indicating studies of ...

    African Journals Online (AJOL)

    Development and validation of stability indicating studies of paliperidone ... A simple and sensitive stability indicating HPLC method is developed for the ... The developed method was proved adequate for quantitative determination of ... Browse By Country · List All Titles · Free To Read Titles This Journal is Open Access.

  2. A VALIDATED STABILITY INDICATED RP-HPLC METHOD FOR DUTASTERIDE

    OpenAIRE

    D. Pavan Kumar a, b *, Naga Jhansi a, G. Srinivasa Rao b, Kirti Kumar Jain a

    2018-01-01

    ABSTRACT A Simple, Stability indicating, Isocratic, reverse phase High Performance Liquid Chromatographic (RPLC) related substance method was developed for Dutasteride in API. This method separates the impurities which are co-eluting in the pharmacopeia method. Successful separation of degradation impurities and synthetic impurities was achieved by YMC Triat phenyl column. Chromatographic was carried out on YMC Triat phenyl (150 X 4.6 mm, 3.0µm) column using 0.01M Potassium Dihydrogen Pho...

  3. Development and Validation of a Stability-Indicating LC-UV Method ...

    African Journals Online (AJOL)

    Keywords: Ketotifen, Cetirizine, Stability indicating method, Stressed conditions, Validation. Tropical ... in biological fluids [13] are also reported. Stability indicating HPLC method is reported for ketotifen where drug is ..... paracetamol, cetirizine.

  4. Development and Validation of a Stability-Indicating RP-HPLC ...

    African Journals Online (AJOL)

    Development and Validation of a Stability-Indicating RP-HPLC Method for ... of Paracetamol, Tramadol HCl and Domperidone in a Combined Dosage Form. ... testing, as well as for quality control of the combined drugs in pharmaceutical ...

  5. Development and Validation of a Stability-Indicating LC-UV Method ...

    African Journals Online (AJOL)

    Development and Validation of a Stability-Indicating LC-UV Method for Simultaneous Determination of Ketotifen and Cetirizine in Pharmaceutical Dosage Forms. ... 5 μm) using an isocratic mobile phase that consisted of acetonitrile and 10 mM disodium hydrogen phosphate buffer (pH 6.5) in a ratio of 45:55 % v/v at a flow ...

  6. Development and validation of a stability indicating HPTLC-densitometric method for lafutidine

    Directory of Open Access Journals (Sweden)

    Dinesh Dhamecha

    2013-01-01

    Full Text Available Background: A simple, selective, precise, and stability indicating high-performance thin layer chromatographic method has been established and validated for analysis of lafutidine in bulk drug and formulations. Materials and Methods: The compounds were analyzed on aluminum backed silica gel 60 F 254 plates with chloroform:ethanol:acetic Acid (8:1:1 as mobile phase. Densitometric analysis of lafutidine was performed at 230 nm. Result : Regression analysis data for the calibration plots were indicative of good linear relationship between response and concentration over the range 100-500 ng per spot. The correlation coefficient (r 2 was 0.998±0.002. Conclusion: Lafutidine was subjected to acid, base, peroxide, and sunlight degradation. In stability tests, the drug was susceptible to acid and basic hydrolysis, oxidation, and photodegradation.

  7. Development and validation of stability indicating UPLC assay method for ziprasidone active pharma ingredient

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    Sonam Mittal

    2012-01-01

    Full Text Available Background: Ziprasidone, a novel antipsychotic, exhibits a potent highly selective antagonistic activity on D2 and 5HT2A receptors. Literature survey for ziprasidone revealed several analytical methods based on different techniques but no UPLC method has been reported so far. Aim: Aim of this research paper is to present a simple and rapid stability indicating isocratic, ultra performance liquid chromatographic (UPLC method which was developed and validated for the determination of ziprasidone active pharmaceutical ingredient. Forced degradation studies of ziprasidone were studied under acid, base, oxidative hydrolysis, thermal stress and photo stress conditions. Materials and Methods: The quantitative determination of ziprasidone drug was performed on a Supelco analytical column (100×2.1 mm i.d., 2.7 ΅m with 10 mM ammonium acetate buffer (pH: 6.7 and acetonitrile (ACN as mobile phase with the ratio (55:45-Buffer:ACN at a flow rate of 0.35 ml/ min. For UPLC method, UV detection was made at 318 nm and the run time was 3 min. Developed UPLC method was validated as per ICH guidelines. Results and Conclusion: Mild degradation of the drug substance was observed during oxidative hydrolysis and considerable degradation observed during basic hydrolysis. During method validation, parameters such as precision, linearity, ruggedness, stability, robustness, and specificity were evaluated, which remained within acceptable limits. Developed UPLC method was successfully applied for evaluating assay of Ziprasidone active Pharma ingredient.

  8. A validated stability-indicating UPLC method for desloratadine and its impurities in pharmaceutical dosage forms.

    Science.gov (United States)

    Rao, Dantu Durga; Satyanarayana, N V; Malleswara Reddy, A; Sait, Shakil S; Chakole, Dinesh; Mukkanti, K

    2010-02-05

    A novel stability-indicating gradient reverse phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the determination of purity of desloratadine in presence of its impurities and forced degradation products. The method was developed using Waters Aquity BEH C18 column with mobile phase containing a gradient mixture of solvents A and B. The eluted compounds were monitored at 280nm. The run time was 8min within which desloratadine and its five impurities were well separated. Desloratadine was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Desloratadine was found to degrade significantly in oxidative and thermal stress conditions and stable in acid, base, hydrolytic and photolytic degradation conditions. The degradation products were well resolved from main peak and its impurities, thus proved the stability-indicating power of the method. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. This method was also suitable for the assay determination of desloratadine in pharmaceutical dosage forms.

  9. A validated specific stability-indicating RP-HPLC assay method for Ambrisentan and its related substances.

    Science.gov (United States)

    Narayana, M B V; Chandrasekhar, K B; Rao, B M

    2014-09-01

    A validated specific stability-indicating reverse-phase liquid chromatographic method was developed for the quantitative determination of Ambrisentan as well as its related substances in bulk samples, pharmaceutical dosage forms in the presence of degradation products and its related impurities. Forced degradation studies were performed on bulk samples of Ambrisentan as per the ICH-prescribed stress conditions using acid, base, oxidative, thermal stress and photolytic degradation to show the stability-indicating power of the LC method. Significant degradation in acidic, basic stress conditions was observed and no degradation was observed in other stress conditions. The chromatographic method was optimized using the samples generated from the forced degradation studies and the impurity-spiked solution. Good resolution between the peaks corresponds to Ambrisentan-related impurities and degradation products from the analyte were achieved on a SunFire C18 column using a mobile phase consisting of a mixture of potassium dihydrogen orthophosphate at a pH adjusted to 2.5 with ortho-phosphoric acid in water and a mixture of acetonitrile:methanol using a simple linear gradient. The detection was carried out at 225 nm. The limit of detection and the limit of quantification for the Ambrisentan and its related impurities were established. The stressed test solutions were assayed against the qualified working standard of Ambrisentan and the mass balance in each case was between 98.9 and 100.3%, indicating that the developed LC method was stability indicating. Validation of the developed LC method was carried out as per the ICH requirements. The developed method was found to be suitable to check the quality of bulk samples of Ambrisentan at the time of batch release and also during its storage (long-term and accelerated stability). © The Author [2013]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  10. Validation of a stability-indicating spectrometric method for the determination of sulfacetamide sodium in pure form and ophthalmic preparations

    Directory of Open Access Journals (Sweden)

    Sofia Ahmed

    2017-01-01

    Full Text Available Introduction: Sulfacetamide sodium is a widely used sulfonamide for ophthalmic infections. Objective: A number of analytical methods have been reported for the analysis of sulfacetamide but they lack the ability to determine both the active drug and its major degradation product, sulfanilamide, simultaneously in a sample. Materials and Methods: In the present study a simple, rapid and economical stability-indicating UV spectrometric method has been validated for the simultaneous assay of sulfacetamide sodium and sulfanilamide in pure form and in ophthalmic preparations. Results: The method has been found to be accurate (recovery 100.03 ±0.589% and precise (RSD 0.587% with detectable and quantifiable limits of 1.67×10–6 M (0.04 mg% and 5.07×10–6 M (0.13 mg%, respectively for the assay of pure sulfacetamide sodium. The method is also found to be accurate and precise to small changes in wavelength, pH and buffer concentration as well as to forced degradation. The study further includes the validation of the method for the assay of pure sulfanilamide in solution, which has been found to be accurate, precise and robust. Conclusion: The results indicate that the proposed two-component spectrometric method is stability-indicating and can be used for the simultaneous assay of both sulfacetamide sodium and sulfanilamide in synthetic mixtures and degraded solutions.

  11. Stability-Indicating Validated HPLC Method for Analysis of Berberine Hydrochloride and Trimethoprim in Pharmaceutical Dosage Form

    Directory of Open Access Journals (Sweden)

    Jing-Chun Wang

    2013-01-01

    Full Text Available A stability-indicating HPLC method was developed and validated for the determination of berberine hydrochloride and trimethoprim in pharmaceutical dosage form in the presence of degradation products. The proposed RP-HPLC method utilizes an Agilent TC-C18, 4.6 mm × 250 mm, 5 μm, column using a mobile phase consisting of acetonitrile-50 mM potassium dihydrogen phosphate (30 : 70, v/v, pH adjusted to 3 with orthophosphoric acid at a flow rate of 1.0 mL/min and UV detection at 271 nm. The linearity of berberine hydrochloride and trimethoprim was in the range of 2 to 60 μg/mL (r=0.9996 and 1 to 30 μg/mL (r=0.9995, respectively. Repeatability and intermediate precisions were also determined with percentage relative standard deviation (% RSD less than 2.0%. The limits of detection were found to be 9.8 ng/mL for berberine hydrochloride and 2.5 ng/mL for trimethoprim. The mean recoveries for berberine hydrochloride and trimethoprim were 99.8 and 98.8%, respectively. The stability of the two drugs was determined under different conditions and the proposed method has shown effective separation for their degradation products. And the proposed assays method can thus be considered stability-indicating.

  12. A Validated Stability-Indicating HPLC Method for Simultaneous Determination of Amoxicillin and Enrofloxacin Combination in an Injectable Suspension

    Directory of Open Access Journals (Sweden)

    Nidal Batrawi

    2017-02-01

    Full Text Available The combination of amoxicillin and enrofloxacin is a well-known mixture of veterinary drugs; it is used for the treatment of Gram-positive and Gram-negative bacteria. In the scientific literature, there is no high-performance liquid chromatography (HPLC-UV method for the simultaneous determination of this combination. The objective of this work is to develop and validate an HPLC method for the determination of this combination. In this regard, a new, simple and efficient reversed-phase HPLC method for simultaneous qualitative and quantitative determination of amoxicillin and enrofloxacin, in an injectable preparation with a mixture of inactive excipients, has been developed and validated. The HPLC separation method was performed using a reversed-phase (RP-C18e (250 mm × 4.0 mm, 5 μm column at room temperature, with a gradient mobile phase of acetonitrile and phosphate buffer containing methanol at pH 5.0, a flow rate of 0.8 mL/min and ultraviolet detection at 267 nm. This method was validated in accordance with the Food and Drug Administration (FDA and the International Conference on Harmonisation (ICH guidelines and showed excellent linearity, accuracy, precision, specificity, robustness, ruggedness, and system suitability results within the acceptance criteria. A stability-indicating study was also carried out and indicated that this method can also be used for purity and degradation evaluation of these formulations.

  13. Validated stability-indicating spectrofluorimetric methods for the determination of ebastine in pharmaceutical preparations

    Directory of Open Access Journals (Sweden)

    Eid Manal

    2011-03-01

    Full Text Available Abstract Two sensitive, selective, economic, and validated spectrofluorimetric methods were developed for the determination of ebastine (EBS in pharmaceutical preparations depending on reaction with its tertiary amino group. Method I involves condensation of the drug with mixed anhydrides (citric and acetic anhydrides producing a product with intense fluorescence, which was measured at 496 nm after excitation at 388 nm. Method (IIA describes quantitative fluorescence quenching of eosin upon addition of the studied drug where the decrease in the fluorescence intensity was directly proportional to the concentration of ebastine; the fluorescence quenching was measured at 553 nm after excitation at 457 nm. This method was extended to (Method IIB to apply first and second derivative synchronous spectrofluorimetric method (FDSFS & SDSFS for the simultaneous analysis of EBS in presence of its alkaline, acidic, and UV degradation products. The proposed methods were successfully applied for the determination of the studied compound in its dosage forms. The results obtained were in good agreement with those obtained by a comparison method. Both methods were utilized to investigate the kinetics of the degradation of the drug.

  14. A validated stability-indicating HPLC method for the simultaneous determination of pheniramine maleate and naphazoline hydrochloride in pharmaceutical formulations.

    Science.gov (United States)

    Huang, Taomin; Chen, Nianzu; Wang, Donglei; Lai, Yonghua; Cao, Zhijuan

    2014-02-01

    A simple, rapid, and accurate stability-indicating reverse phase liquid chromatographic method was developed and validated for the simultaneous determination of pheniramine maleate and naphazoline hydrochloride in bulk drugs and pharmaceutical formulations. Optimum chromatographic separations among pheniramine maleate, naphazoline hydrochloride and stress-induced degradation products have been achieved within 10 minutes by using an Agilent zorbax eclipse XDB C18 column (150 mm × 4.6 mm, 5 μm) as the stationary phase with a mobile phase consisted of 10 mM phosphate buffer pH 2.8 containing 0.5% triethlamine and methanol (68:32, v/v) at a flow rate of 1 mL min-1. Detection was performed at 280 nm using a diode array detector. Theoretical plates for pheniramine maleate and naphazoline hydrochloride were calculated to be 6762 and 6475, respectively. The method was validated in accordance with ICH guidelines with respect to linearity, accuracy, precision, robustness, specificity, limit of detection and quantitation. Regression analysis showed good correlations (R2 > 0.999) for pheniramine maleate in the concentration range of 150-1200 μg mL-1 and naphazoline hydrochloride in 12.5-100 μg mL-1. The method results in excellent separation of both the analytes and degradation products. The peak purity factor is ≥980 for both analytes after all types of stress, indicating complete separation of both analyte peaks from the stress induced degradation products. Overall, the proposed stability-indicating method was suitable for routine quality control and drug analysis of pheniramine maleate and naphazoline hydrochloride in pharmaceutical formulations.

  15. Establishment of inherent stability on piracetam by UPLC/HPLC and development of a validated stability-indicating method

    Directory of Open Access Journals (Sweden)

    Kapendra Sahu

    2017-02-01

    Full Text Available A novel comparative force degradation UPLC assay method was developed and validated for Piracetam and its degradation products. Piracetam was subjected to acid (5 M HCl, neutral (water and alkaline (0.5 M NaOH hydrolytic conditions at 80 °C, as well as to oxidative decomposition (H2O2 at room temperature. Photolytic studies were carried out by exposing this drug into sunlight (60,000–70,000 lux for 2 d. Additionally, the solid drug was subjected to 50 °C for 60 days in a hot air oven for thermal degradation. The UPLC chromatographic separation was performed on Acquity UPLC BEH C18 column (1.7 μm, 2.1 mm × 150 mm using isocratic mode (ACN:water, 25:75 v/v at a flow rate of 0.15 mL min−1 and HPLC chromatographic separation was achieved on phenomenex C18 using isocratic mode (ACN:10 mM ammonium acetate, pH 5.0, 20:80 v/v at a flow rate of 0.9 mL/min. Piracetam was found to degrade only in the base and shows stable behavior under all stress conditions. The UPLC and HPLC linearity of the proposed method was investigated in the range of 10–50 μg mL−1. The r2 value of UPLC and HPLC was found to be 0.999 and 0.999, respectively. Method detection limit (MDL and Method quantification limit (MQL were found to be 0.180 μg mL−1and 1.10 μg mL−1 for UPLC and 0.500 μg mL−1and 1.700 μg mL−1 for HPLC respectively. The %RSD values for intra-day and inter-day precision were <1.2%, confirming that the method was sufficiently precise. The validation studies were carried out fulfilling ICH requirements. The developed method was simple, fast, accurate and precise and hence could be applied for routine quality control analysis of Piracetam in solid dosage forms.

  16. Development and validation of a stability-indicating RP–HPLC method for estimation of atazanavir sulfate in bulk

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    S. Dey

    2017-04-01

    Full Text Available A stability-indicating reverse phase–high performance liquid chromatography (RP–HPLC method was developed and validated for the determination of atazanavir sulfate in tablet dosage forms using C18 column Phenomenix (250 mm×4.6 mm, 5 μm with a mobile phase consisting of 900 mL of HPLC grade methanol and 100 mL of water of HPLC grade. The pH was adjusted to 3.55 with acetic acid. The mobile phase was sonicated for 10 min and filtered through a 0.45 μm membrane filter at a flow rate of 0.5 mL/min. The detection was carried out at 249 nm and retention time of atazanavir sulfate was found to be 8.323 min. Linearity was observed from 10 to 90 μg/mL (coefficient of determination R2 was 0.999 with equation, y=23.427x+37.732. Atazanavir sulfate was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation, and the results showed that it was more sensitive towards acidic degradation. The method was validated as per ICH guidelines.

  17. Stability indicators in network reconstruction.

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    Michele Filosi

    Full Text Available The number of available algorithms to infer a biological network from a dataset of high-throughput measurements is overwhelming and keeps growing. However, evaluating their performance is unfeasible unless a 'gold standard' is available to measure how close the reconstructed network is to the ground truth. One measure of this is the stability of these predictions to data resampling approaches. We introduce NetSI, a family of Network Stability Indicators, to assess quantitatively the stability of a reconstructed network in terms of inference variability due to data subsampling. In order to evaluate network stability, the main NetSI methods use a global/local network metric in combination with a resampling (bootstrap or cross-validation procedure. In addition, we provide two normalized variability scores over data resampling to measure edge weight stability and node degree stability, and then introduce a stability ranking for edges and nodes. A complete implementation of the NetSI indicators, including the Hamming-Ipsen-Mikhailov (HIM network distance adopted in this paper is available with the R package nettools. We demonstrate the use of the NetSI family by measuring network stability on four datasets against alternative network reconstruction methods. First, the effect of sample size on stability of inferred networks is studied in a gold standard framework on yeast-like data from the Gene Net Weaver simulator. We also consider the impact of varying modularity on a set of structurally different networks (50 nodes, from 2 to 10 modules, and then of complex feature covariance structure, showing the different behaviours of standard reconstruction methods based on Pearson correlation, Maximum Information Coefficient (MIC and False Discovery Rate (FDR strategy. Finally, we demonstrate a strong combined effect of different reconstruction methods and phenotype subgroups on a hepatocellular carcinoma miRNA microarray dataset (240 subjects, and we

  18. Validated stability-indicating methods for the determination of zafirlukast in the presence of its alkaline hydrolysis degradation product

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    Amal M. Abou Al Alamein

    2012-12-01

    Full Text Available Three simple stability-indicating methods for the analysis of Zafirlukast (ZAF in the presence of its alkaline degradation products were developed and validated as per the International Conference on Harmonization (ICH guidelines to evaluate the stability-indicating power of the proposed methods. The developed high-performance liquid chromatographic technique was achieved on ZORBAX–ODS (5 μm, 150 × 4.6 mm, i.d. by isocratic elution with a mixture of acetonitrile/0.05 M phosphate buffer, pH 5.0, (50:50; v/v as a mobile phase at flow rate of 1.0 mL min−1, followed by UV detection at 240 nm. The method could determine ZAF in the range of 2–40 μg mL−1 with a mean percentage recovery of 99.73 ± 0.903. The proposed HPLC method was utilized to investigate the kinetics of alkaline degradation of ZAF. First derivative of the ratio spectra (1DD method was applied to analyze the drug under investigation without any interference from its degradation product with a linearity range of 4–32 μg mL−1 and with a mean percentage recovery of 99.85 ± 0.608. A chemometric method was also developed using the partial least squares (PLS model for selective determination of ZAF in the range of 4–40 μg mL−1, the mean percentage recovery was found to be 100.00 ± 0.336.

  19. Establishment of inherent stability of pramipexole and development of validated stability indicating LC–UV and LC–MS method

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    Shubhangi M. Pawar

    2013-04-01

    Full Text Available Pramipexole belongs to a class of nonergot dopamine agonist recently approved for the treatment of early and advanced Parkinson's disease. A validated specific stability indicating reversed-phase liquid chromatographic method has been developed for the quantitative determination of pramipexole in bulk as well as in pharmaceutical dosage forms in the presence of degradation products. Forced degradation studies were performed by exposition of drug to hydrolytic (acidic and basic, oxidative and photolytic stress conditions, as defined under ICH guideline Q1A (R2. Significant degradation was observed under hydrolytic, oxidative and photolytic conditions and the degradation products formed were identified by LC–MS. Keywords: Degradation products, Forced degradation/stress studies, Liquid chromatography mass spectrometry, Pramipexole, Reversed-phase liquid chromatography

  20. Kinetic Study of the Alkaline Degradation of Oseltamivir Phosphate and Valacyclovir Hydrochloride using Validated Stability Indicating HPLC

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    Ramzia I. Al-Bagary

    2014-01-01

    Full Text Available Aqueous alkaline degradation was performed for oseltamivir phosphate (OP and valacyclovir hydrochloride (VA. Isocratic stability indicating the use of high-performance liquid chromatography (HPLC was presented for each drug in the presence of its degradation product. The separations were performed using the Nucleosil ODS column and a mobile phase consisting of phosphate buffer (pH = 7, acetonitrile, and methanol 50:25:25 (v/v/v for OP. For VA separation, a Nucleosil CN column using phosphate buffer (pH = 7 and methanol 85:15 (v/v was used as a mobile phase. Ultraviolet detection at 210 nm and 254 nm was used for OP and VA, respectively. The method showed high sensitivity concerning linearity, accuracy, and precision over the range 1-250 μg mL −1 for both drugs. The proposed method was used to determine the drug in its pharmaceutical formulation and to investigate the degradation kinetics of each drug's alkaline-stressed samples. The reactions were found to follow a first-order reaction. The activation energy could also be estimated. International Conference on Harmonisation guidelines were adopted for method validation.

  1. Analytical Method Validation of High-Performance Liquid Chromatography and Stability-Indicating Study of Medroxyprogesterone Acetate Intravaginal Sponges

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    Nidal Batrawi

    2017-02-01

    Full Text Available Medroxyprogesterone acetate is widely used in veterinary medicine as intravaginal dosage for the synchronization of breeding cycle in ewes and goats. The main goal of this study was to develop reverse-phase high-performance liquid chromatography method for the quantification of medroxyprogesterone acetate in veterinary vaginal sponges. A single high-performance liquid chromatography/UV isocratic run was used for the analytical assay of the active ingredient medroxyprogesterone. The chromatographic system consisted of a reverse-phase C18 column as the stationary phase and a mixture of 60% acetonitrile and 40% potassium dihydrogen phosphate buffer as the mobile phase; the pH was adjusted to 5.6. The method was validated according to the International Council for Harmonisation (ICH guidelines. Forced degradation studies were also performed to evaluate the stability-indicating properties and specificity of the method. Medroxyprogesterone was eluted at 5.9 minutes. The linearity of the method was confirmed in the range of 0.0576 to 0.1134 mg/mL ( R 2 > 0.999. The limit of quantification was shown to be 3.9 µg/mL. Precision and accuracy ranges were found to be %RSD <0.2 and 98% to 102%, respectively. Medroxyprogesterone capacity factor value of 2.1, tailing factor value of 1.03, and resolution value of 3.9 were obtained in accordance with ICH guidelines. Based on the obtained results, a rapid, precise, accurate, sensitive, and cost-effective analysis procedure was proposed for quantitative determination of medroxyprogesterone in vaginal sponges. This analytical method is the only available method to analyse medroxyprogesterone in veterinary intravaginal dosage form.

  2. Development and Validation of Stability Indicating HPTLC and HPLC Methods for Simultaneous Determination of Telmisartan and Atorvastatin in Their Formulations

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    Kaliappan Ilango

    2013-01-01

    Full Text Available The present study describes development and subsequent validation of stability indicating HPLC and HPTLC methods for simultaneous estimation of Telmisartan (TLM and Atorvastatin (ATV in their combined formulation. The proposed RP-HPLC method utilizes a Phenomenex Luna C18 column using acetonitrile: 0.025 M ammonium acetate (38 : 52%, v/v as mobile phase (pH 3.8, flow rate of 1.0 mL/min. Quantification was achieved with UV detection at 281 nm over concentration range of 12 to 72 μg/mL for TLM and 3 to 18 μg/mL for ATV respectively. In HPTLC, separations were performed on silica gel 60 F254 using toluene-methanol-ethyl acetate-acetic acid (5 : 1 : 1 : 0.3, v/v as mobile phase. The compact bands of TLM and ATV at 0.37 ± 0.02 and 0.63 ± 0.01 respectively were scanned at 279 nm. Linear regression analysis revealed linearity in the range of 40 to 240 ng/band for TLM and 10 to 60 ng/band for ATV respectively. For both the methods, dosage form was exposed to thermal, photolytic, acid, alkali and oxidative stress. The methods distinctly separated the drugs and degradation products even in actual samples. In conclusion, the proposed HPLC and HPTLC methods were appropriate for routine quantification of TLM and ATV in tablet formulation.

  3. Development and validation of a stability-indicating LC method for the assay of lodenafil carbonate in tablets.

    Science.gov (United States)

    Codevilla, Cristiane Franco; Lemos, Alice Machado; Delgado, Leila Schreiner; Rolim, Clarice Madalena Bueno; Adams, Andréa Inês Horn; Bergold, Ana Maria

    2011-08-01

    A stability-indicating liquid chromatographic method has been developed for the quantitative determination of lodenafil carbonate in tablets. The method employs a Synergi Fusion C18 column (250 × 4.6 mm, i.d., 4 μm particle size), with mobile phase consisting of a mixture of methanol-acetic acid 0.1% pH 4.0 (65:35, v/v) and UV detection at 290 nm, using a photodiode array detector. A linear response (r = 0.9999) was observed in the range of 10-80 μg/mL. The method showed good recoveries (average 100.3%) and also intra and inter-day precision (RSD lodenafil carbonate peak. The method was found to be stability-indicating and due to its simplicity and accuracy can be applied for routine quality control analysis of lodenafil carbonate in tablets.

  4. Development and validation of a stability-indicating RP-HPLC method for determination of atomoxetine hydrochloride in tablets.

    Science.gov (United States)

    Patel, Sejal K; Patel, Natvarlal J

    2010-01-01

    This paper describes the development of a stability-indicating RP-HPLC method for the determination of atomoxetine hydrochloride (ATX) in the presence of its degradation products generated from forced decomposition studies. The drug substance was subjected to stress conditions of acid, base, oxidation, wet heat, dry heat, and photodegradation. In stability tests, the drug was susceptible to acid, base, oxidation, and dry and wet heat degradation. It was found to be stable under the photolytic conditions tested. The drug was successfully separated from the degradation products formed under stress conditions on a Phenomenex C18 column (250 x 4.6 mm id, 5 microm particle size) by using acetonitrile-methanol-0.032 M ammonium acetate (55 + 05 + 40, v/v/v) as the mobile phase at 1.0 mL/min and 40 degrees C. Photodiode array detection at 275 nm was used for quantitation after RP-HPLC over the concentration range of 0.5-5 microg/mL with a mean recovery of 100.8 +/- 0.4% for ATX. Statistical analysis demonstrated that the method is repeatable, specific, and accurate for the estimation of ATX. Because the method effectively separates the drug from its degradation products, it can be used as a stability-indicating method.

  5. Development and Validation of a Stability-Indicating RP-HPLC Method for Rapid Determination of Doxycycline in Pharmaceutical Bulk and Dosage Forms

    OpenAIRE

    Shabnam Pourmoslemi, Soroush Mirfakhraee, Saeid Yaripour, Ali Mohammadi

    2016-01-01

    Background: A rapid stability-indicating RP-HPLC method for analysis of doxycycline in the presence of its degradation products was developed and validated. Methods: Forced degradation studies were carried out on bulk samples and capsule dosage forms of doxycycline using acid, base, H2O2, heat, and UV light as described by ICH for stress conditions to demonstrate the stability-indicating power of the method. Separations were performed on a Perfectsil® Target ODS column (3-5µm, 125 mm×4 mm), u...

  6. A validated stability-indicating RP-HPLC method for paracetamol and lornoxicam: Application to pharmaceutical dosage forms

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    Karunakaran Kulandaivelu

    2014-01-01

    Full Text Available A new method for the simultaneous determination of paracetamol (PR and lornoxicam (LR has been developed by reversed phase HPLC from the combination drug product. The separation achieved on C18 column using acetonitrile and 0.02 M potassium dihydrogen phosphate was in the ratio of 35:65 (v/v as mobile phase at a flow rate of 1.0 mL/min. Both the components were monitored at a single wavelength at 260 nm and the column temperature was maintained at 30°C throughout the analysis. A linear response was found in the concentration range of 125-375 μg/mL for PR and 2-6 μg/mL for LR, with the correlation coefficient of more than 0.999. Although the tablet contained a high dose of PR (500 mg and a low dose of LR (8 mg, the single HPLC method was developed and the intra as well as inter day precision was obtained at less than 2% of RSD. The accuracy results obtained were between 98% and 102%. The drug was intentionally degraded under acidic, basic, peroxide, thermal, and photolytic conditions. The major degradation observed for both PR and LR under peroxide condition indicated that the drug product is susceptible to oxidation. The degraded peaks were properly resolved from PR and LR. Hence, the method is stability indicating.

  7. A validated stability-indicating RP-HPLC method for levofloxacin in the presence of degradation products, its process related impurities and identification of oxidative degradant.

    Science.gov (United States)

    Lalitha Devi, M; Chandrasekhar, K B

    2009-12-05

    The objective of current study was to develop a validated specific stability indicating reversed-phase liquid chromatographic method for the quantitative determination of levofloxacin as well as its related substances determination in bulk samples, pharmaceutical dosage forms in the presence of degradation products and its process related impurities. Forced degradation studies were performed on bulk sample of levofloxacin as per ICH prescribed stress conditions using acid, base, oxidative, water hydrolysis, thermal stress and photolytic degradation to show the stability indicating power of the method. Significant degradation was observed during oxidative stress and the degradation product formed was identified by LCMS/MS, slight degradation in acidic stress and no degradation was observed in other stress conditions. The chromatographic method was optimized using the samples generated from forced degradation studies and the impurity spiked solution. Good resolution between the peaks corresponds to process related impurities and degradation products from the analyte were achieved on ACE C18 column using the mobile phase consists a mixture of 0.5% (v/v) triethyl amine in sodium dihydrogen orthophosphate dihydrate (25 mM; pH 6.0) and methanol using a simple linear gradient. The detection was carried out at 294 nm. The limit of detection and the limit of quantitation for the levofloxacin and its process related impurities were established. The stressed test solutions were assayed against the qualified working standard of levofloxacin and the mass balance in each case was in between 99.4 and 99.8% indicating that the developed LC method was stability indicating. Validation of the developed LC method was carried out as per ICH requirements. The developed LC method was found to be suitable to check the quality of bulk samples of levofloxacin at the time of batch release and also during its stability studies (long term and accelerated stability).

  8. Development and Validation of a Precise and Stability Indicating LC Method for the Determination of Benzalkonium Chloride in Pharmaceutical Formulation Using an Experimental Design

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    Harshal K. Trivedi

    2010-01-01

    Full Text Available A simple, precise, shorter runtime and stability indicating reverse-phase high performance liquid chromatographic method has been developed and validated for the quantification of benzalkonium chloride (BKC preservative in pharmaceutical formulation of sparfloxacin eye drop. The method was successfully applied for determination of benzalkonium chloride in various ophthalmic formulations like latanoprost, timolol, dexametasone, gatifloxacin, norfloxacin, combination of moxifloxacin and dexamethasone, combination of nepthazoline HCl, zinc sulphate and chlorpheniramine maleate, combination of tobaramycin and dexamethasone, combination of phenylephrine HCl, naphazoline HCl, menthol and camphor. The RP-LC separation was achieved on an Purospher Star RP-18e 75 mm × 4.0 mm, 3.0 μ in the isocratic mode using buffer: acetonitrile (35: 65, v/v, as the mobile phase at a flow rate of 1.8 mL/min. The methods were performed at 215 nm; in LC method, quantification was achieved with PDA detection over the concentration range of 50 to 150 μg/mL. The method is effective to separate four homologs with good resolution in presence of excipients, sparfloxacin and degradable compound due to sparfloxacin and BKC within five minutes. The method was validated and the results were compared statistically. They were found to be simple, accurate, precise and specific. The proposed method was validated in terms of specificity, precision, recovery, solution stability, linearity and range. All the validation parameters were within the acceptance range and concordant to ICH guidelines.

  9. Development and Validation of a Stability-Indicating RP-HPLC Method for Rapid Determination of Doxycycline in Pharmaceutical Bulk and Dosage Forms

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    Shabnam Pourmoslemi, Soroush Mirfakhraee, Saeid Yaripour, Ali Mohammadi

    2016-06-01

    Full Text Available Background: A rapid stability-indicating RP-HPLC method for analysis of doxycycline in the presence of its degradation products was developed and validated. Methods: Forced degradation studies were carried out on bulk samples and capsule dosage forms of doxycycline using acid, base, H2O2, heat, and UV light as described by ICH for stress conditions to demonstrate the stability-indicating power of the method. Separations were performed on a Perfectsil® Target ODS column (3-5µm, 125 mm×4 mm, using a mobile phase consisting of methanol-50 mM ammonium acetate buffer (containing 0.1% v/v trifluoroacetic acid and 0.1% v/v triethylamine, pH 2.5 (50:50 v/v at room temperature. The flow rate was 0.8 mL/min. Results: The method linearity was investigated in the range of 25–500 µg/mL (r > 0.9999. The LOD and LOQ were 5 and 25 µg/mL, respectively. The method selectivity was evaluated by peak purity test using a diode array detector. There was no interference among detection of doxycycline and its stressed degradation products. Total peak purity numbers were in the range of 0.94-0.99, indicating the homogeneity of DOX peaks. Conclusion: These data show the stability-indicating nature of the method for quality control of doxycycline in bulk samples and capsule dosage forms.

  10. A Stability-Indicating HPLC-DAD Method for Determination of Stiripentol: Development, Validation, Kinetics, Structure Elucidation and Application to Commercial Dosage Form

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    Hany W. Darwish

    2014-01-01

    Full Text Available A rapid, simple, sensitive, and accurate isocratic reversed-phase stability-indicating high performance liquid chromatography method has been developed and validated for the determination of stiripentol and its degradation product in its bulk form and pharmaceutical dosage form. Chromatographic separation was achieved on a Symmetry C18 column and quantification was achieved using photodiode array detector (DAD. The method was validated in accordance with the ICH requirements showing specificity, linearity (r2=0.9996, range of 1–25 μg/mL, precision (relative standard deviation lower than 2%, accuracy (mean recovery 100.08±1.73, limits of detection and quantitation (LOD = 0.024 and LOQ = 0.081 μg/mL, and robustness. Stiripentol was subjected to various stress conditions and it has shown marked stability under alkaline hydrolytic stress conditions, thermal, oxidative, and photolytic conditions. Stiripentol degraded only under acidic conditions, forming a single degradation product which was well resolved from the pure drug with significantly different retention time values. This degradation product was characterized by 1H-NMR and 13C-NMR spectroscopy as well as ion trap mass spectrometry. The results demonstrated that the method would have a great value when applied in quality control and stability studies for stiripentol.

  11. Validation of a stability-indicating hydrophilic interaction liquid chromatographic method for the quantitative determination of vitamin k3 (menadione sodium bisulfite) in injectable solution formulation.

    Science.gov (United States)

    Ghanem, Mashhour M; Abu-Lafi, Saleh A; Hallak, Hussein O

    2013-01-01

    A simple, specific, accurate, and stability-indicating method was developed and validated for the quantitative determination of menadione sodium bisulfite in the injectable solution formulation. The method is based on zwitterionic hydrophilic interaction liquid chromatography (ZIC-HILIC) coupled with a photodiode array detector. The desired separation was achieved on the ZIC-HILIC column (250 mm × 4.6 mm, 5 μm) at 25°C temperature. The optimized mobile phase consisted of an isocratic solvent mixture of 200mM ammonium acetate (NH4AC) solution and acetonitrile (ACN) (20:80; v/v) pH-adjusted to 5.7 by glacial acetic acid. The mobile phase was fixed at 0.5 ml/min and the analytes were monitored at 261 nm using a photodiode array detector. The effects of the chromatographic conditions on the peak retention, peak USP tailing factor, and column efficiency were systematically optimized. Forced degradation experiments were carried out by exposing menadione sodium bisulfite standard and the injectable solution formulation to thermal, photolytic, oxidative, and acid-base hydrolytic stress conditions. The degradation products were well-resolved from the main peak and the excipients, thus proving that the method is a reliable, stability-indicating tool. The method was validated as per ICH and USP guidelines (USP34/NF29) and found to be adequate for the routine quantitative estimation of menadione sodium bisulfite in commercially available menadione sodium bisulfite injectable solution dosage forms.

  12. Nifedipine-loaded polymeric nanocapsules: validation of a stability-indicating HPLC method to evaluate the drug entrapment efficiency and in vitro release profiles.

    Science.gov (United States)

    Granada, Andréa; Tagliari, Monika Piazzon; Soldi, Valdir; Silva, Marcos António Segatto; Zanetti-Ramos, Betina Ghiel; Fernandes, Daniel; Stulzer, Hellen Karine

    2013-01-01

    A simple stability-indicating analytical method was developed and validated to quantify nifedipine in polymeric nanocapsule suspensions; an in vitro drug release study was then carried out. The analysis was performed using an RP C18 column, UV-Vis detection at 262 nm, and methanol-water (70 + 30, v/v) mobile phase at a flow rate of 1.2 mL/min. The method was validated in terms of specificity, linearity and range, LOQ, accuracy, precision, and robustness. The results obtained were within the acceptable ranges. The nanocapsules, made of poly(epsilon-caprolactone), were prepared by the solvent displacement technique and showed high entrapment efficiency. The entrapment efficiency was 97.6 and 98.2% for the nifedipine-loaded polymeric nanocapsules prepared from polyvinyl alcohol (PVA) and Pluronic F68 (PF68), respectively. The particle size and zeta potential of nanocapsules were found to be influenced by the nature of the stabilizer used. The mean diameter and zeta potential for nanocapsules with PVA and PF68 were 290.9 and 179.9 nm, and -17.7 mV and -32.7 mV, respectively. The two formulations prepared showed a drug release of up to 70% over 4 days. This behavior indicates the viability of this drug delivery system for use as a controlled-release system.

  13. Development and validation of a stability-indicating capillary zone electrophoretic method for the assessment of entecavir and its correlation with liquid chromatographic methods.

    Science.gov (United States)

    Dalmora, Sergio Luiz; Nogueira, Daniele Rubert; D'Avila, Felipe Bianchini; Souto, Ricardo Bizogne; Leal, Diogo Paim

    2011-01-01

    A stability-indicating capillary zone electrophoresis (CZE) method was validated for the analysis of entecavir in pharmaceutical formulations, using nimesulide as an internal standard. A fused-silica capillary (50 µm i.d.; effective length, 40 cm) was used while being maintained at 25°C; the applied voltage was 25 kV. A background electrolyte solution consisted of a 20 mM sodium tetraborate solution at pH 10. Injections were performed using a pressure mode at 50 mbar for 5 s, with detection at 216 nm. The specificity and stability-indicating capability were proven through forced degradation studies, evaluating also the in vitro cytotoxicity test of the degraded products. The method was linear over the concentration range of 1-200 µg mL(-1) (r(2) = 0.9999), and was applied for the analysis of entecavir in tablet dosage forms. The results were correlated to those of validated conventional and fast LC methods, showing non-significant differences (p > 0.05).

  14. A validated stability-indicating LC method for the separation of enantiomer and potential impurities of Linezolid using polar organic mode

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    T. Satyanarayana Raju

    2012-08-01

    Full Text Available Although a number of methods are available for evaluating Linezolid and its possible impurities, a common method for separation if its potential impurities, degradants and enantiomer in a single method with good efficiency remain unavailable. With the objective of developing an advanced method with shorter runtimes, a simple, precise, accurate stability-indicating LC method was developed for the determination of purity of Linezolid drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its impurities and degradation products. This method is capable of separating all the related substances of Linezolid along with the chiral impurity. This method can also be used for the estimation of assay of Linezolid in drug substance as well as in drug product. The method was developed using Chiralpak IA (250 mm×4.6 mm, 5 μm column. A mixture of acetonitrile, ethanol, n-butyl amine and trifluoro acetic acid in 96:4:0.10:0.16 (v/v/v/v ratio was used as a mobile phase. The eluted compounds were monitored at 254 nm. Linezolid was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and system suitability. Keywords: HPLC, Linezolid, Validation, Polar organic mode, Stability-indicating

  15. Stability indicating method development and validation of assay method for the estimation of rizatriptan benzoate in tablet

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    Chandrashekhar K. Gadewar

    2017-05-01

    Full Text Available A simple, sensitive, precise and specific high performance liquid chromatography method was developed and validated for the determination of rizatriptan in rizatriptan benzoate tablet. The separation was carried out by using a mobile phase consisting of acetonitrile: pH 3.4 phosphate buffer in ratio of 20:80. The column used was Zorbax SB CN 250 mm × 4.6 mm, 5 μ with a flow rate of 1 ml/min using UV detection at 225 nm. The retention time of rizatriptan and benzoic acid was found to be 4.751 and 8.348 min respectively. A forced degradation study of rizatriptan benzoate in its tablet form was conducted under the condition of hydrolysis, oxidation, thermal and photolysis. Rizatriptan was found to be stable in basic buffer while in acidic buffer was found to be degraded (water bath at 60 °C for 15 min. The detector response of rizatriptan is directly proportional to concentration ranging from 30% to 160% of test concentration i.e. 15.032 to 80.172 mcg/ml. Results of analysis were validated statistically and by recovery studies (mean recovery = 99.44. The result of the study showed that the proposed method is simple, rapid, precise and accurate, which is useful for the routine determination of rizatriptan in pharmaceutical dosage forms.

  16. Development and validation of stability indicating method for the quantitative determination of venlafaxine hydrochloride in extended release formulation using high performance liquid chromatography

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    Jaspreet Kaur

    2010-01-01

    Full Text Available Objective : Venlafaxine,hydrochloride is a structurally novel phenethyl bicyclic antidepressant, and is usually categorized as a serotonin-norepinephrine reuptake inhibitor (SNRI but it has been referred to as a serotonin-norepinephrine-dopamine reuptake inhibitor. It inhibits the reuptake of dopamine. Venlafaxine HCL is widely prescribed in the form of sustained release formulations. In the current article we are reporting the development and validation of a fast and simple stability indicating, isocratic high performance liquid chromatographic (HPLC method for the determination of venlafaxine hydrochloride in sustained release formulations. Materials and Methods : The quantitative determination of venlafaxine hydrochloride was performed on a Kromasil C18 analytical column (250 x 4.6 mm i.d., 5 μm particle size with 0.01 M phosphate buffer (pH 4.5: methanol (40: 60 as a mobile phase, at a flow rate of 1.0 ml/min. For HPLC methods, UV detection was made at 225 nm. Results : During method validation, parameters such as precision, linearity, accuracy, stability, limit of quantification and detection and specificity were evaluated, which remained within acceptable limits. Conclusions : The method has been successfully applied for the quantification and dissolution profiling of Venlafaxine HCL in sustained release formulation. The method presents a simple and reliable solution for the routine quantitative analysis of Venlafaxine HCL.

  17. A Validated Stability-indicating Reverse Phase HPLC Assay Method for the Determination of Memantine Hydrochloride Drug Substance with UV-Detection Using Precolumn Derivatization Technique

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    Bhavil Narola

    2010-01-01

    Full Text Available This present paper deals with the development and validation of a stability indicating high performance liquid chromatographic method for the quantitative determination of Memantine hydrochloride. Memantine hydrochloride was derivatized with 0.015 M 9-fluorenylmethyl chloroformate (FMOC and 0.5 M borate buffer solution by keeping it at room temperature for about 20 minutes and the chromatographic separation achieved by injecting 10 μL of the derivatized mixture into a Waters HPLC system with photodiode array detector using a kromasil C18 column (150 × 4.6 mm, 5 μ, The mobile phase consisting of 80% acetonitrile and 20% phosphate buffer solution and a flow rate of 2 milliliter/minute. The Memantine was eluted at approximately 7.5 minutes. The volume of FMOC used in derivatization, concentration of FMOC and derivatization time was optimized and used. Forced degradation studies were performed on bulk sample of Memantine hydrochloride using acid (5.0 Normal (N hydrochloric acid, base (1.0 N sodium hydroxide, oxidation (30% hydrogen peroxide, thermal (105 ° C, photolytic and humidity conditions. The developed LC method was validated with respect to specificity, precision (% RSD about 0.70%, linearity (linearity of range about 70-130 μg/mL, ruggedness (Overall % RSD about 0.35%, stability in analytical solution (Cumulative % RSD about 0.11% after 1450 min. and robustness.

  18. A Stability-Indicating HPLC-DAD Method for Determination of Ferulic Acid into Microparticles: Development, Validation, Forced Degradation, and Encapsulation Efficiency

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    Jessica Mendes Nadal

    2015-01-01

    Full Text Available A simple stability-indicating HPLC-DAD method was validated for the determination of ferulic acid (FA in polymeric microparticles. Chromatographic conditions consisted of a RP C18 column (250 mm × 4.60 mm, 5 μm, 110 Å using a mixture of methanol and water pH 3.0 (48 : 52 v/v as mobile phase at a flow rate of 1.0 mL/min with UV detection at 320 nm. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of quantification, limit of detection, accuracy, precision, and robustness provided suitable results regarding all parameters investigated. The calibration curve was linear in the concentration range of 10.0–70.0 μg/mL with a correlation coefficient >0.999. Precision (intraday and interday was demonstrated by a relative standard deviation lower than 2.0%. Accuracy was assessed by the recovery test of FA from polymeric microparticles (99.02% to 100.73%. Specificity showed no interference from the components of polymeric microparticles or from the degradation products derived from acidic, basic, and photolytic conditions. In conclusion, the method is suitable to be applied to assay FA as bulk drug and into polymeric microparticles and can be used for studying its stability and degradation kinetics.

  19. A Validated Stability-indicating Reverse Phase HPLC Assay Method for the Determination of Memantine Hydrochloride Drug Substance with UV-Detection Using Precolumn Derivatization Technique

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    Bhavil Narola

    2010-07-01

    Full Text Available This present paper deals with the development and validation of a stability indicating high performance liquid chromatographic method for the quantitative determination of Memantine hydrochloride. Memantine hydrochloride was derivatized with 0.015 M 9-fluorenylmethyl chloroformate (FMOC and 0.5 M borate buffer solution by keeping it at room temperature for about 20 minutes and the chromatographic separation achieved by injecting 10 µL of the derivatized mixture into a Waters HPLC system with photodiode array detector using a kromasil C18 column (150 × 4.6 mm, 5 µ. The mobile phase consisting of 80% acetonitrile and 20% phosphate buffer solution and a flow rate of 2 milliliter/minute. The Memantine was eluted at approximately 7.5 minutes. The volume of FMOC used in derivatization, concentration of FMOC and derivatization time was optimized and used. Forced degradation studies were performed on bulk sample of Memantine hydrochloride using acid (5.0 Normal (N hydrochloric acid, base (1.0 N sodium hydroxide, oxidation (30% hydrogen peroxide, thermal (105°C, photolytic and humidity conditions. The developed LC method was validated with respect to specificity, precision (% RSD about 0.70%, linearity (linearity of range about 70–130 µg/mL, ruggedness (Overall % RSD about 0.35%, stability in analytical solution (Cumulative % RSD about 0.11% after 1450 min. and robustness.

  20. Development, validation and comparison of two stability-indicating RP-LC methods using charged aerosol and UV detectors for analysis of lisdexamfetamine dimesylate in capsules

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    Graciela Carlos

    2016-11-01

    Full Text Available Two new stability-indicating liquid chromatographic methods using two detectors, an ultraviolet (UV and a charged aerosol detector (CAD simultaneously connected in series were validated for the assessment of lisdexamfetamine dimesylate (LDX in capsule. The method was optimized and the influence of individual parameters on UV and CAD response and sensitivity was studied. Chromatography was performed on a Zorbax CN column (250 mm × 4.6 mm, 5 μm in an isocratic elution mode, using acetonitrile and 20 mM ammonium formate at pH 4.0 (50:50, v/v as mobile phase and UV detection at 207 nm. The developed method was validated according to ICH guidelines and the parameters’ specificity, limit of detection, limit of quantitation, linearity, accuracy, precision and robustness were evaluated. CAD is designated to be a non-linear detector in a wide dynamic range, however, the method was linear over the concentration range of 70–130 μg mL−1 in both detectors. The method was precise and accurate. Robustness study was performed by a Plackett–Burman design, delivering results within the acceptable range. Neither the excipients nor the degradation products showed interference in the method after studies of specificity as well as under stress conditions. The results of the LC-UV and LC-CAD methods were statistically compared through ANOVA and showed no significant difference (p > 0.05. Both proposed methods could be considered interchangeable and stability-indicating, and can be applied as an appropriate quality control tool for routine analysis of LDX in capsule.

  1. Development and validation of a stability-indicating RP-HPLC method for assay of betamethasone and estimation of its related compounds.

    Science.gov (United States)

    Fu, Qiang; Shou, Minshan; Chien, Dwight; Markovich, Robert; Rustum, Abu M

    2010-02-05

    Betamethasone (9alpha-fluoro-16beta-methylprednisolone) is one of the members of the corticosteriod family of active pharmaceutical ingredient (API), which is widely used as an anti-inflammatory agent and also as a starting material to manufacture various esters of betamethasone. A stability-indicating reverse-phase high performance liquid chromatography (RP-HPLC) method has been developed and validated which can separate and accurately quantitate low levels of 26 betamethasone related compounds. The stability-indicating capability of the method was demonstrated through adequate separation of all potential betamethasone related compounds from betamethasone and also from each other that are present in aged and stress degraded betamethasone stability samples. Chromatographic separation of betamethasone and its related compounds was achieved by using a gradient elution at a flow rate of 1.0mL/min on a ACE 3 C18 column (150mmx4.6mm, 3microm particle size, 100A pore size) at 40 degrees C. Mobile phase A of the gradient was 0.1% methanesulfonic acid in aqueous solution and mobile phase B was a mixture of tert-butanol and 1,4-dioxane (7:93, v/v). UV detection at 254nm was employed to monitor the analytes. For betamethasone 21-aldehyde, the QL and DL were 0.02% and 0.01% respectively. For betamethasone and the rest of the betamethasone related compounds, the QL and DL were 0.05% and 0.02%. The precision of betamethasone assay is 0.6% and the accuracy of betamethasone assay ranged from 98.1% to 99.9%.

  2. Development and Validation of a Stability-Indicating HPLC Method for the Simultaneous Determination of Florfenicol and Flunixin Meglumine Combination in an Injectable Solution

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    Nidal Batrawi

    2017-01-01

    Full Text Available The combination of the powerful antimicrobial agent florfenicol and the nonsteroidal anti-inflammatory flunixin meglumine is used for the treatment of bovine respiratory disease (BRD and control of BRD-associated pyrexia, in beef and nonlactating dairy cattle. This study describes the development and validation of an HPLC-UV method for the simultaneous determination of florfenicol and flunixin, in an injectable preparation with a mixture of excipients. The proposed RP-HPLC method was developed by a reversed phase- (RP- C18e (250 mm × 4.6 mm, 5 μm column at room temperature, with an isocratic mobile phase of acetonitrile and water mixture, and pH was adjusted to 2.8 using diluted phosphoric acid, a flow rate of 1.0 mL/min, and ultraviolet detection at 268 nm. The stability-indicating method was developed by exposing the drugs to stress conditions of acid and base hydrolysis, oxidation, photodegradation, and thermal degradation; the obtained degraded products were successfully separated from the APIs. This method was validated in accordance with FDA and ICH guidelines and showed excellent linearity, accuracy, precision, specificity, robustness, LOD, LOQ, and system suitability results within the acceptance criteria.

  3. A Validated Stability Indicating RP-HPLC Method for the Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Pharmaceutical Dosage Form

    Science.gov (United States)

    Runja, Chinnalalaiah; Ravi Kumar, Pigili; Avanapu, Srinivasa Rao

    2016-01-01

    A new simple, rapid stability indicating assay method has been developed and validated for the determination of emtricitabine, tenofovir disoproxil fumarate, elvitegravir and cobicistat using reverse-phase high-performance liquid chromatography in their pharmaceutical dosage form. The chromatographic separation was performed on an ODS column (250 × 4.6 mm, 5 µm) using mobile phase A (potassium dihydrogen orthophosphate, pH adjusted to 2.5) and mobile phase B (acetonitrile) in the ratio of 55:45% v/v at a flow rate of 1 mL/min. The analytes were detected at 250 nm. The method was found to be linear in the concentration range of 2–12 µg/mL for EMT, 3–18 µg/mL for TNDF, 1.5–9 µg/mL for ELV and COB, with the coefficient value (R2) of >0.9990. The accuracy was measured via recovery studies and found to be acceptable, and the percentage recoveries were found in the range of 99.93–100.08 ± 0.5%. Forced degradation studies were also conducted, and the drugs were subjected to various stress conditions such as acid hydrolysis, base hydrolysis, oxidative, photolytic and thermal degradation. The proposed method was successfully validated and applied for the quantitative estimation of these drugs in both bulk and tablet dosage forms. PMID:26865655

  4. ESI-MSn and LC-ESI-MS studies to characterize forced degradation products of bosentan and a validated stability-indicating LC-UV method.

    Science.gov (United States)

    Bansal, Gulshan; Singh, Ranjit; Saini, Balraj; Bansal, Yogita

    2013-01-01

    The present study reports the characterization of forced degradation products of bosentan and a validated stability-indicating HPLC method for the stability testing of bosentan tablets. The forced degradation was carried out under the conditions of hydrolysis, oxidation, dry heat and photolysis. The drug was found unstable in acid, alkali and oxidative media whereas stable to the hydrolysis in water, to dry heat and to photolysis. In total, six degradation products were formed in all conditions which were resolved in a single run on a C-18 column with gradient elution using ammonium acetate buffer (pH 4.5, 5.0mM), methanol and acetonitrile. Structures of all the degradation products were characterized through +ESI-MS(n) and LC-ESI-MS spectral data of bosentan as well as LC-ESI-MS spectral data of the products. The products II-VI were characterized as 6-amino-[2,2']bipyrimidinyl-4,5-diol, 6-amino-5-(2-methoxyphenoxy)-[2,2']-bipyrimidinyl-4-ol, 2-[6-amino-5-(2-methoxyphenoxy)-[2,2']-bipyrimidinyl-4-yloxy]-ethanol, 4-tert-butyl-N-[6-(1-methoxyethoxy)-5-(2-methoxyphenoxy)-[2,2']-bipyrimidinyl-4-yl]-benzenesulfonamide and 4-tert-butyl-N-[6-hydroxy-5-(2-methoxyphenoxy)-[2,2']bipyrimidinyl-4-yl]-benzenesulfonamide, respectively. The peak of the product I was found to be due to two secondary degradation products which co-eluted and were characterized as β-hydroxyethyl p-tert-butylphenylsulfonate (Ia) and 2-[2-(2-hydroxyethoxy)-phenoxy]-ethanol (Ib). These products were formed due to hydrolysis of sulfonamide and alkylaryl ether and the diaryl ether linkages as well as dehydration of the primary alcohol group. The most probable degradation mechanisms were proposed. The HPLC method was found to be stability-indicating, linear (2-100 μg ml(-1)), accurate, precise, sensitive, specific, rugged and robust for quantitation of the drug. The method was applied to the stability testing of the commercially available bosentan tablets successfully. Copyright © 2012 Elsevier B.V. All

  5. Stability indicating RP-HPLC method development and validation for the simultaneous determination of aminexil and minoxidil in pharmaceutical dosage form.

    Science.gov (United States)

    Siddiraju, S; Sahithi, M

    2015-03-01

    The objective of the present work is to develop stability indicating high-performance liquid chromatographic method for the simultaneous determination of aminexil and minoxidil in pharmaceutical dosage form. The chromatographic separation was achieved with BDS Hypersil C18 column (250 mm×4.6 mm×5 μ) as stationary phase and phosphate buffer and acetonitrile (78:22) as mobile phase. The method was employed by using a flow rate of 1.1 mL/min kept at 30°C. The detection wavelength was kept at 238 nm by using photo-diode array detector. The retention times of the aminexil and minoxidil were found to be 2.3 min and 3.9 min, respectively. The method developed was validated in accordance with ICH guidelines with respect to the stability indicating capacity of the method including system suitability, accuracy, precision, linearity, range, limit of detection, limit of quantification and robustness. The linearity responses of aminexil and minoxidil were found to be in the concentration ranges of 18.75-112.5 μg/mL and 25-150 μg/mL, respectively. The LOD and LOQ values for aminexil were found to be 0.31 and 0.92 μg/mL and minoxidil were found to be 0.03 and 0.10 μg/mL respectively. The percentage recoveries for both the drugs were found in the range of 98-101%. This method is accurate, precise and sensitive; hence, it can be employed for routine quality control of aminexil and minoxidil in pharmaceutical industries and drug testing laboratories. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  6. A novel validated stability indicating high performance liquid chromatographic method for estimation of degradation behavior of ciprofloxacin and tinidazole in solid oral dosage

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    Bhupendrasinh K Vaghela

    2013-01-01

    Full Text Available Objective: The objective of current investigation was to study the degradation behavior of Ciprofloxacin and Tinidazole. The study was performed as per International Conference on Harmonization recommended stress condition. A novel stability-indicating reverse phase HPLC method was developed for the determination of Ciprofloxacin and Tinidazole purity in the presence of its impurities and forced degradation products. This method is also capable to separate placebo peaks as well in pharmaceutical dosage forms. The solid oral dosage form was subjected to the stress conditions such as oxidative, acid, base hydrolysis, heat and photolytic degradation. Materials and Methods: The method was developed using Waters symmetry shield, Reverse Phase (RP C18, 250mm x 4.6mm, 5΅ as a stationary phase. The mobile phase containing a gradient mixture of solvent A and B. 10mM phosphate buffer, adjusted pH 3.0 with phosphoric acid was used as a buffer. Buffer pH 3.0 was used as solvent A and buffer pH 3.0: Acetonitrile in the ratio of 20: 80 v/v were used as solvent B. The eluted compounds were monitored 278 nm (Ciprofloxacin, 317 nm (Tinidazole. The run time was 50 minute. Results: In the precision study the % RSD for the result of Ciprofloxacin, Tinidazole and its impurities was below 10%. The method was linear with the correlation coefficient greater than 0.997. The percentage recoveries were calculated and observed from 93.0% to 106.7%.The peak purity of Ciprofloxacin, Tinidazole peak had not shown any flag, thus proved the stability-indicating power of the method. Conclusion: The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness.

  7. A validated stability-indicating LC method for the separation of enantiomer and potential impurities of Linezolid using polar organic mode.

    Science.gov (United States)

    Satyanarayana Raju, T; Vishweshwari Kutty, O; Ganesh, V; Yadagiri Swamy, P

    2012-08-01

    Although a number of methods are available for evaluating Linezolid and its possible impurities, a common method for separation if its potential impurities, degradants and enantiomer in a single method with good efficiency remain unavailable. With the objective of developing an advanced method with shorter runtimes, a simple, precise, accurate stability-indicating LC method was developed for the determination of purity of Linezolid drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its impurities and degradation products. This method is capable of separating all the related substances of Linezolid along with the chiral impurity. This method can also be used for the estimation of assay of Linezolid in drug substance as well as in drug product. The method was developed using Chiralpak IA (250 mm×4.6 mm, 5 μm) column. A mixture of acetonitrile, ethanol, n-butyl amine and trifluoro acetic acid in 96:4:0.10:0.16 (v/v/v/v) ratio was used as a mobile phase. The eluted compounds were monitored at 254 nm. Linezolid was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and system suitability.

  8. Development and validation of a stability-indicating HPLC-UV method for the determination of triamcinolone acetonide and its degradation products in an ointment formulation

    NARCIS (Netherlands)

    van Heugten, A J P; Boer, W.; de Vries, W S; Markesteijn, C M A; Vromans, H

    2018-01-01

    A stability indicating high performance liquid chromatography method has been developed for the determination of triamcinolone acetonide (TCA) and its main degradation products in ointment formulations. The method, based on extensive stress testing using metal salts, azobisisobutyronitrile, acid,

  9. QbD-Based Development and Validation of a Stability-Indicating HPLC Method for Estimating Ketoprofen in Bulk Drug and Proniosomal Vesicular System.

    Science.gov (United States)

    Yadav, Nand K; Raghuvanshi, Ashish; Sharma, Gajanand; Beg, Sarwar; Katare, Om P; Nanda, Sanju

    2016-03-01

    The current studies entail systematic quality by design (QbD)-based development of simple, precise, cost-effective and stability-indicating high-performance liquid chromatography method for estimation of ketoprofen. Analytical target profile was defined and critical analytical attributes (CAAs) were selected. Chromatographic separation was accomplished with an isocratic, reversed-phase chromatography using C-18 column, pH 6.8, phosphate buffer-methanol (50 : 50v/v) as a mobile phase at a flow rate of 1.0 mL/min and UV detection at 258 nm. Systematic optimization of chromatographic method was performed using central composite design by evaluating theoretical plates and peak tailing as the CAAs. The method was validated as per International Conference on Harmonization guidelines with parameters such as high sensitivity, specificity of the method with linearity ranging between 0.05 and 250 µg/mL, detection limit of 0.025 µg/mL and quantification limit of 0.05 µg/mL. Precision was demonstrated using relative standard deviation of 1.21%. Stress degradation studies performed using acid, base, peroxide, thermal and photolytic methods helped in identifying the degradation products in the proniosome delivery systems. The results successfully demonstrated the utility of QbD for optimizing the chromatographic conditions for developing highly sensitive liquid chromatographic method for ketoprofen. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  10. RP-HPLC Method Development and Validation for the Determination and Stability Indicative Studies of Montelukast in Bulk and its Pharmaceutical Formulations

    Directory of Open Access Journals (Sweden)

    A. Patnaik

    2012-01-01

    Full Text Available A simple, precise, accurate, economical and reproducible HPLC method for estimation of montelukast in tablet dosage form has been developed. Quantitative HPLC was performed with Shimadzu LC2010c HT with Winchrom Software with UV-Visible detector (SPD-IOA, PUMP (LC-IOAT and (LC-IOATvp. Phenomenex C8, 5 μm, 25 cm × 4.6 mm i.d. column was used in the study. The mobile phase of ACN: Acetate buffer= 6.5:3.5 of pH 3 were used in this study. The conditions optimized were: flow rate (1 mL/minute, wavelength (222 nm and run time was 20 min. Retention time was found to be 3.08 min. The linearity was found to be in the concentration range of 10-100 μg/mL. The developed method was evaluated in the assay of commercially available tablet moni containing 10 mg of montelukast. The amount of drug in tablet was found to be 10.34 mg/tab for the brand. Results of analysis were validated statistically and by recovery studies. The recovery studies 99.67% was indicative of the accuracy of proposed method. The precision was calculated as repeatability, inter and intraday variation (%RSD for the drug. By using the method, stability of the drug has been studied.

  11. Simultaneous determination of some water-soluble vitamins and preservatives in multivitamin syrup by validated stability-indicating high-performance liquid chromatography method.

    Science.gov (United States)

    Vidović, Stojanka; Stojanović, Biljana; Veljković, Jelena; Prazić-Arsić, Ljiljana; Roglić, Goran; Manojlović, Dragan

    2008-08-22

    HPLC stability-indicating method has been developed for the simultaneous determination of some water-soluble vitamins (ascorbic acid, thiamine hydrochloride, riboflavin-5'-phosphate sodium, pyridoxine hydrochloride, nicotinamide, D(+)-panthenol) and two preservatives (methylparaben and sodium benzoate) in multivitamin syrup preparation. Water-soluble vitamins, preservatives and their degradants were separated on Zorbax SB-Aq (C(18)) (250 mm x 4.6 mm, 5 microm) column at an ambient temperature. Combined isocratic and gradient elution was performed with a mobile phase consisting of 0.0125 M hexane-1-sulfonic acid sodium salt in 0.1% (m/v) o-phosphoric acid, pH 2.4-2.5 (solvent A) and acetonitrile (solvent B) at the flow-rate 1 ml min(-1). Starting with solvent A an isocratic elution was performed for 15 min, then the composition was changed to 85% of A and 15% of B during the next 20 min and it was constant for 5 min, then the composition was changed to 70% of A and 30% of B during next 15 min and it was constant for 5 min and finally was changed to 100% of A as at the beginning of the elution. Detection was performed with diode array detector at 210, 230 and 254 nm. Multivitamin syrup preparation was subjected to stress testing (forced degradation) in order to demonstrate that degradants from the vitamins, preservatives and/or product excipients do not interfere with the quantification of vitamins and preservatives. Typical validation characteristics: selectivity, accuracy, precision, linearity, range, limit of quantification and limit of detection were evaluated for vitamins and preservatives.

  12. Construct validity of the Groningen Frailty Indicator established in a large sample of home-dwelling elderly persons : Evidence of stability across age and gender

    NARCIS (Netherlands)

    Peters, L. L.; Boter, H.; Burgerhof, J. G. M.; Slaets, J. P. J.; Buskens, E.

    Background: The primary objective of the present study was to evaluate the validity of the Groningen frailty Indicator (GFI) in a sample of Dutch elderly persons participating in LifeLines, a large population-based cohort study. Additional aims were to assess differences between frail and non-frail

  13. A validated stability indicating high-performance liquid chromatographic method for simultaneous estimation of cefuroxime sodium and sulbactam sodium in injection dosage form

    Directory of Open Access Journals (Sweden)

    Falguni M Patel

    2012-01-01

    Full Text Available Background: A fixed dose combination of cefuroxime sodium (β lactam antibiotic and sulbactam sodium (β Lactamase inhibitor is used in ratio of 2:1 as powder for injection for the treatment of resistant lower respiratory tract and other infections. Aims: A simple, precise, and accurate ion-pair reverse-phase high-performance liquid chromatography (RP-HPLC method was developed and validated for determination of cefuroxime Na(CEF and sulbactam Na(SUL in injection. Materials and Methods: Isocratic RP-HPLC separation was achieved on an ACE C 18 column (150×4.6 mm id, 5 μm particle size using the mobile phase 0.002 M tetrabutylammonium hydroxide sulfate (TBAH in 10 mm potassium di-hydrogen phosphate buffer-acetonitrile (86:14 v/v, pH 3.7 at a flow rate of 1.0 ml/min. Results and Conclusion: The retention time of sulbactam Na and cefuroxime Na were 3.2 min and 10.2 min, respectively. The ion-pairing reagent improved the retention of highly polar sulbactam Na on reverse-phase column. The detection was performed at 210 nm. The method was validated for linearity, precision, accuracy, robustness, solution stability, and specificity. The method was validated for linearity, precision, accuracy, robustness, solution stability, and specificity. The method was linear in the concentration range of 10-100 μg/ml for cefuroxime Na and 5-50 μg/ml for sulbactam Na, with a correlation coefficient of 0.9999 and 0.9998 for the respective drugs. The intraday precision was 0.13-0.21% and 0.48-0.65%, and the interday precision was 0.32-0.81% and 0.60-0.83% for cefuroxime Na and sulbactam Na, respectively. The accuracy (recovery was found to be in the range of 98.76-100.61% and 98.99-100.30% for cefuroxime Na and sulbactam Na, respectively. The drugs were found to degrade under hydrolytic and oxidative conditions. The drugs could be effectively separated from different degradation products, and hence the method can be used for stability analysis.

  14. A validated stability-indicating high performance liquid chromatographic method for moxifloxacin hydrochloride and ketorolac tromethamine eye drops and its application in pH dependent degradation kinetics

    Directory of Open Access Journals (Sweden)

    Jayant B Dave

    2013-01-01

    Full Text Available Background and Aim: A fixed dose combination of moxifloxacin hydrochloride and ketorolac tromethamine is used in ratio of 1:1 as eye drops for the treatment of the reduction of post operative inflammatory conditions of the eye. A simple, precise, and accurate High Performance Liquid Chromatographic (HPLC method was developed and validated for determination of moxifloxacin hydrochloride and ketorolac tromethamine in eye drops. Materials and Methods: Isocratic HPLC separation was achieved on a ACE C 18 column (C 18 (5 μm, 150 mm×4.6 mm, i.d. using the mobile phase 10 mM potassium di-hydrogen phosphate buffer pH 4.6-Acetonitrile (75:25 v/v at a flow rate of 1.0 mL/min. The detection was performed at 307 nm. Drugs were subjected to acid, alkali and neutral hydrolysis, oxidation and photo degradation. Moreover, the proposed HPLC method was utilized to investigate the pH dependent degradation kinetics of moxifloxacin hydrochloride and ketorolac tromethamine in buffer solutions at different pH values like 2.0, 6.8 and 9.0. Results and Conclusion: The retention time (t R of moxifloxacin hydrochloride and ketorolac tromethamine were 3.81±0.01 and 8.82±0.02 min, respectively. The method was linear in the concentration range of 2-20 μ/mL each for moxifloxacin hydrochloride and ketorolac tromethamine with a correlation coefficient of 0.9996 and 0.9999, respectively. The method was validated for linearity, precision, accuracy, robustness, specificity, limit of detection and limit of quantitation. The drugs could be effectively separated from different degradation products and hence the method can be used for stability analysis. Different kinetics parameters like apparent first-order rate constant, half-life and t 90 (time for 90% potency left were calculated.

  15. Validated stability indicating liquid chromatographic determination of ebastine in pharmaceuticals after pre column derivatization: Application to tablets and content uniformity testing

    Directory of Open Access Journals (Sweden)

    Eid Manal

    2011-05-01

    Full Text Available Abstract An accurate, simple, sensitive and selective reversed phase liquid chromatographic method has been developed for the determination of ebastine in its pharmaceutical preparations. The proposed method depends on the complexation ability of the studied drug with Zn2+ ions. Reversed phase chromatography was conducted using an ODS C18 (150 × 4.6 mm id stainless steel column at ambient temperature with UV-detection at 260 nm. A mobile phase containing 0.025%w/v Zn2+ in a mixture of (acetonitril/methanol; 1/4 and Britton Robinson buffer (65:35, v/v adjusted to pH 4.2, has been used for the determination of ebastine at a flow rate of 1 ml/min. The calibration curve was rectilinear over the concentration range of 0.3 - 6.0 μg/ml with a detection limit (LOD of 0.13 μg/ml, and quantification limit (LOQ of 0.26 μg/ml. The proposed method was successfully applied for the analysis of ebastine in its dosage forms, the obtained results were favorably compared with those obtained by a comparison method. Furthermore, content uniformity testing of the studied pharmaceutical formulations was also conducted. The composition of the complex as well as its stability constant was also investigated. Moreover, the proposed method was found to be a stability indicating one and was utilized to investigate the kinetics of alkaline and ultraviolet induced degradation of the drug. The first-order rate constant and half life of the degradation products were calculated.

  16. Construct validity of the Groningen Frailty Indicator established in a large sample of home-dwelling elderly persons: Evidence of stability across age and gender.

    Science.gov (United States)

    Peters, L L; Boter, H; Burgerhof, J G M; Slaets, J P J; Buskens, E

    2015-09-01

    The primary objective of the present study was to evaluate the validity of the Groningen Frailty Indicator (GFI) in a sample of Dutch elderly persons participating in LifeLines, a large population-based cohort study. Additional aims were to assess differences between frail and non-frail elderly and examine which individual characteristics were associated with frailty. By December 2012, 5712 elderly persons were enrolled in LifeLines and complied with the inclusion criteria of the present study. Mann-Whitney U or Kruskal-Wallis tests were used to assess the variability of GFI-scores among elderly subgroups that differed in demographic characteristics, morbidity, obesity, and healthcare utilization. Within subgroups Kruskal-Wallis tests were also used to examine differences in GFI-scores across age groups. Multivariate logistic regression analyses were performed to assess associations between individual characteristics and frailty. The GFI discriminated between subgroups: statistically significantly higher GFI-median scores (interquartile range) were found in e.g. males (1 [0-2]), the oldest old (2 [1-3]), in elderly who were single (1 [0-2]), with lower socio economic status (1 [0-3]), with increasing co-morbidity (2 [1-3]), who were obese (2 [1-3]), and used more healthcare (2 [1-4]). Overall age had an independent and statistically significant association with GFI scores. Compared with the non-frail, frail elderly persons experienced statistically significantly more chronic stress and more social/psychological related problems. In the multivariate logistic regression model, psychological morbidity had the strongest association with frailty. The present study supports the construct validity of the GFI and provides an insight in the characteristics of (non)frail community-dwelling elderly persons participating in LifeLines. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. Stress degradation studies of Telmisartan and Metoprolol extended release tablets by a validated stability indicating reverse phase-high performance liquid chromatography method

    Directory of Open Access Journals (Sweden)

    Kabeer Ahmed Shaikh

    2014-01-01

    Full Text Available Background and Aim: A sensitive reverse phase high-performance liquid chromatographic method has been developed for the simultaneous determination of Telimisartan and Metoprolol in tablet dosage form. Materials and Method: The chromatographic separation was achieved on Inertsil ODS 3V, 150 x 4.6 mm, 5μ analytical column. Mobile phase consisting of mobile phase A- 0.05M sodium dihydrogen phosphate buffer pH 3.0 and mobile phase B-Acetonitrile, with gradient program time in min /Mobile phase B% 0/22, 4/45, 6/45,18/22, 20/22. Detector was set at 222nm. Results and Conclusion: The described method shows excellent linearity over a range of 80-2 μg mL−1 for Telmisartan and 100-4 μg mL−1 for Metoprolol. The correlation coefficient for Telmisartan is 0.9998 and Metoprolol is 0.9999. The proposed method was found to be suitable for determination of Telmisartan and Metoprolol in tablet dosage form. Forced degradation of the drug product was conducted in accordance with the ICH guideline. Acidic, basic, hydrolytic, oxidative, thermal and photolytic degradation was used to assess the stability indicating power of the method. The drug product was found to be stable in acid, oxidation, thermal and photolytic stress condition and found degradation in base hydrolysis stress condition.

  18. Development and Validation of Stability-Indicating Method for Estimation of Chlorthalidone in Bulk and Tablets with the Use of Experimental Design in Forced Degradation Experiments

    Directory of Open Access Journals (Sweden)

    Sandeep Sonawane

    2016-01-01

    Full Text Available Chlorthalidone was subjected to various forced degradation conditions. Substantial degradation of chlorthalidone was obtained in acid, alkali, and oxidative conditions. Further full factorial experimental design was applied for acid and alkali forced degradation conditions, in which strength of acid/alkali, temperature, and time of heating were considered as independent variables (factors and % degradation was considered as dependent variable (response. Factors responsible for acid and alkali degradation were statistically evaluated using Yates analysis and Pareto chart. Furthermore, using surface response curve, optimized 10% degradation was obtained. All chromatographic separation was carried out on Phenomenex HyperClone C 18 column (250 × 4.6 mm, 5 μ, using mobile phase comprising methanol : acetonitrile : phosphate buffer (20 mM (pH 3.0 adjusted with o-phosphoric acid: 30 : 10 : 60% v/v. The flow rate was kept constant at 1 mL/min and eluent was detected at 241 nm. In calibration curve experiments, linearity was found to be in the range of 2–12 μg/mL. Validation experiments proved good accuracy and precision of the method. Also there was no interference of excipients and degradation products at the retention time of chlorthalidone, indicating specificity of the method.

  19. Development and application of a validated stability-indicating HPLC method for simultaneous determination of granisetron hydrochloride, benzyl alcohol and their main degradation products in parenteral dosage forms.

    Science.gov (United States)

    Hewala, Ismail; El-Fatatre, Hamed; Emam, Ehab; Mubrouk, Mokhtar

    2010-06-30

    A simple, rapid and sensitive reversed phase high performance liquid chromatographic method using photodiode array detection was developed and validated for the simultaneous determination of granisetron hydrochloride, benzyl alcohol, 1-methyl-1H-indazole-3-carboxylic acid (the main degradation product of granisetron) and benzaldehyde (the main degradation product of benzyl alcohol) in granisetron injections. The separation was achieved on Hypersil BDS C8 (250 mm x 4.6 mm i.d., 5 microm particle diameter) column using a mobile phase consisted of acetonitrile:0.05 M KH(2)PO(4):triethylamine (22:100:0.15) adjusted to pH 4.8. The column was maintained at 25 degrees C and 20 microL of solutions was injected. Photodiode array detector was used to test the peak purity and the chromatograms were extracted at 210 nm. Naphazoline hydrochloride was used as internal standard. The method was validated with respect to specificity, linearity, accuracy, precision, limit of quantitation and limit of detection. The validation acceptance criteria were met in all cases. Identification of the pure peaks was carried out using library match programmer and wavelengths of derivative optima of the spectrograms of the peaks. The method was successfully applied to the determination of the investigated drugs and their degradation products in different batches of granisetron injections. The method was proved to be sensitive for the determination down to 0.03 and 0.01% of granisetron degradation product and benzaldehyde, respectively, which are far below the compendia limits for testing these degradation products in their corresponding intact drugs. Copyright 2010 Elsevier B.V. All rights reserved.

  20. Isolation and characterization of a degradation product in leflunomide and a validated selective stability-indicating HPLC–UV method for their quantification

    Directory of Open Access Journals (Sweden)

    Balraj Saini

    2015-06-01

    Full Text Available Leflunomide (LLM is subjected to forced degradation under conditions of hydrolysis, oxidation, dry heat, and photolysis as recommended by International Conference on Harmonization guideline Q1A(R2. In total, four degradation products (I–IV were formed under different conditions. Products I, II and IV were formed in alkaline hydrolytic, acidic hydrolytic and alkaline photolytic conditions. LLM and all degradation products were optimally resolved by gradient elution over a C18 column. The major degradation product (IV formed in hydrolytic alkaline conditions was isolated through column chromatography. Based on its 1H NMR, IR and mass spectral data, it was characterized as a British Pharmacopoeial impurity B. The HPLC method was found to be linear, accurate, precise, sensitive, specific, rugged and robust for quantification of LLM as well as product IV. Finally, the method was applied to stability testing of the commercially available LLM tablets. Keywords: Leflunomide, Characterization, Forced degradation, Degradation product, HPLC–UV

  1. UPLC and LC-MS studies on degradation behavior of irinotecan hydrochloride and development of a validated stability-indicating ultra-performance liquid chromatographic method for determination of irinotecan hydrochloride and its impurities in pharmaceutical dosage forms.

    Science.gov (United States)

    Kumar, Navneet; Sangeetha, Dhanaraj; Reddy, Sunil P

    2012-10-01

    The objective of the current investigation was to study the degradation behavior of irinotecan hydrochloride under different International Conference on Harmonization (ICH) recommended stress conditions using ultra-performance liquid chromatography and liquid chromatography-mass spectrometry and to establish a validated stability-indicating reverse-phase ultra-performance liquid chromatographic method for the quantitative determination of irinotecan hydrochloride and its seven impurities and degradation products in pharmaceutical dosage forms. Irinotecan hydrochloride was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Irinotecan hydrochloride was found to degrade significantly in oxidative and base hydrolysis and photolytic degradation conditions. The degradation products were well resolved from the main peak and its impurities, thus proving the stability-indicating power of the method. Chromatographic separation was achieved on a Waters Acquity BEH C8 (100 × 2.1 mm) 1.7-µm column with a mobile phase containing a gradient mixture of solvent A (0.02M KH(2)PO(4) buffer, pH 3.4) and solvent B (a mixture of acetonitrile and methanol in the ratio of 62:38 v/v). The mobile phase was delivered at a flow rate of 0.3 mL/min with ultraviolet detection at 220 nm. The run time was 8 min, within which irinotecan and its seven impurities and degradation products were satisfactorily separated. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. This method was also suitable for the assay determination of irinotecan hydrochloride in pharmaceutical dosage forms.

  2. DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING ...

    African Journals Online (AJOL)

    complete separation of torsemide from its degradation product on C8 column ... and quantification of raw material and pharmaceutical products, no method .... themobile phase for 2D, 1DD, TLC and HPLC methods, respectively were prepared. .... the testing of those features which are susceptible to change during storage ...

  3. A simple, rapid and stability indicating validated method for quantification of lamotrigine in human plasma and dry plasma spot using LC-ESI-MS/MS: Application in clinical study.

    Science.gov (United States)

    Namdev, Kuldeep Kumar; Dwivedi, Jaya; Chilkoti, Deepak Chandra; Sharma, Swapnil

    2018-01-01

    Lamotrigine (LTZ) is a phenyltriazine derivative which belongs to anti-epileptic drugs (AEDs) class and prescribed as mono- or adjunctive-therapy in treatment of epilepsy. Therapeutic drug monitoring (TDM) of AEDs provides a valid clinical tool in optimization of overall therapy. However, TDM is challenging due to the high biological samples (plasma/blood) storage/shipment costs and the limited availability of laboratories providing TDM services. Sampling in the form of dry plasma spot (DPS) or dry blood spot (DBS) are suitable alternative to overcome these issues. We developed and validated a new method for quantification of LTZ in human plasma and DPS. The extraction of LTZ from plasma and DPS was performed using liquid-liquid extraction with diethyl ether and an extraction solution composed of diethyl ether- methyl tert-butyl ether- acetone (50:30:20, v/v/v), respectively. Lamotrigine- 13C3, d3 was used as internal standard (ISTD) and the chromatographic separation was achieved on Hypurity Advance C18 column (150×4.6mm, 5μm). Quantitative estimation of LTZ and ISTD was performed on a liquid chromatography tandem mass spectrometer coupled with electrospray ionization interface operated under positive mode of ionization. Calibration curves were linear (r 2 >0.99) over the concentration range of 10-3020ng/mL for both plasma and DPS. Statistical analysis provides insignificant difference between LTZ concentration extracted from plasma and DPS samples. The method is found suitable for application in clinical study and in therapeutic monitoring of LTZ. To the best of our knowledge this is the first report which describing a validated stability indicating assay for quantification of LTZ in dry plasma spot. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Stability-Indicating HPLC Determination of Gemcitabine in Pharmaceutical Formulations

    Science.gov (United States)

    Singh, Rahul; Shakya, Ashok K.; Naik, Rajashri; Shalan, Naeem

    2015-01-01

    A simple, sensitive, inexpensive, and rapid stability indicating high performance liquid chromatographic method has been developed for determination of gemcitabine in injectable dosage forms using theophylline as internal standard. Chromatographic separation was achieved on a Phenomenex Luna C-18 column (250 mm × 4.6 mm; 5μ) with a mobile phase consisting of 90% water and 10% acetonitrile (pH 7.00 ± 0.05). The signals of gemcitabine and theophylline were recorded at 275 nm. Calibration curves were linear in the concentration range of 0.5–50 μg/mL. The correlation coefficient was 0.999 or higher. The limit of detection and limit of quantitation were 0.1498 and 0.4541 μg/mL, respectively. The inter- and intraday precision were less than 2%. Accuracy of the method ranged from 100.2% to 100.4%. Stability studies indicate that the drug was stable to sunlight and UV light. The drug gives 6 different hydrolytic products under alkaline stress and 3 in acidic condition. Aqueous and oxidative stress conditions also degrade the drug. Degradation was higher in the alkaline condition compared to other stress conditions. The robustness of the methods was evaluated using design of experiments. Validation reveals that the proposed method is specific, accurate, precise, reliable, robust, reproducible, and suitable for the quantitative analysis. PMID:25838825

  5. Evaluation of indices for voltage stability monitoring using PMU measurements

    Directory of Open Access Journals (Sweden)

    Sindy Lorena Ramirez Perdomo

    2014-09-01

    Full Text Available Large disturbances such as voltage collapse and its consequences represent a large challenge to the operational safety of power systems. Therefore, it is important to have indicators of the presence of voltage stability problems in real time. Using phasor measure-ments of voltage and current that are presented in Phasor Measurement Units (PMU, indices for voltage stability monitoring can be calculated in real time. This paper presents some indices for voltage stability monitoring using PMU measurements. Evaluation of such indices on a simplified system was carried out, and the indices were classified according to their method of calculation. Finally, one of these indices was used with the New England 39-bus system under different operating scenarios, including load increments, line output and generator output, to check the indices’ behavior for voltage stability monitoring based on synchronized local measurements.

  6. Towards Validating Risk Indicators Based on Measurement Theory (Extended version)

    NARCIS (Netherlands)

    Morali, A.; Wieringa, Roelf J.

    Due to the lack of quantitative information and for cost-efficiency, most risk assessment methods use partially ordered values (e.g. high, medium, low) as risk indicators. In practice it is common to validate risk indicators by asking stakeholders whether they make sense. This way of validation is

  7. A Stability Indicating HPLC Method for the Determination of ...

    African Journals Online (AJOL)

    Erah

    stability indicating reverse phase HPLC method for estimating meloxicam (MLX) in bulk ... acetonitrile-water-glacial acetic acid [55:40:5 (% v/v)] at a flow rate of 1ml/min and detection wavelength .... pore and degassed before use. ... determined to assess the effect of small but ... deviation, the standard error of slope, and the.

  8. The Effect of Zeolite on Aggregate Stability Indices

    Directory of Open Access Journals (Sweden)

    F. Sohrab

    2016-02-01

    Full Text Available Introduction: Soil structural stability affects the profitability and sustainability of agricultural systems. Particle size distribution (PSD and aggregate stability are the important characteristics of soil. Aggregate stability has a significant impact on the development of the root system, water and carbon cycle and soil resistance against soil erosion. Soil aggregate stability, defined as the ability of the aggregates to remain intact when subject to a given stress, is an important soil property that affects the movement and storage of water, aeration, erosion, biological activity and growth of crops. Dry soil aggregate stability (Mean Weight Diameter (MWD, Geometric Mean Diameter (GMD and Wet Aggregate Stability (WAS are important indices for evaluating soil aggregate stability.To improve soil physical properties, including modifying aggregate, using various additives (organic, inorganic and chemicals, zeolites are among what has been studied.According to traditional definition, zeolites are hydratealuminosilicates of alkaline and alkaline-earth minerals. Their structure is made up of a framework of[SiO4]−4 and [AlO4]−5 tetrahedron linked to each other's cornersby sharing oxygen atoms. The substitution of Si+4 by Al+3 intetrahedral sites results inmore negative charges and a high cation exchange capacity.Zeolites, as natural cation exchangers, are suitable substitutes to remove toxic cations. Among the natural zeolites,Clinoptilolite seems to be the most efficient ion exchanger and ion-selective material forremoving and stabilizing heavy metals.Due to theexisting insufficient technical information on the effects of using different levels of zeolite on physical properties of different types of soils in Iran, the aim of this research was to assess the effects of two different types of zeolite (Clinoptilolite natural zeolite, Z4, and Synthetic zeolite, A4 on aggregate stability indicesof soil. Materials and Methods: In this study at first

  9. Relative performance of three stream bed stability indices as indicators of stream health.

    Science.gov (United States)

    Kusnierz, Paul C; Holbrook, Christopher M

    2017-10-16

    Bed stability is an important stream habitat attribute because it affects geomorphology and biotic communities. Natural resource managers desire indices of bed stability that can be used under a wide range of geomorphic conditions, are biologically meaningful, and are easily incorporated into sampling protocols. To eliminate potential bias due to presence of instream wood and increase precision of stability values, we modified a stream bed instability index (ISI) to include measurements of bankfull depth (d bf ) and median particle diameter (D 50 ) only in riffles and increased the pebble count to decrease variability (i.e., increase precision) in D 50 . The new riffle-based instability index (RISI) was compared to two established indices: ISI and the riffle stability index (RSI). RISI and ISI were strongly associated with each other but neither was closely associated with RSI. RISI and ISI were closely associated with both a diatom- and two macrovertebrate-based stream health indices, but RSI was only weakly associated with the macroinvertebrate indices. Unexpectedly, precision of D 50 did not differ between RISI and ISI. Results suggest that RISI is a viable alternative to both ISI and RSI for evaluating bed stability in multiple stream types. With few data requirements and a simple protocol, RISI may also better conform to riffle-based sampling methods used by some water quality practitioners.

  10. Development and application of a validated stability-indicating high-performance liquid chromatographic method using photodiode array detection for simultaneous determination of granisetron, methylparaben, propylparaben, sodium benzoate, and their main degradation products in oral pharmaceutical preparations.

    Science.gov (United States)

    Hewala, Ismail; El-Fatatry, Hamed; Emam, Ehab; Mabrouk, Mokhtar

    2011-01-01

    A simple, rapid, and sensitive RP-HPLC method using photodiode array detection was developed and validated for the simultaneous determination of granisetron hydrochloride, 1-methyl-1H-indazole-3-carboxylic acid (the main degradation product of granisetron), sodium benzoate, methylparaben, propylparaben, and 4-hydroxybenzoic acid (the main degradation product of parabens) in granisetron oral drops and solutions. The separation of the compounds was achieved within 8 min on a SymmetryShield RP18 column (100 x 4.6 mm id, 3.5 microm particle size) using the mobile phase acetonitrile--0.05 M KH2PO4 buffered to pH 3 using H3PO4 (3+7, v/v). The photodiode array detector was used to test the purity of the peaks, and the chromatograms were extracted at 240 nm. The method was validated, and validation acceptance criteria were met in all cases. The robust method was successfully applied to the determination of granisetron and preservatives, as well as their degradation products in different batches of granisetron oral drops and solutions. The method proved to be sensitive for determination down to 0.04% (w/w) of granisetron degradation product relative to granisetron and 0.03% (w/w) 4-hydroxybenzoic acid relative to total parabens.

  11. Validation of data and indicators in the Danish Cholecystectomy Database

    DEFF Research Database (Denmark)

    Harboe, Kirstine Moll; Anthonsen, Kristian; Bardram, Linda

    2009-01-01

    and postoperative complications RESEARCH DESIGN AND SUBJECTS: Data from 1360 medical records of patients undergoing cholecystectomy were compared to the relevant administrative data from the National Patient Registry. The medical records served as the "gold standard". The association between the individual...... indicators and the occurrence of a postoperative complication was assessed. MEASURES: Validation of administrative data against the gold standard was done by the calculation of per cent agreement (including kappa-values) sensitivity/specificity and predictive values. The association between indicators...

  12. A Validation Study of Homeopathic Prescribing and Patient Care Indicators

    Directory of Open Access Journals (Sweden)

    Munmun Koley

    2014-10-01

    Full Text Available A preliminary version of the homeopathic prescribing and patient care indicators was available. The instrument was modified further in this study with an intention to address formally its validity and reliability, audit prescriptions, identify areas of sub-optimal prescribing, and highlight target areas for improving the quality of practices. A cross-sectional study with record analysis was conducted on systematically sampled 377 patients of Mahesh Bhattacharyya Homeopathic Medical College and Hospital (MBHMC and H, Howrah, West Bengal, India. The outcome measures were homeopathic prescribing indicators (6 items and patient care indicators (5 items. Individualized homeopathic prescriptions predominated in the encounters. Areas demanding immediate attention were extremely poor labeling of drugs dispensed from the hospital pharmacy, improper record of case history and disease diagnosis, ongoing therapies, and investigational findings in the prescriptions. Internal consistency of the overall instrument was estimated to be good (Cronbach's alpha: Prescribing indicators 0.752 and patient care indicators 0.791. The prescribing indicators, except items 1 and 3, reflected acceptable item-corrected total correlations – Pearson's r from 0.58 (95% CI: 0.52-0.65 to 0.74 (95% CI: 0.69-0.78. The patient care indicators, except item 2, showed acceptable correlations – Pearson's r from 0.40 (95% CI: 0.31-0.48 to 0.82 (95% CI: 0.78-0.85. The instrument also showed high discriminant validity (prescribing indicators P<0.0001 and patient care indicators P<0.0001. Improper prescribing practice was quite rampant and corrective measures are warranted. The developed indicators appeared to be validated and reliable; however, they are amendable for further development.

  13. A Validation Study of Homeopathic Prescribing and Patient Care Indicators

    Science.gov (United States)

    Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy; Nag, Goutam; Kundu, Monojit; Mondal, Ramkumar; Purkait, Rajib; Patra, Supratim

    2014-01-01

    A preliminary version of the homeopathic prescribing and patient care indicators was available. The instrument was modified further in this study with an intention to address formally its validity and reliability, audit prescriptions, identify areas of sub-optimal prescribing, and highlight target areas for improving the quality of practices. A cross-sectional study with record analysis was conducted on systematically sampled 377 patients of Mahesh Bhattacharyya Homeopathic Medical College and Hospital (MBHMC and H), Howrah, West Bengal, India. The outcome measures were homeopathic prescribing indicators (6 items) and patient care indicators (5 items). Individualized homeopathic prescriptions predominated in the encounters. Areas demanding immediate attention were extremely poor labeling of drugs dispensed from the hospital pharmacy, improper record of case history and disease diagnosis, ongoing therapies, and investigational findings in the prescriptions. Internal consistency of the overall instrument was estimated to be good (Cronbach's alpha: Prescribing indicators 0.752 and patient care indicators 0.791). The prescribing indicators, except items 1 and 3, reflected acceptable item-corrected total correlations – Pearson's r from 0.58 (95% CI: 0.52-0.65) to 0.74 (95% CI: 0.69-0.78). The patient care indicators, except item 2, showed acceptable correlations – Pearson's r from 0.40 (95% CI: 0.31-0.48) to 0.82 (95% CI: 0.78-0.85). The instrument also showed high discriminant validity (prescribing indicators P < 0.0001 and patient care indicators P < 0.0001). Improper prescribing practice was quite rampant and corrective measures are warranted. The developed indicators appeared to be validated and reliable; however, they are amendable for further development. PMID:25379474

  14. The validity and reliability of a dynamic neuromuscular stabilization-heel sliding test for core stability.

    Science.gov (United States)

    Cha, Young Joo; Lee, Jae Jin; Kim, Do Hyun; You, Joshua Sung H

    2017-10-23

    Core stabilization plays an important role in the regulation of postural stability. To overcome shortcomings associated with pain and severe core instability during conventional core stabilization tests, we recently developed the dynamic neuromuscular stabilization-based heel sliding (DNS-HS) test. The purpose of this study was to establish the criterion validity and test-retest reliability of the novel DNS-HS test. Twenty young adults with core instability completed both the bilateral straight leg lowering test (BSLLT) and DNS-HS test for the criterion validity study and repeated the DNS-HS test for the test-retest reliability study. Criterion validity was determined by comparing hip joint angle data that were obtained from BSLLT and DNS-HS measures. The test-retest reliability was determined by comparing hip joint angle data. Criterion validity was (ICC2,3) = 0.700 (preliability was (ICC3,3) = 0.953 (pvalidity data demonstrated a good relationship between the gold standard BSLLT and DNS-HS core stability measures. Test-retest reliability data suggests that DNS-HS core stability was a reliable test for core stability. Clinically, the DNS-HS test is useful to objectively quantify core instability and allow early detection and evaluation.

  15. Stability-Indicating RP-HPLC Method for Assay of Silver Lactate

    Directory of Open Access Journals (Sweden)

    V. Srinivasan

    2011-01-01

    Full Text Available A simple, economic and time-efficient stability-indicating, reverse-phase high-performance liquid chromatographic (RP-HPLC method has been developed for analysis of silver lactate in the presence of degradation products generated by decomposition. When silver lactate was subjected to acid hydrolysis, base hydrolysis, oxidative, photolytic, humidity and thermal stress, degradation was observed during base hydrolysis, oxidation, humidity and thermal stress. The drug was found to be stable to other stress conditions. Successful chromatographic condition of the drug from the degradation products formed under stress conditions was achieved on a phenomenex Gemini column with potassium dihydrogen phosphate buffer, pH adjusted to 2.2 with orthophosphoric acid, as mobile phase. The method was validated for linearity, precision, specificity and robustness and can be used for quality-control during manufacture and assessment of the stability of samples of silver lactate. To the best of our knowledge, a validated stability-indicating LC assay method for silver lactate based on lactic acid is reported for the first time.

  16. [Cognition-correlation indices of gender schema: tests of validity].

    Science.gov (United States)

    Ishida, E

    1994-02-01

    Four-hundred and seventy-seven subjects evaluated a set of traits and behaviors in terms of how masculine and feminine they were and in terms of how well they represented their real and ideal self-images. Within-individual correlation coefficients between these evaluations were proposed as measures of psychological gender schemata, because they would represent the degree of matching between the subjects' gender-image and ideal/real self-images of gender-related attributes. The present study aims at examining the construct validity of these measures, by testing them to psychological variables that are known to reflect gender identity. The individual difference variables used as criteria were (a) satisfaction with one's own sex, (b) general happiness, (c) self-esteem (d) gender-conflict, and (e) school and occupational achievement need. Correlations between the gender-schema indices and the criteria variables supported the construct validity of those measures. Advantages of the present measurement over the conventional simple trait approach, such as BSRI, or PAQ are discussed.

  17. Stability-indicating HPLC determination of pramipexole dihydrochloride in bulk drug and pharmaceutical dosage form

    OpenAIRE

    Panditrao, Vedavati M; Sarkate, Aniket P; Sangshetti, Jaiprakash N; Wakte, Pravin S; Shinde, Devanand B

    2011-01-01

    A novel stability-indicating high-performance liquid chromatographic assay method was developed and validated for quantitative determination of pramipexole dihydrochloride in bulk drugs and in pharmaceutical dosage form in the presence of degradation products. An isocratic, reversed phase HPLC method was developed to separate the drug from the degradation products, using an Ace5-C18 (250×4.6 mm, 5 µm) advance chromatography column, and 10 mmol L-1 ammonium acetate and acetonitrile (75:25 v/v)...

  18. Stability Indicating RP-HPLC Method for Determination of Valsartan in Pure and Pharmaceutical Formulation

    Directory of Open Access Journals (Sweden)

    S. K. Patro

    2010-01-01

    Full Text Available A simple, rapid and accurate and stability indicating RP-HPLC method was developed for the determination of valsartan in pure and tablet forms. The method showed a linear response for concentrations in the range of 50-175 µg/mL using 0.01 M NH4H2PO4 (pH 3.5 buffer: methanol [50:50] as the mobile phase with detection at 210 nm and a flow rate of 1 mL/min and retention time 11.041 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, forced degradation, solution stability and selectivity. Quantitative and recovery studies of the dosage form were also carried out and analyzed; the % RSD from recovery studies was found to be less than 1. Due to simplicity, rapidity and accuracy of the method, we believe that the method will be useful for routine quality control analysis.

  19. The HSE Management Standards Indicator Tool: concurrent and construct validity.

    Science.gov (United States)

    Marcatto, F; Colautti, L; Larese Filon, F; Luis, O; Ferrante, D

    2014-07-01

    The Health & Safety Executive Management Standards Indicator Tool (HSE-MS IT) is a questionnaire commonly used to assess work-related stress risks at an organizational level. A critical factor in determining whether this instrument is actually useful is that higher levels of stress risk in the work-design domains should predict higher levels of stress and stress-related outcomes in workers. Only a few studies, however, have addressed this issue. To test both the concurrent and construct validity of the HSE-MS IT, by relating it with another widely used instrument, the Job Content Questionnaire (JCQ), and by examining its relationships with a set of work-related stress outcomes. An anonymous cross-sectional questionnaire was administered to a sample of employees in an Italian municipality. The questionnaire included the HSE-MS IT, self-reported measures of job satisfaction, job motivation and stress at work, the Satisfaction with Life Scale and the reduced form of the JCQ. A total of 760 out of 779 employees completed the questionnaire. Results showed moderate to strong correlation among the corresponding HSE-MS IT and JCQ scales. Hierarchical regression highlighted the specific contribution of each of the HSE-MS IT scales in predicting three relevant work-related stress outcomes (self-reported stress, job satisfaction and job motivation), after controlling for gender, age and life satisfaction. Our findings consolidated the HSE-MS IT validity and showed the specific sensitivity of its scales to assess different aspects of work-related distress, including self-perception of stress at work. These results can have practical implications for the occupational well-being of employees. © The Author 2014. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  20. Utilizing the social media data to validate 'climate change' indices

    Science.gov (United States)

    Molodtsova, T.; Kirilenko, A.; Stepchenkova, S.

    2013-12-01

    Reporting the observed and modeled changes in climate to public requires the measures understandable by the general audience. E.g., the NASA GISS Common Sense Climate Index (Hansen et al., 1998) reports the change in climate based on six practically observable parameters such as the air temperature exceeding the norm by one standard deviation. The utility of the constructed indices for reporting climate change depends, however, on an assumption that the selected parameters are felt and connected with the changing climate by a non-expert, which needs to be validated. Dynamic discussion of climate change issues in social media may provide data for this validation. We connected the intensity of public discussion of climate change in social networks with regional weather variations for the territory of the USA. We collected the entire 2012 population of Twitter microblogging activity on climate change topic, accumulating over 1.8 million separate records (tweets) globally. We identified the geographic location of the tweets and associated the daily and weekly intensity of twitting with the following parameters of weather for these locations: temperature anomalies, 'hot' temperature anomalies, 'cold' temperature anomalies, heavy rain/snow events. To account for non-weather related events we included the articles on climate change from the 'prestige press', a collection of major newspapers. We found that the regional changes in parameters of weather significantly affect the number of tweets published on climate change. This effect, however, is short-lived and varies throughout the country. We found that in different locations different weather parameters had the most significant effect on climate change microblogging activity. Overall 'hot' temperature anomalies had significant influence on climate change twitting intensity.

  1. Stability-indicating RP-HPLC method for the simultaneous determination of escitalopram oxalate and clonazepam.

    Science.gov (United States)

    Kakde, Rajendra B; Satone, Dinesh D; Gadapayale, Kamalesh K; Kakde, Megha G

    2013-07-01

    The objective of the current study was to develop a validated, specific stability-indicating reversed-phase liquid chromatographic (LC) method for the quantitative determination of escitalopram oxalate and clonazepam and their related substances in bulk drugs and pharmaceutical dosage forms in the presence of degradation products. Forced degradation studies were performed on the pure drugs of escitalopram oxalate and clonazepam, as per the stress conditions prescribed by the International Conference on Harmonization (ICH) using acid, base, oxidation, thermal stress and photolytic degradation to show the stability-indicating power of the method. Significant degradation was observed during acid and alkaline hydrolysis and no degradation was observed in other stress conditions. The chromatographic method was optimized using the samples generated from forced degradation studies. Good resolution between the peaks corresponded to the active pharmaceutical ingredients, escitalopram oxalate and clonazepam, and degradation products from the analyte were achieved on an ODS Hypersil C18 column (250 × 4.6 mm) using a mobile phase consisting of a mixture of acetonitrile-50 mM phosphate buffer + 10 mM triethylamine (70:30, v/v). The detection was conducted at 268 nm. The limit of detection and the limit of quantitation for escitalopram oxalate and clonazepam were established. The stress test solutions were assayed against the qualified working standards of escitalopram oxalate and clonazepam, which indicated that the developed LC method was stability-indicating. Validation of the developed LC method was conducted as per ICH requirements. The developed LC method was found to be suitable to check the quality of bulk samples of escitalopram oxalate and clonazepam.

  2. EXTERNAL VALIDATION OF THE DIABETES EARLY READMISSION RISK INDICATOR (DERRI™).

    Science.gov (United States)

    Rubin, Daniel J; Recco, Dominic; Turchin, Alexander; Zhao, Huaqing; Golden, Sherita Hill

    2018-04-06

    The Diabetes Early Readmission Risk Indicator (DERRI ™ ) was previously developed and internally validated as a tool to predict the risk of all-cause readmission within 30 days of discharge (30-d readmission) of hospitalized patients with diabetes. In this study, the predictive performance of the DERRI ™ with and without additional predictors was assessed in an external sample. We conducted a retrospective cohort study of adult patients with diabetes discharged from 2 academic medical centers between 1/1/2000 and 12/31/2014. We applied the previously developed DERRI ™ , which includes admission laboratory results, sociodemographics, a diagnosis of certain comorbidities, and recent discharge information, and evaluated the effect of adding metabolic indicators on predictive performance using multivariable logistic regression. Total cholesterol and A1c were selected based on clinical relevance and univariate association with 30-d readmission. Among 105,974 discharges, 19,032 (18.0%) were followed by 30-d readmission for any cause. The DERRI ™ had a C-statistic of 0.634 for 30-d readmission. Total cholesterol (TC) was the lipid parameter most strongly associated with 30-d readmission. The DERRI ™ predictors, A1c, and TC were significantly associated with 30-d readmission; however, their addition to the DERRI ™ did not significantly change model performance (C-statistic 0.643 [95% CI, 0.638-0.647], p=0.92). Performance of the DERRI ™ in this external cohort was modest but comparable to other readmission prediction models. Addition of A1c and TC to the DERRI ™ did not significantly improve performance. Although the DERRI ™ may be useful to direct resources toward diabetes patients at higher risk, better prediction is needed. DERRI = Diabetes Early Readmission Risk Indicator; TC = Total cholesterol; A1c = hemoglobin A1c; HDL-C = high-density lipoprotein cholesterol; LDL-C = low-density lipoprotein cholesterol; DKA = diabetic ketoacidosis; HHS

  3. Validation of analytical methods for the stability studies of naproxen suppositories for infant and adult use

    International Nuclear Information System (INIS)

    Rodriguez Hernandez, Yaslenis; Suarez Perez, Yania; Garcia Pulpeiro, Oscar

    2011-01-01

    Analytical and validating studies were performed in this paper, with a view to using them in the stability studies of the future formulations of naproxen suppositories for children and adults. The most influential factors in the naproxen stability were determined, that is, the major degradation occurred in acid medium, oxidative medium and by light action. One high-performance liquid chromatography-based method was evaluated, which proved to be adequate to quantify naproxen in suppositories and was selective against degradation products. The quantification limit was 3,480 μg, so it was valid for these studies. Additionally, the parameters specificity for stability, detection and quantification limits were evaluated for the direct semi-aqueous acid-base method, which was formerly validated for the quality control and showed satisfactory results. Nevertheless, the volumetric methods were not regarded as stability indicators; therefore, this method will be used along with the chromatographic methods of choice, that is, thin-layer chromatography and highperformance liquid chromatography, to determine the degradation products

  4. Stability-Indicating HPLC Method for the Simultaneous ...

    African Journals Online (AJOL)

    Tropical Journal of Pharmaceutical Research May 2014; 13 (5): 809-817. ISSN: 1596-5996 ... indicating method for the simultaneous estimation of valsartan and ezetimibe in combined tablet ... techniques like spectrometric methods [1-3] and.

  5. Validation of Helicopter Gear Condition Indicators Using Seeded Fault Tests

    Science.gov (United States)

    Dempsey, Paula; Brandon, E. Bruce

    2013-01-01

    A "seeded fault test" in support of a rotorcraft condition based maintenance program (CBM), is an experiment in which a component is tested with a known fault while health monitoring data is collected. These tests are performed at operating conditions comparable to operating conditions the component would be exposed to while installed on the aircraft. Performance of seeded fault tests is one method used to provide evidence that a Health Usage Monitoring System (HUMS) can replace current maintenance practices required for aircraft airworthiness. Actual in-service experience of the HUMS detecting a component fault is another validation method. This paper will discuss a hybrid validation approach that combines in service-data with seeded fault tests. For this approach, existing in-service HUMS flight data from a naturally occurring component fault will be used to define a component seeded fault test. An example, using spiral bevel gears as the targeted component, will be presented. Since the U.S. Army has begun to develop standards for using seeded fault tests for HUMS validation, the hybrid approach will be mapped to the steps defined within their Aeronautical Design Standard Handbook for CBM. This paper will step through their defined processes, and identify additional steps that may be required when using component test rig fault tests to demonstrate helicopter CI performance. The discussion within this paper will provide the reader with a better appreciation for the challenges faced when defining a seeded fault test for HUMS validation.

  6. Stability Indicating Reverse Phase HPLC Method for Estimation of Rifampicin and Piperine in Pharmaceutical Dosage Form.

    Science.gov (United States)

    Shah, Umang; Patel, Shraddha; Raval, Manan

    2018-01-01

    High performance liquid chromatography is an integral analytical tool in assessing drug product stability. HPLC methods should be able to separate, detect, and quantify the various drug-related degradants that can form on storage or manufacturing, plus detect any drug-related impurities that may be introduced during synthesis. A simple, economic, selective, precise, and stability-indicating HPLC method has been developed and validated for analysis of Rifampicin (RIFA) and Piperine (PIPE) in bulk drug and in the formulation. Reversed-phase chromatography was performed on a C18 column with Buffer (Potassium Dihydrogen Orthophosphate) pH 6.5 and Acetonitrile, 30:70), (%, v/v), as mobile phase at a flow rate of 1 mL min-1. The detection was performed at 341 nm and sharp peaks were obtained for RIFA and PIPE at retention time of 3.3 ± 0.01 min and 5.9 ± 0.01 min, respectively. The detection limits were found to be 2.385 ng/ml and 0.107 ng/ml and quantification limits were found to be 7.228ng/ml and 0.325ng/ml for RIFA and PIPE, respectively. The method was validated for accuracy, precision, reproducibility, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines. Stress study was performed on RIFA and PIPE and it was found that these degraded sufficiently in all applied chemical and physical conditions. Thus, the developed RP-HPLC method was found to be suitable for the determination of both the drugs in bulk as well as stability samples of capsule containing various excipients. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  7. HPLC-DAD stability indicating determination of nizatidine in bulk and capsules dosage form

    Directory of Open Access Journals (Sweden)

    Tarek S. Belal

    2013-12-01

    Full Text Available This work describes the stability-indicating determination of the H2-receptor antagonist nizatidine in its bulk and capsules dosage form using high performance liquid chromatography coupled with diode array detector (HPLC-DAD. The developed method involved the use of Thermo Hypersil BDS-C8 (4.6 × 250 mm, 5 μm particle size column and a mobile phase composed of 0.05 M phosphoric acid and acetonitrile (50:50, v/v. The mobile phase was pumped at a flow rate of 1 mL/min. Quantification of nizatidine was based on measuring its peak area at 320 nm. The retention time for nizatidine was about 3.61 min. The reliability and analytical performance of the proposed HPLC procedure were statistically validated with respect to linearity, range, precision, accuracy, specificity, robustness, detection and quantification limits. Calibration curve of nizatidine was linear in the range of 5–50 μg/mL with correlation coefficient >0.9999. The drug was subjected to forced-degradation conditions of acidic and basic hydrolysis, oxidation, dry heat and UV photolysis where it showed considerable degradation in basic and oxidative conditions. The proposed method proved to be specific and stability-indicating by resolution of the drug from its forced-degradation products. The validated HPLC method was applied to the analysis of nizatidine in capsules dosage form where it was quantified with recoveries not less than 98.2%. Assay results were statistically compared to USP 2011 pharmacopeial method where no significant difference was observed between the proposed and reference methods.

  8. Stability-Indicating HPLC Assay for Determination of Idebenone in Pharmaceutical Forms

    Directory of Open Access Journals (Sweden)

    Sonoube Kombath

    2015-01-01

    Full Text Available A stability-indicating method was validated for the determination in pharmaceutical forms of idebenone a coenzyme Q10-like compound. The assay was achieved by liquid chromatography analysis using a reversed-phase C18 column and a detector set at 480 nm. The optimized mobile phase consisted of isocratic flow rate at 1.0 mL/min for 3 min with methanol. The linearity of the assay was demonstrated in the range of 3.0 to 8.0 mg/mL with a correlation coefficient r2>0.998. The limits of detection and quantification were 0.03 and 0.05 mg/mL, respectively. The intraday and interday precisions were less than 1.0%. Accuracy of the method ranged from 98.6 to 101.5% with RSD < 0.6%. Specificity of the assay showed no interference from tablets components and breakdown products formed by alkaline, acidic, oxidative, sunlight, and high temperature conditions. This method allows accurate and reliable determination of idebenone for drug stability assay in pharmaceutical studies.

  9. Expected usability is not a valid indicator of experienced usability

    Directory of Open Access Journals (Sweden)

    Meinald T. Thielsch

    2015-09-01

    Full Text Available Usability is a core construct of website evaluation and inherently defined as interactive. Yet, when analysing first impressions of websites, expected usability, i.e., before use, is of interest. Here we investigate to what extend ratings of expected usability are related to (a experienced usability, i.e., ratings after use, and (b objective usability measures, i.e., task performance. Furthermore, we try to elucidate how ratings of expected usability are correlated to aesthetic judgments. In an experiment, 57 participants submitted expected usability ratings after the presentation of website screenshots in three viewing-time conditions (50, 500, and 10,000 ms and after an interactive task (experienced usability. Additionally, objective usability measures (task completion and duration and subjective aesthetics evaluations were recorded for each website. The results at both the group and individual level show that expected usability ratings are not significantly related either to experienced usability or objective usability measures. Instead, they are highly correlated with aesthetics ratings. Taken together, our results highlight the need for interaction in empirical website usability testing, even when exploring very early usability impressions. In our study, user ratings of expected usability were no valid proxy neither for objective usability nor for experienced website usability.

  10. Bioassessment in nonperennial streams: Hydrologic stability influences assessment validity

    Science.gov (United States)

    Mazor, R. D.; Stein, E. D.; Schiff, K.; Ode, P.; Rehn, A.

    2011-12-01

    Nonperennial streams pose a challenge for bioassessment, as assessment tools developed in perennial streams may not work in these systems. For example, indices of biotic integrity (IBIs) developed in perennial streams may give improper indications of impairment in nonperennial streams, or may be unstable. We sampled benthic macroinvertebrates from 12 nonperennial streams in southern California. In addition, we deployed loggers to obtain continuous measures of flow. 3 sites were revisited over 2 years. For each site, we calculated several metrics, IBIs, and O/E scores to determine if assessments were consistent and valid throughout the summer. Hydrology varied widely among the streams, with several streams drying between sampling events. IBIs suggested good ecological health at the beginning of the study, but declined sharply at some sites. Multivariate ordination suggested that, despite differences among sites, changes in community structure were similar, with shifts from Ephemeroptera, Plecoptera, and Trichoptera to Coleoptera and more tolerant organisms. Site revisits revealed a surprising level of variability, as 2 of the 3 revisited sites had perennial or near-perennial flow in the second year of sampling. IBI scores were more consistent in streams with stable hydrographs than in those with strongly intermittent hydrographs. These results suggest that nonperennial streams can be monitored successfully, but they may require short index periods and distinct metrics from those used in perennial streams. In addition, better approaches to mapping nonperennial streams are required.

  11. Stability of vertical posture explored with unexpected mechanical perturbations: synergy indices and motor equivalence.

    Science.gov (United States)

    Yamagata, Momoko; Falaki, Ali; Latash, Mark L

    2018-03-21

    We explored the relations between indices of mechanical stability of vertical posture and synergy indices under unexpected perturbations. The main hypotheses predicted higher posture-stabilizing synergy indices and higher mechanical indices of center of pressure stability during perturbations perceived by subjects as less challenging. Healthy subjects stood on a force platform and held in fully extended arms a bar attached to two loads acting downward and upward. One of the loads was unexpectedly released by the experimenter causing a postural perturbations. In different series, subjects either knew or did not know which of the two loads would be released. Forward perturbations were perceived as more challenging and accompanied by co-activation patterns among the main agonist-antagonist pairs. Backward perturbation led to reciprocal muscle activation patterns and was accompanied by indices of mechanical stability and of posture-stabilizing synergy which indicated higher stability. Changes in synergy indices were observed as early as 50-100 ms following the perturbation reflecting involuntary mechanisms. In contrast, predictability of perturbation direction had weak or no effect on mechanical and synergy indices of stability. These observations are interpreted within a hierarchical scheme of synergic control of motor tasks and a hypothesis on the control of movements with shifts of referent coordinates. The findings show direct correspondence between stability indices based on mechanics and on the analysis of multi-muscle synergies. They suggest that involuntary posture-stabilizing mechanisms show synergic organization. They also show that predictability of perturbation direction has strong effects on anticipatory postural adjustment but not corrective adjustments. We offer an interpretation of co-activation patterns that questions their contribution to postural stability.

  12. A comparative study of voltage stability indices in a power system

    Energy Technology Data Exchange (ETDEWEB)

    Sinha, A.K. [I.I.T., Kharagpur (India). Dept. of Electrical Engineering; Hazarika, D. [Assam Engineering College (India)

    2000-11-01

    The paper compares the effectiveness of voltage stability indices in providing information about the proximity of voltage instability of a power system. Three simple voltage stability indices are proposed and their effectiveness is compared with some of the recently proposed indices. The comparison is carried out over a wide range of system operating conditions by changing the load power factor and feeder X/R ratios. Test results for the IEEE 57 bus and IEEE 118 bus system are presented. (author)

  13. Wide Area Prosumption Control and Sensitivities of Aperiodic Small Signal Stability Indicators

    DEFF Research Database (Denmark)

    Wittrock, Martin Lindholm; Jóhannsson, Hjörtur; Nielsen, Arne Hejde

    2014-01-01

    and patterns, stability indicators for aperiodic small signal angular stability (ASSA) are examined, while the concept of prosumption is described. The methodology presented is shown to be able to assess the margin to instability and to predict how this margin can be affected if a load is changed in the grid...

  14. Evaluation of biologic occupational risk control practices: quality indicators development and validation.

    Science.gov (United States)

    Takahashi, Renata Ferreira; Gryschek, Anna Luíza F P L; Izumi Nichiata, Lúcia Yasuko; Lacerda, Rúbia Aparecida; Ciosak, Suely Itsuko; Gir, Elucir; Padoveze, Maria Clara

    2010-05-01

    There is growing demand for the adoption of qualification systems for health care practices. This study is aimed at describing the development and validation of indicators for evaluation of biologic occupational risk control programs. The study involved 3 stages: (1) setting up a research team, (2) development of indicators, and (3) validation of the indicators by a team of specialists recruited to validate each attribute of the developed indicators. The content validation method was used for the validation, and a psychometric scale was developed for the specialists' assessment. A consensus technique was used, and every attribute that obtained a Content Validity Index of at least 0.75 was approved. Eight indicators were developed for the evaluation of the biologic occupational risk prevention program, with emphasis on accidents caused by sharp instruments and occupational tuberculosis prevention. The indicators included evaluation of the structure, process, and results at the prevention and biologic risk control levels. The majority of indicators achieved a favorable consensus regarding all validated attributes. The developed indicators were considered validated, and the method used for construction and validation proved to be effective. Copyright (c) 2010 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

  15. Stability-indicating UPLC method for determining related substances and degradants in dronedarone.

    Science.gov (United States)

    Pydimarry, Surya Prakash Rao; Cholleti, Vijay Kumar; Vangala, Ranga Reddy

    2014-08-01

    A simple, sensitive and reproducible method was developed on ultra-performance liquid chromatography coupled with photodiode array detection for the quantitative determination of dronedarone hydrochloride (DRO) in drug substance and pharmaceutical dosage forms. The method is applicable for the quantification of related substances and assays of drug substances. Chromatographic separation was achieved on Acquity UPLC BEH C8 100 mm, 2.1 mm and 1.7 µm columns, using gradient elution within a short run time of 10.0 min. The eluted compounds were monitored at 288 nm, the flow rate was 0.5 mL/min and the column oven temperature was maintained at 40°C. The resolution of DRO and 11 impurities (potentials and by-products) was greater than 2.0 for all pairs of components. The high correlation coefficient value (>0.9995) indicates the clear correlations between the concentrations of investigated compound and their peak areas within the test ranges. The repeatability and intermediate precision, expressed by the relative standard deviation, were less than 2.5%. The accuracy and validity of the method were further ascertained by performing recovery studies via a spike method. The accuracy of the method, expressed as relative error, was satisfactory. No interference was observed from concomitant substances normally added to the tablets. DRO was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. DRO was found to degrade significantly in acid and base stress conditions and to remain stable in thermal, photolytic degradation, oxidative and hydrolytic conditions. The degradation products were well resolved from primary peak and its impurities, proving that the method is stability indicating. The developed method was validated as per International Conference on Harmonization guidelines with respect to specificity, limit of detection, limit of quantification, linearity, accuracy, precision, solution stability and robustness

  16. Physics validation for design change of KSTAR passive stabilizer

    Science.gov (United States)

    Jeon, Y. M.; Kim, J. Y.; Oh, Y. K.; Yang, H. L.; Kim, W. C.; Kim, H. K.; Sabbagh, S. A.; Bialek, J. M.; Humphreys, D. A.; Welander, A. S.; Walker, M. L.

    2009-11-01

    Recently, the design of the passive stabilizer in KSTAR has been changed to improve controllability of the active control system and reduce the possibility of producing an additional error field. Originally the passive stabilizer in KSTAR was designed for RWM and vertical instability (or VDE) stabilizations and plasma startup efficiency, so that current bridges were designed and combined through 3D saddle-loop connections. Since the key design change is removing the current bridges, it's essential to assure satisfactory control performance for these instabilities under the design change. Control capability for n=1 RWM and achievable βN will be addressed as a primary goal of the passive stabilizer together with vertical instability control and effects on plasma startup. In addition, the changes in electro-magnetic force on conducting structures will be discussed qualitatively as a key engineering issue of the design change.

  17. Stability-Indicating HPLC Method for Simultaneous Determination of Chloramphenicol, Dexamethasone Sodium Phosphate and Tetrahydrozoline Hydrochloride in Ophthalmic Solution.

    Science.gov (United States)

    AlAani, Hashem; Alnukkary, Yasmin

    2016-03-01

    A simple stability-indicating RP-HPLC assay method was developed and validated for quantitative determination of Chloramphenicol, Dexamethasone Sodium Phosphate and Tetrahydrozoline Hydrochloride in ophthalmic solution in the presence of 2-amino-1-(4-nitrophenyl)propane-1,3-diol, a degradation product of Chloramphenicol, and Dexamethasone, a degradation product of Dexamethasone Sodium Phosphate. Effective chromatographic separation was achieved using C18 column (250 mm, 4.6 mm i.d., 5 μm) with isocratic mobile phase consisting of acetonitrile - phosphate buffer (pH 4.0; 0.05 M) (30:70, v/v) at a flow rate of 1 mL/minute. The column temperature was maintained at 40°C and the detection wavelength was 230 nm. The proposed HPLC procedure was statistically validated according to the ICH guideline, and was proved to be stability-indicating by resolution of the APIs from their forced degradation products. The developed method is suitable for the routine analysis as well as stability studies.

  18. [Preventable drug-related morbidity: determining valid indicators for primary care in Portugal].

    Science.gov (United States)

    Guerreiro, Mara Pereira; Cantrill, Judith A; Martins, Ana Paula

    2007-01-01

    Preventable drug-related morbidity (PDRM) indicators are operational measures of therapeutic risk management. These clinical indicators, which cover a wide range of drugs, combine process and outcome in the same instrument. They were developed in the US and have been validated for primary care settings in the US, UK and Canada. This study is part of a research programme; it aimed to determine a valid set of PDRM indicators for adult patients in primary care in Portugal. Face validity of 61 US and UK-derived indicators translated to Portuguese was preliminarily determined by means of a postal questionnaire using a purposive sample of four Portuguese pharmacists with different backgrounds. Preliminary content validity of indicators approved in the previous stage was determined by cross-checking each definition of PDRM with standard drug information sources in Portugal. Face and content validity of indicators yielded by preliminary work were then established by a 37 expert panel (20 community pharmacists and 17 general practitioners) using a two-round Delphi survey. Data were analysed using SPSS release 11.5. Nineteen indicators were ruled out in preliminary validation. Changes were made in the content of eight of the remaining 42 indicators; these were related to differences in the drugs being marketed and patterns of drug monitoring between countries. Thirty-five indicators were consensus approved as PDRM for adult patients in Portuguese primary care by the Delphi panel.

  19. Bioremediation of Contaminated Lake Sediments and Evaluation of Maturity Indicies as Indicators of Compost Stability

    Directory of Open Access Journals (Sweden)

    Y. Anjaneyulu

    2005-08-01

    Full Text Available Land contamination is one of the widely addressed problems, which is gaining importance in many developed and developing countries. International efforts are actively envisaged to remediate contaminated sites as a response to adverse health effects. Popular conventional methodologies only transfer the phase of the contaminant involving cost intensive liabilities besides handling risk of the hazardous waste. Physico-chemical methods are effective for specific wastes, but are technically complex and lack public acceptance for land remediation. “Bioremediation”, is one of the emerging low-cost technologies that offer the possibility to destroy various contaminants using natural biological activities. Resultant non -toxic end products due to the microbial activity and insitu applicability of this technology is gaining huge public acceptance. In the present study, composting is demonstrated as a bioremediation methodology for the stabilization of contaminated lake sediments of Hyderabad, A.P, India. Lake sediment contaminated with organics is collected from two stratums – upper (0.25 m and lower (0.5m to set up as Pile I (Upper and Pile II (Lower in the laboratory. Lime as a pretreatment to the lake sediments is carried out to ensure metal precipitation. The pretreated sediment is then mixed with organic and inorganic fertilizers like cow dung, poultry manure, urea and super phosphate as initial seeding amendments. Bulking agents like sawdust and other micronutrients are provided. Continuous monitoring of process control parameters like pH, moisture content, electrical conductivity, total volatile solids and various forms of nitrogen were carried out during the entire course of the study. The stability of the compost was evaluated by assessing maturity indices like C/N, Cw (water soluble carbon, CNw (Cw/Nw, nitrification index (NH4/NO-3, Cation Exchange Capacity (CEC, germination index, humification ratio, compost

  20. New Stability Indicating RP-HPLC Method for the Estimation of Cefpirome Sulphate in Bulk and Pharmaceutical Dosage Forms

    OpenAIRE

    Rao, Kareti Srinivasa; Kumar, Keshar Nargesh; Joydeep, Datta

    2011-01-01

    A simple stability indicating reversed-phase HPLC method was developed and subsequently validated for estimation of Cefpirome sulphate (CPS) present in pharmaceutical dosage forms. The proposed RP-HPLC method utilizes a LiChroCART-Lichrosphere100, C18 RP column (250 mm ? 4mm ? 5 ?m) in an isocratic separation mode with mobile phase consisting of methanol and water in the proportion of 50:50 % (v/v), at a flow rate 1ml/min, and the effluent was monitored at 270 nm. The retention time of CPS wa...

  1. Feature selection for anomaly–based network intrusion detection using cluster validity indices

    CSIR Research Space (South Africa)

    Naidoo, Tyrone

    2015-09-01

    Full Text Available data, which is rarely available in operational networks. It uses normalized cluster validity indices as an objective function that is optimized over the search space of candidate feature subsets via a genetic algorithm. Feature sets produced...

  2. Method validation and stability study of quercetin in topical emulsions

    Directory of Open Access Journals (Sweden)

    Rúbia Casagrande

    2009-01-01

    Full Text Available This study validated a high performance liquid chromatography (HPLC method for the quantitative evaluation of quercetin in topical emulsions. The method was linear within 0.05 - 200 μg/mL range with a correlation coefficient of 0.9997, and without interference in the quercetin peak. The detection and quantitation limits were 18 and 29 ng/mL, respectively. The intra- and inter-assay precisions presented R.S.D. values lower than 2%. An average of 93% and 94% of quercetin was recovered for non-ionic and anionic emulsions, respectively. The raw material and anionic emulsion, but not non-ionic emulsion, were stable in all storage conditions for one year. The method reported is a fast and reliable HPLC technique useful for quercetin determination in topical emulsions.

  3. A Critical Assessment of the Quality and Validity of Composite Indicators of Innovation

    Energy Technology Data Exchange (ETDEWEB)

    Vértesy, D.

    2016-07-01

    While it is generally accepted that monitoring innovation system performance requires a set of indicators, there is a constant debate on whether and how composite indices can be used to summarize them. This paper enters this discussion by assessing the validity and quality of the most commonly used composite indicators of innovation. In our framework, the validity of an index relates to the link between component indicators or aggregates and to the aspect(s) of national systems of innovation they seek to measure, while the quality of an indicator relates to its statistical properties. To better understand validity, we discuss how the evolution of the national system of innovation concept and its use in policy has shifted demand from an advocacy to more analytical functions of composite indicators of innovation.We next examine selected composite indicators of innovation (the WIPO-INSEAD’s Global Innovation Indicator, the Summary Innovation Index and Innovation Output Indicator of the European Commission and the Fraunhofer Innovation Index) in different contexts of external and internal validity and conduct global sensitivity analyses on them. Our policy-relevant findings highlight the need for analytically stronger composites of a more limited set of indicators.We also found significant quality differences across the indices, as some included components which explain little or none of the variance in composite scores, and were more sensitive to modeling choices. The indices studied differed in how validly they represented various innovation system functions and types of innovation, and showed information relevant for a broader or a more limited set of stakeholders. We argue that further development of innovation indicators should put more emphasis on identifying tradeoffs within innovation policy, and unintended consequences of innovative activities. (Author)

  4. Stability Indicating HPLC Method for Simultaneous Quantification of Trihexyphenidyl Hydrochloride, Trifluoperazine Hydrochloride and Chlorpromazine Hydrochloride from Tablet Formulation

    Directory of Open Access Journals (Sweden)

    P. Shetti

    2010-01-01

    Full Text Available A new, simple, precise, rapid, selective and stability indicating reversed-phase high performance liquid chromatographic (HPLC method has been developed and validated for simultaneous quantification of trihexyphenidyl hydrochloride, trifluoperazine hydrochloride and chlorpromazine hydrochloride from combined tablet formulation. The method is based on reverse-phase using C-18 (250×4.6 mm, 5 μm particle size column. The separation is achieved using isocratic elution by methanol and ammonium acetate buffer (1% w/v, pH 6.5 in the ratio of 85:15 v/v, pumped at flow rate 1.0 mL/min and UV detection at 215 nm. The column is maintained at 30 °C through out the analysis. This method gives baseline resolution. The total run time is 15 min. Stability indicating capability is established buy forced degradation experiment. The method is validated for specificity, accuracy, precision and linearity as per International conference of harmonisation (ICH. The method is accurate and linear for quantification of trihexyphenidyl hydrochloride, trifluoperazine hydrochloride and Chlorpromazine hydrochloride between 5 - 15 μg/mL, 12.5- 37.5 μg/mL and 62.5 - 187.5 μg/mL respectively.

  5. The Comparative Ratings and Indices as the Instruments of Measurement of Political Stability

    Directory of Open Access Journals (Sweden)

    Анна Олеговна Ярославцева

    2012-06-01

    Full Text Available In the given article the main comparative ratings and indices of measurement of political stability in different countries are analyzed. The author proves that despite the broad acknowledgement and heuristic value of these ratings they often lack objectivity when depict situation in Russia.

  6. The Predictive Validity of CBM Writing Indices for Eighth-Grade Students

    Science.gov (United States)

    Amato, Janelle M.; Watkins, Marley W.

    2011-01-01

    Curriculum-based measurement (CBM) is an alternative to traditional assessment techniques. Technical work has begun to identify CBM writing indices that are psychometrically sound for monitoring older students' writing proficiency. This study examined the predictive validity of CBM writing indices in a sample of 447 eighth-grade students.…

  7. Development and Validation of Evaluation Indicators for Teaching Competency in STEAM Education in Korea

    Science.gov (United States)

    Kim, Bang-Hee; Kim, Jinsoo

    2016-01-01

    The purpose of this study is to develop and validate the evaluation indicators of teaching competency in STEAM education. The teaching competencies in STEAM education were drawn up utilizing both behavioral event interview (BEI) and a literature review. The initial evaluation indicators were then reviewed by 15 experts and two pilot tests were…

  8. Waste Stabilization Ponds and Aerated Lagoons Performance in Removal of Wastewater Indicator Microorganisms

    Directory of Open Access Journals (Sweden)

    Seyed ali Ghasemi

    2013-08-01

    Full Text Available In this work, the performance of two treatment plants in the City of Mashhad, one with an aerated lagoons system and the other one with waste stabilization ponds system were evaluated in regard to their efficiency in reduction of pathogenic microorganisms. For this purpose, over a period of one year (with 15-days intervals, samples were taken from the influent and effluent (prior to disinfection unit of the above mentioned treatment plants. The samples then were analyzed for parameters such as temperature, pH, density of total coliforms (TC and fecal coliforms (FC, dissolved oxygen and total suspended solids concentration. The results indicated that the aerated lagoons system was much more efficient in removal of indicator bacteria than the waste stabilization ponds during autumn and winter periods. However during the summer months, the waste stabilization ponds showed a higher efficiency in this regard. In general, the waste stabilization ponds system reduced the density of TC and FC by 0.21-2.15 log10 and 0.20-2.33 log10, respectively. In contrast, the levels of reduction in aerated lagoons system were in the range of 0.29-2.03 log10 for TC and 0.42-2.40 log10 for FC. Results indicated that solar intensity, pH and dissolved oxygen concentration were found to be the most significant parameters that reduced the microorganisms population in waste stabilization ponds, While, in the aerated lagoons system, the dissolved oxygen concentration in aerated basin and solar intensity play the most important role. In general, without receiving an adequate disinfection, the effluent from waste stabilization ponds and aerated lagoons cannot provide the microbiological standards required for irrigation of agricultural crops.

  9. Validation of risk-based performance indicators: Safety system function trends

    International Nuclear Information System (INIS)

    Boccio, J.L.; Vesely, W.E.; Azarm, M.A.; Carbonaro, J.F.; Usher, J.L.; Oden, N.

    1989-10-01

    This report describes and applies a process for validating a model for a risk-based performance indicator. The purpose of the risk-based indicator evaluated, Safety System Function Trend (SSFT), is to monitor the unavailability of selected safety systems. Interim validation of this indicator is based on three aspects: a theoretical basis, an empirical basis relying on statistical correlations, and case studies employing 25 plant years of historical data collected from five plants for a number of safety systems. Results using the SSFT model are encouraging. Application of the model through case studies dealing with the performance of important safety systems shows that statistically significant trends in, and levels of, system performance can be discerned which thereby can provide leading indications of degrading and/or improving performances. Methods for developing system performance tolerance bounds are discussed and applied to aid in the interpretation of the trends in this risk-based indicator. Some additional characteristics of the SSFT indicator, learned through the data-collection efforts and subsequent data analyses performed, are also discussed. The usefulness and practicality of other data sources for validation purposes are explored. Further validation of this indicator is noted. Also, additional research is underway in developing a more detailed estimator of system unavailability. 9 refs., 18 figs., 5 tabs

  10. Content validation of the Tilburg Frailty Indicator from the perspective of frail elderly

    DEFF Research Database (Denmark)

    Andreasen, Jane; Lund, Hans; Aadahl, Mette

    2015-01-01

    validation. AIM: To validate the Tilburg Frailty Indicator on content in relation to the physical, psychological and social domain by exploring the experience of daily life of community dwelling frail elderly. METHODS: The design was a qualitative content validation study. The participants were acutely...... admitted frail elderly discharged to home and interviewed one week after discharge. A deductive content analysis, with categories structured in advance, was performed. RESULTS: A total of 422 meaning units were extracted from the transcriptions; 131 units related to the physical domain, 106 units...

  11. Certain Actions from the Functional Movement Screen Do Not Provide an Indication of Dynamic Stability

    Science.gov (United States)

    Lockie, Robert G.; Callaghan, Samuel J.; Jordan, Corrin A.; Luczo, Tawni M.; Jeffriess, Matthew D.; Jalilvand, Farzad; Schultz, Adrian B.

    2015-01-01

    Dynamic stability is an essential physical component for team sport athletes. Certain Functional Movement Screen (FMS) exercises (deep squat; left- and right-leg hurdle step; left- and right-leg in-line lunge [ILL]; left- and right-leg active straight-leg raise; and trunk stability push-up [TSPU]) have been suggested as providing an indication of dynamic stability. No research has investigated relationships between these screens and an established test of dynamic stability such as the modified Star Excursion Balance Test (mSEBT), which measures lower-limb reach distance in posteromedial, medial, and anteromedial directions, in team sport athletes. Forty-one male and female team sport athletes completed the screens and the mSEBT. Participants were split into high-, intermediate-, and low-performing groups according to the mean of the excursions when both the left and right legs were used for the mSEBT stance. Any between-group differences in the screens and mSEBT were determined via a one-way analysis of variance with Bonferroni post hoc adjustment (p in any of the screens, and only two positive correlations between the screens and the mSEBT (TSPU and right stance leg posteromedial excursion, r = 0.37; left-leg ILL and left stance leg posteromedial excursion, r = 0.46). The mSEBT clearly indicated participants with different dynamic stability capabilities. In contrast to the mSEBT, the selected FMS exercises investigated in this study have a limited capacity to identify dynamic stability in team sport athletes. PMID:26557187

  12. Certain Actions from the Functional Movement Screen Do Not Provide an Indication of Dynamic Stability

    Directory of Open Access Journals (Sweden)

    Lockie Robert G.

    2015-09-01

    Full Text Available Dynamic stability is an essential physical component for team sport athletes. Certain Functional Movement Screen (FMS exercises (deep squat; left- and right-leg hurdle step; left- and right-leg in-line lunge [ILL]; left- and right-leg active straight-leg raise; and trunk stability push-up [TSPU] have been suggested as providing an indication of dynamic stability. No research has investigated relationships between these screens and an established test of dynamic stability such as the modified Star Excursion Balance Test (mSEBT, which measures lower-limb reach distance in posteromedial, medial, and anteromedial directions, in team sport athletes. Forty-one male and female team sport athletes completed the screens and the mSEBT. Participants were split into high-, intermediate-, and low-performing groups according to the mean of the excursions when both the left and right legs were used for the mSEBT stance. Any between-group differences in the screens and mSEBT were determined via a one-way analysis of variance with Bonferroni post hoc adjustment (p < 0.05. Data was pooled for a correlation analysis (p < 0.05. There were no between-group differences in any of the screens, and only two positive correlations between the screens and the mSEBT (TSPU and right stance leg posteromedial excursion, r = 0.37; left-leg ILL and left stance leg posteromedial excursion, r = 0.46. The mSEBT clearly indicated participants with different dynamic stability capabilities. In contrast to the mSEBT, the selected FMS exercises investigated in this study have a limited capacity to identify dynamic stability in team sport athletes.

  13. The use of stability indices in predicting asphaltene problems in upstream and downstream oil operations

    Energy Technology Data Exchange (ETDEWEB)

    Asomaning, S. [Baker Petrolite, Sugar Land, TX (United States)

    2003-07-01

    A series of test methods have been developed to determine the stability of asphaltenes in crude oils. They were developed due to the high cost of remediating asphaltene deposition in offshore operations. This study described the characteristics of the Oliensis Spot Test, two saturates, aromatics, resins and asphaltenes (SARA)-based screens (the Colloidal Instability Index and Asphaltene-Resin ratio), a solvent titration method with near infrared radiation (NIR) solids detection, and live oil depressurization. Each method is used to predict the stability of asphaltenes in crude oils with different API gravity. A complete description of the test methods was provided along with experimental data. The effectiveness of the different tests in predicting the stability of asphaltenes in crude oils was also assessed. Results indicate that the prediction of a crude oil's tendency towards asphaltene precipitation was more accurate with the Colloidal Instability Index and the solvent titration method. Live oil depressurization proved to be very effective in predicting the stability of asphaltenes for light oils, where most stability tests fail. tabs., figs.

  14. Field Validation of the Stability Limit of a Multi MW Turbine

    Science.gov (United States)

    Kallesøe, Bjarne S.; Kragh, Knud A.

    2016-09-01

    Long slender blades of modern multi-megawatt turbines exhibit a flutter like instability at rotor speeds above a critical rotor speed. Knowing the critical rotor speed is crucial to a safe turbine design. The flutter like instability can only be estimated using geometrically non-linear aeroelastic codes. In this study, the estimated rotor speed stability limit of a 7 MW state of the art wind turbine is validated experimentally. The stability limit is estimated using Siemens Wind Powers in-house aeroelastic code, and the results show that the predicted stability limit is within 5% of the experimentally observed limit.

  15. Respiration and enzymatic activities as indicators of stabilization of sewage sludge composting.

    Science.gov (United States)

    Nikaeen, Mahnaz; Nafez, Amir Hossein; Bina, Bijan; Nabavi, BiBi Fatemeh; Hassanzadeh, Akbar

    2015-05-01

    The objective of this work was to study the evolution of physico-chemical and microbial parameters in the composting process of sewage sludge (SS) with pruning wastes (PW) in order to compare these parameters with respect to their applicability in the evaluation of organic matter (OM) stabilization. To evaluate the composting process and organic matter stability, different microbial activities were compared during composting of anaerobically digested SS with two volumetric ratios, 1:1 and 3:1 of PW:SS and two aeration techniques including aerated static piles (ASP) and turned windrows (TW). Dehydrogenase activity, fluorescein diacetate hydrolysis, and specific oxygen uptake rate (SOUR) were used as microbial activity indices. These indices were compared with traditional parameters, including temperature, pH, moisture content, organic matter, and C/N ratio. The results showed that the TW method and 3:1 (PW:SS) proportion was superior to the ASP method and 1:1 proportion, since the former accelerate the composting process by catalyzing the OM stabilization. Enzymatic activities and SOUR, which reflect microbial activity, correlated well with temperature fluctuations. Based on these results it appears that SOUR and the enzymatic activities are useful parameters to monitor the stabilization of SS compost. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. Stability Indicating RP-HPLC Method for Simultaneous Determination of Aspirin and Clopidrogel in Dosage Form

    International Nuclear Information System (INIS)

    Mohd Gousuddin; Sengupta, P.; Tripathi, V.D.; Das, A.

    2016-01-01

    Stability-indicating High Performance Liquid Chromatographic (HPLC) method was developed for simultaneous Aspirin and Clopidogrel, A Phenomenex Gemini C-18, 5 μm column having 250 mm x 4.6 mm i.d. in isocratic mode, with mobile phase containing buffer solution 0.3 % orthophosphoric acid : acetonitrile (65:35, v/v). The flow rate was 1 ml/ min and effluents were monitored at 266 nm. For linearity seven points calibration curve were obtained in a concentration range from 0.030-0.120 mg/ ml for aspirin and 0.015-0.060 mg/ ml for clopidogrel with correlation coefficient 0.9999. In the present study stability indicating HPLC method for the combination was tested by degrading the drugs together under various stress conditions like acid hydrolysis, base hydrolysis, oxidation, thermal and photolytic stress which is recommended by ICH guideline. (author)

  17. Performance Evaluation of Spectral Clustering Algorithm using Various Clustering Validity Indices

    OpenAIRE

    M. T. Somashekara; D. Manjunatha

    2014-01-01

    In spite of the popularity of spectral clustering algorithm, the evaluation procedures are still in developmental stage. In this article, we have taken benchmarking IRIS dataset for performing comparative study of twelve indices for evaluating spectral clustering algorithm. The results of the spectral clustering technique were also compared with k-mean algorithm. The validity of the indices was also verified with accuracy and (Normalized Mutual Information) NMI score. Spectral clustering algo...

  18. Development and initial validation of prescribing quality indicators for patients with chronic kidney disease

    NARCIS (Netherlands)

    Smits, Kirsten P J; Sidorenkov, Grigory; Bilo, Henk J G; Bouma, Margriet; van Ittersum, Frans J; Voorham, Jaco; Navis, Gerjan; Denig, Petra

    2016-01-01

    BACKGROUND: Quality assessment is a key element for improving the quality of care. Currently, a comprehensive indicator set for measuring the quality of medication treatment in patients with chronic kidney disease (CKD) is lacking. Our aim was to develop and validate a set of prescribing quality

  19. Feature selection for anomaly–based network intrusion detection using cluster validity indices

    CSIR Research Space (South Africa)

    Naidoo, T

    2015-09-01

    Full Text Available for Anomaly–Based Network Intrusion Detection Using Cluster Validity Indices Tyrone Naidoo_, Jules–Raymond Tapamoy, Andre McDonald_ Modelling and Digital Science, Council for Scientific and Industrial Research, South Africa 1tnaidoo2@csir.co.za 3...

  20. FINANCIAL STABILITY CROSS-REFERENCE BASED ON CALCULATION OF ABSOLUTE INDICATORS

    Directory of Open Access Journals (Sweden)

    Neli MUNTEAN

    2017-04-01

    Full Text Available The lack of applied methods in the national practice that would allow the realization of a complex analysis of financial stability in the corporate sector is one of the primary problems outlined in the process of organizing the fair and efficient management system of numerous factors that determine the financial performance in this sector. Under these circumstances, the need for a comprehensive analysis of financial stability in the corporate sector significantly increases, being an integrated part of the entity's financial situation analysis. The purpose and objectives of the article consist in the generalization of theoretical principles, financial stability analysis instruments and techniques in terms of absolute indicators adaptation to the norms and requirements of International Financial Reporting Standards, and in the comparative analysis of several methods that can be used to measure financial stability in the corporate sector. Thus, the following study, developed as a fusion of existing knowledge and authors own research, aims to provide a basis for reflection and discussion with theorists, practitioners and analysts within the financial field.

  1. Comparison of five cluster validity indices performance in brain [18 F]FET-PET image segmentation using k-means.

    Science.gov (United States)

    Abualhaj, Bedor; Weng, Guoyang; Ong, Melissa; Attarwala, Ali Asgar; Molina, Flavia; Büsing, Karen; Glatting, Gerhard

    2017-01-01

    Dynamic [ 18 F]fluoro-ethyl-L-tyrosine positron emission tomography ([ 18 F]FET-PET) is used to identify tumor lesions for radiotherapy treatment planning, to differentiate glioma recurrence from radiation necrosis and to classify gliomas grading. To segment different regions in the brain k-means cluster analysis can be used. The main disadvantage of k-means is that the number of clusters must be pre-defined. In this study, we therefore compared different cluster validity indices for automated and reproducible determination of the optimal number of clusters based on the dynamic PET data. The k-means algorithm was applied to dynamic [ 18 F]FET-PET images of 8 patients. Akaike information criterion (AIC), WB, I, modified Dunn's and Silhouette indices were compared on their ability to determine the optimal number of clusters based on requirements for an adequate cluster validity index. To check the reproducibility of k-means, the coefficients of variation CVs of the objective function values OFVs (sum of squared Euclidean distances within each cluster) were calculated using 100 random centroid initialization replications RCI 100 for 2 to 50 clusters. k-means was performed independently on three neighboring slices containing tumor for each patient to investigate the stability of the optimal number of clusters within them. To check the independence of the validity indices on the number of voxels, cluster analysis was applied after duplication of a slice selected from each patient. CVs of index values were calculated at the optimal number of clusters using RCI 100 to investigate the reproducibility of the validity indices. To check if the indices have a single extremum, visual inspection was performed on the replication with minimum OFV from RCI 100 . The maximum CV of OFVs was 2.7 × 10 -2 from all patients. The optimal number of clusters given by modified Dunn's and Silhouette indices was 2 or 3 leading to a very poor segmentation. WB and I indices suggested in

  2. Stability-Indicating Assay for the Determination of Pentobarbital Sodium in Liquid Formulations

    Directory of Open Access Journals (Sweden)

    Myriam Ajemni

    2015-01-01

    Full Text Available A stability-indicating assay by reversed-phase high performance liquid chromatography (RP-HPLC method was developed for the determination of pentobarbital sodium in oral formulations: a drug used for infant sedation in computed tomography (CT or magnetic resonance imaging (MRI scan. The chromatographic separation was achieved on a reversed-phase C18 column, using isocratic elution and a detector set at 214 nm. The optimized mobile phase consisted of a 0.01 M potassium buffer pH 3 and methanol (40 : 60, v/v. The flow rate was 1.0 mL/min and the run time of analysis was 5 min. The linearity of the method was demonstrated in the range of 5 to 250 μg/mL pentobarbital sodium solution (r2 = 0.999. The limit of detection and limit of quantification were 2.10 and 3.97 μg/mL, respectively. The intraday and interday precisions were less than 2.1%. Accuracy of the method ranged from 99.2 to 101.3%. Stability studies indicate that the drug is stable to sunlight and in aqueous solution. Accelerated pentobarbital sodium breakdown by strong alkaline, acidic, or oxidative stress produced noninterfering peaks. This method allows accurate and reliable determination of pentobarbital sodium for drug stability assay in pharmaceutical studies.

  3. Stability-Indicating RP-HPLC Method for Determination of Guanfacine Hydrochloride in Bulk Drugs and in Pharmaceutical Dosage Form

    Directory of Open Access Journals (Sweden)

    Vinod K. Ahirrao

    2011-04-01

    Full Text Available A novel stability-indicating RP-HPLC method was developed and validated for quantitative determination of guanfacine hydrochloride in bulk drug and in pharmaceutical dosage form. An isocratic, reversed phase HPLC method was developed to separate the drug from the degradation products, using Apollo, C18 (250mm x 4.6mm, 5µm column with mobile phase of 50mM Ammonium acetate (volatile buffer and acetonitrile (65:35, v/v. UV detection has been done at wavelength 220 nm. The guanfacine hydrochloride was subjected to the stress conditions of hydrolysis (acid, base, oxidation, photolysis and thermal degradation. The stressed samples were analyzed by the proposed method. The analyte peak shape was excellent. The described method shows excellent linearity over a range of 30 – 450 µg/mL. The correlation coefficient for guanfacine hydrochloride was 0.999. The limit of detection for Guanfacine hydrochloride is 0.011 µg/mL and the limit of quantification is 0.038 µg/mL respectively.Degradation was observed for guanfacine hydrochloride in base, thermal and in 30% H2O2 conditions. The drug was found to be stable in the other stress conditions attempted. The degradation products were well resolved from main peak. The percentage recovery of guanfacine hydrochloride was ranged from (99.2% to 100.5% in pharmaceutical dosage form. The developed method was validated with respect to the linearity, accuracy (recovery, precision, specificity and robustness. The forced degradation studies prove the stability indicating power of the method.

  4. Soil aggregate stability as an indicator for eco-engineering effectiveness?

    Science.gov (United States)

    Graf, Frank

    2015-04-01

    Eco-engineering aims at stabilising soil and slopes by applying technical and biological measures. Engineering structures are commonly well defined, immediately usable and operative, and their stability effects quantifiable and verifiable. Differently, the use of plants requires more restrictive boundary conditions and the protection potential is rarely easily calculable and develop-ing as a function of growth rate. Although the use of vegetation is widely appreciated and their stabilising effect recognised, there is an increasing demand on sound facts on its efficiency, in particular, in relation to time. Conclusively, a certain necessity has been recognised to monitor, assess and quantify the effectiveness of ecological restora-tion measures in order to facilitate the transfer of technology and knowledge. Recent theoretical models emphasize the im-portance of taking an integrated monitoring approach that considers multiple variables. However, limited financial and time resources often prevent such comprehensive assessments. A solution to this problem may be to use integrated indicators that reflect multiple aspects and, therefore, allow extensive information on ecosystem status to be gathered in a relatively short time. Among various other indicators, such as fractal dimension of soil particle size distribution or microbiological parameters, soil aggregate stability seems the most appropriate indicator with regard to protecting slopes from superficial soil failure as it is critical to both plant growth and soil structure. Soil aggregation processes play a crucial role in re-establishing soil structure and function and, conclusively, for successful and sustainable re-colonisation. Whereas the key role of soil aggregate stability in ecosystem functioning is well known concerning water, gas, and nutrient fluxes, only limited information is available with regard to soil mechanical and geotechnical aspects. Correspondingly, in the last couple of years several studies

  5. Validating the Heat Stress Indices for Using In Heavy Work Activities in Hot and Dry Climates.

    Science.gov (United States)

    Hajizadeh, Roohalah; Golbabaei, Farideh; Farhang Dehghan, Somayeh; Beheshti, Mohammad Hossein; Jafari, Sayed Mohammad; Taheri, Fereshteh

    2016-01-01

    Necessity of evaluating heat stress in the workplace, require validation of indices and selection optimal index. The present study aimed to assess the precision and validity of some heat stress indices and select the optimum index for using in heavy work activities in hot and dry climates. It carried out on 184 workers from 40 brick kilns workshops in the city of Qom, central Iran (as representative hot and dry climates). After reviewing the working process and evaluation the activity of workers and the type of work, environmental and physiological parameters according to standards recommended by International Organization for Standardization (ISO) including ISO 7243 and ISO 9886 were measured and indices were calculated. Workers engaged in indoor kiln experienced the highest values of natural wet temperature, dry temperature, globe temperature and relative humidity among studied sections (Pstress index (HSI) indices had the highest correlation with other physiological parameters among the other heat stress indices. Relationship between WBGT index and carotid artery temperature (r=0.49), skin temperature (r=0.319), and oral temperature (r=0.203) was statistically significant (P=0.006). Since WBGT index, as the most applicable index for evaluating heat stress in workplaces is approved by ISO, and due to the positive features of WBGT such as ease of measurement and calculation, and with respect to some limitation in application of HSI; WBGT can be introduced as the most valid empirical index of heat stress in the brick workshops.

  6. A combined sensitivity analysis and kriging surrogate modeling for early validation of health indicators

    International Nuclear Information System (INIS)

    Lamoureux, Benjamin; Mechbal, Nazih; Massé, Jean-Rémi

    2014-01-01

    To increase the dependability of complex systems, one solution is to assess their state of health continuously through the monitoring of variables sensitive to potential degradation modes. When computed in an operating environment, these variables, known as health indicators, are subject to many uncertainties. Hence, the stochastic nature of health assessment combined with the lack of data in design stages makes it difficult to evaluate the efficiency of a health indicator before the system enters into service. This paper introduces a method for early validation of health indicators during the design stages of a system development process. This method uses physics-based modeling and uncertainties propagation to create simulated stochastic data. However, because of the large number of parameters defining the model and its computation duration, the necessary runtime for uncertainties propagation is prohibitive. Thus, kriging is used to obtain low computation time estimations of the model outputs. Moreover, sensitivity analysis techniques are performed upstream to determine the hierarchization of the model parameters and to reduce the dimension of the input space. The validation is based on three types of numerical key performance indicators corresponding to the detection, identification and prognostic processes. After having introduced and formalized the framework of uncertain systems modeling and the different performance metrics, the issues of sensitivity analysis and surrogate modeling are addressed. The method is subsequently applied to the validation of a set of health indicators for the monitoring of an aircraft engine’s pumping unit

  7. Empirical validation of the New Zealand serious non-fatal injury outcome indicator for 'all injury'

    DEFF Research Database (Denmark)

    Cryer, Colin; Davie, Gabrielle S; Gulliver, Pauline J

    2018-01-01

    Our purpose was to empirically validate the official New Zealand (NZ) serious non-fatal 'all injury' indicator. To that end, we aimed to investigate the assumption that cases selected by the indicator have a high probability of admission. Using NZ hospital in-patient records, we identified serious...... injury diagnoses were calculated and inference made to New Zealand. The admission probabilities were 0.82, 0.89 and 0.90 for the regions of Canada, Denmark and Greece, respectively. This work provides evidence that the threshold set for the official New Zealand serious non-fatal injury indicator for 'all...

  8. Review article: what makes a good healthcare quality indicator? A systematic review and validation study.

    Science.gov (United States)

    Jones, Peter; Shepherd, Michael; Wells, Susan; Le Fevre, James; Ameratunga, Shanthi

    2014-04-01

    Indicators measuring aspects of performance to assess quality of care are often chosen arbitrarily. The present study aimed to determine what should be considered when selecting healthcare quality indicators, particularly focusing on the application to emergency medicine. Structured searches of electronic databases were supplemented by website searches of quality of care and benchmarking organisations, citation searches and discussions with experts. Candidate attributes of 'good' healthcare indicators were extracted independently by two authors. The validity of each attribute was independently assessed by 16 experts in quality of care and emergency medicine. Valid and reliable attributes were included in a critical appraisal tool for healthcare quality indicators, which was piloted by emergency medicine specialists. Twenty-three attributes were identified, and all were rated moderate to extremely important by an expert panel. The reliability was high: alpha = 0.98. Twelve existing tools explicitly stated a median (range) of 14 (8-17) attributes. A critical appraisal tool incorporating all the attributes was developed. This was piloted by four emergency medicine specialists who were asked to appraise and rank a set of six candidate indicators. Although using the tool took more time than implicit gestalt decision making: median (interquartile range) 190 (43-352) min versus 17.5 (3-34) min, their rankings changed after using the tool. To inform the appraisal of quality improvement indicators for emergency medicine, a comprehensive list of indicator attributes was identified, validated, developed into a tool and piloted. Although expert consensus is still required, this tool provides an explicit basis for discussions around indicator selection. © 2014 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  9. Stability Indicating LC-Method for Estimation of Paracetamol and Lornoxicam in Combined Dosage Form

    OpenAIRE

    Shah, Dimal A.; Patel, Neel J.; Baldania, Sunil L.; Chhalotiya, Usman K.; Bhatt, Kashyap K.

    2011-01-01

    A simple, specific and stability indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of paracetamol and lornoxicam in tablet dosage form. A Brownlee C-18, 5 μm column having 250×4.6 mm i.d. in isocratic mode, with mobile phase containing 0.05 M potassium dihydrogen phosphate:methanol (40:60, v/v) was used. The flow rate was 1.0 ml/min and effluents were monitored at 266 nm. The retention times of paracetamol and lornoxicam ...

  10. Reliability and validity of the Tilburg Frailty Indicator (TFI) among Chinese community-dwelling older people.

    Science.gov (United States)

    Dong, Lijuan; Liu, Na; Tian, Xiaoyu; Qiao, Xiaoxia; Gobbens, Robbert J J; Kane, Robert L; Wang, Cuili

    2017-11-01

    To translate the Tilburg Frailty Indicator (TFI) into Chinese and assess its reliability and validity. A sample of 917 community-dwelling older people, aged ≥60 years, in a Chinese city was included between August 2015 and March 2016. Construct validity was assessed using alternative measures corresponding to the TFI items, including self-rated health status (SRH), unintentional weight loss, walking speed, timed-up-and-go tests (TUGT), making telephone calls, grip strength, exhaustion, Short Portable Mental Status Questionnaire (SPMSQ), Geriatric Depression scale (GDS-15), emotional role, Adaptability Partnership Growth Affection and Resolve scale (APGAR) and Social Support Rating Scale (SSRS). Fried's phenotype and frailty index were measured to evaluate criterion validity. Adverse health outcomes (ADL and IADL disability, healthcare utilization, GDS-15, SSRS) were used to assess predictive (concurrent) validity. The internal consistency reliability was good (Cronbach's α=0.71). The test-retest reliability was strong (r=0.88). Kappa coefficients showed agreements between the TFI items and corresponding alternative measures. Alternative measures correlated as expected with the three domains of TFI, with an exclusion that alternative psychological measures had similar correlations with psychological and physical domains of the TFI. The Chinese TFI had excellent criterion validity with the AUCs regarding physical phenotype and frailty index of 0.87 and 0.86, respectively. The predictive (concurrent) validities of the adverse health outcomes and healthcare utilization were acceptable (AUCs: 0.65-0.83). The Chinese TFI has good validity and reliability as an integral instrument to measure frailty of older people living in the community in China. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. Scale indicators of social exchange relationships: a comparison of relative content validity.

    Science.gov (United States)

    Colquitt, Jason A; Baer, Michael D; Long, David M; Halvorsen-Ganepola, Marie D K

    2014-07-01

    Although social exchange theory has become one of the most oft-evoked theories in industrial and organizational psychology, there remains no consensus about how to measure its key mechanism: social exchange relationships (Blau, 1964). Drawing on Cropanzano and Byrne's (2000) review of contemporary social exchange theorizing, we examined the content validity of perceived support, exchange quality, affective commitment, trust, and psychological contract fulfillment as indicators of social exchange relationships. We used Hinkin and Tracey's (1999) quantitative approach to content validation, which asks participants to rate the correspondence between scale items and definitions of intended (and unintended) constructs. Our results revealed that some of the most frequently utilized indicators of social exchange relationships--perceived support and exchange quality--were significantly less content valid than rarely used options like affect-based trust. Our results also revealed that 2 direct measures--Bernerth, Armenakis, Feild, Giles, and Walker's (2007) scale and a scale created for this study--were content valid. We discuss the implications of these results for future applications of social exchange theory.

  12. Cognitive performance and electrophysiological indices of cognitive control: a validation study of conflict adaptation.

    Science.gov (United States)

    Clayson, Peter E; Larson, Michael J

    2012-05-01

    Psychiatric and neurologic disorders are associated with deficits in the postconflict recruitment of cognitive control. The primary aim of this study was to validate the relationship between cognitive functioning and indices of conflict adaptation. Event-related potentials were obtained from 89 healthy individuals who completed an Eriksen flanker task. Neuropsychological domains tested included memory, verbal fluency, and attention/executive functioning. Behavioral measures and N2 amplitudes showed significant conflict adaptation (i.e., previous-trial congruencies influenced current-trial measures). Higher scores on the attention/executive functioning and verbal fluency domains were associated with larger incongruent-trial N2 conflict adaptation; measures of cognitive functioning were not related to behavioral indices. This study provides initial validation of N2 conflict adaptation effects as cognitive function-related aspects of cognitive control. Copyright © 2012 Society for Psychophysiological Research.

  13. What do conscientious people do? Development and validation of the Behavioral Indicators of Conscientiousness (BIC)

    OpenAIRE

    Jackson, Joshua J.; Wood, Dustin; Bogg, Tim; Walton, Kate E.; Harms, Peter D.; Roberts, Brent W.

    2010-01-01

    Typical assessments of personality traits collapse behaviors, thoughts, and feelings into a single measure without distinguishing between these different manifestations. To address this lack of specification, the current study develops and validates a measure that assesses a number of broad behaviors associated with the personality trait of conscientiousness (the Behavioral Indicators of Conscientiousness; BIC). Findings suggest that the lower-order structure of conscientious behaviors is mos...

  14. Indicators of the relative availability of healthy versus unhealthy foods in supermarkets: a validation study

    OpenAIRE

    Vandevijvere, Stefanie; Mackenzie, Tara; Mhurchu, Cliona Ni

    2017-01-01

    Background In-store availability of healthy and unhealthy foods may influence consumer purchases. Methods used to measure food availability, however, vary widely. A simple, valid, and reliable indicator to collect comparable data on in-store food availability is needed. Methods Cumulative linear shelf length of and variety within 22 healthy and 28 unhealthy food groups, determined based on a comparison of three nutrient profiling systems, were measured in 15 New Zealand supermarkets. Inter-ra...

  15. [Validation and adhesion to GESIDA quality indicators in patients with HIV infection].

    Science.gov (United States)

    Riera, Melchor; Esteban, Herminia; Suarez, Ignacio; Palacios, Rosario; Lozano, Fernando; Blanco, Jose R; Valencia, Eulalia; Ocampo, Antonio; Amador, Concha; Frontera, Guillem; vonWichmann-de Miguel, Miguel Angel

    2016-01-01

    The objective of the study is to validate the relevant GESIDA quality indicators for HIV infection, assessing the reliability, feasibility and adherence to them. The reliability was evaluated using the reproducibility of 6 indicators in peer review, with the second observer being an outsider. The feasibility and measurement of the level of adherence to the 22 indicators was conducted with annual fragmented retrospective collection of information from specific databases or the clinical charts of the nine participating hospitals. Reliability was very high, with interobserver agreement levels higher than 95% in 5 of the 6 indicators. The median time to achieve the indicators ranged between 5 and 600minutes, but could be achieved progressively from specific databases, enabling obtaining them automatically. As regards adherence to the indicators related with the initial evaluation of the patients, instructions and suitability of the guidelines for ART, adherence to ART, follow-up in clinics, and achieve an undetectable HIV by PCR at week 48 of the ART. Indicators of quality related to the prevention of opportunistic infections and control of comorbidities, the standards set were not achieved, and significant heterogeneity was observed between hospitals. The GESIDA quality indicators of HIV infection enabled the relevant indicators to be feasibly and reliably measured, and should be collected in all the units that care for patients with HIV infection. Copyright © 2015 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  16. A rapid stability indicating LC-method for determination of praziquantel in presence of its pharmacopoeial impurities

    Directory of Open Access Journals (Sweden)

    Hisham Hashem

    2017-02-01

    Full Text Available This study reports for the first time about a stability indicating RP-HPLC method for quantitative determination of Praziquantel (PZQ in bulk powder and dosage form and in presence of its pharmacopoeial impurities. The chromatographic separation was carried out on (Caltrex AI® calixarene column, a relatively new packing material. Chromatography was done using an isocratic binary mobile phase consisting of ACN and 25 mM ammonium acetate (NH4Ac in the ratio of 40:60 at flow rate of 1 mL min−1, 30 °C and 210 nm wavelength for detection. The elution time of PZQ was found to be 6.15 ± 0.03 min. The method was validated for system suitability, linearity, precision, limits of detection and quantitation, specificity, stability and robustness. The robustness study was done for small changes in temperature, flow rate, wavelength of detection and % of ACN in mobile phase. Stability tests were done through exposure of the analyte solution to five different stress conditions: Reflux with 1 N HCl, reflux with 1 N NaOH, reflux with 30% H2O2, thermal degradation of powder and exposure to UV radiation. Limits of detection and quantification were found to be 0.56 and 1.70 μg mL−1, respectively. The recovery value of this method was 100.30% ± 1.10 and the reproducibility was within 1.31.

  17. Indications for spine surgery: validation of an administrative coding algorithm to classify degenerative diagnoses

    Science.gov (United States)

    Lurie, Jon D.; Tosteson, Anna N.A.; Deyo, Richard A.; Tosteson, Tor; Weinstein, James; Mirza, Sohail K.

    2014-01-01

    Study Design Retrospective analysis of Medicare claims linked to a multi-center clinical trial. Objective The Spine Patient Outcomes Research Trial (SPORT) provided a unique opportunity to examine the validity of a claims-based algorithm for grouping patients by surgical indication. SPORT enrolled patients for lumbar disc herniation, spinal stenosis, and degenerative spondylolisthesis. We compared the surgical indication derived from Medicare claims to that provided by SPORT surgeons, the “gold standard”. Summary of Background Data Administrative data are frequently used to report procedure rates, surgical safety outcomes, and costs in the management of spinal surgery. However, the accuracy of using diagnosis codes to classify patients by surgical indication has not been examined. Methods Medicare claims were link to beneficiaries enrolled in SPORT. The sensitivity and specificity of three claims-based approaches to group patients based on surgical indications were examined: 1) using the first listed diagnosis; 2) using all diagnoses independently; and 3) using a diagnosis hierarchy based on the support for fusion surgery. Results Medicare claims were obtained from 376 SPORT participants, including 21 with disc herniation, 183 with spinal stenosis, and 172 with degenerative spondylolisthesis. The hierarchical coding algorithm was the most accurate approach for classifying patients by surgical indication, with sensitivities of 76.2%, 88.1%, and 84.3% for disc herniation, spinal stenosis, and degenerative spondylolisthesis cohorts, respectively. The specificity was 98.3% for disc herniation, 83.2% for spinal stenosis, and 90.7% for degenerative spondylolisthesis. Misclassifications were primarily due to codes attributing more complex pathology to the case. Conclusion Standardized approaches for using claims data to accurately group patients by surgical indications has widespread interest. We found that a hierarchical coding approach correctly classified over 90

  18. What do conscientious people do? Development and validation of the Behavioral Indicators of Conscientiousness (BIC).

    Science.gov (United States)

    Jackson, Joshua J; Wood, Dustin; Bogg, Tim; Walton, Kate E; Harms, Peter D; Roberts, Brent W

    2010-08-01

    Typical assessments of personality traits collapse behaviors, thoughts, and feelings into a single measure without distinguishing between these different manifestations. To address this lack of specification, the current study develops and validates a measure that assesses a number of broad behaviors associated with the personality trait of conscientiousness (the Behavioral Indicators of Conscientiousness; BIC). Findings suggest that the lower-order structure of conscientious behaviors is mostly similar to the lower-order structure in extant trait measures. Furthermore, a daily diary method was used to validate the BIC against frequency counts of conscientious behavior. Overall, the results identify specific behaviors that conscientious individuals tend to perform and highlight possible advantages of this approach over broad trait assessment.

  19. Indicators validation for the improvement of environmental and social impact quantitative assessment

    International Nuclear Information System (INIS)

    Cloquell-Ballester, Vicente-Agustin; Cloquell-Ballester, Victor-Andres; Monterde-Diaz, Rafael; Santamarina-Siurana, Maria-Cristina

    2006-01-01

    Environmental and social impact quantitative assessment is an essential tool for the correct location of economic activities within the territory. The main problem of impact quantification lies in establishing the appropriateness of the instruments (indicators) utilised, such that their level of objectivity is the highest possible. To improve the quality of this kind of studies, the present contribution discusses this problematic question and its consequences and proposes a methodology for the validation of indicators. Finally, the methodology proposed is subjected to an observational and experimental test to demonstrate the feasibility of the proposal. The test is performed on four indicators, which are designed ad hoc to assess alternatives in industrial facility location problems where the decision-making process has to be supported by an environmental and social impact assessment

  20. Cross-validation of picture completion effort indices in personal injury litigants and disability claimants.

    Science.gov (United States)

    Davis, Jeremy J; McHugh, Tara S; Bagley, Amy D; Axelrod, Bradley N; Hanks, Robin A

    2011-12-01

    Picture Completion (PC) indices from the Wechsler Adult Intelligence Scale, Third Edition, were investigated as performance validity indicators (PVIs) in a sample referred for independent neuropsychological examination. Participants from an archival database were included in the study if they were between the ages of 18 and 65 and were administered at least two PVIs. Effort measure performance yielded groups that passed all or failed one measure (Pass; n= 95) and failed two or more PVIs (Fail-2; n= 61). The Pass group performed better on PC than the Fail-2 group. PC cut scores were compared in differentiating Pass and Fail-2 groups. PC raw score of ≤12 showed the best classification accuracy in this sample correctly classifying 91% of Pass and 41% of Fail-2 cases. Overall, PC indices show good specificity and low sensitivity for exclusive use as PVIs, demonstrating promise for use as adjunctive embedded measures.

  1. Development of Aa New Time Temperature Indicator for Enzymatic Validation of Pasteurization of Meat Products.

    Science.gov (United States)

    Brizio, Ana Paula Dutra Resem; Prentice, Carlos

    2015-06-01

    This paper presents the development of a new smart time-temperature indicator (TTI) of pasteurization whose operating principle is based on the complexation reaction between starch and iodine, and the subsequent action of an amylase on this complex causing its discoloration at a rate dependent on time and temperature of the medium. Laboratory simulations and tests in a manufacturing plant evaluated different enzyme concentrations in the TTI prototypes when exposed to pasteurization conditions. The results showed that the color response of the indicators was visually interpreted as adaptive to measurement using appropriate equipment, with satisfactory reliability in all conditions studied. The TTI containing 6.5% amylase was one whose best results were suited for use in validating the cooking of hams. When attached to the primary packaging of the product, this TTI indicated the pasteurization process inexpensively, easily, accurately, and nondestructively. © 2015 Institute of Food Technologists®

  2. Assessment of environmental stability of agroserous soil according to indicator of energy potential of organic substances

    Science.gov (United States)

    Murtazina, S. G.; Gaffarova, L. G.; Murtazin, MG

    2018-01-01

    Studies of the group and fractional composition of humus have determineded that the long-term use of soil (for 20 years) without the use of fertilizers (control) leads to a decrease in the content of humic acids and fulvic acids relative to the initial soil, which indicates an increase in mineralization of the soil humus. Under the influence of a long application of high doses of mineral fertilizers, the content of mobile fractions of humic and fulvic acids in the field rotation increases in the humus content. In systems of agriculture that are not balanced by organic matter, which are predominant in most farms of the Republic of Tatarstan, the use of very high doses of potassium fertilizers is not justified energetically. To compensate for losses of humus and its energy potential in calculating organic fertilizers on backgrounds with high doses of mineral fertilizers, the humification coefficients of organic residues should be increased by 30-40% during the rotational period of 5-6 years, which will reduce the loss of energy reserves and thereby improve the ecological stability of soils and the stability of agricultural landscapes

  3. Assessing Temporal Stability for Coarse Scale Satellite Moisture Validation in the Maqu Area, Tibet

    Science.gov (United States)

    Bhatti, Haris Akram; Rientjes, Tom; Verhoef, Wouter; Yaseen, Muhammad

    2013-01-01

    This study evaluates if the temporal stability concept is applicable to a time series of satellite soil moisture images so to extend the common procedure of satellite image validation. The area of study is the Maqu area, which is located in the northeastern part of the Tibetan plateau. The network serves validation purposes of coarse scale (25–50 km) satellite soil moisture products and comprises 20 stations with probes installed at depths of 5, 10, 20, 40, 80 cm. The study period is 2009. The temporal stability concept is applied to all five depths of the soil moisture measuring network and to a time series of satellite-based moisture products from the Advance Microwave Scanning Radiometer (AMSR-E). The in-situ network is also assessed by Pearsons's correlation analysis. Assessments by the temporal stability concept proved to be useful and results suggest that probe measurements at 10 cm depth best match to the satellite observations. The Mean Relative Difference plot for satellite pixels shows that a RMSM pixel can be identified but in our case this pixel does not overlay any in-situ station. Also, the RMSM pixel does not overlay any of the Representative Mean Soil Moisture (RMSM) stations of the five probe depths. Pearson's correlation analysis on in-situ measurements suggests that moisture patterns over time are more persistent than over space. Since this study presents first results on the application of the temporal stability concept to a series of satellite images, we recommend further tests to become more conclusive on effectiveness to broaden the procedure of satellite validation. PMID:23959237

  4. Stability indicating RP-HPLC method for simultaneous determination of pantoprazole sodium and itopride hydrochloride in bulk and capsule

    Directory of Open Access Journals (Sweden)

    Krishna R. Gupta

    2011-03-01

    Full Text Available A stability indicating reversed-phase HPLC method has been developed and subsequently validated for simultaneous estimation of pantoprazole present as pantoprazole sodium sesquihydrate (PSS, and itopride hydrochloride from their combination product. The proposed RP-HPLC method utilizes a Phenomenex® C18, 5 µm, 250 mm X 4.6 mm i.d. column, mobile phase consisting of phosphate buffer and acetonitrile in the proportion of 55:45 (v/v with apparent pH adjusted to 5.0, and UV detection at 289.0 nm using a UV detector. PAN, ITH and their combination drug product were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. The described method was linear over a range of 4-20 µg/mL for PAN and 15-75 µg/mL for ITH. The mean recoveries were 100.02 and 99.88 for PAN and ITH, respectively. Chromatographic peak purity data of PAN and ITH indicated no co-eluting peaks with the main peaks of drugs which demonstrated the specificity of assay method for their estimation in presence of degradation products. The proposed method can be useful in the quality control of combination drug products.

  5. Validity of maximal isometric knee extension strength measurements obtained via belt-stabilized hand-held dynamometry in healthy adults.

    Science.gov (United States)

    Ushiyama, Naoko; Kurobe, Yasushi; Momose, Kimito

    2017-11-01

    [Purpose] To determine the validity of knee extension muscle strength measurements using belt-stabilized hand-held dynamometry with and without body stabilization compared with the gold standard isokinetic dynamometry in healthy adults. [Subjects and Methods] Twenty-nine healthy adults (mean age, 21.3 years) were included. Study parameters involved right side measurements of maximal isometric knee extension strength obtained using belt-stabilized hand-held dynamometry with and without body stabilization and the gold standard. Measurements were performed in all subjects. [Results] A moderate correlation and fixed bias were found between measurements obtained using belt-stabilized hand-held dynamometry with body stabilization and the gold standard. No significant correlation and proportional bias were found between measurements obtained using belt-stabilized hand-held dynamometry without body stabilization and the gold standard. The strength identified using belt-stabilized hand-held dynamometry with body stabilization may not be commensurate with the maximum strength individuals can generate; however, it reflects such strength. In contrast, the strength identified using belt-stabilized hand-held dynamometry without body stabilization does not reflect the maximum strength. Therefore, a chair should be used to stabilize the body when performing measurements of maximal isometric knee extension strength using belt-stabilized hand-held dynamometry in healthy adults. [Conclusion] Belt-stabilized hand-held dynamometry with body stabilization is more convenient than the gold standard in clinical settings.

  6. Is the Readmission Rate a Valid Quality Indicator? A Review of the Evidence

    Science.gov (United States)

    Fischer, Claudia; Lingsma, Hester F.; Marang-van de Mheen, Perla J.; Kringos, Dionne S.; Klazinga, Niek S.; Steyerberg, Ewout W.

    2014-01-01

    Introduction Hospital readmission rates are increasingly used for both quality improvement and cost control. However, the validity of readmission rates as a measure of quality of hospital care is not evident. We aimed to give an overview of the different methodological aspects in the definition and measurement of readmission rates that need to be considered when interpreting readmission rates as a reflection of quality of care. Methods We conducted a systematic literature review, using the bibliographic databases Embase, Medline OvidSP, Web-of-Science, Cochrane central and PubMed for the period of January 2001 to May 2013. Results The search resulted in 102 included papers. We found that definition of the context in which readmissions are used as a quality indicator is crucial. This context includes the patient group and the specific aspects of care of which the quality is aimed to be assessed. Methodological flaws like unreliable data and insufficient case-mix correction may confound the comparison of readmission rates between hospitals. Another problem occurs when the basic distinction between planned and unplanned readmissions cannot be made. Finally, the multi-faceted nature of quality of care and the correlation between readmissions and other outcomes limit the indicator's validity. Conclusions Although readmission rates are a promising quality indicator, several methodological concerns identified in this study need to be addressed, especially when the indicator is intended for accountability or pay for performance. We recommend investing resources in accurate data registration, improved indicator description, and bundling outcome measures to provide a more complete picture of hospital care. PMID:25379675

  7. Is the readmission rate a valid quality indicator? A review of the evidence.

    Directory of Open Access Journals (Sweden)

    Claudia Fischer

    Full Text Available Hospital readmission rates are increasingly used for both quality improvement and cost control. However, the validity of readmission rates as a measure of quality of hospital care is not evident. We aimed to give an overview of the different methodological aspects in the definition and measurement of readmission rates that need to be considered when interpreting readmission rates as a reflection of quality of care.We conducted a systematic literature review, using the bibliographic databases Embase, Medline OvidSP, Web-of-Science, Cochrane central and PubMed for the period of January 2001 to May 2013.The search resulted in 102 included papers. We found that definition of the context in which readmissions are used as a quality indicator is crucial. This context includes the patient group and the specific aspects of care of which the quality is aimed to be assessed. Methodological flaws like unreliable data and insufficient case-mix correction may confound the comparison of readmission rates between hospitals. Another problem occurs when the basic distinction between planned and unplanned readmissions cannot be made. Finally, the multi-faceted nature of quality of care and the correlation between readmissions and other outcomes limit the indicator's validity.Although readmission rates are a promising quality indicator, several methodological concerns identified in this study need to be addressed, especially when the indicator is intended for accountability or pay for performance. We recommend investing resources in accurate data registration, improved indicator description, and bundling outcome measures to provide a more complete picture of hospital care.

  8. Validation of a high performance liquid chromatography method for the stabilization of epigallocatechin gallate.

    Science.gov (United States)

    Fangueiro, Joana F; Parra, Alexander; Silva, Amélia M; Egea, Maria A; Souto, Eliana B; Garcia, Maria L; Calpena, Ana C

    2014-11-20

    Epigallocatechin gallate (EGCG) is a green tea catechin with potential health benefits, such as anti-oxidant, anti-carcinogenic and anti-inflammatory effects. In general, EGCG is highly susceptible to degradation, therefore presenting stability problems. The present paper was focused on the study of EGCG stability in HEPES (N-2-hydroxyethylpiperazine-N'-2-ethanesulfonic acid) medium regarding the pH dependency, storage temperature and in the presence of ascorbic acid a reducing agent. The evaluation of EGCG in HEPES buffer has demonstrated that this molecule is not able of maintaining its physicochemical properties and potential beneficial effects, since it is partially or completely degraded, depending on the EGCG concentration. The storage temperature of EGCG most suitable to maintain its structure was shown to be the lower values (4 or -20 °C). The pH 3.5 was able to provide greater stability than pH 7.4. However, the presence of a reducing agent (i.e., ascorbic acid) was shown to provide greater protection against degradation of EGCG. A validation method based on RP-HPLC with UV-vis detection was carried out for two media: water and a biocompatible physiological medium composed of Transcutol®P, ethanol and ascorbic acid. The quantification of EGCG for purposes, using pure EGCG, requires a validated HPLC method which could be possible to apply in pharmacokinetic and pharmacodynamics studies. Copyright © 2014. Published by Elsevier B.V.

  9. Development and validation of an HPLC method for stability evaluation of nystatin

    Directory of Open Access Journals (Sweden)

    Ana Paola Prata Cione

    2010-06-01

    Full Text Available A liquid chromatography method for evaluating the stability of Nystatin (Nys in an ointment was developed and validated, since the traditional pharmacopeial microbiological methods are unable to indicate stability. The stress experiments showed that Nys was found to significantly degrade in alkaline and acidic conditions and also under oxidative stress. Lower levels of degradation were detected under heat and with the sample exposed to Xenon light. Resolutions higher than 2 for Nys and degradation products (DP chromatographic peaks were achieved by using an Inerstil ODS-3 column, isocratic elution with methanol:water and UV detection at 305 nm. The system was found to be linear over a range of 102 to 310 IU mL-1 and proved precise, since the RSD(% was 0.24% for the six replicates tested. The method also exhibited good levels of recovery (from 98.24% to 100.74%. Therefore, the validation fulfilled pharmacopeial requirements and the procedure was found to be reliable, precise, accurate and selective for determination of Nys and its degradation products.Um método indicador de estabilidade por cromatografia líquida foi desenvolvido e validado para a análise de Nistatina (Nys em uma pomada, uma vez que os métodos microbiológicos tradicionais não têm a habilidade de serem indicadores de estabilidade. A nistatina degradou significativamente em condições alcalinas e ácidas e também em meio oxidante. Quando a amostra foi exposta a luz de xenônio, foram observados menores níveis de degradação. A resolução entre os picos cromatográficos de Nys e seus produtos de degradação (PD foi maior que 2, utilizando-se uma coluna Inerstil ODS-3, eluição isocrática com metanol: água e detecção no UV em 305 nm. O sistema foi linear entre a faixa de 102 a 310 UI mL-1 e preciso uma vez que o DPR(% foi de 0,24% entre as seis replicatas testadas. Além disso, o método exibiu bons níveis de recuperação (de 98,24% a 100,74%. Consequentemente

  10. [Nurse's competence indicators: linguistic and cultural validation of the Nurse Competence Scale].

    Science.gov (United States)

    Finotto, Stefano; Cantarelli, William

    2009-01-01

    For some years, the clinical performance of new-graduate nurses, has been a leading topic in international scientific literature. In Italy there are many criticisms to basic education; ever since the basic education moved from the regional schools to the university, the main question that the teachers, the clinical nurses and the nursing managers are asking is whether the level of competence of new-graduates is appropriate to the demands of the world of work. Many criticisms have been addressed to the gap between theory and practice and between education and clinic. In Italy this has stimulated a debate towards a shared definition of competence and especially towards defining indicators that can assess/measure this phenomenon. The purposes of this study are: translating the indicators of Nurse Competence Scale (NCS) in the Italian language and test its validity and reliability; provide a tool for evaluating competence in Italian in order to use it in the context of our country. after a research on the Medline and Cinhal electronic data base, the NCS was identified and submitted to a process of linguistic translation (English-Italian-English) and to a process of validation using the test-retest methodology (test of Wilcoxon), the Intraclass Correlation Coefficient (ICC) and Cronbach's alpha. the evaluation given by nurses in the first administration does not differ significantly with those of the second one. For all sections of the NCS the ICC reports values greater than 0.85. the Nurse Competence Scale appears valid in its Italian version and it might be used to measure the competences of Italian nurses.

  11. TRACE/PARCS validation for BWR stability based on OECD/NEA Oskarshamn-2 benchmark

    International Nuclear Information System (INIS)

    Kozlowski, T.; Roshan, S.; Lefvert, T.; Downar, T.; Xu, Y.; Wysocki, A.; Ivanov, K.; Magedanz, J.; Hardgrove, M.; Netterbrant, C.; March-Leuba, J.; Hudson, N.; Sandervag, O.; Bergman, A.

    2011-01-01

    On February 25, 1999, the Oskarshamn-2 NPP experienced a stability event, which culminated in diverging power oscillations with decay ratio greater than 1.3. The event was successfully modeled by TRACE/PARCS coupled code system and the details of the modeling and solution are described in the paper. The obtained results show excellent agreement with the plant data, capturing the entire behavior of the transient including onset of instability, growth of oscillation (decay ratio) and the oscillation frequency. The event allows coupled code validation for BWR with a real, challenging stability event, which challenges accuracy of neutron kinetics (NK), thermal-hydraulics (TH) and TH/NK coupling. The success of this work has demonstrated the ability of 3-D coupled code systems to capture the complex behavior of BWR stability events. The problem is released as an international OECD/NEA benchmark, and it is the first benchmark based on measured plant data for a stability event with a DR greater than one. Interested participants are invited to contact authors for more information. (author)

  12. Experiment of Laser Pointing Stability on Different Surfaces to validate Micrometric Positioning Sensor

    CERN Document Server

    AUTHOR|(SzGeCERN)721924; Mainaud Durand, Helene; Piedigrossi, Didier; Sandomierski, Jacek; Sosin, Mateusz; Geiger, Alain; Guillaume, Sebastien

    2014-01-01

    CLIC requires 10 μm precision and accuracy over 200m for the pre-alignment of beam related components. A solution based on laser beam as straight line reference is being studied at CERN. It involves camera/shutter assemblies as micrometric positioning sensors. To validate the sensors, it is necessary to determine an appropriate material for the shutter in terms of laser pointing stability. Experiments are carried out with paper, metal and ceramic surfaces. This paper presents the standard deviations of the laser spot coordinates obtained on the different surfaces, as well as the measurement error. Our experiments validate the choice of paper and ceramic for the shutter of the micrometric positioning sensor. It also provides an estimate of the achievable precision and accuracy of the determination of the laser spot centre with respect to the shutter coordinate system defined by reference targets.

  13. Stability-indicating HPLC method for the determination of the stability of oxytocin parenteral solutions prepared in polyolefin bags.

    Science.gov (United States)

    Kaushal, G; Sayre, B E; Prettyman, T

    2012-02-01

    Oxytocin is very commonly used in clinical settings and is a nonapeptide hormone that stimulates the contraction of uterine smooth muscles. In this study the stability of extemporaneously compounded oxytocin solutions was investigated in polyolefin bags. The sterile preparations of oxytocin were compounded to the strength of 0.02 U/mL in accordance with United States Pharmacopeia (USP) standards. In order to carry out the stability testing of these parenteral products, the solutions were stored under three different temperature conditions of -20°C (frozen), 2-6°C (refrigerated), and 22-25°C (room temperature). Three solutions from each temperature were withdrawn and were assessed for stability on days 0, 7, 15, 21, and 30 as per the USP guidelines. The assay of oxytocin was examined by an HPLC method at each time point. No precipitation, cloudiness or color change was observed during this study at all temperatures. The assay content by HPLC revealed that oxytocin retains greater than at least 90% of the initial concentrations for 21 days. There was no significant change in pH and absorbance values for 21 days under all the conditions of storage. Oxytocin parenteral solutions in the final concentration of 0.02 U/mL and diluted in normal saline are stable for at least 30 days under frozen and refrigerated conditions for 30 days. At the room temperature, the oxytocin solutions were stable for at least 21 days. The stability analysis results show that the shelf-life of 21 days observed in this study was far better than their recommended expiration dates.

  14. Validation of a French version of the Sleep Condition Indicator: a clinical screening tool for insomnia disorder according to DSM-5 criteria.

    Science.gov (United States)

    Bayard, Sophie; Lebrun, Cindy; Maudarbocus, Khaalid Hassan; Schellaert, Vanessa; Joffre, Alicia; Ferrante, Esther; Le Louedec, Marie; Cournoulat, Alice; Gely-Nargeot, Marie-Christine; Luik, Annemarie I

    2017-12-01

    Insomnia disorder is frequent in the population, yet there is no French screening instrument available that is based on the updated DSM-5 criteria. We evaluated the validity and reliability of the French version of an insomnia screening instrument based on DSM-5 criteria, the Sleep Condition Indicator, in a population-based sample of adults. A total of 366 community-dwelling participants completed a face-to-face clinical interview to determine insomnia disorder against DSM-5 criteria and several questionnaires including the French Sleep Condition Indicator version. Three-hundred and twenty-nine participants completed the Sleep Condition Indicator again after 1 month. Statistical analyses were performed to determine the reliability, construct validity, divergent validity and temporal stability of the French translation of the Sleep Condition Indicator. In addition, an explanatory factor analysis was performed to assess the underlying structure. The internal consistency (α = 0.87) and temporal stability (r = 0.86, P French Sleep Condition Indicator were high. When using the previously defined cut-off value of ≤ 16, the area under the receiver operating characteristic curve was 0.93 with a sensitivity of 95% and a specificity of 75%. Additionally, good construct and divergent validity were demonstrated. The factor analyses showed a two-factor structure with a focus on sleep and daytime effects. The French version of the Sleep Condition Indicator demonstrates satisfactory psychometric properties while being a useful instrument in detecting cases of insomnia disorder, consistent with features of DSM-5, in the general population. © 2017 European Sleep Research Society.

  15. Stability-indicating liquid chromatographic method for quantification of new anti-epileptic drug lacosamide in bulk and pharmaceutical formulation

    Directory of Open Access Journals (Sweden)

    Chhalotiya Usmangani K.

    2012-01-01

    Full Text Available An isocratic stability indicating reversed-phase liquid chromatographic determination was developed for the quantitative determination of lacosamide in the pharmaceutical dosage form. A Hypersil C-18, 4.5μm column with mobile phase containing acetonitrile-water (20:80, v/v was used. The flow rate was 1.0 mL min-1 and effluents were monitored at 258 nm. The retention time of lacosamide was 8.9 min. The method was found to be linear in the concentration range of 5-100 μg/ml and the recovery was found to be in the range of 99.15 - 100.09 %. The limit of detection and limit of quantification were found to be 2 μg/ml and 5 μg/ml, respectively. Lacosamide stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation and dry heat degradation. The drug was found to be stable to the dry heat and acidic condition attempted. The proposed method was validated and successfully applied to the estimation of lacosamide in tablet dosage forms.

  16. New Stability Indicating RP-HPLC Method for the Estimation of Cefpirome Sulphate in Bulk and Pharmaceutical Dosage Forms.

    Science.gov (United States)

    Rao, Kareti Srinivasa; Kumar, Keshar Nargesh; Joydeep, Datta

    2011-01-01

    A simple stability indicating reversed-phase HPLC method was developed and subsequently validated for estimation of Cefpirome sulphate (CPS) present in pharmaceutical dosage forms. The proposed RP-HPLC method utilizes a LiChroCART-Lichrosphere100, C18 RP column (250 mm × 4mm × 5 μm) in an isocratic separation mode with mobile phase consisting of methanol and water in the proportion of 50:50 % (v/v), at a flow rate 1ml/min, and the effluent was monitored at 270 nm. The retention time of CPS was 2.733 min and its formulation was exposed to acidic, alkaline, photolytic, thermal and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. The described method was linear over a range of 0.5-200μg/ml. The percentage recovery was 99.46. F-test and t-test at 95% confidence level were used to check the intermediate precision data obtained under different experimental setups; the calculated value was found to be less than the critical value.

  17. Spatial scale of similarity as an indicator of metacommunity stability in exploited marine systems.

    Science.gov (United States)

    Shackell, Nancy L; Fisher, Jonathan A D; Frank, Kenneth T; Lawton, Peter

    2012-01-01

    The spatial scale of similarity among fish communities is characteristically large in temperate marine systems: connectivity is enhanced by high rates of dispersal during the larval/juvenile stages and the increased mobility of large-bodied fish. A larger spatial scale of similarity (low beta diversity) is advantageous in heavily exploited systems because locally depleted populations are more likely to be "rescued" by neighboring areas. We explored whether the spatial scale of similarity changed from 1970 to 2006 due to overfishing of dominant, large-bodied groundfish across a 300 000-km2 region of the Northwest Atlantic. Annually, similarities among communities decayed slowly with increasing geographic distance in this open system, but through time the decorrelation distance declined by 33%, concomitant with widespread reductions in biomass, body size, and community evenness. The decline in connectivity stemmed from an erosion of community similarity among local subregions separated by distances as small as 100 km. Larger fish, of the same species, contribute proportionally more viable offspring, so observed body size reductions will have affected maternal output. The cumulative effect of nonlinear maternal influences on egg/larval quality may have compromised the spatial scale of effective larval dispersal, which may account for the delayed recovery of certain member species. Our study adds strong support for using the spatial scale of similarity as an indicator of metacommunity stability both to understand the spatial impacts of exploitation and to refine how spatial structure is used in management plans.

  18. Stability-Indicating HPTLC Method for Simultaneous Estimation of Flurbiprofen and Chloramphenicol in Ophthalmic Solution.

    Science.gov (United States)

    Sadakwala, Vaishnavi M; Chauhan, Renu S; Shah, Shailesh A; Shah, Dinesh R

    2016-01-01

    A specific, accurate and reproducible stability-indicating high performance thin layer chromatography (HPTLC) method was developed for the estimation of flurbiprofen and chloramphenicol in the presence of their degradation products. Degradation studies of both the drugs were carried out in acidic, alkaline, neutral, oxidative, photolytic and thermal stress conditions. Separation was performed on thin layer chromatography plate precoated with silica gel 60 F254 using ethyl acetate : n-hexane : methanol : tri-ethyl amine (5 : 4 : 2 : 0.5, v/v/v/v). Spots at retention factor 0.29 and 0.62 were recognized as flurbiprofen and chloramphenicol, respectively, and were quantified through densitometric measurements at wavelength 267 nm. Method was found to be linear over the concentration range 12-60 ng/spot with correlation coefficient of 0.9997 for flurbiprofen and 200-1,000 ng/spot with correlation coefficient of 0.9977 for chloramphenicol. The proposed method was applied to the estimation of flurbiprofen and chloramphenicol in commercial ophthalmic formulation. The developed HPTLC method can be applied for routine analysis of flurbiprofen and chloramphenicol in the presence of their degradation products in their individual as well as combined pharmaceutical formulations. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  19. Stabilization

    Directory of Open Access Journals (Sweden)

    Muhammad H. Al-Malack

    2016-07-01

    Full Text Available Fuel oil flyash (FFA produced in power and water desalination plants firing crude oils in the Kingdom of Saudi Arabia is being disposed in landfills, which increases the burden on the environment, therefore, FFA utilization must be encouraged. In the current research, the effect of adding FFA on the engineering properties of two indigenous soils, namely sand and marl, was investigated. FFA was added at concentrations of 5%, 10% and 15% to both soils with and without the addition of Portland cement. Mixtures of the stabilized soils were thoroughly evaluated using compaction, California Bearing Ratio (CBR, unconfined compressive strength (USC and durability tests. Results of these tests indicated that stabilized sand mixtures could not attain the ACI strength requirements. However, marl was found to satisfy the ACI strength requirement when only 5% of FFA was added together with 5% of cement. When the FFA was increased to 10% and 15%, the mixture’s strength was found to decrease to values below the ACI requirements. Results of the Toxicity Characteristics Leaching Procedure (TCLP, which was performed on samples that passed the ACI requirements, indicated that FFA must be cautiously used in soil stabilization.

  20. Development and Validation of a Stability-Indicating LC-UV Method ...

    African Journals Online (AJOL)

    Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, 300001 Nigeria. All rights reserved. Available online at http://www.tjpr.org ... dihydrochloride in solid dosage forms. Methods: Chromatographic separation was achieved on Grace Smart C18 column (250 × 4.6 mm, 5 μm) using an isocratic mobile ...

  1. Development and validation of a thin-layer chromatography method for stability studies of naproxen

    International Nuclear Information System (INIS)

    Rodriguez Hernandez, Yaslenis; Suarez Perez, Yania; Garcia Pulpeiro, Oscar; Rodriguez Borges, Tania

    2011-01-01

    The validation of an analytical method was carried out to be applied to the stability studies of the future formulations of naproxen suppositories for infant and adult use. The factors which mostly influenced in the naproxen stability were determined, the major degradation occurred in oxidizing acid medium and by action of light. The possible formation of esters between the free carboxyl group present in naproxen and the glyceryl monoestereate present in the base was identified as one of the degradation paths in the new formulation. The results were satisfactory. A thin-layer chromatography-based method was developed as well as the best chromatographic conditions were selected. GF 254 silica gel plates and ultraviolet developer at 254 nm were employed. Three solvent systems were evaluated of which A made up of glacial acetic: tetrahydrofurane:toluene (3:9:90 v/v/v)allowed adequate resolution between the analyte and the possible degradation products, with detection limit of 1 μg. The use of the suggested method was restricted to the identification of possible degradation products just for qualitative purposes and not as final test. The method proved to be sensitive and selective enough to be applied for the stated objective, according to the validation results

  2. Experiments of Laser Pointing Stability in Air and in Vacuum to Validate Micrometric Positioning Sensor

    CERN Document Server

    Stern, G; Piedigrossi, D; Sandomierski, J; Sosin, M; Geiger, A; Guillaume, S

    2014-01-01

    Aligning accelerator components over 200m with 10 μm accuracy is a challenging task within the Compact Linear Collider (CLIC) study. A solution based on laser beam in vacuum as straight line reference is proposed. The positions of the accelerator’s components are measured with respect to the laser beam by sensors made of camera/shutter assemblies. To validate these sensors, laser pointing stability has to be studied over 200m. We perform experiments in air and in vacuum in order to know how laser pointing stability varies with the distance of propagation and with the environment. The experiments show that the standard deviations of the laser spot coordinates increase with the distance of propagation. They also show that the standard deviations are much smaller in vacuum (8 μm at 35m) than in air (2000 μm at 200m). Our experiment validates the concept of laser beam in vacuum with camera/shutter assembly for micrometric positioning over 35m. It also gives an estimation of the achievable precision.

  3. Validation of SIMULATE-3K for stability analysis of Laguna Verde nuclear plant

    Energy Technology Data Exchange (ETDEWEB)

    Castillo, Rogelio, E-mail: rogelio.castillo@inin.gob.mx [Instituto Nacional de Investigaciones Nucleares, Carretera México-Toluca s/n, La Marquesa, Ocoyoacac, Estado de México 52750 (Mexico); Alonso, Gustavo, E-mail: gustavo.alonso@inin.gob.mx [Instituto Nacional de Investigaciones Nucleares, Carretera México-Toluca s/n, La Marquesa, Ocoyoacac, Estado de México 52750 (Mexico); Instituto Politecnico Nacional, Unidad Profesional Adolfo Lopez Mateos, Ed. 9, Lindavista, D.F. 07300 (Mexico); Ramírez, J. Ramón, E-mail: ramon.ramirez@inin.gob.mx [Instituto Nacional de Investigaciones Nucleares, Carretera México-Toluca s/n, La Marquesa, Ocoyoacac, Estado de México 52750 (Mexico)

    2013-12-15

    Highlights: • Neutronic/thermal hydraulic event in Laguna Verde is modeled. • A good agreement is obtained between SIMULATE-3K results and data plant for frequency and DR. • Other noise analysis techniques are used for the same purpose with good agreement. • Validation of SIMULATE-3K for stability analysis of Laguna Verde is confirmed - Abstract: Boiling Water Reactors are two phase flow systems which are susceptible to different types of flow instabilities. Among these are the coupled neutronic/thermal-hydraulic instabilities, these may compromise established fuel safety limits. These instabilities are characterized by periodic core-power and hydraulic oscillations. SIMULATE-3K code has been tested for stability analysis for several benchmarks, however to qualify the SIMULATE-3K code for a particular power plant a specific reactor plant analysis must be done. In this paper, the plant model of Laguna Verde Nuclear Power Plant is built and SIMULATE-3K is tested against the 1995 coupled neutronic/thermal-hydraulic instability event of Laguna Verde. Results obtained show the adequacy of this code to specific Laguna Verde power plant stability analysis.

  4. Validity of Mind Monitoring System as a Mental Health Indicator using Voice

    Directory of Open Access Journals (Sweden)

    Naoki Hagiwara

    2017-05-01

    Full Text Available We have been developing a method of evaluating the mental health condition of a person based on the sound of their voice. Currently, we have applied this technology to create a smartphone application that shows the vitality and the mental activity as mental health condition indices. Using voice to measure one’s mental health condition is a non-invasive method. Moreover, this application can be used continually through a smartphone call. Unlike a periodic checkup every year, it could be used for monitoring on a daily basis. The purpose of this study is to compare the vitality index to the widely used Beck depression inventory (BDI and to evaluate its validity. This experiment was conducted at the Center of Innovation Program of the University of Tokyo with 50 employees of one corporation as participants between early December 2015 and early February 2016. Each participant was given a smartphone with our application that recorded his/her voice automatically during calls. In addition, the participants had to read and record a fixed phrase daily. The BDI test was conducted at the beginning of the experimental period. The vitality index was calculated based on the voice data collected during the first two weeks of the experiment and was considered as the vitality index at the time when the BDI test was conducted. When the vitality and the mental activity indicators were compared to BDI score, we found that there was a negative correlation between the BDI score and these indices. Additionally, these indices were a useful method to discriminate a participant of high risk of disease with a high BDI score. And the mental activity index shows a higher performance than the vitality index.

  5. Sound quality indicators for urban places in Paris cross-validated by Milan data.

    Science.gov (United States)

    Ricciardi, Paola; Delaitre, Pauline; Lavandier, Catherine; Torchia, Francesca; Aumond, Pierre

    2015-10-01

    A specific smartphone application was developed to collect perceptive and acoustic data in Paris. About 3400 questionnaires were analyzed, regarding the global sound environment characterization, the perceived loudness of some emergent sources and the presence time ratio of sources that do not emerge from the background. Sound pressure level was recorded each second from the mobile phone's microphone during a 10-min period. The aim of this study is to propose indicators of urban sound quality based on linear regressions with perceptive variables. A cross validation of the quality models extracted from Paris data was carried out by conducting the same survey in Milan. The proposed sound quality general model is correlated with the real perceived sound quality (72%). Another model without visual amenity and familiarity is 58% correlated with perceived sound quality. In order to improve the sound quality indicator, a site classification was performed by Kohonen's Artificial Neural Network algorithm, and seven specific class models were developed. These specific models attribute more importance on source events and are slightly closer to the individual data than the global model. In general, the Parisian models underestimate the sound quality of Milan environments assessed by Italian people.

  6. Software Verification and Validation Report for the 244-AR Vault Interim Stabilization Ventilation System

    International Nuclear Information System (INIS)

    YEH, T.

    2002-01-01

    This document reports on the analysis, testing and conclusions of the software verification and validation for the 244-AR Vault Interim Stabilization ventilation system. Automation control system will use the Allen-Bradley software tools for programming and programmable logic controller (PLC) configuration. The 244-AR Interim Stabilization Ventilation System will be used to control the release of radioactive particles to the environment in the containment tent, located inside the canyon of the 244-AR facility, and to assist the waste stabilization efforts. The HVAC equipment, ducts, instruments, PLC hardware, the ladder logic executable software (documented code), and message display terminal are considered part of the temporary ventilation system. The system consists of a supply air skid, temporary ductwork (to distribute airflow), and two skid-mounted, 500-cfm exhausters connected to the east filter building and the vessel vent system. The Interim Stabilization Ventilation System is a temporary, portable ventilation system consisting of supply side and exhaust side. Air is supplied to the containment tent from an air supply skid. This skid contains a constant speed fan, a pre-filter, an electric heating coil, a cooling coil, and a constant flow device (CFD). The CFD uses a passive component that allows a constant flow of air to pass through the device. Air is drawn out of the containment tent, cells, and tanks by two 500-cfm exhauster skids running in parallel. These skids are equipped with fans, filters, stack, stack monitoring instrumentation, and a PLC for control. The 500CFM exhaust skids were fabricated and tested previously for saltwell pumping activities. The objective of the temporary ventilation system is to maintain a higher pressure to the containment tent, relative to the canyon and cell areas, to prevent contaminants from reaching the containment tent

  7. Stability-indicating methods for the determination of racecadotril in the presence of its degradation products.

    Science.gov (United States)

    Mohamed, Afaf O; Fouad, Manal M; Hasan, Mona M; Abdel Razeq, Sawsan A; Elsherif, Zeinab A

    2009-12-01

    Three stability-indicating methods were developed for the determination of racecadotril (RCT) in the presence of its alkaline degradation products. The first was an HPLC method in which efficient chromatographic separation was achieved on a C18 analytical column and a mobile phase of acetonitrile-methanol-water-acetic acid (52:28:20:0.1, v/v/v/v). Linearity was obtained in the range of 4-40 microg/mL with mean accuracy of 99.5 +/- 0.88%. The second method was a densitometric evaluation of thin-layer chromatograms of the drug using a mobile phase of isopropanol-ammonia (33%)-n-hexane (9:0.5:20, v/v/v). The chromatograms were scanned at 232 nm, a wavelength at which RCT can be readily separated from its degradation products and determined in the range of 2-20 microg per spot with mean accuracy of 99.5 +/- 0.56%. The third method is based on the use of first-derivative spectrophotometry (D1) at 240 nm, and the drug was determined in the range of 5-40 microg/mL with mean accuracy of 99.2 +/- 1.02%. The three methods provided satisfactory recovery of the intact drug (100.8 +/- 0.82, 100.4 +/- 0.55, and 99.9 +/- 0.72%, respectively) in the presence of up to 90% of its degradation products. Determination was also successful when analyzing RCT in a formulation in the form of acetorphan packets. Results were statistically analyzed and found to be in accordance with those given by a reported method.

  8. Feasibility and validity of International Classification of Diseases based case mix indices.

    Science.gov (United States)

    Yang, Che-Ming; Reinke, William

    2006-10-06

    Severity of illness is an omnipresent confounder in health services research. Resource consumption can be applied as a proxy of severity. The most commonly cited hospital resource consumption measure is the case mix index (CMI) and the best-known illustration of the CMI is the Diagnosis Related Group (DRG) CMI used by Medicare in the U.S. For countries that do not have DRG type CMIs, the adjustment for severity has been troublesome for either reimbursement or research purposes. The research objective of this study is to ascertain the construct validity of CMIs derived from International Classification of Diseases (ICD) in comparison with DRG CMI. The study population included 551 acute care hospitals in Taiwan and 2,462,006 inpatient reimbursement claims. The 18th version of GROUPER, the Medicare DRG classification software, was applied to Taiwan's 1998 National Health Insurance (NHI) inpatient claim data to derive the Medicare DRG CMI. The same weighting principles were then applied to determine the ICD principal diagnoses and procedures based costliness and length of stay (LOS) CMIs. Further analyses were conducted based on stratifications according to teaching status, accreditation levels, and ownership categories. The best ICD-based substitute for the DRG costliness CMI (DRGCMI) is the ICD principal diagnosis costliness CMI (ICDCMI-DC) in general and in most categories with Spearman's correlation coefficients ranging from 0.938-0.462. The highest correlation appeared in the non-profit sector. ICD procedure costliness CMI (ICDCMI-PC) outperformed ICDCMI-DC only at the medical center level, which consists of tertiary care hospitals and is more procedure intensive. The results of our study indicate that an ICD-based CMI can quite fairly approximate the DRGCMI, especially ICDCMI-DC. Therefore, substituting ICDs for DRGs in computing the CMI ought to be feasible and valid in countries that have not implemented DRGs.

  9. Feasibility and validity of International Classification of Diseases based case mix indices

    Directory of Open Access Journals (Sweden)

    Reinke William

    2006-10-01

    Full Text Available Abstract Background Severity of illness is an omnipresent confounder in health services research. Resource consumption can be applied as a proxy of severity. The most commonly cited hospital resource consumption measure is the case mix index (CMI and the best-known illustration of the CMI is the Diagnosis Related Group (DRG CMI used by Medicare in the U.S. For countries that do not have DRG type CMIs, the adjustment for severity has been troublesome for either reimbursement or research purposes. The research objective of this study is to ascertain the construct validity of CMIs derived from International Classification of Diseases (ICD in comparison with DRG CMI. Methods The study population included 551 acute care hospitals in Taiwan and 2,462,006 inpatient reimbursement claims. The 18th version of GROUPER, the Medicare DRG classification software, was applied to Taiwan's 1998 National Health Insurance (NHI inpatient claim data to derive the Medicare DRG CMI. The same weighting principles were then applied to determine the ICD principal diagnoses and procedures based costliness and length of stay (LOS CMIs. Further analyses were conducted based on stratifications according to teaching status, accreditation levels, and ownership categories. Results The best ICD-based substitute for the DRG costliness CMI (DRGCMI is the ICD principal diagnosis costliness CMI (ICDCMI-DC in general and in most categories with Spearman's correlation coefficients ranging from 0.938-0.462. The highest correlation appeared in the non-profit sector. ICD procedure costliness CMI (ICDCMI-PC outperformed ICDCMI-DC only at the medical center level, which consists of tertiary care hospitals and is more procedure intensive. Conclusion The results of our study indicate that an ICD-based CMI can quite fairly approximate the DRGCMI, especially ICDCMI-DC. Therefore, substituting ICDs for DRGs in computing the CMI ought to be feasible and valid in countries that have not

  10. Safety Performance Indicator for alcohol in road accidents--international comparison, validity and data quality.

    Science.gov (United States)

    Assum, Terje; Sørensen, Michael

    2010-03-01

    Safety Performance Indicators, SPIs, are developed for various areas within road safety such as speed, car occupant protection, alcohol and drugs, vehicle safety, etc. SPIs can be used to indicate the road safety situation and to compare road safety performance between countries and over time and to understand the process leading to accidents, helping to select the measures to reduce them. This article describes an alcohol SPI defined as the percentage of fatalities resulting from accidents involving at least one driver impaired by alcohol. The calculation of the alcohol SPI for 26 European countries shows that the SPI varies from 4.4% in Bulgaria to 72.2% in Italy. These results raise the question if the results reflect the real situation or if there is a methodological explanation. To answer this question three different studies were carried out: comparison with other alcohol SPIs, in-depth studies of data quality in seven selected countries, and a study of correlations between the SPI and influencing factors. These studies indicate clearly that there is a need to improve quality of the data used for the alcohol SPI. Most importantly, the total number of drivers involved in fatal accidents, the number tested for alcohol and the number not tested, should be reported, in addition to the number of alcohol positive and negative drivers among those tested. Until these improvements are made, the validity of this SPI seems poor and comparison of the alcohol SPI results across countries should be made with caution. Copyright 2009 Elsevier Ltd. All rights reserved.

  11. Analytical method validation for quality control and the study of the 50 mg Propylthiouracil stability

    International Nuclear Information System (INIS)

    Valdes Bendoyro, Maria Olga; Garcia Penna, Caridad Margarita; Fernandez, Juan Lugones; Garcia Borges, Lisandra; Martinez Espinosa, Vivian

    2010-01-01

    A high-performance liquid chromatography analytical method was developed and validated for the quality control and stability studies of 50 mg Propylthiouracil tablets. Method is based in active principle separation through a 100 RP-18 RP-18 (5 μm) (250 x 4 mm) Lichrospher chromatography with UV detection to 272 nm, using a mobile phase composed by a ungaseous mixture of a 0.025 M buffer solution-monobasic potassium phosphate to pH= 4,6 ad acetonitrile in a 80:20 ratio with a flux speed of 0,5 mL/min. Analytical method was linear, precise, specific and exact in the study concentrations interval

  12. Validity and Stability of the Decisional Balance for Sun Protection Inventory

    Directory of Open Access Journals (Sweden)

    Hui-Qing Yin

    2014-01-01

    Full Text Available The 8-item Decisional Balance for sun protection inventory (SunDB assesses the relative importance of the perceived advantages (Pros and disadvantages (Cons of sun protective behaviors. This study examined the psychometric properties of the SunDB measure, including invariance of the measurement model, in a population-based sample of N=1336 adults. Confirmatory factor analyses supported the theoretically based 2-factor (Pros, Cons model, with high internal consistencies for each subscale (α≥.70. Multiple-sample CFA established that this factor pattern was invariant across multiple population subgroups, including gender, racial identity, age, education level, and stage of change subgroups. Multivariate analysis by stage of change replicated expected patterns for SunDB (Pros η2=.15, Cons η2=.02. These results demonstrate the internal and external validity and measurement stability of the SunDB instrument in adults, supporting its use in research and intervention.

  13. A Validation of Object-Oriented Design Metrics as Quality Indicators

    Science.gov (United States)

    Basili, Victor R.; Briand, Lionel C.; Melo, Walcelio

    1997-01-01

    This paper presents the results of a study in which we empirically investigated the suits of object-oriented (00) design metrics introduced in another work. More specifically, our goal is to assess these metrics as predictors of fault-prone classes and, therefore, determine whether they can be used as early quality indicators. This study is complementary to the work described where the same suite of metrics had been used to assess frequencies of maintenance changes to classes. To perform our validation accurately, we collected data on the development of eight medium-sized information management systems based on identical requirements. All eight projects were developed using a sequential life cycle model, a well-known 00 analysis/design method and the C++ programming language. Based on empirical and quantitative analysis, the advantages and drawbacks of these 00 metrics are discussed. Several of Chidamber and Kamerer's 00 metrics appear to be useful to predict class fault-proneness during the early phases of the life-cycle. Also, on our data set, they are better predictors than 'traditional' code metrics, which can only be collected at a later phase of the software development processes.

  14. Analysis of genetic association using hierarchical clustering and cluster validation indices.

    Science.gov (United States)

    Pagnuco, Inti A; Pastore, Juan I; Abras, Guillermo; Brun, Marcel; Ballarin, Virginia L

    2017-10-01

    It is usually assumed that co-expressed genes suggest co-regulation in the underlying regulatory network. Determining sets of co-expressed genes is an important task, based on some criteria of similarity. This task is usually performed by clustering algorithms, where the genes are clustered into meaningful groups based on their expression values in a set of experiment. In this work, we propose a method to find sets of co-expressed genes, based on cluster validation indices as a measure of similarity for individual gene groups, and a combination of variants of hierarchical clustering to generate the candidate groups. We evaluated its ability to retrieve significant sets on simulated correlated and real genomics data, where the performance is measured based on its detection ability of co-regulated sets against a full search. Additionally, we analyzed the quality of the best ranked groups using an online bioinformatics tool that provides network information for the selected genes. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Stability indicating spectrophotometric and spectrodensitometric methods for the determination of diatrizoate sodium in presence of its degradation product

    Science.gov (United States)

    Abd El-Rahman, Mohamed K.; Riad, Safaa M.; Abdel Gawad, Sherif A.; Fawaz, Esraa M.; Shehata, Mostafa A.

    2015-02-01

    Three sensitive, selective, and precise stability indicating methods for the determination of the X-ray contrast agent, diatrizoate sodium (DTA), in the presence of its acidic degradation product (highly cytotoxic 3,5 diamino metabolite) and in pharmaceutical formulation were developed and validated. The first method is a first derivative (D1) spectrophotometric one, which allows the determination of DTA in the presence of its degradate at 231.2 nm (corresponding to zero crossing of the degradate) over a concentration range of 2-24 μg/mL with mean percentage recovery 99.95 ± 0.97%. The second method is the first derivative of the ratio spectra (DD1) by measuring the peak amplitude at 227 nm over the same concentration range as D1 spectrophotometric method, with mean percentage recovery 99.99 ± 1.15%. The third method is a TLC-densitometric one, where DTA was separated from its degradate on silica gel plates using chloroform:methanol:ammonium hydroxide (20:10:2 by volume) as a developing system. This method depends on quantitative densitometric evaluation of thin layer chromatogram of DTA at 238 nm over a concentration range of 4-20 μg/spot, with mean percentage recovery 99.88 ± 0.89%. The selectivity of the proposed methods was tested using laboratory-prepared mixtures. The proposed methods have been successfully applied to the analysis of DTA in pharmaceutical dosage forms without interference from other dosage form additives. The results were statistically compared with the official US pharmacopeial method. No significant difference for either accuracy or precision was observed.

  16. Amphenicols stability in medicated feed – development and validation of liquid chromatography method

    Directory of Open Access Journals (Sweden)

    Pietro Wojciech Jerzy

    2014-12-01

    Full Text Available A liquid chromatography-ultraviolet detection method for the determination of florfenicol (FF and thiamphenicol (TAP in feeds is presented. The method comprises the extraction of analytes from the matrix with a mixture of methanol and acetonitrile, drying of the extract, and its dissolution in phosphate buffer. The analysis was performed with a gradient programme of the mobile phase composed of acetonitrile and buffer (pH = 7.3 on a Zorbax Eclipse Plus C18 (150 × 4.6 mm, 5 μm analytical column with UV (λ = 220 nm detection. The analytical procedure has been successfully adopted and validated for quantitative determination of florfenicol and thiamphenicol in feed samples. Sensitivity, specificity, linearity, repeatability, and intralaboratory reproducibility were included in the validation. The mean recovery of amphenicols was 93.5% within the working range of 50-4000 mg/kg. Simultaneous determination of chloramphenicol, which is banned in the feed, was also included within the same procedure of FF and TAP stability studies. Storing the medicated feed at room temperature for up to one month decreased concentration in the investigated drugs even by 45%. These findings are relevant to successful provision of therapy to animals.

  17. Stability indicating high performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in combined dosage form.

    Science.gov (United States)

    Bageshwar, Deepak; Khanvilkar, Vineeta; Kadam, Vilasrao

    2011-11-01

    A specific, precise and stability indicating high-performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in pharmaceutical formulations was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F 254 as the stationary phase. The solvent system consisted of methanol:water:ammonium acetate; 4.0:1.0:0.5 (v/v/v). This system was found to give compact and dense spots for both itopride hydrochloride ( R f value of 0.55±0.02) and pantoprazole sodium ( R f value of 0.85±0.04). Densitometric analysis of both drugs was carried out in the reflectance-absorbance mode at 289 nm. The linear regression analysis data for the calibration plots showed a good linear relationship with R 2 =0.9988±0.0012 in the concentration range of 100-400 ng for pantoprazole sodium. Also, the linear regression analysis data for the calibration plots showed a good linear relationship with R 2 =0.9990±0.0008 in the concentration range of 200-1200 ng for itopride hydrochloride. The method was validated for specificity, precision, robustness and recovery. Statistical analysis proves that the method is repeatable and selective for the estimation of both the said drugs. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating method.

  18. Stability-indicating HPLC-DAD methods for determination of two binary mixtures: Rabeprazole sodium-mosapride citrate and rabeprazole sodium-itopride hydrochloride.

    Science.gov (United States)

    El-Fatatry, Hamed M; Mabrouk, Mokhtar M; Hewala, Ismail I; Emam, Ehab H

    2014-08-01

    Two selective stability-indicating HPLC methods are described for determination of rabeprazole sodium (RZ)-mosapride citrate (MR) and RZ-itopride hydrochloride (IO) mixtures in the presence of their ICH-stress formed degradation products. Separations were achieved on X-Bridge C18 column using two mobile phases: the first for RZ-MR mixture consisted of acetonitrile: 0.025 M KH 2 PO 4 solution: TEA (30:69:1 v/v; pH 7.0); the second for RZ-IO mixture was at ratio of 25:74:1 (v/v; pH 9.25). The detection wavelength was 283 nm. The two methods were validated and validation acceptance criteria were met in all cases. Peak purity testing using contrast angle theory, relative absorbance and log  A versus the wavelengths plots were presented. The % recoveries of the intact drugs were between 99.1% and 102.2% with RSD% values less than 1.6%. Application of the proposed HPLC methods indicated that the methods could be adopted to follow the stability of their formulations.

  19. VALIDATING A COMPUTER-BASED TECHNIQUE FOR ASSESSING STABILITY TO FAILURE STRESS

    Directory of Open Access Journals (Sweden)

    I. F. Arshava

    2013-03-01

    Full Text Available An upsurge of interest in the implicit personality assessment, currently observed both in personality psycho-diagnostics and in experimental studies of social attitudes and prejudices, signals the shifting of researchers’ attention from de?ning between-person personality taxonomy to specifying comprehensive within-person processes, the dynamics of which can be captured at the level of an individual case. This research examines the possibility of the implicit assessment of the individual’s stability vs. susceptibility to failure stress by comparing the degrees of ef?cacy in the voluntary self-regulation of a computer-simulated information-processing activity under different conditions (patent of Ukraine № 91842, issued in 2010. By exposing two groups of participants (university undergraduates to processing the information, the scope of which exceeds the human short-term memory capacity at one of the stages of the modeled activity an unexpected and unavoidable failure is elicited. The participants who retain stability of their self-regulation behavior after having been exposed to failure, i.e. who keep processing information as effectively as they did prior to failure, are claimed to retain homeostasis and thus possess emotional stability. Those, who loose homeostasis after failure and display lower standards of self-regulation behavior, are considered to be susceptible to stress. The validity of the suggested type of the implicit diagnostics was empirically tested by clustering (K-means algorithm two samples of the participants on the  properties of their self-regulation behavior and testing between-cluster differences by a set of the explicitly assessed variables: Action control ef?cacy (Kuhl, 2001, preferred strategies of Coping with Stressful Situations (Endler, Parker, 1990,  Purpose-in-Life orientation (a Russian version of the test by Crumbaugh and Maholick, modi?ed by D.Leontiev, 1992, Psychological Well-being (Ryff, 1989

  20. Stability indicating high performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in combined dosage form

    Directory of Open Access Journals (Sweden)

    Deepak Bageshwar

    2011-11-01

    Full Text Available A specific, precise and stability indicating high-performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in pharmaceutical formulations was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F254 as the stationary phase. The solvent system consisted of methanol:water:ammonium acetate; 4.0:1.0:0.5 (v/v/v. This system was found to give compact and dense spots for both itopride hydrochloride (Rf value of 0.55±0.02 and pantoprazole sodium (Rf value of 0.85±0.04. Densitometric analysis of both drugs was carried out in the reflectance–absorbance mode at 289 nm. The linear regression analysis data for the calibration plots showed a good linear relationship with R2=0.9988±0.0012 in the concentration range of 100–400 ng for pantoprazole sodium. Also, the linear regression analysis data for the calibration plots showed a good linear relationship with R2=0.9990±0.0008 in the concentration range of 200–1200 ng for itopride hydrochloride. The method was validated for specificity, precision, robustness and recovery. Statistical analysis proves that the method is repeatable and selective for the estimation of both the said drugs. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating method. Keywords: Gastroesophageal reflux disease (GERD, Itopride hydrochloride, Pantoprazole sodium, High performance thin layer chromatography (HPTLC, Stability indicating, Forced degradation

  1. Validation of a liquid chromatography method for the simultaneous determination of sulfadimethoxine and trimethoprim and application to a stability study.

    Science.gov (United States)

    Louati, K; Mistiri, F; Kallel, M; Safta, F

    2010-03-01

    A liquid chromatography method is described for the simultaneous determination of sulfadimetoxine and trimethoprim from a veterinary formulation at the proportion of 187 mg and 40 mg respectively in presence of some excipient. The solution was subjected to different International Conference On Harmonisation prescribed stress conditions (hydrolysis, oxidation and photolysis). A stability-indicating high-performance liquid chromatography method was developed for the analysis of active substances in presence of their major degradation products. It involved a Knauer Eurospher C18 thermostated column at 25 degrees C, and 9.57 mM phosphate buffer (pH adjusted to 2.0 with orthophosphoric acid)-acetonitrile (70:30 v/v) as mobile phase. The mobile phase flow rate and sample volume injected were 1.2 mL/min and 20 microL, respectively. The selected wavelength for the determination was 248 nm. The method was validated for linearity, precision, accuracy and specificity, and then applied to a stability study of sulfadimetoxine and trimethoprim in the veterinary solution packaged in high density polyethylene plastic bottles of 1 L and 100 mL thermosealed and no thermosealed and corked by a white cap, at both accelerated and long-term conditions required by the International Conference On Harmonisation. The method developed, which separates all of the most degradation products formed under variety of conditions, proved to be simple, accurate, precise and specific. The results of the stress degradation show that the solution is more sensitive to hydrolysis. The stability studies carried out on three batches of each presentation show that the finished product remains stable for six months. Copyright 2010 Elsevier Masson SAS. All rights reserved.

  2. Dynamic Properties of Savinase by Integrative Structural Biology — Indications to Structural Stability

    DEFF Research Database (Denmark)

    Wu, Shanshan

    In recent years, enzymes have become widely used as the additives in laundry products for reducing the energy consumption and satisfying the customer-expected cleaning effect. Boosting the stability of these enzymes has become a crucial task in both industry and laboratory. Subtilisin savinase, a...

  3. Concurrent Validation of the Clinical Opiate Withdrawal Scale (COWS) and Single-Item Indices against the Clinical Institute Narcotic Assessment (CINA) Opioid Withdrawal Instrument

    Science.gov (United States)

    Tompkins, D. Andrew; Bigelow, George E.; Harrison, Joseph A.; Johnson, Rolley E.; Fudala, Paul J.; Strain, Eric C.

    2009-01-01

    Introduction The Clinical Opiate Withdrawal Scale (COWS) is an 11-item clinician-administered scale assessing opioid withdrawal. Though commonly used in clinical practice, it has not been systematically validated. The present study validated the COWS in comparison to the validated Clinical Institute Narcotic Assessment (CINA) scale. Method Opioid-dependent volunteers were enrolled in a residential trial and stabilized on morphine 30 mg given subcutaneously four times daily. Subjects then underwent double-blind, randomized challenges of intramuscularly administered placebo and naloxone (0.4 mg) on separate days, during which the COWS, CINA, and visual analog scale (VAS) assessments were concurrently obtained. Subjects completing both challenges were included (N=46). Correlations between mean peak COWS and CINA scores as well as self-report VAS questions were calculated. Results Mean peak COWS and CINA scores of 7.6 and 24.4, respectively, occurred on average 30 minutes post-injection of naloxone. Mean COWS and CINA scores 30 minutes after placebo injection were 1.3 and 18.9, respectively. The Pearson correlation coefficient for peak COWS and CINA scores during the naloxone challenge session was 0.85 (p<0.001). Peak COWS scores also correlated well with peak VAS self-report scores of bad drug effect (r=0.57, p<0.001) and feeling sick (r=0.57, p<0.001), providing additional evidence of concurrent validity. Placebo was not associated with any significant elevation of COWS, CINA, or VAS scores, indicating discriminant validity. Cronbach’s alpha for the COWS was 0.78, indicating good internal consistency (reliability). Discussion COWS, CINA, and certain VAS items are all valid measurement tools for acute opiate withdrawal. PMID:19647958

  4. Mirror trends of plasticity and stability indicators in primate prefrontal cortex.

    Science.gov (United States)

    García-Cabezas, Miguel Á; Joyce, Mary Kate P; John, Yohan J; Zikopoulos, Basilis; Barbas, Helen

    2017-10-01

    Research on plasticity markers in the cerebral cortex has largely focused on their timing of expression and role in shaping circuits during critical and normal periods. By contrast, little attention has been focused on the spatial dimension of plasticity-stability across cortical areas. The rationale for this analysis is based on the systematic variation in cortical structure that parallels functional specialization and raises the possibility of varying levels of plasticity. Here, we investigated in adult rhesus monkeys the expression of markers related to synaptic plasticity or stability in prefrontal limbic and eulaminate areas that vary in laminar structure. Our findings revealed that limbic areas are impoverished in three markers of stability: intracortical myelin, the lectin Wisteria floribunda agglutinin, which labels perineuronal nets, and parvalbumin, which is expressed in a class of strong inhibitory neurons. By contrast, prefrontal limbic areas were enriched in the enzyme calcium/calmodulin-dependent protein kinase II (CaMKII), known to enhance plasticity. Eulaminate areas have more elaborate laminar architecture than limbic areas and showed the opposite trend: they were enriched in markers of stability and had lower expression of the plasticity-related marker CaMKII. The expression of glial fibrillary acidic protein (GFAP), a marker of activated astrocytes, was also higher in limbic areas, suggesting that cellular stress correlates with the rate of circuit reshaping. Elevated markers of plasticity may endow limbic areas with flexibility necessary for learning and memory within an affective context, but may also render them vulnerable to abnormal structural changes, as seen in neurologic and psychiatric diseases. © 2017 Federation of European Neuroscience Societies and John Wiley & Sons Ltd.

  5. Evaluation of the stability and validity of participant samples recruited over the Internet.

    Science.gov (United States)

    Lieberman, Daniel Z

    2008-12-01

    Research conducted via the Internet has the potential to reach important clinical populations of participants who would not participate in traditional studies. Concerns exist, however, about the validity of samples recruited in this manner, especially when participants are anonymous and never have contact with study staff. This study evaluated two anonymous samples that were recruited over the Internet to test an online program designed to help problem drinkers. The two studies were conducted 3 years apart, and different recruitment strategies were utilized. Despite these differences, the two samples were highly similar in demographic and clinical features. Correlations that have been found between variables in traditional non-anonymous studies were also found in both online samples, supporting the validity of the data that was collected. Appropriate skepticism is required when critically evaluating Internet studies. Nevertheless, the results of this study indicate that it is possible to obtain stable, valid data from anonymous participants over the Internet, even when there are significant differences in the way the participants are obtained.

  6. Stability indicating studies on NMITLI 118RT+ (standardized extract of withania somnifera dunal)

    OpenAIRE

    Ahmad, Hafsa; Khandelwal, Kiran; Pachauri, Shakti Deep; Sanghwan, Rajender Singh; Dwivedi, Anil Kumar

    2014-01-01

    Background: Withania somnifera Dunal (Ashwagandha) is an Indian medicinal plant of great medicinal value; used in many clinically proven conditions. NMITLI-118RT+ is a candidate drug under a Council of Scientific and Industrial Research (CSIR) networking project. It is a chemotype of W. somnifera's root extract, which has been used for the present study. Objectives: The present investigation aims to develop and validate a simple isocratic reverse phase-high performance liquid chromatography (...

  7. Stability of the thermodynamic equilibrium - A test of the validity of dynamic models as applied to gyroviscous perpendicular magnetohydrodynamics

    Science.gov (United States)

    Faghihi, Mustafa; Scheffel, Jan; Spies, Guenther O.

    1988-05-01

    Stability of the thermodynamic equilibrium is put forward as a simple test of the validity of dynamic equations, and is applied to perpendicular gyroviscous magnetohydrodynamics (i.e., perpendicular magnetohydrodynamics with gyroviscosity added). This model turns out to be invalid because it predicts exponentially growing Alfven waves in a spatially homogeneous static equilibrium with scalar pressure.

  8. Stability of the thermodynamic equilibrium: A test of the validity of dynamic models as applied to gyroviscous perpendicular magnetohydrodynamics

    International Nuclear Information System (INIS)

    Faghihi, M.; Scheffel, J.; Spies, G.O.

    1988-01-01

    Stability of the thermodynamic equilibrium is put forward as a simple test of the validity of dynamic equations, and is applied to perpendicular gyroviscous magnetohydrodynamics (i.e., perpendicular magnetohydrodynamics with gyroviscosity added). This model turns out to be invalid because it predicts exponentially growing Alfven waves in a spatially homogeneous static equilibrium with scalar pressure

  9. Stability-indicating liquid Chromatographic assaymethod for Opthalmic solutions containing combination of Dexamethasone and Chloramphenicol

    International Nuclear Information System (INIS)

    Rao, R.M.; Al-Ashban, R.M.; Shah, A.H.

    2004-01-01

    A selective high-performance chromatographic procedure for the stability monitoring of ophthalmic solutions containing a combination of dexamethasone and chloramphenicolis demonstrated. The separation of the active components and the degradation product of chloramphenicol (1-amino-1-(4-nitrophenyl)-propane-1, 3diol) was achieved on a u-Bondapack C-18 column ( 5 um, 300 mm x 3.9 mm) maintained at ambient temperature (15-20C) by utilizing a mobile phase consisting acidified water (5% actified water with glacial acetic acid ) : acetonitrile : triethyl amine 700 : 300 : 2and pH was adjusted to 5.0 by using 10 M Na OH. The flow rate was 1.5 ml min-1; and elutes were followed with UV-detection at 254 nm. Complete resolution of dexamethasone, chloramphenicol and its hydrolytic product could be attained. The sensitivity, accuracy and specificity were tested. The method was successfully applied in post-marketing stability of the commercial batches of ophthalmic solutions. (author)

  10. Application of spectrophotometric, densitometric, and HPLC techniques as stability indicating methods for determination of Zaleplon in pharmaceutical preparations

    Science.gov (United States)

    Metwally, Fadia H.; Abdelkawy, M.; Abdelwahab, Nada S.

    2007-12-01

    Spectrophotometric, spectrodensitometric and HPLC are stability indicating methods described for determination of Zaleplon in pure and dosage forms. As Zaleplon is easily degradable, the proposed techniques in this manuscript are adopted for its determination in presence of its alkaline degradation product, namely N-[4-(3-cyano-pyrazolo[1,5a]pyridin-7-yl)-phenyl]- N-ethyl-acetamide. These approaches are successfully applied to quantify Zaleplon using the information included in the absorption spectra of appropriate solutions. The second derivative (D 2) spectrophotometric method, allows determination of Zaleplon without interference of its degradate at 235.2 nm using 0.01N HCl as a solvent with obedience to Beer's law over a concentration range of 1-10 μg ml -1 with mean percentage recovery 100.24 ± 0.86%. The first derivative of the ratio spectra ( 1DD) based on the simultaneous use of ( 1DD) and measurement at 241.8 nm using the same solvent and over the same concentration range as (D 2) spectrophotometric method, with mean percentage recovery 99.9 ± 1.07%. The spectrodensitometric analysis allows the separation and quantitation of Zaleplon from its degradate on silica gel plates using chloroform:acetone:ammonia solution (9:1:0.2 by volume) as a mobile phase. This method depends on quantitave densitometric evaluation of thin layer chromatogram of Zaleplon at 338 nm over a concentration range of 0.2-1 μg band -1, with mean percentage recovery 99.73 ± 1.35. Also a reversed-phase liquid chromatographic method using 5-C8 (22 cm × 4.6 mm i.d. 5 μm particle size) column was described and validated for quantitation of Zaleplon using acetonitrile:deionised water (35:65, v/v) as a mobile phase using Paracetamol as internal standard and a flow rate of 1.5 ml min -1 with UV detection of the effluent at 232 nm at ambient temperature over a concentration range of 2-20 μg ml -1 with mean percentage recovery 100.19 ± 1.15%. The insignificance difference of the proposed

  11. Is the readmission rate a valid quality indicator? A review of the evidence

    NARCIS (Netherlands)

    Fischer, Claudia; Lingsma, Hester F.; Marang-van de Mheen, Perla J.; Kringos, Dionne S.; Klazinga, Niek S.; Steyerberg, Ewout W.

    2014-01-01

    Hospital readmission rates are increasingly used for both quality improvement and cost control. However, the validity of readmission rates as a measure of quality of hospital care is not evident. We aimed to give an overview of the different methodological aspects in the definition and measurement

  12. Stability indicating HPLC-UV method for detection of curcumin in Curcuma longa extract and emulsion formulation.

    Science.gov (United States)

    Syed, Haroon Khalid; Liew, Kai Bin; Loh, Gabriel Onn Kit; Peh, Kok Khiang

    2015-03-01

    A stability-indicating HPLC-UV method for the determination of curcumin in Curcuma longa extract and emulsion was developed. The system suitability parameters, theoretical plates (N), tailing factor (T), capacity factor (K'), height equivalent of a theoretical plate (H) and resolution (Rs) were calculated. Stress degradation studies (acid, base, oxidation, heat and UV light) of curcumin were performed in emulsion. It was found that N>6500, Tcurcumin were ⩽0.87% and ⩽2.0%, while the inter-day precision and accuracy values were ⩽2.1% and ⩽-1.92. Curcumin degraded in emulsion under acid, alkali and UV light. In conclusion, the stability-indicating method could be employed to determine curcumin in bulk and emulsions. Copyright © 2014 Elsevier Ltd. All rights reserved.

  13. A performance indicator for reduction in vulnerability through stabilization of plutonium

    International Nuclear Information System (INIS)

    Marchese, A.R.; Neogy, P.; Azarm, M.A.

    1997-01-01

    The US Department of Energy (DOE) is currently storing several metric tons of plutonium in various forms in a variety of facilities throughout the DOE complex. Since the cessation of weapons production in 1990, many of these facilities with plutonium in storage have not operated. Since the shutdown was regarded as temporary, little attempt was made at that time to empty the process lines of plutonium, or to place the plutonium in containers or packages that would provide safe storage for extended periods of time. As a result, the packages and containers providing interim storage are vulnerable to failure through leakage, rupture and other modes, and pose potential hazards to facility workers, the public and the environment. Here, an approach to measuring and tracking the reduction in vulnerabilities resulting from stabilizing and repackaging plutonium is developed and presented. The approach utilizes results obtained by the DOE Working Group on the vulnerabilities associated with plutonium storage

  14. Figure-ground processing during fixational saccades in V1: indication for higher-order stability.

    Science.gov (United States)

    Gilad, Ariel; Pesoa, Yair; Ayzenshtat, Inbal; Slovin, Hamutal

    2014-02-26

    In a typical visual scene we continuously perceive a "figure" that is segregated from the surrounding "background" despite ongoing microsaccades and small saccades that are performed when attempting fixation (fixational saccades [FSs]). Previously reported neuronal correlates of figure-ground (FG) segregation in the primary visual cortex (V1) showed enhanced activity in the "figure" along with suppressed activity in the noisy "background." However, it is unknown how this FG modulation in V1 is affected by FSs. To investigate this question, we trained two monkeys to detect a contour embedded in a noisy background while simultaneously imaging V1 using voltage-sensitive dyes. During stimulus presentation, the monkeys typically performed 1-3 FSs, which displaced the contour over the retina. Using eye position and a 2D analytical model to map the stimulus onto V1, we were able to compute FG modulation before and after each FS. On the spatial cortical scale, we found that, after each FS, FG modulation follows the stimulus retinal displacement and "hops" within the V1 retinotopic map, suggesting visual instability. On the temporal scale, FG modulation is initiated in the new retinotopic position before it disappeared from the old retinotopic position. Moreover, the FG modulation developed faster after an FS, compared with after stimulus onset, which may contribute to visual stability of FG segregation, along the timeline of stimulus presentation. Therefore, despite spatial discontinuity of FG modulation in V1, the higher-order stability of FG modulation along time may enable our stable and continuous perception.

  15. Validation of an analytical method applicable to study of 1 mg/mL oral Risperidone solution stability

    International Nuclear Information System (INIS)

    Abreu Alvarez, Maikel; Garcia Penna, Caridad Margarita; Martinez Miranda, Lissette

    2010-01-01

    A validated analytical method by high-performance liquid chromatography (HPLC) was applicable to study of 1 mg/mL Risperidone oral solution stability. The above method was linear, accurate, specific and exact. A stability study of the 1 mg/mL Risperidone oral solution was developed determining its expiry date. The shelf life study was conducted for 24 months at room temperature; whereas the accelerated stability study was conducted with product under influence of humidity and temperature; analysis was made during 3 months. Formula fulfilled the quality specifications described in Pharmacopeia. The results of stability according to shelf life after 24 months showed that the product maintains the parameters determining its quality during this time and in accelerated studies there was not significant degradation (p> 0.05) in the product. Under mentioned conditions expiry date was of 2 years

  16. A cluster randomized trial for the implementation of an antibiotic checklist based on validated quality indicators: the AB-checklist

    NARCIS (Netherlands)

    Daalen, F.V. van; Prins, J.M.; Opmeer, B.C.; Boermeester, M.A.; Visser, C.E.; Hest, R.M. van; Hulscher, M.; Geerlings, S.E.

    2015-01-01

    BACKGROUND: Recently we developed and validated generic quality indicators that define 'appropriate antibiotic use' in hospitalized adults treated for a (suspected) bacterial infection. Previous studies have shown that with appropriate antibiotic use a reduction of 13% of length of hospital stay can

  17. A cluster randomized trial for the implementation of an antibiotic checklist based on validated quality indicators: the AB-checklist

    NARCIS (Netherlands)

    van Daalen, Frederike V.; Prins, Jan M.; Opmeer, Brent C.; Boermeester, Marja A.; Visser, Caroline E.; van Hest, Reinier M.; Hulscher, Marlies E. J. L.; Geerlings, Suzanne E.

    2015-01-01

    Background: Recently we developed and validated generic quality indicators that define 'appropriate antibiotic use' in hospitalized adults treated for a (suspected) bacterial infection. Previous studies have shown that with appropriate antibiotic use a reduction of 13% of length of hospital stay can

  18. Stability-indicating spectrofluorimetric method for determination of itopride hydrochloride in raw material and pharmaceutical formulations.

    Science.gov (United States)

    Walash, Mohamed I; Ibrahim, Fawzia; Eid, Manal I; El Abass, Samah Abo

    2013-11-01

    A simple, sensitive and rapid spectrofluorimetric method for determination of itopride hydrochloride in raw material and tablets has been developed. The proposed method is based on the measurement of the native fluorescence of the drug in water at 363 nm after excitation at 255 nm. The relative fluorescence intensity-concentration plot was rectilinear over the range of 0.1-2 μg/mL (2.5 × 10(-7)-5.06 × 10(-6) mole/L), with good correlation (r = 0.9999), limit of detection of 0.015 μg/mL and a lower limit of quantification of 0.045 μg/mL. The described method was successfully applied for the determination of itopride hydrochloride in its commercial tablets with average percentage recovery of 100.11 ± 0.32 without interference from common excipients. Additionally, the proposed method can be applied for determination of itopride in combined tablets with rabeprazole or pantoprazole without prior separation. The method was extended to stability study of itopride. The drug was exposed to acidic, alkaline, oxidative and photolytic degradation according to ICH guidelines. Moreover, the method was utilized to investigate the kinetics of the alkaline, acidic and oxidative degradation of the drug. A proposal for the degradation pathways was postulated.

  19. The Stability of School Effectiveness Indices across Grade Levels and Subject Areas.

    Science.gov (United States)

    Mandeville, Garrett K.; Anderson, Lorin W.

    1987-01-01

    School effectiveness indices based on regressing achievement test scores onto earlier scores and a socioeconomic status measure were obtained for South Carolina students in grades one to four. Results were unstable across grades, and grade-to-grade correlations were more significant for mathematics achievement than for reading. (Author/GDC)

  20. An Analysis of Financial Stability Indicators in European Banking: The Role of Common Factors

    NARCIS (Netherlands)

    Kool, C.J.M.

    2006-01-01

    In this paper, we investigate the information content of three market indicators of financial instability using daily data on subordinated debt spreads (SND), credit default swap spreads (CDS) and implied option volatility (IV) over the period January 2001 – January 2004 for a sample of twenty major

  1. Stability-Indicating RP-UPLC Method for the Simultaneous Determination of Potential Degradation and Process Impurities of Amlodipine Basylate and Benazepril HCl in Pharmaceutical Dosage Form

    Directory of Open Access Journals (Sweden)

    Gajanan B. Kasawar

    2014-10-01

    Full Text Available A stability-indicating RP-UPLC method was developed for the quantification of related impurities of amlodipine basylate (AB and Benazepril hydrochloride (BH in solid pharmaceutical dosages form. The chromatographic separation employs a C18 column using a gradient elution, being solvent-A (1.36 g of potassium dihydrogen phosphate dissolved in one liter of water, adjusted to pH 3.0 with orthophosphoric acid and solvent-B (acetonitrile delivered at a flow rate of 0.3 mL min-1. The analytes were detected and quantified at 217 nm and 240 nm using photo diode-array detector. The method was validated demonstrating to be accurate and precise within the corresponding linear range of all components. The stability of the method was investigated under different stress conditions including hydrolytic, oxidative, exposed to photolytic, humidity and thermal as recommended by ICH guidelines. Relevant degradation was found under hydrolytic and oxidative conditions. Robustness against small modification in mobile phase pH, column oven temperature, flow rate and percentage of the mobile phase composition was ascertained. Lower limit of quantification and detection was also determined. The peak purity indices (purity angle < purity threshold obtained with the aid of PDA detector and satisfactory resolution between related impurities established the specificity of the determination.

  2. Stability-indicating UPLC method for determination of Valsartan and their degradation products in active pharmaceutical ingredient and pharmaceutical dosage forms.

    Science.gov (United States)

    Krishnaiah, Ch; Reddy, A Raghupathi; Kumar, Ramesh; Mukkanti, K

    2010-11-02

    A simple, precise, accurate stability-indicating gradient reverse phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the quantitative determination of purity of Valsartan drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its impurities and degradation products. The method was developed using Waters Aquity BEH C18 (100 mm x 2.1 mm, 1.7 microm) column with mobile phase containing a gradient mixture of solvents A and B. The eluted compounds were monitored at 225 nm, the run time was within 9.5 min, which Valsartan and its seven impurities were well separated. Valsartan was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Valsartan was found to degrade significantly in acid and oxidative stress conditions and stable in base, hydrolytic and photolytic degradation conditions. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per international conference on harmonization (ICH) guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. This method was also suitable for the assay determination of Valsartan in pharmaceutical dosage forms.

  3. Prevalence of Invalid Performance on Baseline Testing for Sport-Related Concussion by Age and Validity Indicator.

    Science.gov (United States)

    Abeare, Christopher A; Messa, Isabelle; Zuccato, Brandon G; Merker, Bradley; Erdodi, Laszlo

    2018-03-12

    Estimated base rates of invalid performance on baseline testing (base rates of failure) for the management of sport-related concussion range from 6.1% to 40.0%, depending on the validity indicator used. The instability of this key measure represents a challenge in the clinical interpretation of test results that could undermine the utility of baseline testing. To determine the prevalence of invalid performance on baseline testing and to assess whether the prevalence varies as a function of age and validity indicator. This retrospective, cross-sectional study included data collected between January 1, 2012, and December 31, 2016, from a clinical referral center in the Midwestern United States. Participants included 7897 consecutively tested, equivalently proportioned male and female athletes aged 10 to 21 years, who completed baseline neurocognitive testing for the purpose of concussion management. Baseline assessment was conducted with the Immediate Postconcussion Assessment and Cognitive Testing (ImPACT), a computerized neurocognitive test designed for assessment of concussion. Base rates of failure on published ImPACT validity indicators were compared within and across age groups. Hypotheses were developed after data collection but prior to analyses. Of the 7897 study participants, 4086 (51.7%) were male, mean (SD) age was 14.71 (1.78) years, 7820 (99.0%) were primarily English speaking, and the mean (SD) educational level was 8.79 (1.68) years. The base rate of failure ranged from 6.4% to 47.6% across individual indicators. Most of the sample (55.7%) failed at least 1 of 4 validity indicators. The base rate of failure varied considerably across age groups (117 of 140 [83.6%] for those aged 10 years to 14 of 48 [29.2%] for those aged 21 years), representing a risk ratio of 2.86 (95% CI, 2.60-3.16; P indicator and the age of the examinee. The strong age association, with 3 of 4 participants aged 10 to 12 years failing validity indicators, suggests that the

  4. Postpartum haemorrhage in midwifery care in the Netherlands: validation of quality indicators for midwifery guidelines.

    Science.gov (United States)

    Smit, Marrit; Chan, Kar-Li L; Middeldorp, Johanna M; van Roosmalen, Jos

    2014-12-07

    Postpartum haemorrhage (PPH) is still one of the major causes of severe maternal morbidity and mortality worldwide. Currently, no guideline for PPH occurring in primary midwifery care in the Netherlands is available. A set of 25 quality indicators for prevention and management of PPH in primary care has been developed by an expert panel consisting of midwives, obstetricians, ambulance personal and representatives of the Royal Dutch College of Midwives (KNOV) and the Dutch Society of Obstetrics and Gynecology (NVOG). This study aims to assess the performance of these quality indicators as an assessment tool for midwifery care and suitability for incorporation in a professional midwifery guideline. From April 2008 to April 2010, midwives reported cases of PPH. Cases were assessed using the 25 earlier developed quality indicators. Quality criteria on applicability, feasibility, adherence to the indicator, and the indicator's potential to monitor improvement were assessed. 98 cases of PPH were reported during the study period, of which 94 were analysed. Eleven indicators were found to be applicable and feasible. Five of these indicators showed improvement potential: routine administration of uterotonics, quantifying blood loss by weighing, timely referral to secondary care in homebirth and treatment of PPH using catherisation, uterine massage and oxytocin and the use of oxygen. Eleven out of 25 indicators were found to be suitable as an assessment tool for midwifery care of PPH and are therefore suitable for incorporation in a professional midwifery guideline. Larger studies are necessary to confirm these results.

  5. A comparative study between three stability indicating spectrophotometric methods for the determination of diatrizoate sodium in presence of its cytotoxic degradation product based on two-wavelength selection

    Science.gov (United States)

    Riad, Safaa M.; El-Rahman, Mohamed K. Abd; Fawaz, Esraa M.; Shehata, Mostafa A.

    2015-06-01

    Three sensitive, selective, and precise stability indicating spectrophotometric methods for the determination of the X-ray contrast agent, diatrizoate sodium (DTA) in the presence of its acidic degradation product (highly cytotoxic 3,5-diamino metabolite) and in pharmaceutical formulation, were developed and validated. The first method is ratio difference, the second one is the bivariate method, and the third one is the dual wavelength method. The calibration curves for the three proposed methods are linear over a concentration range of 2-24 μg/mL. The selectivity of the proposed methods was tested using laboratory prepared mixtures. The proposed methods have been successfully applied to the analysis of DTA in pharmaceutical dosage forms without interference from other dosage form additives. The results were statistically compared with the official US pharmacopeial method. No significant difference for either accuracy or precision was observed.

  6. Ratio manipulating spectrophotometry versus chemometry as stability indicating methods for cefquinome sulfate determination.

    Science.gov (United States)

    Yehia, Ali M; Arafa, Reham M; Abbas, Samah S; Amer, Sawsan M

    2016-01-15

    Spectral resolution of cefquinome sulfate (CFQ) in the presence of its degradation products was studied. Three selective, accurate and rapid spectrophotometric methods were performed for the determination of CFQ in the presence of either its hydrolytic, oxidative or photo-degradation products. The proposed ratio difference, derivative ratio and mean centering are ratio manipulating spectrophotometric methods that were satisfactorily applied for selective determination of CFQ within linear range of 5.0-40.0 μg mL(-1). Concentration Residuals Augmented Classical Least Squares was applied and evaluated for the determination of the cited drug in the presence of its all degradation products. Traditional Partial Least Squares regression was also applied and benchmarked against the proposed advanced multivariate calibration. Experimentally designed 25 synthetic mixtures of three factors at five levels were used to calibrate and validate the multivariate models. Advanced chemometrics succeeded in quantitative and qualitative analyses of CFQ along with its hydrolytic, oxidative and photo-degradation products. The proposed methods were applied successfully for different pharmaceutical formulations analyses. These developed methods were simple and cost-effective compared with the manufacturer's RP-HPLC method. Copyright © 2015 Elsevier B.V. All rights reserved.

  7. Stability-indicating RP-HPLC method for simultaneous determination of gatifloxacin and flurbiprofen in binary combination

    Directory of Open Access Journals (Sweden)

    Islam Ullah Khan

    2014-04-01

    Full Text Available A stability-indicating RP-HPLC method is presented for determination of gatifloxacin and flurbiprofen in binary combination. Gatifloxacin, flurbiprofen and their degradation products were detected at 254 nm using a BDS Hypersil C8 (250 X 4.6 mm, 5 µm column and mixture of 20 mM phosphate buffer (pH 3.0 and methanol 30:70 v/v as mobile phase. Response was linear over the range of 15-105 mg mL-1 for gatifloxacin (r² > 0.998 and of 1.5-10.5 mg mL-1 for flurbiprofen (r² > 0.999. The developed method efficiently separated the analytical peaks from degradation products (peak purity index > 0.9999. The method developed can be applied successfully for determination of gatifloxacin and flurbiprofen in human serum, urine, pharmaceutical formulations, and their stability studies.

  8. Design rules for piping: experimental validation of flexibility and elastic stress indices for elbows under bending

    International Nuclear Information System (INIS)

    Touboul, F.; Ben Jdidia, M.; Acker, D.

    1989-01-01

    Design rules for class 1 piping components are based on stress indices (B, C, K) and flexibility factors (k). For elbows, adjacent straight parts and internal pressure inhibit ovalization of the cross-section, so reducing the sub-mentioned indices. Published theoretical works and experimental results allow for improvement of coded values. End effect may be represented by a suitable function of the elbow angle. The favourable effect of pressure on C 2 , for fatigue damage evaluation, can be taken into account

  9. Evaluation of Discrimination Indices Validity for Screening of β-Thalassemia Trait

    Directory of Open Access Journals (Sweden)

    Ahmadi A.

    2009-11-01

    Full Text Available AbstractBackground and Objectives: β-thalassemia trait (β-TT and iron deficiency anemia (IDA are the most common forms of microcytic anemia. Screening of β-thalassemia trait is important for medical counseling before marriage and preventing β-thalassemia major birth results. The most common problem in screening -TT is differentiating it from IDA. The aim of this study was to define the sensitivity, specificity, and predictive values of some discrimination indices for screening of β-TT in a sample of such patients.Methods: A total of 82 patients with microcytic anemia (MCV< 80 fl were selected from Namazi Hospital, Shiraz, Iran, and 9 discrimination indices were calculated for them. The patients were divided intotwo groups: 42 patients with β-TT and 40 patients with IDA. The sensitivity, specificity, positive and negative predictive values and Youden,s index of each discrimination index were calculated for screening β-TT.Results: None of the discrimination indices showed 100% of sensitivity and specificity. But the Shin and Lal index, RDW index and RBC count showed the highest and valuable value for screening β-TT.Conclusion: Some discrimination indices like Shin and Lal index, RDW index and RBC index are valuable indices in screening β-TT.Keywords: Beta- Thalassemia; Anemia, Iron Deficiency.

  10. Development and validation of a system of assimilation indices: A mixed method approach to understand change in psychotherapy.

    Science.gov (United States)

    Neto, David D; Baptista, Telmo M; Dent-Brown, Kim

    2015-06-01

    Assimilation is an important process in understanding change in psychotherapy. Similar to other psychological processes, assimilation may be traceable in the speech of clients by attending to its signs or indices. In the present research, we aimed to build a system of indices of assimilation. This research follows a mixed method design. The indices were derived through qualitative analysis, using grounded theory. Subsequently, the indices were adjusted quantitatively and applied to 30 single psychotherapy sessions of adult clients with depression and 11 therapists. Forty-two indices were found and grouped into the following five process categories of assimilation: external distress, pain, noticing, decentring and action. The indices showed good inter-rater reliability and internal consistency. Except for noticing, all process categories correlated significantly with each other according to conceptual proximity. The system of indices also showed convergent validity with an existing coding system of assimilation for two process categories. The results suggest that the system of indices is a useful approach for understanding assimilation. The consideration of assimilation in a continuous fashion through sub-processes may help to extend our knowledge of this process and provide a tool for clinical practice. Assimilation is an important process in understanding change in psychotherapy in the sense that it takes into account insight and action-related processes. Clients convey in their speech signs or indices of the assimilation process which can be observed both in the style and content of their utterances. Using these indices, therapists can continuously assess assimilation and use this information in choosing interventions. Limitations: This study follows a cross-sectional design and does not allow consideration of the predictive value of the indices. The outcome of the therapy was not taken into account, which restricts validity considerations to the comparison with

  11. Effectiveness of Stability Indices for Bread Wheat Genotypes Selection to Water Deficit Tolerant

    Directory of Open Access Journals (Sweden)

    A Naderi

    2013-12-01

    Full Text Available In countries such as Iran which will be faced water deficit as the main challenge in the future and the food production is going to be dependent to water recourses, wheat water-deficit tolerant and adapted genotypes release is one of the most important strategies under such a condition. In order to study the adaptation and terminal water deficit stress tolerance, fifteen bread wheat lines and Chamran cultivar as the check were evaluated. This research was carried out at Ahvaz, Dezfool, Zabol and Darab, south warm region research stations, in 2007-08 and 2008-09, in two separated experiments (1-well-watered and 2- terminal water deficit stress, using complete randomized block design with three replications. Data were analyzed and genotypes response was evaluated based on tolerance indices. Results showed that the difference among stations, years, genotypes and double and triple effects of source variations were significant at 1% probability level. Mean grain yield was 4300 Kg/ha in first year, while grain yield increased significantly in second year and reached to 5692 Kg/ha. Mean grain yield were 5840 and 4591Kg/ha under well-watered and terminal water deficit stress conditions, respectively. Correlation coefficients among STI, GMP ،MP and K1STI were significant. Correlation coefficient between slop of linear regression of grain yield in response to drought stress intensity and grain yield under terminal water deficit stress was positively and, with K2STI, TOL and SSI was negatively significant. Grain yield index, (YIR the proportion of grain yield of each genotype to grand mean of grain yield of all genotypes was the most important components to define grain yield in stepwise regression under both experiment conditions. According to the results of this research and based on tolerance indices, lines No. 2, 14 and 15 were selected as the high potential- terminal water deficit stress tolerant genotypes.

  12. Measuring disability: a systematic review of the validity and reliability of the Global Activity Limitations Indicator (GALI).

    Science.gov (United States)

    Van Oyen, Herman; Bogaert, Petronille; Yokota, Renata T C; Berger, Nicolas

    2018-01-01

    GALI or Global Activity Limitation Indicator is a global survey instrument measuring participation restriction. GALI is the measure underlying the European indicator Healthy Life Years (HLY). Gali has a substantial policy use within the EU and its Member States. The objective of current paper is to bring together what is known from published manuscripts on the validity and the reliability of GALI. Following the PRISMA guidelines, two search strategies (PUBMED, Google Scholar) were combined to identify manuscripts published in English with publication date 2000 or beyond. Articles were classified as reliability studies, concurrent or predictive validity studies, in national or international populations. Four cross-sectional studies (of which 2 international) studied how GALI relates to other health measures (concurrent validity). A dose-response effect by GALI severity level on the association with the other health status measures was observed in the national studies. The 2 international studies (SHARE, EHIS) concluded that the odds of reporting participation restriction was higher in subjects with self-reported or observed functional limitations. In SHARE, the size of the Odds Ratio's (ORs) in the different countries was homogeneous, while in EHIS the size of the ORs varied more strongly. For the predictive validity, subjects were followed over time (4 studies of which one international). GALI proved, both in national and international data, to be a consistent predictor of future health outcomes both in terms of mortality and health care expenditure. As predictors of mortality, the two distinct health concepts, self-rated health and GALI, acted independently and complementary of each other. The one reliability study identified reported a sufficient reliability of GALI. GALI as inclusive one question instrument fits all conceptual characteristics specified for a global measure on participation restriction. In none of the studies, included in the review, there was

  13. Noncredible cognitive performance at clinical evaluation of adult ADHD: An embedded validity indicator in a visuospatial working memory test.

    Science.gov (United States)

    Fuermaier, Anselm B M; Tucha, Oliver; Koerts, Janneke; Lange, Klaus W; Weisbrod, Matthias; Aschenbrenner, Steffen; Tucha, Lara

    2017-12-01

    The assessment of performance validity is an essential part of the neuropsychological evaluation of adults with attention-deficit/hyperactivity disorder (ADHD). Most available tools, however, are inaccurate regarding the identification of noncredible performance. This study describes the development of a visuospatial working memory test, including a validity indicator for noncredible cognitive performance of adults with ADHD. Visuospatial working memory of adults with ADHD (n = 48) was first compared to the test performance of healthy individuals (n = 48). Furthermore, a simulation design was performed including 252 individuals who were randomly assigned to either a control group (n = 48) or to 1 of 3 simulation groups who were requested to feign ADHD (n = 204). Additional samples of 27 adults with ADHD and 69 instructed simulators were included to cross-validate findings from the first samples. Adults with ADHD showed impaired visuospatial working memory performance of medium size as compared to healthy individuals. Simulation groups committed significantly more errors and had shorter response times as compared to patients with ADHD. Moreover, binary logistic regression analysis was carried out to derive a validity index that optimally differentiates between true and feigned ADHD. ROC analysis demonstrated high classification rates of the validity index, as shown in excellent specificity (95.8%) and adequate sensitivity (60.3%). The visuospatial working memory test as presented in this study therefore appears sensitive in indicating cognitive impairment of adults with ADHD. Furthermore, the embedded validity index revealed promising results concerning the detection of noncredible cognitive performance of adults with ADHD. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  14. Stability study on an anti-cancer drug 4-(3,5-bis(2-chlorobenzylidene-4-oxo-piperidine-1-yl-4-oxo-2-butenoic acid (CLEFMA using a stability-indicating HPLC method

    Directory of Open Access Journals (Sweden)

    Dhawal Raghuvanshi

    2017-02-01

    Full Text Available CLEFMA, 4-(3,5-bis(2-chlorobenzylidene-4-oxo-piperidine-1-yl-4-oxo-2-butenoic acid, is a new chemical entity with anti-cancer and anti-inflammatory activities. Here, we report its stability in solution against stress conditions of exposure to acid/base, light, oxidant, high temperature, and plasma. The identity of the degradation products was ascertained by mass and proton nuclear magnetic resonance spectroscopy. To facilitate this study, we developed and validated a reverse phase high performance liquid chromatography method for detection of CLEFMA and its degradation. The method was linear over a range of 1–100 µg/mL; the accuracy and precision were within acceptable limits; it was stability-indicating as it successfully separated cis-/trans-isomers of CLEFMA as well as its degradation product. The major degradation product was produced from amide hydrolysis at maleic acid functionality caused by an acidic buffer, oxidant (3% hydrogen peroxide, or temperature stress (40–60 °C. The log k-pH profile showed that CLEFMA was most stable at neutral pH. In accelerated stability study we found that the shelf-life (T90% of CLEFMA at 25 °C and 4 °C was 45 days and 220 days, respectively. Upon exposure to UV-light (365 nm, the normally prevalent trans-CLEFMA attained cis-configuration. This isomerization also involved the maleic acid moiety. CLEFMA was stable in plasma from which it could be efficiently extracted by an acetonitrile precipitation method. These results indicate that CLEFMA is sensitive to hydrolytic cleavage at its maleic acid moiety, and it is recommended that its samples should be stored under refrigerated and light-free conditions, and under inert environment.

  15. Postpartum haemorrhage in midwifery care in the Netherlands: validation of quality indicators for midwifery guidelines

    NARCIS (Netherlands)

    Smit, M.; Chan, K.L.L.; Middeldorp, J.M.; van Roosmalen, J.

    2014-01-01

    Background: Postpartum haemorrhage (PPH) is still one of the major causes of severe maternal morbidity and mortality worldwide. Currently, no guideline for PPH occurring in primary midwifery care in the Netherlands is available. A set of 25 quality indicators for prevention and management of PPH in

  16. Validating operational food insecurity indicators against a dynamic benchmark : evidence from Mali

    OpenAIRE

    Christiaensen, Luc J.; Boisvert, Richard N.; Hoddinott, John

    2000-01-01

    The authors develop an explicitly forward-looking indicator of food insecurity that takes into account both current dietary inadequacy and vulnerability to dietary inadequacy in the future. Application of this measure to data from northern Mali shows that neglecting the future dimension of food insecurity causes serious underestimation of food insecurity in this area. The authors evaluate ...

  17. Validity of Some Anthropometric Indicators in the Prediction of High Systolic Blood Pressure among Indian Adolescents

    Directory of Open Access Journals (Sweden)

    Shobha Rao

    2008-01-01

    Full Text Available Background In view of the increasing prevalence of obesity in children, it is necessary to investigate the relative performance of different indicators used for its assessment and health consequences. Objectives To examine concordance between various indicators used for assessing obesity among adolescents and to examine their ability to predict risk of high systolic blood pressure. Design Cross-sectional study, from two schools catering to affluent class. Subjects Children in age 9–16 yr (n = 1146 boys and 1036 girls. Measurements Body weight, height, skinfold thickness at triceps (TSFT and body fat percent by trained investigators and blood pressure measurement by a pediatrician using sphygmomanometer. Results Prevalence of overweight was lowest with criterion of TSFT (11.7% in boys; 7.6% in girls and was highest using criterion of body fat percent (53.7% in boys and 28.4% in girls. Body mass index (BMI had high significant correlation with each of the indicator and with systolic blood pressure (SBP as well, in both sexes. All the indicators with conventional cut offs showed poor sensitivity for predicting high SBP. However, receiver operating characteristics (ROC cut-offs improved sensitivity considerably, but the values were much lower compared to conventional cut-offs. Conclusions There is considerable disparity in the estimates of overweight children obtained by different indicators. Lower values of ROC cut-offs highlights the need for population specific customized classification systems for assessing obesity in view of the probable population differences in relative risks of non-communicable adult diseases.

  18. Validity indices of the Rorschach test and Personality Assessment Inventory: a comparison in pathological and healthy subjects.

    Directory of Open Access Journals (Sweden)

    Santo F. Di Nuovo

    2016-08-01

    Full Text Available The debate about the validity of the Rorschach test, compared with psychometric inventories, is particularly relevant in the forensic evaluation. The aim of the study is to present an overview on the control indices proposed in Rorschach (e.g. R,  F%, Lambda Index and in a personality inventory (Personality Assessment Inventory: e.g., openness, desirability, inconsistency, infrequency, negative and positive impression, malingering and defensiveness, treatment rejection and to cross-correlate these indices. The sample consisted of 50 adult inpatients with diagnosis of severe depression or psychosis, and a control group of healthy subjects, matched by gender, age and educational level. The results show that the analytic style, as opposed to the global one, is related to greater openness to psychological assessment, less social desirability and defensive tendency. The Rorschach Lambda index demonstrates good validity in detecting tendency to defensiveness, social desirability and dissimulation, both in normal and pathological protocols.

  19. Behavioral Indicators on a Mobile Sensing Platform Predict Clinically Validated Psychiatric Symptoms of Mood and Anxiety Disorders.

    Science.gov (United States)

    Place, Skyler; Blanch-Hartigan, Danielle; Rubin, Channah; Gorrostieta, Cristina; Mead, Caroline; Kane, John; Marx, Brian P; Feast, Joshua; Deckersbach, Thilo; Pentland, Alex Sandy; Nierenberg, Andrew; Azarbayejani, Ali

    2017-03-16

    There is a critical need for real-time tracking of behavioral indicators of mental disorders. Mobile sensing platforms that objectively and noninvasively collect, store, and analyze behavioral indicators have not yet been clinically validated or scalable. The aim of our study was to report on models of clinical symptoms for post-traumatic stress disorder (PTSD) and depression derived from a scalable mobile sensing platform. A total of 73 participants (67% [49/73] male, 48% [35/73] non-Hispanic white, 33% [24/73] veteran status) who reported at least one symptom of PTSD or depression completed a 12-week field trial. Behavioral indicators were collected through the noninvasive mobile sensing platform on participants' mobile phones. Clinical symptoms were measured through validated clinical interviews with a licensed clinical social worker. A combination hypothesis and data-driven approach was used to derive key features for modeling symptoms, including the sum of outgoing calls, count of unique numbers texted, absolute distance traveled, dynamic variation of the voice, speaking rate, and voice quality. Participants also reported ease of use and data sharing concerns. Behavioral indicators predicted clinically assessed symptoms of depression and PTSD (cross-validated area under the curve [AUC] for depressed mood=.74, fatigue=.56, interest in activities=.75, and social connectedness=.83). Participants reported comfort sharing individual data with physicians (Mean 3.08, SD 1.22), mental health providers (Mean 3.25, SD 1.39), and medical researchers (Mean 3.03, SD 1.36). Behavioral indicators passively collected through a mobile sensing platform predicted symptoms of depression and PTSD. The use of mobile sensing platforms can provide clinically validated behavioral indicators in real time; however, further validation of these models and this platform in large clinical samples is needed. ©Skyler Place, Danielle Blanch-Hartigan, Channah Rubin, Cristina Gorrostieta

  20. Optimization of Forced Degradation Using Experimental Design and Development of a Stability-Indicating Liquid Chromatographic Assay Method for Rebamipide in Bulk and Tablet Dosage Form

    Directory of Open Access Journals (Sweden)

    Sandeep SONAWANE

    2016-09-01

    Full Text Available A novel stability-indicating RP-HPLC assay method was developed and validated for quantitative determination of rebamipide in bulk and tablet dosage form. Rebamipide (drug and drug product solutions were exposed to acid and alkali hydrolysis, thermal stress, oxidation by hydrogen peroxide and photodegradation. Experimental design has been used during forced degradation to determine significant factors responsible for degradation and to obtain optimal degradation conditions. In addition, acid and alkali hydrolysis was performed using a microwave oven. The chromatographic method employed the HiQ sil C-18HS (250 × 4.6 mm; 5 μm column with mobile phase consisting of 0.02 M potassium phosphate (pH adjusted to 6.8 and methanol (40:60, v/v and the detection was performed at 230 nm. The procedure was validated for specificity, linearity, accuracy, precision and robustness. There was no interference observed of excipients and degradation products in the determination of the active pharmaceutical ingredient. The method showed good accuracy and precision (intra and inter day and the response was linear in a range from 0.5 to 5 μg mL−1. The method was found to be simple and fast with less trial and error experimentation by making use of experimental design. Also, it proved that microwave energy can be used to expedite hydrolysis of rebamipide.

  1. A Simple and Specific Stability- Indicating RP-HPLC Method for Routine Assay of Adefovir Dipivoxil in Bulk and Tablet Dosage Form.

    Science.gov (United States)

    Darsazan, Bahar; Shafaati, Alireza; Mortazavi, Seyed Alireza; Zarghi, Afshin

    2017-01-01

    A simple and reliable stability-indicating RP-HPLC method was developed and validated for analysis of adefovir dipivoxil (ADV).The chromatographic separation was performed on a C 18 column using a mixture of acetonitrile-citrate buffer (10 mM at pH 5.2) 36:64 (%v/v) as mobile phase, at a flow rate of 1.5 mL/min. Detection was carried out at 260 nm and a sharp peak was obtained for ADV at a retention time of 5.8 ± 0.01 min. No interferences were observed from its stress degradation products. The method was validated according to the international guidelines. Linear regression analysis of data for the calibration plot showed a linear relationship between peak area and concentration over the range of 0.5-16 μg/mL; the regression coefficient was 0.9999and the linear regression equation was y = 24844x-2941.3. The detection (LOD) and quantification (LOQ) limits were 0.12 and 0.35 μg/mL, respectively. The results proved the method was fast (analysis time less than 7 min), precise, reproducible, and accurate for analysis of ADV over a wide range of concentration. The proposed specific method was used for routine quantification of ADV in pharmaceutical bulk and a tablet dosage form.

  2. Stability-Indicating TLC-Densitometric and HPLC Methods for the Simultaneous Determination of Piracetam and Vincamine in the Presence of Their Degradation Products.

    Science.gov (United States)

    Ahmed, Amal B; Abdelrahman, Maha M; Abdelwahab, Nada S; Salama, Fathy M

    2016-11-01

    Newly established TLC-densitometric and RP-HPLC methods were developed and validated for the simultaneous determination of Piracetam (PIR) and Vincamine (VINC) in their pharmaceutical formulation and in the presence of PIR and VINC degradation products, PD and VD, respectively. The proposed TLC-densitometric method is based on the separation and quantitation of the studied components using a developing system that consists of chloroform-methanol-glacial acetic acid-triethylamine (8 + 2 + 0.1 + 0.1, v/v/v/v) on TLC silica gel 60 F254 plates, followed by densitometric scanning at 230 nm. On the other hand, the developed RP-HPLC method is based on the separation of the studied components using an isocratic elution of 0.05 M KH2PO4 (containing 0.1% triethylamine adjusted to pH 3 with orthophosphoric acid)-methanol (95 + 5, v/v) on a C8 column at a flow rate of 1 mL/min with diode-array detection at 230 nm. The developed methods were validated according to International Conference on Harmonization guidelines and demonstrated good accuracy and precision. Moreover, the developed TLC-densitometric and RP-HPLC methods are suitable as stability-indicating assay methods for the simultaneous determination of PD and VD either in bulk powder or pharmaceutical formulation. The results were statistically compared with those obtained by the reported RP-HPLC method using t- and F-tests.

  3. Support vector regression and artificial neural network models for stability indicating analysis of mebeverine hydrochloride and sulpiride mixtures in pharmaceutical preparation: A comparative study

    Science.gov (United States)

    Naguib, Ibrahim A.; Darwish, Hany W.

    2012-02-01

    A comparison between support vector regression (SVR) and Artificial Neural Networks (ANNs) multivariate regression methods is established showing the underlying algorithm for each and making a comparison between them to indicate the inherent advantages and limitations. In this paper we compare SVR to ANN with and without variable selection procedure (genetic algorithm (GA)). To project the comparison in a sensible way, the methods are used for the stability indicating quantitative analysis of mixtures of mebeverine hydrochloride and sulpiride in binary mixtures as a case study in presence of their reported impurities and degradation products (summing up to 6 components) in raw materials and pharmaceutical dosage form via handling the UV spectral data. For proper analysis, a 6 factor 5 level experimental design was established resulting in a training set of 25 mixtures containing different ratios of the interfering species. An independent test set consisting of 5 mixtures was used to validate the prediction ability of the suggested models. The proposed methods (linear SVR (without GA) and linear GA-ANN) were successfully applied to the analysis of pharmaceutical tablets containing mebeverine hydrochloride and sulpiride mixtures. The results manifest the problem of nonlinearity and how models like the SVR and ANN can handle it. The methods indicate the ability of the mentioned multivariate calibration models to deconvolute the highly overlapped UV spectra of the 6 components' mixtures, yet using cheap and easy to handle instruments like the UV spectrophotometer.

  4. Data on corrosion and scaling potential of drinking water resources using stability indices in Jolfa, East Azerbaijan, Iran

    Directory of Open Access Journals (Sweden)

    Mahmood Yousefi

    2018-02-01

    Full Text Available This cross-sectional study was conducted on the drinking water resources of the city of Jolfa (East Azerbaijan province, Iran from samples taken from 30 wells. Calcium hardness, pH, total alkalinity, TDS, temperature and other chemical parameters were measured using standard methods. The Langelier, Rayzner, Puckhorius and aggressive indices were calculated. The results showed that the Langelier, Reynar, Puckorius, Larson-skold and aggressive indices were 1.15 (± 0.43, 6.92 (± 0.54, 6.42 (± 0.9, 0.85 (± 0.72 and 12.79 (± 0.47, respectively. In terms of water classification, 30% of samples fell into the NaCl category and 26.6% in the NaHCO3 category and 43.4% samples in the CaHCO3, MgHCO3 and MgCl category. The sedimentation indices indicated that the water of the wells could be considered as corrosive. Keywords: Corrosion and scaling potential, Stability indices, Ground water, Jolfa

  5. Stability and Predictive Validity of the Parent-Child Sleep Interactions Scale: A Longitudinal Study Among Preschoolers.

    Science.gov (United States)

    Barrios, Chelsey S; Jay, Samantha Y; Smith, Victoria C; Alfano, Candice A; Dougherty, Lea R

    2018-01-01

    Little research has examined the processes underlying children's persistent sleep problems and links with later psychopathology. The current study examined the stability of parent-child sleep interactions as assessed with the parent-reported Parent-Child Sleep Interactions Scale (PSIS) and examined whether sleep interactions in preschool-age children predict sleep problems and psychiatric symptoms later in childhood. Participants included 108 preschool-age children (50% female) and their parents. Parents completed the PSIS when children were 3-5 years (T1) and again when they were 6-9 years (T2). The PSIS includes three subscales-Sleep Reinforcement (reassurance of child sleep behaviors), Sleep Conflict (parent-child conflict at bedtime), Sleep Dependence (difficulty going to sleep without parent)-and a total score. Higher scores indicate more problematic bedtime interactions. Children's sleep problems and psychiatric symptoms at T1 and T2 were assessed with a clinical interview. PSIS scores were moderately stable from T1 to T2, and the factor structure of the PSIS remained relatively consistent over time. Higher total PSIS scores at T1 predicted increases in children's sleep problems at T2. Higher PSIS Sleep Conflict scores at T1 predicted increases in oppositional defiant disorder symptoms at T2. Children with more sleep problems and higher PSIS Sleep Reinforcement scores at T1 showed increases in attention deficit/hyperactivity disorder, depressive, and anxiety symptoms at T2. These findings provide evidence for the predictive validity of the PSIS and highlight the importance of early parent-child sleep interactions in the development of sleep and psychiatric symptoms in childhood. Parent-child sleep interactions may serve as a useful target for interventions.

  6. Development and validation of a UV-spectrophotometric method for the determination of pheniramine maleate and its stability studies

    Science.gov (United States)

    Raghu, M. S.; Basavaiah, K.; Ramesh, P. J.; Abdulrahman, Sameer A. M.; Vinay, K. B.

    2012-03-01

    A sensitive, precise, and cost-effective UV-spectrophotometric method is described for the determination of pheniramine maleate (PAM) in bulk drug and tablets. The method is based on the measurement of absorbance of a PAM solution in 0.1 N HCl at 264 nm. As per the International Conference on Harmonization (ICH) guidelines, the method was validated for linearity, accuracy, precision, limits of detection (LOD) and quantification (LOQ), and robustness and ruggedness. A linear relationship between absorbance and concentration of PAM in the range of 2-40 μg/ml with a correlation coefficient (r) of 0.9998 was obtained. The LOD and LOQ values were found to be 0.18 and 0.39 μg/ml PAM, respectively. The precision of the method was satisfactory: the value of relative standard deviation (RSD) did not exceed 3.47%. The proposed method was applied successfully to the determination of PAM in tablets with good accuracy and precision. Percentages of the label claims ranged from 101.8 to 102.01% with the standard deviation (SD) from 0.64 to 0.72%. The accuracy of the method was further ascertained by recovery studies via a standard addition procedure. In addition, the forced degradation of PAM was conducted in accordance with the ICH guidelines. Acidic and basic hydrolysis, thermal stress, peroxide, and photolytic degradation were used to assess the stability-indicating power of the method. A substantial degradation was observed during oxidative and alkaline degradations. No degradation was observed under other stress conditions.

  7. Loads in wind farms under non-neutral ABL stability conditions: A full-scale validation study of the DWM model

    DEFF Research Database (Denmark)

    The purpose of this study is twofold: To validate a generalized version of the DWM approach for load prediction under non-neural atmospheric stability conditions, and to demonstrate the importance of atmospheric stability for wind turbines operating in wind farm conditions.......The purpose of this study is twofold: To validate a generalized version of the DWM approach for load prediction under non-neural atmospheric stability conditions, and to demonstrate the importance of atmospheric stability for wind turbines operating in wind farm conditions....

  8. Feasibility and validity of animal-based indicators for on-farm welfare assessment of thermal stress in dairy goats

    Science.gov (United States)

    Battini, Monica; Barbieri, Sara; Fioni, Luna; Mattiello, Silvana

    2016-02-01

    This investigation tested the feasibility and validity of indicators of cold and heat stress in dairy goats for on-farm welfare assessment protocols. The study was performed on two intensive dairy farms in Italy. Two different 3-point scale (0-2) scoring systems were applied to assess cold and heat stress. Cold and heat stress scores were visually assessed from outside the pen in the morning, afternoon and evening in January-February, April-May and July 2013 for a total of nine sessions of observations/farm. Temperature (°C), relative humidity (%) and wind speed (km/h) were recorded and Thermal Heat Index (THI) was calculated. The sessions were allocated to three climatic seasons, depending on THI ranges: cold (65). Score 2 was rarely assessed; therefore, scores 1 and 2 were aggregated for statistical analysis. The amount of goats suffering from cold stress was significantly higher in the cold season than in neutral ( P farm feasibility of both indicators: No constraint was found and time required was less than 10 min. Our results show that cold and heat stress scores are valid indicators to detect thermal stress in intensively managed dairy goats. The use of a binary scoring system (presence/absence), merging scores 1 and 2, may be a further refinement to improve the feasibility. This study also allows the prediction of optimal ranges of THI for dairy goat breeds in intensive husbandry systems, setting a comfort zone included into 55 and 70.

  9. Cross sectional study of performance indicators for English Primary Care Trusts: testing construct validity and identifying explanatory variables

    Directory of Open Access Journals (Sweden)

    Lilford Richard

    2006-06-01

    Full Text Available Abstract Background The performance of Primary Care Trusts in England is assessed and published using a number of different performance indicators. Our study has two broad purposes. Firstly, to find out whether pairs of indicators that purport to measure similar aspects of quality are correlated (as would be expected if they are both valid measures of the same construct. Secondly, we wanted to find out whether broad (global indicators correlated with any particular features of Primary Care Trusts, such as expenditure per capita. Methods Cross sectional quantitative analysis using data from six 2004/05 PCT performance indicators for 303 English Primary Care Trusts from four sources in the public domain: Star Rating, aggregated Quality and Outcomes Framework scores, Dr Foster mortality index, Dr Foster equity index (heart by-pass and hip replacements, NHS Litigation Authority Risk Management standards and Patient Satisfaction scores from the Star Ratings. Forward stepwise multiple regression analysis to determine the effect of Primary Care Trust characteristics on performance. Results Star Rating and Quality and Outcomes Framework total, both summary measures of global quality, were not correlated with each other (F = 0.66, p = 0.57. There were however positive correlations between Quality and Outcomes Framework total and patient satisfaction (r = 0.61, p Conclusion Performance assessment in healthcare remains on the Government's agenda, with new core and developmental standards set to replace the Star Ratings in 2006. Yet the results of this analysis provide little evidence that the current indicators have sufficient construct validity to measure the underlying concept of quality, except when the specific area of screening is considered.

  10. The concurrent validity of the technical test battery as an indicator of work performance in a telecommunications company

    Directory of Open Access Journals (Sweden)

    Marelize Barnard

    2005-10-01

    Full Text Available The purpose of this study was to assess the concurrent validity of the Technical Test Battery (TTB in a South African telecommunications institution. The Technical Test Battery (TTB was administered to a sample of 107 technical officers. Their test scores were compared to the scores obtained from a job performance rating scale specifically designed for this position on the basis of a thorough job analysis. The TTB demonstrated high concurrent validity as an indicator of work performance for technical posts in the telecommunications environment. These results suggest that the TTB may have a high predictive validity for performance in technical positions. The findings and implications of the study are discussed. Opsomming Die doel van hierdie studie was om die samevallende geldigheid van die “Technical Test Battery (TTB�? in ’n Suid-Afrikaanse telekommunikasie instansie te bepaal. Die TTB is op ’n steekproef van 107 tegniese personeel toegepas. Die toetstellings is in verband gebring met die tellings van ’n werksprestasiemaatstaf wat spesifiek vir die pos ontwikkel is op grond van ’n deeglike posanalise. Daar is bevind dat die TTB ’n hoë samevallende geldigheid as aanduider van werksprestasie vir tegniese poste in the telekommunikasiebedryf toon. Dié resultate dui op ’n sterk moontlikheid dat die TTB ’n goeie voorspeller van werksprestasie vir tegniese beroepe kan wees. Die bevindinge en implikasies van die studie word bespreek.

  11. Food-related lifestyles: Cross-cultural validity and intra-cultural stability

    DEFF Research Database (Denmark)

    Scholderer, Joachim; Brunsø, Karen; Bredahl, Lone

    in terms of factor pattern, factor loadings, factor covariances and factor variances. In the second factor part of the analysis, replication samples from France (N1 = 1000, N2 = 1000), Germany (N1 = 1000, N2 = 1042), and the UK (N1 = 1000, N2 = 1000) are examined for intra-cultural stability using the same...

  12. Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) processing speed scores as measures of noncredible responding: The third generation of embedded performance validity indicators.

    Science.gov (United States)

    Erdodi, Laszlo A; Abeare, Christopher A; Lichtenstein, Jonathan D; Tyson, Bradley T; Kucharski, Brittany; Zuccato, Brandon G; Roth, Robert M

    2017-02-01

    Research suggests that select processing speed measures can also serve as embedded validity indicators (EVIs). The present study examined the diagnostic utility of Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) subtests as EVIs in a mixed clinical sample of 205 patients medically referred for neuropsychological assessment (53.3% female, mean age = 45.1). Classification accuracy was calculated against 3 composite measures of performance validity as criterion variables. A PSI ≤79 produced a good combination of sensitivity (.23-.56) and specificity (.92-.98). A Coding scaled score ≤5 resulted in good specificity (.94-1.00), but low and variable sensitivity (.04-.28). A Symbol Search scaled score ≤6 achieved a good balance between sensitivity (.38-.64) and specificity (.88-.93). A Coding-Symbol Search scaled score difference ≥5 produced adequate specificity (.89-.91) but consistently low sensitivity (.08-.12). A 2-tailed cutoff on the Coding/Symbol Search raw score ratio (≤1.41 or ≥3.57) produced acceptable specificity (.87-.93), but low sensitivity (.15-.24). Failing ≥2 of these EVIs produced variable specificity (.81-.93) and sensitivity (.31-.59). Failing ≥3 of these EVIs stabilized specificity (.89-.94) at a small cost to sensitivity (.23-.53). Results suggest that processing speed based EVIs have the potential to provide a cost-effective and expedient method for evaluating the validity of cognitive data. Given their generally low and variable sensitivity, however, they should not be used in isolation to determine the credibility of a given response set. They also produced unacceptably high rates of false positive errors in patients with moderate-to-severe head injury. Combining evidence from multiple EVIs has the potential to improve overall classification accuracy. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  13. Initial validation of a proxy indicator of functioning as a potential tool for establishing a clinically meaningful cocaine use outcome.

    Science.gov (United States)

    Kiluk, Brian D; Babuscio, Theresa A; Nich, Charla; Carroll, Kathleen M

    2017-10-01

    Establishing a non-abstinence cocaine use outcome as clinically meaningful has been elusive, in part due to the lack of association between cocaine use outcomes and meaningful indicators of long-term functioning. Using data pooled across 7 clinical trials evaluating treatments for cocaine (N=718), a dichotomous indicator of functioning was created to represent a meaningful outcome ('problem-free functioning' - PFF), defined as the absence of problems across non-substance-related domains on the Addiction Severity Index. Its validity was evaluated at multiple time points (baseline, end-of-treatment, terminal follow-up) and used to explore associations with cocaine use. The percentage of participants meeting PFF criteria increased over time (baseline=18%; end-of-treatment=32%; terminal follow-up=37%). At each time point, ANOVAs indicated those who met PFF criteria reported significantly less distress on the Brief Symptom Inventory and less perceived stress on the Perceived Stress Scale. Generalized linear models indicated categorical indices of self-reported cocaine use at the end of treatment were predictive of the probability of meeting PFF criteria during follow-up (β=-0.01, pcocaine use in the final month of treatment was associated with PFF during follow-up, with strongest associations between PFF and abstinence or 'occasional' use. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. Stability-indicating HPLC–DAD methods for determination of two binary mixtures: Rabeprazole sodium–mosapride citrate and rabeprazole sodium–itopride hydrochloride

    Directory of Open Access Journals (Sweden)

    Hamed M. El-Fatatry

    2014-08-01

    Full Text Available Two selective stability-indicating HPLC methods are described for determination of rabeprazole sodium (RZ–mosapride citrate (MR and RZ–itopride hydrochloride (IO mixtures in the presence of their ICH-stress formed degradation products. Separations were achieved on X-Bridge C18 column using two mobile phases: the first for RZ–MR mixture consisted of acetonitrile: 0.025 M KH2PO4 solution: TEA (30:69:1 v/v; pH 7.0; the second for RZ–IO mixture was at ratio of 25:74:1 (v/v; pH 9.25. The detection wavelength was 283 nm. The two methods were validated and validation acceptance criteria were met in all cases. Peak purity testing using contrast angle theory, relative absorbance and log A versus the wavelengths plots were presented. The % recoveries of the intact drugs were between 99.1% and 102.2% with RSD% values less than 1.6%. Application of the proposed HPLC methods indicated that the methods could be adopted to follow the stability of their formulations. Keywords: Rabeprazole sodium, Mosapride citrate, Itopride hydrochloride, Stability-indicating HPLC–DAD, Peak purity

  15. Validity of genito-urinary discharges, genital ulcers and genital rashes as indicators of seroincident HSV-2 infection

    Directory of Open Access Journals (Sweden)

    Eziyi Iche Kalu

    2015-06-01

    Full Text Available Objective: To evaluate the validity of vaginal discharges, urethral discharges, genital rashes, and painful genital ulcers as indicators of early detection of incident herpes simplex virus type 2 (HSV-2 infection among pregnant women in Benin metropolis. Methods: Participants were antenatal clinic attendees of University of Benin Teaching Hospital and Central Hospital, Benin. Baseline sociodemographic, obstetric and HSV-2 serological data were collected. The HSV-2-seronegative returned for a repeat HSV-2 antibody assay before delivery date. Data on incidence of genital rashes, abnormal vaginal discharges, painful genital ulcers and urethral discharges were collected. Results: The sensitivities of abnormal vaginal discharges, genital rashes, urethral discharges and painful genital ulcers were 82.3%, 70.6%, 41.2% and 28.6% respectively; while their positive-predictive values were 53.8%, 60.0%, 58.3% and 66.7% respective. All the symptoms had >95% specificities and 95% negative-predictive values for seroincident HSV-2 infection. Conclusions: Abnormal vaginal discharge, genital rashes, urethral discharges and genital ulcers are valid indicators of seroincident HSV-2 infection and could be useful in formulation of screening tools in resource-limited settings.

  16. Feasibility and validity of animal-based indicators for on-farm welfare assessment of thermal stress in dairy goats.

    Science.gov (United States)

    Battini, Monica; Barbieri, Sara; Fioni, Luna; Mattiello, Silvana

    2016-02-01

    This investigation tested the feasibility and validity of indicators of cold and heat stress in dairy goats for on-farm welfare assessment protocols. The study was performed on two intensive dairy farms in Italy. Two different 3-point scale (0-2) scoring systems were applied to assess cold and heat stress. Cold and heat stress scores were visually assessed from outside the pen in the morning, afternoon and evening in January-February, April-May and July 2013 for a total of nine sessions of observations/farm. Temperature (°C), relative humidity (%) and wind speed (km/h) were recorded and Thermal Heat Index (THI) was calculated. The sessions were allocated to three climatic seasons, depending on THI ranges: cold (65). Score 2 was rarely assessed; therefore, scores 1 and 2 were aggregated for statistical analysis. The amount of goats suffering from cold stress was significantly higher in the cold season than in neutral (P stress were recorded only in the hot season (P stress scores are valid indicators to detect thermal stress in intensively managed dairy goats. The use of a binary scoring system (presence/absence), merging scores 1 and 2, may be a further refinement to improve the feasibility. This study also allows the prediction of optimal ranges of THI for dairy goat breeds in intensive husbandry systems, setting a comfort zone included into 55 and 70.

  17. Derivation and validation of a multivariable model to predict when primary care physicians prescribe antidepressants for indications other than depression

    Directory of Open Access Journals (Sweden)

    Wong J

    2018-04-01

    Full Text Available Jenna Wong, Michal Abrahamowicz, David L Buckeridge, Robyn Tamblyn Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada Objective: Physicians commonly prescribe antidepressants for indications other than depression that are not evidence-based and need further evaluation. However, lack of routinely documented treatment indications for medications in administrative and medical databases creates a major barrier to evaluating antidepressant use for indications besides depression. Thus, the aim of this study was to derive a model to predict when primary care physicians prescribe antidepressants for indications other than depression and to identify important determinants of this prescribing practice. Methods: Prediction study using antidepressant prescriptions from January 2003–December 2012 in an indication-based electronic prescribing system in Quebec, Canada. Patients were linked to demographic files, medical billings data, and hospital discharge summary data to create over 370 candidate predictors. The final prediction model was derived on a random 75% sample of the data using 3-fold cross-validation integrated within a score-based forward stepwise selection procedure. The performance of the final model was assessed in the remaining 25% of the data. Results: Among 73,576 antidepressant prescriptions, 32,405 (44.0% were written for indications other than depression. Among 40 predictors in the final model, the most important covariates included the molecule name, the patient’s education level, the physician’s workload, the prescribed dose, and diagnostic codes for plausible indications recorded in the past year. The final model had good discrimination (concordance (c statistic 0.815; 95% CI, 0.787–0.847 and good calibration (ratio of observed to expected events 0.986; 95% CI, 0.842–1.136. Conclusion: In the absence of documented treatment indications, researchers may be able to use

  18. Stability-indicating HPLC-DAD/UV-ESI/MS impurity profiling of the anti-malarial drug lumefantrine.

    Science.gov (United States)

    Verbeken, Mathieu; Suleman, Sultan; Baert, Bram; Vangheluwe, Elien; Van Dorpe, Sylvia; Burvenich, Christian; Duchateau, Luc; Jansen, Frans H; De Spiegeleer, Bart

    2011-02-28

    Lumefantrine (benflumetol) is a fluorene derivative belonging to the aryl amino alcohol class of anti-malarial drugs and is commercially available in fixed combination products with β-artemether. Impurity characterization of such drugs, which are widely consumed in tropical countries for malaria control programmes, is of paramount importance. However, until now, no exhaustive impurity profile of lumefantrine has been established, encompassing process-related and degradation impurities in active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs). Using HPLC-DAD/UV-ESI/ion trap/MS, a comprehensive impurity profile was established based upon analysis of market samples as well as stress, accelerated and long-term stability results. In-silico toxicological predictions for these lumefantrine related impurities were made using Toxtree® and Derek®. Several new impurities are identified, of which the desbenzylketo derivative (DBK) is proposed as a new specified degradant. DBK and the remaining unspecified lumefantrine related impurities are predicted, using Toxtree® and Derek®, to have a toxicity risk comparable to the toxicity risk of the API lumefantrine itself. From unstressed, stressed and accelerated stability samples of lumefantrine API and FPPs, nine compounds were detected and characterized to be lumefantrine related impurities. One new lumefantrine related compound, DBK, was identified and characterized as a specified degradation impurity of lumefantrine in real market samples (FPPs). The in-silico toxicological investigation (Toxtree® and Derek®) indicated overall a toxicity risk for lumefantrine related impurities comparable to that of the API lumefantrine itself.

  19. VALIDITY OF EXCESS ENTROPY PRODUCTION CRITERION OF THERMODYNAMIC STABILITY FOR NONEQUILIBRIUM STEADY STATES

    Institute of Scientific and Technical Information of China (English)

    吴金平

    1991-01-01

    The relation between the excess entropy production criterion of thermodynamic stabilityfor nonequilibrium states and kinetic linear stability principle is discussed. It is shown thatthe condition required by the excess entropy production criterion generally is sufficient, butnot necessary to judge the system stability. The condition required by the excess entropyproduction criterion is stronger than that of the linear stability principle. Only when theproduct matrix between the linearized matrix of kinetic equations and matrix of quadraticform of second-order excess entropy is symmetric, is the condition required by the excessentropy production criterion that the steady steate is asymptotically stable (δ_xP>0) necessaryand sufficient. The counterexample given by Fox to prove that the excess entropy, (δ~2S)ss,is not a Liapunov function is incorrect. Contradictory to his conclusion, the counterexampleis just a positive one that proves that the excess entropy is a Liapunov function. Moreover,the excess entropy production criterion is not limited by symmetric conditions of the linear-ized matrix of kinetic equations. The excess entropy around nonequilibrium steady states,(δ~2S)ss, is a Liapunov function of thermodynamic system.

  20. Validation of enhanced stabilization of municipal solid waste under controlled leachate recirculation using FTIR and XRD.

    Science.gov (United States)

    Sethi, Sapna; Kothiyal, N C; Nema, Arvind K

    2012-07-01

    Leachate recirculation at neutral PH accompanied with buffer/nutrients addition has been used successfully in earlier stabilization of municipal solid waste in bioreactor landfills. In the present study, efforts were made to enhance the stabilization rate of municipal solid waste (MSW) and organic solid waste (OSW) in simulated landfill bioreactors by controlling the pH of recirculated leachate towards slightly alkaline side in absence of additional buffer and nutrients addition. Enhanced stabilization in waste samples was monitored with the help of analytical tools like Fourier Transform Infrared Spectroscopy (FTIR) and X-Ray Diffraction (XRD). Predominance of bands assigned to inorganic compounds and comparatively lower intensities of bands for organic compounds in the FTIR spectra of waste samples degraded with leachate recirculation under controlled pH confirmed higher rate of biodegradation and mineralization of waste than the samples degraded without controlled leachate recirculation. XRD spectra also confirmed to a greater extent of mineralization in the waste samples degraded under leachate recirculation with controlled pH. Comparison of XRD spectra of two types of wastes pointed out higher degree of mineralization in organic solid waste as compared to municipal solid waste.

  1. Validation of quality indicators for the organization of palliative care: a modified RAND Delphi study in seven European countries (the Europall project).

    Science.gov (United States)

    Woitha, Kathrin; Van Beek, Karen; Ahmed, Nisar; Jaspers, Birgit; Mollard, Jean M; Ahmedzai, Sam H; Hasselaar, Jeroen; Menten, Johan; Vissers, Kris; Engels, Yvonne

    2014-02-01

    Validated quality indicators can help health-care professionals to evaluate their medical practices in a comparative manner to deliver optimal clinical care. No international set of quality indicators to measure the organizational aspects of palliative care settings exists. To develop and validate a set of structure and process indicators for palliative care settings in Europe. A two-round modified RAND Delphi process was conducted to rate clarity and usefulness of a previously developed set of 110 quality indicators. In total, 20 multi-professional palliative care teams of centers of excellence from seven European countries. In total, 56 quality indicators were rated as useful. These valid quality indicators concerned the following domains: the definition of a palliative care service (2 quality indicators), accessibility to palliative care (16 quality indicators), specific infrastructure to deliver palliative care (8 quality indicators), symptom assessment tools (1 quality indicator), specific personnel in palliative care services (9 quality indicators), documentation methodology of clinical data (14 quality indicators), evaluation of quality and safety procedures (1 quality indicator), reporting of clinical activities (1 quality indicator), and education in palliative care (4 quality indicator). The modified RAND Delphi process resulted in 56 international face-validated quality indicators to measure and compare organizational aspects of palliative care. These quality indicators, aimed to assess and improve the organization of palliative care, will be pilot tested in palliative care settings all over Europe and be used in the EU FP7 funded IMPACT project.

  2. Phase Stability in the Mo-Ti-Zr-C System via Thermodynamic Modeling and Diffusion Multiple Validation

    Science.gov (United States)

    Kar, Sujoy Kumar; Dheeradhada, Voramon S.; Lipkin, Don M.

    2013-08-01

    Alloys in the Mo-rich corner of the Mo-Ti-Zr-C system have found broad applications in non-oxidizing environments requiring structural integrity well beyond 1273 K (1000 °C). Alloys such as TZM (Mo-0.5Ti-0.08Zr-0.03C by weight %) and TZC (Mo-1.2Ti-0.3Zr-0.1C by weight) owe much of their high temperature strength and microstructural stability to MC and M2C carbide phases. In turn, the stability of the respective carbides and the subsequent mechanical behavior of the alloys are strongly dependent on the alloying additions and thermal history. A CALPHAD-based thermodynamic modeling approach is employed to develop a quaternary thermodynamic database for the Mo-Ti-Zr-C system. The thermodynamic database thus developed is validated with diffusion multiple experiments and the validated database is exercised to elucidate the effects of alloying and thermal history on the phase equilibrium in Mo-rich alloys.

  3. Stability indicating HPLC-DAD method for analysis of Ketorolac binary and ternary mixtures in eye drops: Quantitative analysis in rabbit aqueous humor.

    Science.gov (United States)

    El Yazbi, Fawzy A; Hassan, Ekram M; Khamis, Essam F; Ragab, Marwa A A; Hamdy, Mohamed M A

    2017-11-15

    Ketorolac tromethamine (KTC) with phenylephrine hydrochloride (PHE) binary mixture (mixture 1) and their ternary mixture with chlorpheniramine maleate (CPM) (mixture 2) were analyzed using a validated HPLC-DAD method. The developed method was suitable for the in vitro as well as quantitative analysis of the targeted mixtures in rabbit aqueous humor. The analysis in dosage form (eye drops) was a stability indicating one at which drugs were separated from possible degradation products arising from different stress conditions (in vitro analysis). For analysis in aqueous humor, Guaifenesin (GUF) was used as internal standard and the method was validated according to FDA regulation for analysis in biological fluids. Agilent 5 HC-C18(2) 150×4.6mm was used as stationary phase with a gradient eluting solvent of 20mM phosphate buffer pH 4.6 containing 0.2% triethylamine and acetonitrile. The drugs were resolved with retention times of 2.41, 5.26, 7.92 and 9.64min for PHE, GUF, KTC and CPM, respectively. The method was sensitive and selective to analyze simultaneously the three drugs in presence of possible forced degradation products and dosage form excipients (in vitro analysis) and also with the internal standard, in presence of aqueous humor interferences (analysis in biological fluid), at a single wavelength (261nm). No extraction procedure was required for analysis in aqueous humor. The simplicity of the method emphasizes its capability to analyze the drugs in vivo (in rabbit aqueous humor) and in vitro (in pharmaceutical formulations). Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Application of quality by design concept to develop a dual gradient elution stability-indicating method for cloxacillin forced degradation studies using combined mixture-process variable models.

    Science.gov (United States)

    Zhang, Xia; Hu, Changqin

    2017-09-08

    Penicillins are typical of complex ionic samples which likely contain large number of degradation-related impurities (DRIs) with different polarities and charge properties. It is often a challenge to develop selective and robust high performance liquid chromatography (HPLC) methods for the efficient separation of all DRIs. In this study, an analytical quality by design (AQbD) approach was proposed for stability-indicating method development of cloxacillin. The structures, retention and UV characteristics rules of penicillins and their impurities were summarized and served as useful prior knowledge. Through quality risk assessment and screen design, 3 critical process parameters (CPPs) were defined, including 2 mixture variables (MVs) and 1 process variable (PV). A combined mixture-process variable (MPV) design was conducted to evaluate the 3 CPPs simultaneously and a response surface methodology (RSM) was used to achieve the optimal experiment parameters. A dual gradient elution was performed to change buffer pH, mobile-phase type and strength simultaneously. The design spaces (DSs) was evaluated using Monte Carlo simulation to give their possibility of meeting the specifications of CQAs. A Plackett-Burman design was performed to test the robustness around the working points and to decide the normal operating ranges (NORs). Finally, validation was performed following International Conference on Harmonisation (ICH) guidelines. To our knowledge, this is the first study of using MPV design and dual gradient elution to develop HPLC methods and improve separations for complex ionic samples. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. Stress degradation studies and development of stability-indicating TLC-densitometry method for determination of prednisolone acetate and chloramphenicol in their individual and combined pharmaceutical formulations

    Directory of Open Access Journals (Sweden)

    Musharraf Syed

    2012-01-01

    Full Text Available Abstract A rapid and reproducible stability indicating TLC method was developed for the determination of prednisolone acetate and chloramphenicol in presence of their degraded products. Uniform degradation conditions were maintained by refluxing sixteen reaction mixtures for two hours at 80°C using parallel synthesizer including acidic, alkaline and neutral hydrolysis, oxidation and wet heating degradation. Oxidation at room temperature, photochemical and dry heating degradation studies were also carried out. Separation was done on TLC glass plates, pre-coated with silica gel 60F-254 using chloroform: methanol (14:1 v/v. Spots at Rf 0.21 ± 0.02 and Rf 0.41 ± 0.03 were recognized as chloramphenicol and prednisolone acetate, respectively. Quantitative analysis was done through densitometric measurements at multiwavelength (243 nm, λmax of prednisolone acetate and 278 nm, λmax of chloramphenicol, simultaneously. The developed method was optimized and validated as per ICH guidelines. Method was found linear over the concentration range of 200-6000 ng/spot with the correlation coefficient (r2 ± S.D. of 0.9976 ± 3.5 and 0.9920 ± 2.5 for prednisolone acetate and chloramphenicol, respectively. The developed TLC method can be applied for routine analysis of prednisolone acetate and chloramphenicol in presence of their degraded products in their individual and combined pharmaceutical formulations.

  6. Stability-Indicating Reversed-Phase UHPLC Method Development and Characterization of Degradation Products of Almotriptan Maleate by LC-QTOF-MS/MS.

    Science.gov (United States)

    Saibaba, B; Vishnuvardhan, Ch; Johnsi Rani, P; Satheesh Kumar, N

    2018-01-01

    Almotriptan maleate (ALMT), a highly selective 5-hydroxy tryptamine 1B/1D (5-HT1B/1D) receptor agonist used in the treatment of migraine headache was subjected to various ICH (Q1A (R2)) specified guidelines. The drug underwent significant degradation under hydrolytic (acid, base and neutral), oxidative and photolytic stress conditions, while it was stable under thermal stress condition. A total of seven significant degradation products (DPs) were obtained. A simple, selective and reliable UPLC method has been developed for the separation of ALMT and its DPs using Acquity UPLC HSS Cyano (100 × 2.1 mm, 1.8 μm) column with mobile phase consisting of ammonium acetate (10 mM, pH 4.4) buffer and acetonitrile in gradient elution mode. Chromatographic analysis was performed at a flow rate of 0.3 mL/min using a PDA detector at a wavelength of 230 nm. All the DPs (DP-1 to DP-7) were characterized using UHPLC-ESI-QTOF based on mass fragmentation pattern and accurate m/z values. The developed UPLC method was validated in terms of specificity, linearity, precision and accuracy. The developed stability-indicating method helps in quantification of drug in the presence of DPs. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  7. Measuring personality functioning in older adults: construct validity of the Severity Indices of Personality Functioning - Short Form (SIPP-SF).

    Science.gov (United States)

    Rossi, Gina; Debast, Inge; van Alphen, S P J

    2017-07-01

    The dimensional personality disorders model in the Diagnostic and Statistical Manual (DSM)-5 section III conceptually differentiates impaired personality functioning (criterion A) from the presence of pathological traits (criterion B). This study is the first to specifically address the measurement of criterion A in older adults. Moreover, the convergent/divergent validity of criterion A and criterion B will be compared in younger and older age groups. The Severity Indices of Personality Functioning - Short Form (SIPP-SF) was administered in older (N = 171) and younger adults (N = 210). The factorial structure was analyzed with exploratory structural equation modeling. Differences in convergent/divergent validity between personality functioning (SIPP-SF) and pathological traits (Personality Inventory for DSM-5; Dimensional Assessment of Personality Pathology-Basic Questionnaire) were examined across age groups. Identity Integration, Relational Capacities, Responsibility, Self-Control, and Social Concordance were corroborated as higher order domains. Although the SIPP-SF domains measured unique variation, some high correlations with pathological traits referred to overlapping constructs. Moreover, in older adults, personality functioning was more strongly related to Psychoticism, Disinhibition, Antagonism and Dissocial Behavior compared to younger adults. The SIPP-SF construct validity was demonstrated in terms of a structure of five higher order domains of personality functioning. The instrument is promising as a possible measure of impaired personality functioning in older adults. As such, it is a useful clinical tool to follow up effects of therapy on levels of personality functioning. Moreover, traits were associated with different degrees of personality functioning across age groups.

  8. Comparing the validity of informant and self-reports of personality using laboratory indices of emotional responding as criterion variables.

    Science.gov (United States)

    Lieberman, Lynne; Liu, Huiting; Huggins, Ashley A; Katz, Andrea C; Zvolensky, Michael J; Shankman, Stewart A

    2016-09-01

    Personality traits relate to risk for psychopathology and can inform predictions about treatment outcome. In an effort to obtain a comprehensive index of personality, informant reports of personality are sometimes obtained in addition to self-reports of personality. However, there is limited research comparing the validity of self- and informant reports of personality, particularly among those with internalizing psychopathology. This is important given that informants may provide an additional (and perhaps different) perspective on individuals' personality. The present study therefore compared how both reports of positive affectivity (PA) and negative affectivity (NA) relate to psychophysiological and subjective measures of emotional responding to positive and negative stimuli. Given that our sample (n = 117) included individuals with no history of psychopathology, as well as individuals with major depressive disorder (MDD) and/or panic disorder (PD), we were also able to explore whether these internalizing diagnoses moderated the association between personality reports and measures of emotional responding. Informant-reported PA predicted physiological responses to positive stimuli (but not negative). Informant-reported NA predicted physiological responses to negative stimuli (but not positive). Self-reported personality did not predict physiological responding, but did predict subjectively measured emotional responding (NA for negative responding, PA for positive responding). Diagnoses of internalizing psychopathology (PD or MDD) did not moderate these associations. Results suggest self- and informant reports of personality may each provide valid indices of an individual's emotional response tendencies, but predict different aspects of those tendencies. © 2016 Society for Psychophysiological Research.

  9. Comparing the Validity of Informant- and Self-reports of Personality Using Laboratory Indices of Emotional Responding as Criterion Variables

    Science.gov (United States)

    Lieberman, Lynne; Liu, Huiting; Huggins, Ashley A.; Katz, Andrea C.; Zvolensky, Michael J.; Shankman, Stewart A.

    2016-01-01

    Personality traits relate to risk for psychopathology and can inform predictions about treatment outcome. In an effort to obtain a comprehensive index of personality, informant-reports of personality are sometimes obtained in addition to self-reports of personality. However, there is limited research comparing the validity of self- and informant-reports of personality, particularly among those with internalizing psychopathology. This is important given that informants may provide an additional (and perhaps different) perspective on individuals’ personality. The present study therefore compared how both reports of positive affectivity (PA) and negative affectivity (NA) relate to psychophysiological and subjective measures of emotional responding to positive and negative stimuli. Given that our sample (n = 117) included individuals with no history of psychopathology, as well as individuals with major depressive disorder (MDD) and/or panic disorder (PD), we were also able to explore whether these internalizing diagnoses moderated the association between personality reports and measures of emotional responding. Informant-reported PA predicted physiological responses to positive stimuli (but not negative). Informant reported NA predicted physiological responses to negative stimuli (but not positive). Self-reported personality did not predict physiological responding, but did predict subjectively measured emotional responding (NA for negative responding; PA for positive responding). Diagnoses of internalizing psychopathology (PD or MDD) did not moderate these associations. Results suggest self- and informant-reports of personality may each provide valid indices of an individual’s emotional response tendencies, but predict different aspects of those tendencies. PMID:27273802

  10. Experiments at the GELINA facility for the validation of the self-indication neutron resonance densitometry technique

    Directory of Open Access Journals (Sweden)

    Rossa Riccardo

    2017-01-01

    Full Text Available Self-Indication Neutron Resonance Densitometry (SINRD is a passive non-destructive method that is being investigated to quantify the 239Pu content in a spent fuel assembly. The technique relies on the energy dependence of total cross sections for neutron induced reaction. The cross sections show resonance structures that can be used to quantify the presence of materials in objects, e.g. the total cross-section of 239Pu shows a strong resonance close to 0.3 eV. This resonance will cause a reduction of the number of neutrons emitted from spent fuel when 239Pu is present. Hence such a reduction can be used to quantify the amount of 239Pu present in the fuel. A neutron detector with a high sensitivity to neutrons in this energy region is used to enhance the sensitivity to 239Pu. This principle is similar to self-indication cross section measurements. An appropriate detector can be realized by surrounding a 239Pu-loaded fission chamber with appropriate neutron absorbing material. In this contribution experiments performed at the GELINA time-of-flight facility of the JRC at Geel (Belgium to validate the simulations are discussed. The results confirm that the strongest sensitivity to the target material was achieved with the self-indication technique, highlighting the importance of using a 239Pu fission chamber for the SINRD measurements.

  11. Danish version of the Tilburg Frailty Indicator-translation, cross-cultural adaption and validity pretest by cognitive interviewing

    DEFF Research Database (Denmark)

    Andreasen, Jane; Sørensen, Erik E; Gobbens, Robbert J J

    2014-01-01

    The Tilburg Frailty Indicator (TFI) is a self-administered questionnaire with a bio-psycho-social integrated approach that measures the degree of frailty in elderly persons. The TFI was developed in the Netherlands and tested in a population of elderly Dutch men and women. The aim of this study...... was to translate and culturally adapt the TFI to a Danish context, and to test face validity of the Danish version by cognitive interviewing. An internationally recognized procedure was applied as a basis for the translation process. The primary tasks were forward translation, reconciliation, back translation......, harmonization and pretest. Pretest and review of the preliminary version by cognitive interviewing, were performed at a local community center and in an acute medical ward at the University Hospital in Aalborg, Denmark respectively. A large agreement regarding meaning of the items in the forward translation...

  12. Stability-Indicating RP-HPLC Method for Analysis of Paracetamol and Tramadol in a Pharmaceutical Dosage Form

    Directory of Open Access Journals (Sweden)

    Rajesh M. Kamble

    2012-01-01

    Full Text Available A simple, isocratic, rapid and accurate reversed phase high performance liquid chromatography method was developed for the quantitative determination of paracetamol and tramadol in commercial medicinal tablets. The chromatographic separation was achieved on an Intersil C18 (250 mm x 4.6 mm, 5μm column using water pH 3.4 with orthophosphoric acid: methanol (60:40, v/v as a mobile phase, and UV detection at 228 nm. The chromatographic resolutions between paracetamol and tramadol were found greater than five. The linear range for paracetamol and tramadol were 20.8–39.0 μg/ml and 2.4–4.5 μg/ ml was obtained with correlation coefficients ≥0.999 for each analyte. The retention time were found to be 2.1 and 3.9 min for tramadol and paracetamol respectively. Paracetamol and tramadol was subjected to stress conditions (hydrolysis (acid, base oxidation, photolysis and thermal degradation and the stressed samples were analyzed by use of the method. The major degradation was observed in acid and minor in base, thermal, oxidation and photolysis. The forced degradation studies prove the stability indicating power of the method.

  13. Investigation of Spiral Bevel Gear Condition Indicator Validation Via AC-29-2C Using Damage Progression Tests

    Science.gov (United States)

    Dempsey, Paula J.

    2014-01-01

    This report documents the results of spiral bevel gear rig tests performed under a NASA Space Act Agreement with the Federal Aviation Administration (FAA) to support validation and demonstration of rotorcraft Health and Usage Monitoring Systems (HUMS) for maintenance credits via FAA Advisory Circular (AC) 29-2C, Section MG-15, Airworthiness Approval of Rotorcraft (HUMS) (Ref. 1). The overarching goal of this work was to determine a method to validate condition indicators in the lab that better represent their response to faults in the field. Using existing in-service helicopter HUMS flight data from faulted spiral bevel gears as a "Case Study," to better understand the differences between both systems, and the availability of the NASA Glenn Spiral Bevel Gear Fatigue Rig, a plan was put in place to design, fabricate and test comparable gear sets with comparable failure modes within the constraints of the test rig. The research objectives of the rig tests were to evaluate the capability of detecting gear surface pitting fatigue and other generated failure modes on spiral bevel gear teeth using gear condition indicators currently used in fielded HUMS. Nineteen final design gear sets were tested. Tables were generated for each test, summarizing the failure modes observed on the gear teeth for each test during each inspection interval and color coded based on damage mode per inspection photos. Gear condition indicators (CI) Figure of Merit 4 (FM4), Root Mean Square (RMS), +/- 1 Sideband Index (SI1) and +/- 3 Sideband Index (SI3) were plotted along with rig operational parameters. Statistical tables of the means and standard deviations were calculated within inspection intervals for each CI. As testing progressed, it became clear that certain condition indicators were more sensitive to a specific component and failure mode. These tests were clustered together for further analysis. Maintenance actions during testing were also documented. Correlation coefficients were

  14. Validation of nine years of MOPITT V5 NIR using MOZAIC/IAGOS measurements: biases and long-term stability

    Directory of Open Access Journals (Sweden)

    A. T. J. de Laat

    2014-11-01

    Full Text Available Validation results from a comparison between Measurement Of Pollution In The Troposphere (MOPITT V5 Near InfraRed (NIR carbon monoxide (CO total column measurements and Measurement of Ozone and Water Vapour on Airbus in-service Aircraft (MOZAIC/In-Service Aircraft for a Global Observing System (IAGOS aircraft measurements are presented. A good agreement is found between MOPITT and MOZAIC/IAGOS measurements, consistent with results from earlier studies using different validation data and despite large variability in MOPITT CO total columns along the spatial footprint of the MOZAIC/IAGOS measurements. Validation results improve when taking the large spatial footprint of the MOZAIC/IAGOS data into account. No statistically significant drift was detected in the validation results over the period 2002–2010 at global, continental and local (airport scales. Furthermore, for those situations where MOZAIC/IAGOS measurements differed from the MOPITT a priori, the MOPITT measurements clearly outperformed the MOPITT a priori data, indicating that MOPITT NIR retrievals add value to the MOPITT a priori. Results from a high spatial resolution simulation of the chemistry-transport model MOCAGE (MOdèle de Chimie Atmosphérique à Grande Echelle showed that the most likely explanation for the large MOPITT variability along the MOZAIC-IAGOS profile flight path is related to spatio-temporal CO variability, which should be kept in mind when using MOZAIC/IAGOS profile measurements for validating satellite nadir observations.

  15. Validation of deep freezing of pilot samples for checking of time stability of indirect analyses of basic milk composition and for their long shelf-life

    Directory of Open Access Journals (Sweden)

    Oto Hanuš

    2008-01-01

    result agreement between indirect and reference method. Relevant sd varied from ±0.025 % for L to ±0.059 % for F (in J breed with exception CP ±0.085 % in J sample. Also B procedure was shown as applicable for instrumental sability control in half year period. In practice the one reference value for concrete FPS is valid from one to next calibration. Persistent trend in repeatability of FPSs can indicate an inadequate instrumental drift. The applied FPS procedure is usable for stability control of instrumental measurement in milk laboratories.

  16. 11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.

    Science.gov (United States)

    Islam, Rafiq; Briscoe, Chad; Bower, Joseph; Cape, Stephanie; Arnold, Mark; Hayes, Roger; Warren, Mark; Karnik, Shane; Stouffer, Bruce; Xiao, Yi Qun; van der Strate, Barry; Sikkema, Daniel; Fang, Xinping; Tudoroniu, Ariana; Tayyem, Rabab; Brant, Ashley; Spriggs, Franklin; Barry, Colin; Khan, Masood; Keyhani, Anahita; Zimmer, Jennifer; Caturla, Maria Cruz; Couerbe, Philippe; Khadang, Ardeshir; Bourdage, James; Datin, Jim; Zemo, Jennifer; Hughes, Nicola; Fatmi, Saadya; Sheldon, Curtis; Fountain, Scott; Satterwhite, Christina; Colletti, Kelly; Vija, Jenifer; Yu, Mathilde; Stamatopoulos, John; Lin, Jenny; Wilfahrt, Jim; Dinan, Andrew; Ohorodnik, Susan; Hulse, James; Patel, Vimal; Garofolo, Wei; Savoie, Natasha; Brown, Michael; Papac, Damon; Buonarati, Mike; Hristopoulos, George; Beaver, Chris; Boudreau, Nadine; Williard, Clark; Liu, Yansheng; Ray, Gene; Warrino, Dominic; Xu, Allan; Green, Rachel; Hayward-Sewell, Joanne; Marcelletti, John; Sanchez, Christina; Kennedy, Michael; Charles, Jessica St; Bouhajib, Mohammed; Nehls, Corey; Tabler, Edward; Tu, Jing; Joyce, Philip; Iordachescu, Adriana; DuBey, Ira; Lindsay, John; Yamashita, Jim; Wells, Edward

    2018-04-01

    The 11th Global CRO Council Closed Forum was held in Universal City, CA, USA on 3 April 2017. Representatives from international CRO members offering bioanalytical services were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The second CRO-Pharma Scientific Interchange Meeting was held on 7 April 2017, which included Pharma representatives' sharing perspectives on the topics discussed earlier in the week with the CRO members. The issues discussed at the meetings included cumulative stability evaluations, matrix stability evaluations, the 2016 US FDA Immunogenicity Guidance and recent and unexpected FDA Form 483s on immunogenicity assays, the bioanalytical laboratory's role in writing PK sample collection instructions, biosimilars, CRO perspectives on the use of chiral versus achiral methods, hybrid LBA/LCMS assays, applications of fit-for-purpose validation and, at the Global CRO Council Closed Forum only, the status and trend of current regulated bioanalytical practice in China under CFDA's new BMV policy. Conclusions from discussions of these topics at both meetings are included in this report.

  17. Validation of key indicators in cattle farms at high risk of animal welfare problems: a qualitative case-control study.

    Science.gov (United States)

    Kelly, P C; More, S J; Blake, M; Higgins, I; Clegg, T; Hanlon, A

    2013-03-23

    The objective of this study was to validate four key farmer performance indicators (KFPI), identified in a previous study, as indicators of on-farm cattle welfare incidents in Ireland, through comparison of the distribution of these KPFIs in the national herd (n=109,925) and in case herds (n=18), where welfare incidents were previously studied. The KFPIs identified were late registrations, and exits from the herd by on-farm burial, by moves to knackeries and by moves to 'herd unknown'. Data were extracted from two Department of Agriculture, Food and the Marine databases for the national herd and the case herds. All four KFPIs differed significantly between the case herds and the national herd, and one further KFPI was identified, namely moves to factories. The data for these KFPIs are routinely stored on national databases, which were established in order to comply with Regulation (EC) 1760/2000. Based on the results obtained in this study, it may be possible in the future to use routine data capture to improve strategy towards on-farm animal welfare. At this point, however, based on calculated specificities and sensitivities, none of these five KFPIs, at the cut-offs investigated and using several combinations, are able to distinguish herds with and without on-farm animal welfare problems at an accuracy suitable for routine national use in Ireland.

  18. Using GPS-surveyed intertidal zones to determine the validity of shorelines automatically mapped by Landsat water indices

    Science.gov (United States)

    Kelly, Joshua T.; Gontz, Allen M.

    2018-03-01

    Satellite remote sensing has been used extensively in a variety of shoreline studies and validated using aerial photography. This ground truth method only represents an instantaneous depiction of the shoreline at the time of acquisition and does not take into account the spatial and temporal variability of the dynamic shoreline boundary. Landsat 8‧s Operational Land Imager sensor's capability to accurately delineate a shoreline is assessed by comparing all known Landsat water index-derived shorelines with two GPS-surveyed intertidal zones that coincide with the satellite flyover date, one of which had near-neap tide conditions. Seven indices developed for automatically classifying water pixels were evaluated for their ability to delineate shorelines. The shoreline is described here as the area above and below maximum low and high tide, otherwise known as the intertidal zone. The high-water line, or wet/dry sediment line, was chosen as the shoreline indicator to be mapped using a handheld GPS. The proportion of the Landsat-derived shorelines that fell within this zone and their alongshore profile lengths were calculated. The most frequently used water index and the predecessor to Modified Normalized Difference Water Index (MNDWI), Normalized Difference Water Index (NDWI), was found to be the least accurate by a significant margin. Other indices required calibration of their threshold value to achieve accurate results, thus diminishing their replicability success for other regions. MNDWI was determined to be the best index for automated shoreline mapping, based on its superior accuracy and repeatable, stable threshold value.

  19. A cluster randomized trial for the implementation of an antibiotic checklist based on validated quality indicators: the AB-checklist.

    Science.gov (United States)

    van Daalen, Frederike V; Prins, Jan M; Opmeer, Brent C; Boermeester, Marja A; Visser, Caroline E; van Hest, Reinier M; Hulscher, Marlies E J L; Geerlings, Suzanne E

    2015-03-19

    Recently we developed and validated generic quality indicators that define 'appropriate antibiotic use' in hospitalized adults treated for a (suspected) bacterial infection. Previous studies have shown that with appropriate antibiotic use a reduction of 13% of length of hospital stay can be achieved. Our main objective in this project is to provide hospitals with an antibiotic checklist based on these quality indicators, and to evaluate the introduction of this checklist in terms of (cost-) effectiveness. The checklist applies to hospitalized adults with a suspected bacterial infection for whom antibiotic therapy is initiated, at first via the intravenous route. A stepped wedge study design will be used, comparing outcomes before and after introduction of the checklist in nine hospitals in the Netherlands. At least 810 patients will be included in both the control and the intervention group. The primary endpoint is length of hospital stay. Secondary endpoints are appropriate antibiotic use measured by the quality indicators, admission to and duration of intensive care unit stay, readmission within 30 days, mortality, total antibiotic use, and costs associated with implementation and hospital stay. Differences in numerical endpoints between the two periods will be evaluated with mixed linear models; for dichotomous outcomes generalized estimating equation models will be used. A process evaluation will be performed to evaluate the professionals' compliance with use of the checklist. The key question for the economic evaluation is whether the benefits of the checklist, which include reduced antibiotic use, reduced length of stay and associated costs, justify the costs associated with implementation activities as well as daily use of the checklist. If (cost-) effective, the AB-checklist will provide physicians with a tool to support appropriate antibiotic use in adult hospitalized patients who start with intravenous antibiotics. Dutch trial registry: NTR4872.

  20. Validation of cytoplasmic-to-nuclear ratio of survivin as an indicator of improved prognosis in breast cancer

    International Nuclear Information System (INIS)

    Rexhepaj, Elton; Jirstrom, Karin; O'Connor, Darran P; O'Brien, Sallyann L; Landberg, Goran; Duffy, Michael J; Brennan, Donal J; Gallagher, William M

    2010-01-01

    Conflicting data exist regarding the prognostic and predictive impact of survivin (BIRC5) in breast cancer. We previously reported survivin cytoplasmic-to-nuclear ratio (CNR) as an independent prognostic indicator in breast cancer. Here, we validate survivin CNR in a separate and extended cohort. Furthermore, we present new data suggesting that a low CNR may predict outcome in tamoxifen-treated patients. Survin expression was assessed using immunhistochemistry on a breast cancer tissue microarray (TMA) containing 512 tumours. Whole slide digital images were captured using an Aperio XT scanner. Automated image analysis was used to identify tumour from stroma and then to quantify tumour-specific nuclear and cytoplasmic survivin. A decision tree model selected using a 10-fold cross-validation approach was used to identify prognostic subgroups based on nuclear and cytoplasmic survivin expression. Following optimisation of the staining procedure, it was possible to evaluate survivin protein expression in 70.1% (n = 359) of the 512 tumours represented on the TMA. Decision tree analysis predicted that nuclear, as opposed to cytoplasmic, survivin was the most important determinant of overall survival (OS) and breast cancer-specific survival (BCSS). The decision tree model confirmed CNR of 5 as the optimum threshold for survival analysis. Univariate analysis demonstrated an association between a high CNR (>5) and a prolonged BCSS (HR 0.49, 95% CI 0.29-0.81, p = 0.006). Multivariate analysis revealed a high CNR (>5) was an independent predictor of BCSS (HR 0.47, 95% CI 0.27-0.82, p = 0.008). An increased CNR was associated with ER positive (p = 0.045), low grade (p = 0.007), Ki-67 (p = 0.001) and Her2 (p = 0.026) negative tumours. Finally, a high CNR was an independent predictor of OS in tamoxifen-treated ER-positive patients (HR 0.44, 95% CI 0.23-0.87, p = 0.018). Using the same threshold as our previous study, we have validated survivin CNR as a marker of good prognosis in

  1. Validation of cytoplasmic-to-nuclear ratio of survivin as an indicator of improved prognosis in breast cancer

    LENUS (Irish Health Repository)

    Rexhepaj, Elton

    2010-11-23

    Abstract Background Conflicting data exist regarding the prognostic and predictive impact of survivin (BIRC5) in breast cancer. We previously reported survivin cytoplasmic-to-nuclear ratio (CNR) as an independent prognostic indicator in breast cancer. Here, we validate survivin CNR in a separate and extended cohort. Furthermore, we present new data suggesting that a low CNR may predict outcome in tamoxifen-treated patients. Methods Survin expression was assessed using immunhistochemistry on a breast cancer tissue microarray (TMA) containing 512 tumours. Whole slide digital images were captured using an Aperio XT scanner. Automated image analysis was used to identify tumour from stroma and then to quantify tumour-specific nuclear and cytoplasmic survivin. A decision tree model selected using a 10-fold cross-validation approach was used to identify prognostic subgroups based on nuclear and cytoplasmic survivin expression. Results Following optimisation of the staining procedure, it was possible to evaluate survivin protein expression in 70.1% (n = 359) of the 512 tumours represented on the TMA. Decision tree analysis predicted that nuclear, as opposed to cytoplasmic, survivin was the most important determinant of overall survival (OS) and breast cancer-specific survival (BCSS). The decision tree model confirmed CNR of 5 as the optimum threshold for survival analysis. Univariate analysis demonstrated an association between a high CNR (>5) and a prolonged BCSS (HR 0.49, 95% CI 0.29-0.81, p = 0.006). Multivariate analysis revealed a high CNR (>5) was an independent predictor of BCSS (HR 0.47, 95% CI 0.27-0.82, p = 0.008). An increased CNR was associated with ER positive (p = 0.045), low grade (p = 0.007), Ki-67 (p = 0.001) and Her2 (p = 0.026) negative tumours. Finally, a high CNR was an independent predictor of OS in tamoxifen-treated ER-positive patients (HR 0.44, 95% CI 0.23-0.87, p = 0.018). Conclusion Using the same threshold as our previous study, we have

  2. Simplification and Validation of a Spectral-Tensor Model for Turbulence Including Atmospheric Stability

    Science.gov (United States)

    Chougule, Abhijit; Mann, Jakob; Kelly, Mark; Larsen, Gunner C.

    2018-02-01

    A spectral-tensor model of non-neutral, atmospheric-boundary-layer turbulence is evaluated using Eulerian statistics from single-point measurements of the wind speed and temperature at heights up to 100 m, assuming constant vertical gradients of mean wind speed and temperature. The model has been previously described in terms of the dissipation rate ɛ , the length scale of energy-containing eddies L , a turbulence anisotropy parameter Γ, the Richardson number Ri, and the normalized rate of destruction of temperature variance η _θ ≡ ɛ _θ /ɛ . Here, the latter two parameters are collapsed into a single atmospheric stability parameter z / L using Monin-Obukhov similarity theory, where z is the height above the Earth's surface, and L is the Obukhov length corresponding to Ri,η _θ. Model outputs of the one-dimensional velocity spectra, as well as cospectra of the streamwise and/or vertical velocity components, and/or temperature, and cross-spectra for the spatial separation of all three velocity components and temperature, are compared with measurements. As a function of the four model parameters, spectra and cospectra are reproduced quite well, but horizontal temperature fluxes are slightly underestimated in stable conditions. In moderately unstable stratification, our model reproduces spectra only up to a scale ˜ 1 km. The model also overestimates coherences for vertical separations, but is less severe in unstable than in stable cases.

  3. Tests of regional elemental tracers of pollution aerosols. 1. Distinctness of regional signatures, stability during transport, and empirical validation

    International Nuclear Information System (INIS)

    Lowenthal, D.H.; Wunschel, K.R.; Rahn, K.A.

    1988-01-01

    The two major requirements for a successful regional tracer system are distinctness of signatures and stability of signatures during transport. Dissimilarity of the five regional signatures from eastern North America is shown by collinearity diagnostics and by apportionment of synthetic samples generated randomly. Stability of regional signatures during transport is shown first by use of tracer elements in coarse and fine aerosol to predict the maximum possible change of ratios from particle-size effects alone and then by examination of actual changes in signatures during transport from the Midwest to Underhill, VT. Two recent empirical validations of the tracer system are presented: qualitative agreement of pulses of mid-western aerosol in Vermont with pulses of perfluorocarbon tracer gas released in Ohio during CAPTEX '83 and reproduction of our three major northeastern and mid-western signatures by other investigators. The tracer system currently uses the seven elements As, Se, Sb, Zn, In, noncrustal Mn, and noncrustal V as measured by instrumental neutron activation

  4. Preliminary model validation for integral stability behavior in molten salt natural circulation

    International Nuclear Information System (INIS)

    Cai Chuangxiong; He Zhaozhong; Chen Kun

    2017-01-01

    Passive safety system is an important characteristic of Fluoride-Salt-Cooled High-Temperature Reactor (FHR). In order to remove the decay heat, a direct reactor auxiliary cooling system (DRACS) which uses the passive safety technology is proposed to the FHR as the ultimate heat sink. The DRACS is relying on the natural circulation, so the study of molten salt natural circulation plays an important role at TMSR. A high-temperature molten salt natural circulation test loop has been designed and constructed at the TMSR center of the Chinese Academy of Sciences (CAS) to understand the characteristics of the natural circulation and verify the design model. It adopts nitrate salt as the working fluid to simulate fluoride salts, and uses air as the ultimate heat sink. The test shows the operation very well and has a very nice performance, the Heat transfer coefficients (salt-salt or salt-air), power of the loop, heat loss of molten salt pool (or molten salt pipe or air cooling tower), starting time of the loop, flow rate that can be verified in this loop. A series of experiments have been done and the results show that the experimental data are well matched with the design data. This paper aims at analyzing the molten salt circulation model, studying the characteristics of the natural circulation, and verifying the Integral stability behavior by three different natural circulation experiments. Also, the experiment is going on, and more experiments will been carry out to study the molten salt natural circulation for optimizing the design. (author)

  5. Development and validation of UPLC/ESI-Q-TOF-MS for carteolol in aqueous humour: Stability, stress degradation and application in pharmacokinetics of nanoformulation

    Directory of Open Access Journals (Sweden)

    Ameeduzzafar

    2017-05-01

    Full Text Available Carteolol (CRT is currently under development as a potential therapeutic agent for the treatment of open angle glaucoma. The purpose of the present work is to develop and validate a stability indicating assay method and its application to estimate CRT in aqueous humour and study the pharmacokinetic parameters. An ultra performance liquid chromatographic tandem mass spectroscopy (UPLC–MS/MS method was developed and validated for the quantitative determination of CRT in rabbit aqueous humour, using propranolol as the internal standard (I.S.. Aqueous humour samples were prepared by a simple liquid–liquid extraction technique (LLE. The analyte and internal standard were separated by an Acquity UPLC BEH C18 (100.0 × 2.1 mm; 1.7 μm column with a mobile phase of acetonitrile – 2 mM (milli mole ammonium acetate (90/10, v/v over 3 min of retention time. Detection was based on the multiple reactions monitoring with the precursor-to-product ion transitions m/z 293.2 → 237.12 for CRT and m/z 260.09 → 183.04 for I.S. The method was validated according to FDA guidelines on the bio-analytical method validation. The method developed was linear (r2 = 0.999 over the concentration range of 1–1000 ng/mL. The selectivity, sensitivity, linearity, accuracy, precision, extraction recovery, and stability were within the acceptable ranges. Forced degradation studies were performed on bulk sample of CRT as per ICH prescribed stress conditions, such as acid, base, oxidative and photolytic to show the forced of the method. Significant degradation was observed during basic stress condition. The pharmacokinetic study of CRT solution and nanoparticles in aqueous humour of rabbit eye was performed and results showed that CRT nanoparticles enhance the ocular bioavailability by 5.61-fold as compared to CRT-solution.

  6. EO-1 Hyperion Reflectance Time Series at Calibration and Validation Sites: Stability and Sensitivity to Seasonal Dynamics

    Science.gov (United States)

    Campbell, Petya K. Entcheva; Middleton, Elizabeth M.; Thome, Kurt J.; Kokaly, Raymond F.; Huemmrich, Karl Fred; Lagomasino, David; Novick, Kimberly A.; Brunsell, Nathaniel A.

    2013-01-01

    This study evaluated Earth Observing 1 (EO-1) Hyperion reflectance time series at established calibration sites to assess the instrument stability and suitability for monitoring vegetation functional parameters. Our analysis using three pseudo-invariant calibration sites in North America indicated that the reflectance time series are devoid of apparent spectral trends and their stability consistently is within 2.5-5 percent throughout most of the spectral range spanning the 12-plus year data record. Using three vegetated sites instrumented with eddy covariance towers, the Hyperion reflectance time series were evaluated for their ability to determine important variables of ecosystem function. A number of narrowband and derivative vegetation indices (VI) closely described the seasonal profiles in vegetation function and ecosystem carbon exchange (e.g., net and gross ecosystem productivity) in three very different ecosystems, including a hardwood forest and tallgrass prairie in North America, and a Miombo woodland in Africa. Our results demonstrate the potential for scaling the carbon flux tower measurements to local and regional landscape levels. The VIs with stronger relationships to the CO2 parameters were derived using continuous reflectance spectra and included wavelengths associated with chlorophyll content and/or chlorophyll fluorescence. Since these indices cannot be calculated from broadband multispectral instrument data, the opportunity to exploit these spectrometer-based VIs in the future will depend on the launch of satellites such as EnMAP and HyspIRI. This study highlights the practical utility of space-borne spectrometers for characterization of the spectral stability and uniformity of the calibration sites in support of sensor cross-comparisons, and demonstrates the potential of narrowband VIs to track and spatially extend ecosystem functional status as well as carbon processes measured at flux towers.

  7. EO-1 Hyperion reflectance time series at calibration and validation sites: stability and sensitivity to seasonal dynamics

    Science.gov (United States)

    Campbell, P.K.E.; Middleton, E.M.; Thome, K.J.; Kokaly, Raymond F.; Huemmrich, K.F.; Novick, K.A.; Brunsell, N.A.

    2013-01-01

    This study evaluated Earth Observing 1 (EO-1) Hyperion reflectance time series at established calibration sites to assess the instrument stability and suitability for monitoring vegetation functional parameters. Our analysis using three pseudo-invariant calibration sites in North America indicated that the reflectance time series are devoid of apparent spectral trends and their stability consistently is within 2.5-5 percent throughout most of the spectral range spanning the 12+ year data record. Using three vegetated sites instrumented with eddy covariance towers, the Hyperion reflectance time series were evaluated for their ability to determine important variables of ecosystem function. A number of narrowband and derivative vegetation indices (VI) closely described the seasonal profiles in vegetation function and ecosystem carbon exchange (e.g., net and gross ecosystem productivity) in three very different ecosystems, including a hardwood forest and tallgrass prairie in North America, and a Miombo woodland in Africa. Our results demonstrate the potential for scaling the carbon flux tower measurements to local and regional landscape levels. The VIs with stronger relationships to the CO2 parameters were derived using continuous reflectance spectra and included wavelengths associated with chlorophyll content and/or chlorophyll fluorescence. Since these indices cannot be calculated from broadband multispectral instrument data, the opportunity to exploit these spectrometer-based VIs in the future will depend on the launch of satellites such as EnMAP and HyspIRI. This study highlights the practical utility of space-borne spectrometers for characterization of the spectral stability and uniformity of the calibration sites in support of sensor cross-comparisons, and demonstrates the potential of narrowband VIs to track and spatially extend ecosystem functional status as well as carbon processes measured at flux towers.

  8. Introducing conjoint analysis method into delayed lotteries studies: its validity and time stability are higher than in adjusting.

    Science.gov (United States)

    Białek, Michał; Markiewicz, Łukasz; Sawicki, Przemysław

    2015-01-01

    The delayed lotteries are much more common in everyday life than are pure lotteries. Usually, we need to wait to find out the outcome of the risky decision (e.g., investing in a stock market, engaging in a relationship). However, most research has studied the time discounting and probability discounting in isolation using the methodologies designed specifically to track changes in one parameter. Most commonly used method is adjusting, but its reported validity and time stability in research on discounting are suboptimal. The goal of this study was to introduce the novel method for analyzing delayed lotteries-conjoint analysis-which hypothetically is more suitable for analyzing individual preferences in this area. A set of two studies compared the conjoint analysis with adjusting. The results suggest that individual parameters of discounting strength estimated with conjoint have higher predictive value (Study 1 and 2), and they are more stable over time (Study 2) compared to adjusting. We discuss these findings, despite the exploratory character of reported studies, by suggesting that future research on delayed lotteries should be cross-validated using both methods.

  9. Introducing conjoint analysis method into delayed lotteries studies: Its validity and time stability are higher than in adjusting

    Directory of Open Access Journals (Sweden)

    Michal eBialek

    2015-01-01

    Full Text Available The delayed lotteries are much more common in everyday life than are pure lotteries. Usually, we need to wait to find out the outcome of the risky decision (e.g., investing in a stock market, engaging in a relationship. However, most research has studied the time discounting and probability discounting in isolation using the methodologies designed specifically to track changes in one parameter. Most commonly used method is adjusting, but its reported validity and time stability in research on discounting are suboptimal.The goal of this study was to introduce the novel method for analyzing delayed lotteries - conjoint analysis - which hypothetically is more suitable for analyzing individual preferences in this area. A set of two studies compared the conjoint analysis with adjusting. The results suggest that individual parameters of discounting strength estimated with conjoint have higher predictive value (Study 1 & 2, and they are more stable over time (Study 2 compared to adjusting. We discuss these findings, despite the exploratory character of reported studies, by suggesting that future research on delayed lotteries should be cross-validated using both methods.

  10. Utilizing In Situ Directional Hyperspectral Measurements to Validate Bio-Indicator Simulations for a Corn Crop Canopy

    Science.gov (United States)

    Cheng, Yen-Ben; Middleton, Elizabeth M.; Huemmrich, Karl F.; Zhang, Qingyuan; Campbell, Petya K. E.; Corp, Lawrence A.; Russ, Andrew L.; Kustas, William P.

    2010-01-01

    Two radiative transfer canopy models, SAIL and the two-layer Markov-Chain Canopy Reflectance Model (MCRM), were coupled with in situ leaf optical properties to simulate canopy-level spectral band ratio vegetation indices with the focus on the photochemical reflectance index in a cornfield. In situ hyperspectral measurements were made at both leaf and canopy levels. Leaf optical properties were obtained from both sunlit and shaded leaves. Canopy reflectance was acquired for eight different relative azimuth angles (psi) at three different view zenith angles (Theta (sub v)), and later used to validate model outputs. Field observations of photochemical reflectance index (PRI) for sunlit leaves exhibited lower values than shaded leaves, indicating higher light stress. Canopy PRI expressed obvious sensitivity to viewing geometry, as a function of both Theta (sub v) and psi . Overall, simulations from MCRM exhibited better agreements with in situ values than SAIL. When using only sunlit leaves as input, the MCRM-simulated PRI values showed satisfactory correlation and RMSE, as compared to in situ values. However, the performance of the MCRM model was significantly improved after defining a lower canopy layer comprised of shaded leaves beneath the upper sunlit leaf layer. Four other widely used band ratio vegetation indices were also studied and compared with the PRI results. MCRM simulations were able to generate satisfactory simulations for these other four indices when using only sunlit leaves as input; but unlike PRI, adding shaded leaves did not improve the performance of MCRM. These results support the hypothesis that the PRI is sensitive to physiological dynamics while the others detect static factors related to canopy structure. Sensitivity analysis was performed on MCRM in order to better understand the effects of structure related parameters on the PRI simulations. Leaf area index (LAI) showed the most significant impact on MCRM-simulated PRI among the parameters

  11. Validation of the Engineering Plant Analyzer methodology with Peach Bottom 2 stability tests

    International Nuclear Information System (INIS)

    Rohatgi, U.S.; Mallen, A.N.; Cheng, H.S.; Wulff, W.

    1994-01-01

    The Engineering Plant Analyzer (EPA) had been developed in 1984 at Brookhaven National Laboratory to simulate plant transients in boiling water reactors (BWR). Recently, the EPA with its High-Speed Interactive Plant Analyzer code for BWRs ( ppercase HIPA-BWR ) simulated for the first time oscillatory transients with large, non-linear power and flow amplitudes; transients which are centered around the March 9, 1988 instability at the LaSalle-2 BWR power plant.The EPA's capability to simulate oscillatory transients has been demonstrated first by comparing simulation results with LaSalle-2 plant data (Wulff et al., NUREG/CR-5816, BNL-NUREG-52312, Brookhaven National Laboratory, 1992). This paper presents an EPA assessment on the basis of the Peach Bottom 2 instability tests (Carmichael and Niemi, EPRI NP-564, Electric Power Research Institute, Palo Alto, CA, 1978). This assessment of the EPA appears to constitute the first validation of a time-domain reactor systems code on the basis of frequency-domain criteria, namely power spectral density, gain and phase shift of the pressure-to-power transfer function.The reactor system pressure was disturbed in the Peach Bottom 2 power plant tests, and in their EPA simulation, by a pseudo-random, binary sequence signal. The data comparison revealed that the EPA predicted for Peach Bottom tests PT1, PT2, and PT4 the gain of the power-to-pressure transfer function with the biases and standard deviations of (-10±28)%, (-1±40)% and (+28±52)%, respectively. The respective frequencies at the peak gains were predicted with the errors of +6%, +3%, and -28%. The differences between the predicted and the measured phase shift increased with increasing frequency, but stayed within the margin of experimental uncertainty. ((orig.))

  12. Work-related stress risk assessment in Italy: the validation study of health safety and executive indicator tool.

    Science.gov (United States)

    Rondinone, Bruna Maria; Persechino, Benedetta; Castaldi, Tiziana; Valenti, Antonio; Ferrante, Pierpaolo; Ronchetti, Matteo; Iavicoli, Sergio

    2012-01-01

    In compliance with the Italian occupational health and safety regulatory framework, as provided by the Lgs. Decree 81/2008, the "work-related stress" risk assessment should follow the same principles as other risk assessments, in accordance with the European Agreement of 8 October 2004; therefore, validated and scientifically proven methodological tools are needed to conduct an adequate work-related stress risk assessment. The UK's Health Safety and Executive (HSE) Indicator Tool (IT) is used for assessing the risk of work-related stress. The aim of this study is to test the factor structure of IT as a measure of work-related stress in a sample of Italian workers. Data collected from 65 Italian organizations (6378 workers) was used for a Confirmatory Factor Analysis (CFA) on the 35-item seven-factor model. The results showed acceptable fit to the data (CFI .90; TLI .89, RMSEA .045). A second CFA was done to test a 35-item six-factor model (CFI .89, TLI .87, RMSEA .047). Both models were tested after removing six items (factor loadings less than .50.), resulting in a 29-item model. Here again, there was an acceptable fit to the data (29-item seven-factor model: CFI .93, TLI .91, RMSEA .044; 29-item six-factor model: CFI .92, TLI .90, RMSEA .046). These findings show that the HSE model satisfactorily adapts to use in a sample of Italian workers. One of the most important innovations introduced in the assessment of work-related stress with the HSE IT is the global approach for identifying work-related stress risk factors, aimed at establishing the best strategy from the viewpoints of prevention officers and also of workers.

  13. Development and Validation of an HIV Risk Exposure and Indicator Conditions Questionnaire to Support Targeted HIV Screening.

    Science.gov (United States)

    Elías, María Jesús Pérez; Gómez-Ayerbe, Cristina; Elías, Pilar Pérez; Muriel, Alfonso; de Santiago, Alberto Diaz; Martinez-Colubi, María; Moreno, Ana; Santos, Cristina; Polo, Lidia; Barea, Rafa; Robledillo, Gema; Uranga, Almudena; Espín, Agustina Cano; Quereda, Carmen; Dronda, Fernando; Casado, Jose Luis; Moreno, Santiago

    2016-02-01

    The aim of our study was to develop a Spanish-structured HIV risk of exposure and indicator conditions (RE&IC) questionnaire. People attending to an emergency room or to a primary clinical care center were offered to participate in a prospective, 1 arm, open label study, in which all enrolled patients filled out our developed questionnaire and were HIV tested. Questionnaire accuracy, feasibility, and reliability were evaluated.Valid paired 5329 HIV RE&IC questionnaire and rapid HIV tests were performed, 69.3% in the primary clinical care center, 49.6% women, median age 37 years old, 74.9% Spaniards, 20.1% Latin-Americans. Confirmed hidden HIV infection was detected in 4.1%, while HIV RE&IC questionnaire was positive in 51.2%. HIV RE&IC questionnaire sensitivity was 100% to predict HIV infection, with a 100% negative predictive value. When considered separately, RE or IC items sensitivity decreases to 86.4% or 91%, and similarly their negative predictive value to 99.9% for both of them. The majority of people studied, 90.8% self-completed HIV RE&IC questionnaire. Median time to complete was 3 minutes. Overall HIV RE&IC questionnaire test-retest Kappa agreement was 0.82 (almost perfect), likewise for IC items 0.89, while for RE items was lower 0.78 (substantial).A feasible and reliable Spanish HIV RE&IC self questionnaire accurately discriminated all non-HIV-infected people without missing any HIV diagnoses, in a low prevalence HIV infection area. The best accuracy and reliability were obtained when combining HIV RE&IC items.

  14. Validating the proposed diagnostic and statistical manual of mental disorders, 5th edition, severity indicator for personality disorder.

    Science.gov (United States)

    Morey, Leslie C; Bender, Donna S; Skodol, Andrew E

    2013-09-01

    The authors sought to determine whether a 5-point global rating of personality dysfunction on the Level of Personality Functioning Scale proposed as a severity index for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), would be related to DSM-IV personality disorder diagnosis as well as to other key clinical judgments. Data were collected from a national sample of 337 mental health clinicians who provided complete diagnostic information relevant to DSM-IV and proposed DSM-5 personality disorder diagnoses, as well as demographic information and other clinical judgments, on one of their patients. Of the 337 patients described, 248 met criteria for 1 of the 10 specific DSM-IV personality disorders. A "moderate" or greater rating of impairment in personality functioning on the Level Scale demonstrated 84.6% sensitivity and 72.7% specificity for identifying patients meeting criteria for a specific DSM-IV personality disorder. The Level of Personality Functioning Scale had significant and substantial validity correlations with other measures of personality pathology and with clinical judgments regarding functioning, risk, prognosis, and optimal treatment intensity. Furthermore, the single-item Level of Personality Functioning rating was viewed as being as clinically useful as the 10 DSM-IV categories for treatment planning and patient description and was a better predictor of clinician ratings of broad psychosocial functioning than were the 10 DSM-IV categories combined. These results confirm hypotheses that the single-item Level of Personality Functioning Scale rating provides an indication of severity of personality pathology that predicts both assignment of personality disorder diagnosis and clinician appraisals of functioning, risk, prognosis, and needed treatment intensity.

  15. Validated LC-MS/MS Method for the Quantification of Ponatinib in Plasma: Application to Metabolic Stability.

    Directory of Open Access Journals (Sweden)

    Adnan A Kadi

    Full Text Available In the current work, a rapid, specific, sensitive and validated liquid chromatography tandem mass-spectrometric method was developed for the quantification of ponatinib (PNT in human plasma and rat liver microsomes (RLMs with its application to metabolic stability. Chromatographic separation of PNT and vandetanib (IS were accomplished on Agilent eclipse plus C18 analytical column (50 mm × 2.1 mm, 1.8 μm particle size maintained at 21±2°C. Flow rate was 0.25 mLmin-1 with run time of 4 min. Mobile phase consisted of solvent A (10 mM ammonium formate, pH adjusted to 4.1 with formic acid and solvent B (acetonitrile. Ions were generated by electrospray (ESI and multiple reaction monitoring (MRM was used as basis for quantification. The results revealed a linear calibration curve in the range of 5-400 ngmL-1 (r2 ≥ 0.9998 with lower limit of quantification (LOQ and lower limit of detection (LOD of 4.66 and 1.53 ngmL-1 in plasma, 4.19 and 1.38 ngmL-1 in RLMs. The intra- and inter-day precision and accuracy in plasma ranged from1.06 to 2.54% and -1.48 to -0.17, respectively. Whereas in RLMs ranged from 0.97 to 2.31% and -1.65 to -0.3%. The developed procedure was applied for quantification of PNT in human plasma and RLMs for study metabolic stability of PNT. PNT disappeared rapidly in the 1st 10 minutes of RLM incubation and the disappearance plateaued out for the rest of the incubation. In vitro half-life (t1/2 was 6.26 min and intrinsic clearance (CLin was 15.182± 0.477.

  16. Quality Indicators for In-Hospital Pharmaceutical Care of Dutch Elderly Patients Development and Validation of an ACOVE-Based Quality Indicator Set

    NARCIS (Netherlands)

    Wierenga, Peter C.; Klopotowska, Joanna E.; Smorenburg, Susanne M.; van Kan, Hendrikus J.; Bijleveld, Yuma A.; Dijkgraaf, Marcel G.; de Rooij, Sophia E.

    2011-01-01

    Background: In 2001, the ACOVE (Assessing Care Of Vulnerable Elders) quality indicators (QIs) were developed in the US to measure the quality of care of vulnerable elderly patients. However, the ACOVE QI set was developed mainly to assess the overall quality of care of community-dwelling vulnerable

  17. Noncredible cognitive performance at clinical evaluation of adult ADHD : An embedded validity indicator in a visuospatial working memory test

    NARCIS (Netherlands)

    Fuermaier, Anselm B M; Tucha, Oliver; Koerts, Janneke; Lange, Klaus W; Weisbrod, Matthias; Aschenbrenner, Steffen; Tucha, Lara

    2017-01-01

    The assessment of performance validity is an essential part of the neuropsychological evaluation of adults with attention-deficit/hyperactivity disorder (ADHD). Most available tools, however, are inaccurate regarding the identification of noncredible performance. This study describes the development

  18. Validation of analytical method to quality control and the stability study of 0.025 % eyedrops Ketotiphen

    International Nuclear Information System (INIS)

    Troche Concepcion, Yenilen; Romero Diaz, Jacqueline Aylema; Garcia Penna, Caridad M

    2010-01-01

    The Ketotiphen eyedrop is prescribed to relief the signs and symptoms of allergic conjunctivitis due to its potent H 1a ntihistaminic effect showing some ability to inhibit the histamine release and other mediators in cases of mastocytosis. The aim of present paper was to develop and validate an analytical method for the high-performance liquid chromatography, to quality control and the stability studies of 0.025 % eyedrop Ketotiphen. Method was based on active principle separation by means of a Lichrosorb RP-18 (5 μm) (250 x 4 mm), with UV detection to 296 nm using a mobile phase including a non-gasified mixture of methanol:buffer-phosphate (75:25; pH 8.5) adding 1 mL of Isopropanol by each 1 000 mL of the previous mixture at a 1.2 mL/min flow velocity. The analytical method was linear, accurate, specific and exact during the study concentrations

  19. Further examination of embedded performance validity indicators for the Conners' Continuous Performance Test and Brief Test of Attention in a large outpatient clinical sample.

    Science.gov (United States)

    Sharland, Michael J; Waring, Stephen C; Johnson, Brian P; Taran, Allise M; Rusin, Travis A; Pattock, Andrew M; Palcher, Jeanette A

    2018-01-01

    Assessing test performance validity is a standard clinical practice and although studies have examined the utility of cognitive/memory measures, few have examined attention measures as indicators of performance validity beyond the Reliable Digit Span. The current study further investigates the classification probability of embedded Performance Validity Tests (PVTs) within the Brief Test of Attention (BTA) and the Conners' Continuous Performance Test (CPT-II), in a large clinical sample. This was a retrospective study of 615 patients consecutively referred for comprehensive outpatient neuropsychological evaluation. Non-credible performance was defined two ways: failure on one or more PVTs and failure on two or more PVTs. Classification probability of the BTA and CPT-II into non-credible groups was assessed. Sensitivity, specificity, positive predictive value, and negative predictive value were derived to identify clinically relevant cut-off scores. When using failure on two or more PVTs as the indicator for non-credible responding compared to failure on one or more PVTs, highest classification probability, or area under the curve (AUC), was achieved by the BTA (AUC = .87 vs. .79). CPT-II Omission, Commission, and Total Errors exhibited higher classification probability as well. Overall, these findings corroborate previous findings, extending them to a large clinical sample. BTA and CPT-II are useful embedded performance validity indicators within a clinical battery but should not be used in isolation without other performance validity indicators.

  20. Stability Indicating HPLC Method for the Determination of Chiral Purity of R-(-)-5-[2-aminopropyl]-2-methoxybenzene Sulfonamide

    OpenAIRE

    Kasawar, G. B.; Farooqui, M. N.

    2009-01-01

    A chiral reverse phase liquid chromatographic method was developed for the enantiomeric resolution of racemic mixture of (-)-5-[2-aminopropyl]-2-methoxybenzene sulfonamide in bulk drug. The enantiomeric separation of sulfonamide was resolved on a Crownpak CR (+) column using perchloric acid buffer of pH 1.0 as mobile phase and with UV detection at 226 nm. The method is validated and proved to be robust. The limit of detection and quantification of S (-)-(5)-[2-aminopropyl]-2-methoxyben...

  1. Anthropometric parameters as indicators of metabolic derangements in schizophrenia patients stabilized on olanzapine in an Indian rural population

    Directory of Open Access Journals (Sweden)

    Jayanta Kumar Rout

    2012-01-01

    Full Text Available Context: For any given body mass, Asian Indians have higher central obesity than Europeans. A periodic measurement of body mass index (BMI and waist hip ratio (WHR is practically more feasible than other parameters of metabolic syndrome by repeated blood collection. However, few studies are available on the relative importance of BMI and WHR as markers of dyslipidemia and insulin resistance in schizophrenia patients stabilized on second generation antipsychotics in Indian population. Aim: We conducted the present study on such patients to examine whether BMI or WHR can better predict dyslipidemia and insulin resistance in these patients in a rural area. Settings and Design: The study was a hospital based case control study under rural settings on 38 schizophrenia patients stabilized on olanzapine and 30 matched controls. Materials and Methods: Fasting concentrations of blood glucose, lipid parameters and serum insulin were assessed. Data for Homeostatic model for assessment of insulin resistance (HOMA-IR, BMI, and WHR were obtained to assess the insulin resistance, overall body fat distribution and abdominal fat dispensation respectively. Statistical analysis used: ′t′ test was performed to assay any difference in corresponding mean values between cases and controls. Dependence of HOMA-IR on key parameters was assessed by analysis of co-variance (ANCOVA study. Results: Cases exhibited significantly higher values for HOMA-IR, serum triglyceride and low density lipoprotein cholesterol (LDLc with a significantly lower high density lipoprotein cholesterol (HDLc level. ANCOVA study reflected that irrespective of age and sex, HOMA-IR was dependent on serum triglyceride level and WHR (F=8.3 and 5.7 respectively, P<0.05, but not on BMI (F<0.001, P=0.997. Conclusions: Central obesity could be more closely associated with the pathogenesis of prediabetic state in our case group. So, WHR is a better anthropometric parameter than BMI for an early

  2. Migration as an indicator of people’s social and psychological stability (as exemplified in the Pskov Region.

    Directory of Open Access Journals (Sweden)

    Kostromina S.N.

    2015-03-01

    Full Text Available Years of social, economic, and political changes have resulted in intensive and extensive migration activity. The appearance of compelled and voluntary migrants has brought about the development of a new direction in social psychology: the psychology of migration. Many disciplines are connected with the study of migration, the problems of migrants, and adaptation processes. In the social-psychological literature, various models of adaptation to new conditions of a social-cultural environment are considered (I. Jasinskaja-Lahti, K. Liebkind, J. Berry; S.-K. Lee, J. Sobal, E. Frongillo. Various social-psychological features of migrants are studied: for example, ethnic identity, characteristics of psychological adaptation, emotional well-being, and mental health. In the Russian scientific literature the following problems are considered: emigrants’ interactions with representatives of foreign cultures (N. S. Khrustaleva, degree of cultural similarity (T.G. Stefanenko, personal features of emigrants (S. H. Schwartz, E. Prince-Gibson, features of ethnic identity (G.U. Soldatova, S. D. Gurieva, and many others. In Russia, research regarding the influence of the social-cultural environment on processes of adaptation were begun only in 2004. The main objective of our study was to identify psychological mechanisms of migration flows (incoming and outgoing as indicators of sociopolitical and psychological stability in the Pskov Region. Participants in the study were citizens permanently residing in the Pskov Region who by age and social characteristics represented the population structure of a part of that region. In total, 52 persons aged 17 to 69, with an average age of 42.3, participated. The technique used was focus groups. A content analysis was made of the answers received in the focus-group sessions. During these sessions, participants could freely share their views on questions asked by the facilitators who had a college-level psychological

  3. Chromium Oxidation State in Planetary Basalts: Oxygen Fugacity Indicator and Critical Variable for Cr-Spinel Stability

    Science.gov (United States)

    Bell, A. S.; Burger, P. V.; Le, Loan; Papike, J. J.; Jone, J.; Shearer, C. K.

    2014-01-01

    Cr is a ubiquitous and relatively abundant minor element in basaltic, planetary magmas. At the reduced oxidation states (stability and Cr concentration of magmatic phases such as spinel, clinopyroxene, and olivine. However, understanding the Cr valence in quenched melts has historically been plagued with analytical issues, and only recently has reliable methodology for quantifying Cr valence in quenched melts been developed. Despite this substantial difficulty, the pioneering works of Hanson and Jones and Berry and O'Neill provided important insights into the oxidation state of Cr in in silicate melts. Here we present a series of 1-bar gas mixing experiments performed with a Fe-rich basaltic melt in which have determined the Cr redox ratio of the melt at over a range of fO2 values by measuring this quantity in olivine with X-ray Absorption Near Edge Spectroscopy (XANES). The measured Cr redox ratio of the olivine phenocrysts can be readily converted to the ratio present in the conjugate melt via the ratio of crystal-liquid partition coefficients for Cr3+ and Cr2+. We have applied these results to modeling Cr spinel stability and Cr redox ratios in a primitive, iron-rich martian basalt.

  4. Gaze Stabilization Test Asymmetry Score as an Indicator of Previous Concussion in a Cohort of Collegiate Football Players.

    Science.gov (United States)

    Honaker, Julie A; Criter, Robin E; Patterson, Jessie N; Jones, Sherri M

    2015-07-01

    Vestibular dysfunction may lead to decreased visual acuity with head movements, which may impede athletic performance and result in injury. The purpose of this study was to test the hypothesis that athletes with history of concussion would have differences in gaze stabilization test (GST) as compared with those without a history of concussion. Cross-sectional, descriptive. University Athletic Medicine Facility. Fifteen collegiate football players with a history of concussion, 25 collegiate football players without a history of concussion. Participants completed the dizziness handicap inventory (DHI), static visual acuity, perception time test, active yaw plane GST, stability evaluation test (SET), and a bedside oculomotor examination. Independent samples t test was used to compare GST, SET, and DHI scores per group, with Bonferroni-adjusted alpha at P history of concussion. The results support further research on the use of GST for sport-related concussion evaluation and monitoring. Inclusion of objective vestibular tests in the concussion protocol may reveal the presence of peripheral vestibular or visual-vestibular deficits. Therefore, the GST may add an important perspective on the effects of concussion.

  5. Stability-Indicating RP-HPLC Methods for the Determination of Fluorometholone in Its Mixtures with Sodium Cromoglycate and Tetrahydrozoline Hydrochloride.

    Science.gov (United States)

    El-Bagary, Ramzia I; Fouad, Marwa A; El-Shal, Manal A; Tolba, Enas H

    2016-07-01

    Two stability-indicating reversed-phase liquid chromatographic methods were developed and validated for the determination of fluorometholone (FLU) in its mixtures with sodium cromoglycate (SCG) and tetrahydrozoline hydrochloride (THZ). The first HPLC method (Method 1) was based on isocratic elution of FLU and SCG along with their alkaline degradation products on a reversed phase C18 column (250 × 4.6 mm id)-ACE Generix 5, using a mobile phase consisting of methanol-water (70 : 30, v/v), pH adjusted to 2.5 using orthophosphoric acid at a flow rate of 1.2 mL min(-1) Quantitation was achieved with UV detection at 240 nm. The second HPLC method (Method 2) was based on isocratic elution of FLU, its alkaline degradation product and THZ on a reversed phase C8 column (250 × 4.6 mm)-ACE Generix 5, using a mobile phase consisting of acetonitrile-50 mM potassium dihydrogen orthophosphate (40 : 60, v/v) at a flow rate of 2 mL min(-1) Quantitation was achieved by applying dual-wavelength detection, where FLU and its alkaline degradation product were detected at 240 nm and THZ was detected at 215 nm at ambient temperatures. Linearity, accuracy and precision were found to be acceptable over the concentration range of 5-50 and 10-500 μg mL(-1) for FLU and SCG (Method 1) and over the concentration range of 5-80 and 5-60 μg mL(-1) for FLU and THZ (Method 2), respectively. Besides, the FLU alkaline degradation product was verified using IR, NMR and LC-MS spectroscopy. The two proposed methods could be successfully applied for the routine analysis of the studied drugs either in their pure bulk powders or in their pharmaceutical preparations without any preliminary separation step. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  6. Development of RP-HPLC, Stability Indicating Method for Degradation Products of Linagliptin in Presence of Metformin HCl by Applying 2 Level Factorial Design; and Identification of Impurity-VII, VIII and IX and Synthesis of Impurity-VII

    Directory of Open Access Journals (Sweden)

    Sushant B. Jadhav

    2017-06-01

    Full Text Available The novel reverse phase-high performance liquid chromatography (RP-HPLC, stability indicating method was developed for determination of linagliptin (LGP and its related substances in linagliptin and metformin HCl (MET HCl tablets by implementing design of experiment to understand the critical method parameters and their relation with critical method attributes; to ensure robustness of the method. The separation of nine specified impurities was achieved with a Zorbax SB-Aq 250 × 4.6 mm, 5 µm column, using gradient elution and a detector wavelength of 225 nm, and validated in accordance with International Conference on Harmonization (ICH guidelines and found to be accurate, precise, reproducible, robust, and specific. The drug was found to be degrading extensively in heat, humidity, basic, and oxidation conditions and was forming degradation products during stability studies. After slight modification in the buffer and the column, the same method was used for liquid chromatography–mass spectrometry (LC-MS and ultra-performance liquid chromatography -time-of-flight/mass spectrometry UPLC-TOF/MS analysis, to identify m/z and fragmentation of maximum unspecified degradation products i.e., Impurity-VII (7, Impurity-VIII (8, and Impurity-IX (9 formed during stability studies. Based on the results, a degradation pathway for the drug has been proposed and synthesis of Impurity-VII (7 is also discussed to ensure an in-depth understanding of LGP and its related degradation products and optimum performance during the lifetime of the product.

  7. VALIDATION OF THE RUSSIAN VERSION OF A QUESTIONNAIRE FOR THE ASSESSMENT OF UTILITARIAN INDICES IN PEDIATRIC PRACTICE. STAGE II

    Directory of Open Access Journals (Sweden)

    I. V. Vinyarskaya

    2014-01-01

    Full Text Available Aim: To create the Russian-language version of the standardized international questionnaire Health Utilities Index (HUI applicable for children's age, on the basis of the relevant international requirements to linguistic ratification and validation of tools. Patients and methods: 427 children of the first and 233 children of the second health group have taken part in the research. Average age of patients made10.8 ± 4.6 years. Criteria validity of the HUI questionnaire was assessed by comparison of patients' answers who had the different health status, a convergent validity — by comparison of the HUI attributes with scales of the PedsQL questionnaire, reliability — by calculation of Cronbach's alfa and the analysis of correlations between questions of the HUI classification. Results: Between the first and second health group there were significant distinctions on each attribute of the HUI questionnaire (p < 0.001. Average value of a number of the reduced attributes significantly differed depending on the state of health of patients: the worse the state of health is, the higher number of limited attributes is (p < 0.05. Significant correlations between the scales estimating similar concepts on questionnaires HUI and PedsQL are established. In assessment of the reliability Cronbach's according to the HUI3 and HUI2 system made 0.79 and 0.8, respectively. Significantcorrelations between the questions estimating identical attributes (sight, hearing, speech, cognitive abilities are shown. The validity and reliability assessment executed for children with various state of health, allowed to assess all attributes of the HUI2 and HUI3 systems. The received results showed satisfactory psychometric properties of the new language version of a questionnaire. Conclusion: The offeredRussian version of the international questionnaire HUI is a validated tool for the development of utility coefficients for various chronic diseases in children, creation of the

  8. The validity of indicators for assessing quality of care: a review of the European literature on hospital readmission rate

    NARCIS (Netherlands)

    Fischer, Claudia; Anema, Helen A.; Klazinga, Niek S.

    2012-01-01

    Background: Quality indicators are increasingly being implemented in Europe for policy and management purposes. Many of these indicators were initially developed and implemented in the USA. However, the suitability of directly adopting indicators that have been developed in a different health care

  9. Stability indicating high performance thin layer chromatographic method for quantitation of venlafaxine in bulk and pharmaceutical dosage form

    Directory of Open Access Journals (Sweden)

    Sunil K Dubey

    2015-01-01

    Full Text Available Background: Venlafaxine (VEN is a phenethylamine bicyclic compound, chemically, 1-(2-[dimethyl amino]-1-[4-methoxy phenyl] ethyl cyclo-hexan-1ol hydrochloride. It is a antidepressant. It inhibits the reuptake of serotonin, nor adrenaline and dopamine to a lesser extent at the presynaptic membrane. Aim: A simple, rapid, precise, accurate, and economical high performance thin layer chromatographic (HPTLC method has been developed and validated for the determination of VEN both as a bulk drug and in formulation. Materials and Methods: The method uses aluminum plates precoated with silica gel 60 F254 as the stationary phase and dichloromethane:acetonitrile:N-hexane:triethylamine: 0.5:0.5:4:0.7 (v/v/v/v as mobile phase. Results: This system gave compact spots for VEN (R f = 0.46 ± 0.05. Forced degradation studies were done by subjecting VEN to acid and alkali hydrolysis, oxidation, and reduction. The peak of the degradation product was well resolved from that of the pure drug and had significant different R f values. Analysis of VEN was performed in the absorbance mode at 225 nm. The limit of detection and quantification were 12.48 and 37.81 ng/spot respectively. Conclusions: The developed method was validated and found to be simple, specific, accurate and precise and can be used for routine quality control analysis of VEN in bulk and pharmaceutical formulation.

  10. Integrated community profiling indicates long-term temporal stability of the predominant faecal microbiota in captive cheetahs.

    Directory of Open Access Journals (Sweden)

    Anne A M J Becker

    Full Text Available Understanding the symbiotic relationship between gut microbes and their animal host requires characterization of the core microbiota across populations and in time. Especially in captive populations of endangered wildlife species such as the cheetah (Acinonyx jubatus, this knowledge is a key element to enhance feeding strategies and reduce gastrointestinal disorders. In order to investigate the temporal stability of the intestinal microbiota in cheetahs under human care, we conducted a longitudinal study over a 3-year period with bimonthly faecal sampling of 5 cheetahs housed in two European zoos. For this purpose, an integrated 16S rRNA DGGE-clone library approach was used in combination with a series of real-time PCR assays. Our findings disclosed a stable faecal microbiota, beyond intestinal community variations that were detected between zoo sample sets or between animals. The core of this microbiota was dominated by members of Clostridium clusters I, XI and XIVa, with mean concentrations ranging from 7.5-9.2 log10 CFU/g faeces and with significant positive correlations between these clusters (P<0.05, and by Lactobacillaceae. Moving window analysis of DGGE profiles revealed 23.3-25.6% change between consecutive samples for four of the cheetahs. The fifth animal in the study suffered from intermediate episodes of vomiting and diarrhea during the monitoring period and exhibited remarkably more change (39.4%. This observation may reflect the temporary impact of perturbations such as the animal's compromised health, antibiotic administration or a combination thereof, which temporarily altered the relative proportions of Clostridium clusters I and XIVa. In conclusion, this first long-term monitoring study of the faecal microbiota in feline strict carnivores not only reveals a remarkable compositional stability of this ecosystem, but also shows a qualitative and quantitative similarity in a defined set of faecal bacterial lineages across the five

  11. Integrated Community Profiling Indicates Long-Term Temporal Stability of the Predominant Faecal Microbiota in Captive Cheetahs

    Science.gov (United States)

    Becker, Anne A. M. J.; Janssens, Geert P. J.; Snauwaert, Cindy; Hesta, Myriam; Huys, Geert

    2015-01-01

    Understanding the symbiotic relationship between gut microbes and their animal host requires characterization of the core microbiota across populations and in time. Especially in captive populations of endangered wildlife species such as the cheetah (Acinonyx jubatus), this knowledge is a key element to enhance feeding strategies and reduce gastrointestinal disorders. In order to investigate the temporal stability of the intestinal microbiota in cheetahs under human care, we conducted a longitudinal study over a 3-year period with bimonthly faecal sampling of 5 cheetahs housed in two European zoos. For this purpose, an integrated 16S rRNA DGGE-clone library approach was used in combination with a series of real-time PCR assays. Our findings disclosed a stable faecal microbiota, beyond intestinal community variations that were detected between zoo sample sets or between animals. The core of this microbiota was dominated by members of Clostridium clusters I, XI and XIVa, with mean concentrations ranging from 7.5-9.2 log10 CFU/g faeces and with significant positive correlations between these clusters (Pcheetahs. The fifth animal in the study suffered from intermediate episodes of vomiting and diarrhea during the monitoring period and exhibited remarkably more change (39.4%). This observation may reflect the temporary impact of perturbations such as the animal’s compromised health, antibiotic administration or a combination thereof, which temporarily altered the relative proportions of Clostridium clusters I and XIVa. In conclusion, this first long-term monitoring study of the faecal microbiota in feline strict carnivores not only reveals a remarkable compositional stability of this ecosystem, but also shows a qualitative and quantitative similarity in a defined set of faecal bacterial lineages across the five animals under study that may typify the core phylogenetic microbiome of cheetahs. PMID:25905625

  12. Quantification of carotid artery plaque stability with multiple region of interest based ultrasound strain indices and relationship with cognition

    Science.gov (United States)

    Meshram, N. H.; Varghese, T.; Mitchell, C. C.; Jackson, D. C.; Wilbrand, S. M.; Hermann, B. P.; Dempsey, R. J.

    2017-08-01

    Vulnerability and instability in carotid artery plaque has been assessed based on strain variations using noninvasive ultrasound imaging. We previously demonstrated that carotid plaques with higher strain indices in a region of interest (ROI) correlated to patients with lower cognition, probably due to cerebrovascular emboli arising from these unstable plaques. This work attempts to characterize the strain distribution throughout the entire plaque region instead of being restricted to a single localized ROI. Multiple ROIs are selected within the entire plaque region, based on thresholds determined by the maximum and average strains in the entire plaque, enabling generation of additional relevant strain indices. Ultrasound strain imaging of carotid plaques, was performed on 60 human patients using an 18L6 transducer coupled to a Siemens Acuson S2000 system to acquire radiofrequency data over several cardiac cycles. Patients also underwent a battery of neuropsychological tests under a protocol based on National Institute of Neurological Disorders and Stroke and Canadian Stroke Network guidelines. Correlation of strain indices with composite cognitive index of executive function revealed a negative association relating high strain to poor cognition. Patients grouped into high and low cognition groups were then classified using these additional strain indices. One of our newer indices, namely the average L  -  1 norm with plaque (AL1NWP) presented with significantly improved correlation with executive function when compared to our previously reported maximum accumulated strain indices. An optimal combination of three of the new indices generated classifiers of patient cognition with an area under the curve (AUC) of 0.880, 0.921 and 0.905 for all (n  =  60), symptomatic (n  =  33) and asymptomatic patients (n  =  27) whereas classifiers using maximum accumulated strain indices alone provided AUC values of 0.817, 0.815 and 0

  13. Validating activity indices from camera traps for commensal rodents and other wildlife in and around farm buildings.

    Science.gov (United States)

    Lambert, Mark; Bellamy, Fiona; Budgey, Richard; Callaby, Rebecca; Coats, Julia; Talling, Janet

    2018-01-01

    Indices of rodent activity are used as indicators of population change during field evaluation of rodenticides. We investigated the potential for using camera traps to determine activity indices for commensal rodents living in and around farm buildings, and sought to compare these indices against previously calibrated survey methods. We recorded 41 263 images of 23 species, including Norway rats (Rattus norvegicus Berk.) and house mice (Mus musculus L.). We found a positive correlation between activity indices from camera traps and activity indices from a method (footprint tracking) previously shown to have a linear relationship with population size for Norway rats. Filtering the camera trap data to simulate a 30-s delay between camera trigger events removed 59.9% of data and did not adversely affect the correlation between activity indices from camera traps and footprint tracking. The relationship between activity indices from footprint tracking and Norway rat population size is known from a previous study; from this, we determined the relationship between activity indices from camera traps and population size for Norway rats living in and around farm buildings. Systematic use of camera traps was used to determine activity indices for Norway rats living in and around farm buildings; the activity indices were positively correlated with those derived from a method previously calibrated against known population size for this species in this context. © 2017 Crown copyright. Pest Management Science © 2017 Society of Chemical Industry. © 2017 Crown copyright. Pest Management Science © 2017 Society of Chemical Industry.

  14. Stability Indicating HPLC Method for the Determination of Chiral Purity of R-(-)-5-[2-aminopropyl]-2-methoxybenzene Sulfonamide.

    Science.gov (United States)

    Kasawar, G B; Farooqui, M N

    2009-09-01

    A chiral reverse phase liquid chromatographic method was developed for the enantiomeric resolution of racemic mixture of (-)-5-[2-aminopropyl]-2-methoxybenzene sulfonamide in bulk drug. The enantiomeric separation of sulfonamide was resolved on a Crownpak CR (+) column using perchloric acid buffer of pH 1.0 as mobile phase and with UV detection at 226 nm. The method is validated and proved to be robust. The limit of detection and quantification of S (-)-(5)-[2-aminopropyl]-2-methoxybenzene sulfonamide] was found to be 0.084 and 0.159 mug/ml, respectively for 20 mul injection volume. The percentage recovery of S (-)-(5)-[2-aminopropyl]-2-methoxybenzene sulfonamide] ranged from 99.57 to 101.88 in bulk drug samples of R (-)-(5)-[2- aminopropyl]-2-methoxybenzene sulfonamide].

  15. Removal of fecal indicators and pathogens in a waste stabilization pond system treating municipal wastewater in India.

    Science.gov (United States)

    Tyagi, Vinay Kumar; Kazmi, A A; Chopra, A K

    2008-11-01

    This study assess the removal of fecal indicators (i.e., total coliforms, fecal coliforms, E. coli, fecal streptococci, and pathogens [Salmonella sp. and helminth eggs]) in a full-scale facultative and maturation pond system with primary screening and manual grit removal facility. The capacity of the plant is 6 ML/d. The results showed that the system was able to remove approximately 2.0 to 3.5 log units of fecal indicators and almost 100% of helminth eggs. Meanwhile, Salmonella was not eliminated significantly, as only 1.26 log units removal was found. Removal efficiency of fecal indicator bacteria was reported maximum during summers (3.4 to 4.0 log units) and minimum (1.9 to 2.0 log units) in winters. Further efforts were made to seek the correlation between key physicochemical wastewater quality parameters (biochemical oxygen demand, turbidity, and suspended solids) and indicator microorganisms (total coliforms, fecal coliforms, and fecal streptococci). Among all these parameters, suspended solids showed the highest correlation coefficient (r2) with total coliforms (0.79), fecal coliforms (0.78), and fecal streptococci (0.75). These correlations manifest that the improvement of microbiological quality of wastewater is strongly linked to the removal of suspended solids.

  16. Data on corrosion and scaling potential of drinking water resources using stability indices in Jolfa, East Azerbaijan, Iran.

    Science.gov (United States)

    Yousefi, Mahmood; Saleh, Hossein Najafi; Mahvi, Amir Hossein; Alimohammadi, Mahmood; Nabizadeh, Ramin; Mohammadi, Ali Akbar

    2018-02-01

    This cross-sectional study was conducted on the drinking water resources of the city of Jolfa (East Azerbaijan province, Iran) from samples taken from 30 wells. Calcium hardness, pH, total alkalinity, TDS, temperature and other chemical parameters were measured using standard methods. The Langelier, Rayzner, Puckhorius and aggressive indices were calculated. The results showed that the Langelier, Reynar, Puckorius, Larson-skold and aggressive indices were 1.15 (± 0.43), 6.92 (± 0.54), 6.42 (± 0.9), 0.85 (± 0.72) and 12.79 (± 0.47), respectively. In terms of water classification, 30% of samples fell into the NaCl category and 26.6% in the NaHCO 3 category and 43.4% samples in the CaHCO 3 , MgHCO 3 and MgCl category. The sedimentation indices indicated that the water of the wells could be considered as corrosive.

  17. Constructing and Validating a Multiple-Indicator Construct of Economic Hardship in a National Sample of Adolescents with Disabilities

    Science.gov (United States)

    Murray, Christopher; Doren, Bonnie; Gau, Jeff M.; Zvoch, Keith; Seeley, John R.

    2015-01-01

    The purpose of the current study was to develop a multi-indicator construct of economic hardship among adolescents with disabilities (N = 9,230) participating in the National Longitudinal Transition Study-2, the largest, most comprehensive investigation of adolescents with disabilities ever conducted. Five theoretically relevant indicators (i.e.,…

  18. Towards valid 'serious non-fatal injury' indicators for international comparisons based on probability of admission estimates

    DEFF Research Database (Denmark)

    Cryer, Colin; Miller, Ted R; Lyons, Ronan A

    2017-01-01

    in regions of Canada, Denmark, Greece, Spain and the USA. International Classification of Diseases (ICD)-9 or ICD-10 4-digit/character injury diagnosis-specific ED attendance and inpatient admission counts were provided, based on a common protocol. Diagnosis-specific and region-specific PrAs with 95% CIs...... diagnoses with high estimated PrAs. These diagnoses can be used as the basis for more valid international comparisons of life-threatening injury, based on hospital discharge data, for countries with well-developed healthcare and data collection systems....

  19. Stability indicating RP-LC-PDA method for the quantitative analysis of saxagliptin in pharmaceutical dosage form

    Directory of Open Access Journals (Sweden)

    Laís Engroff Scheeren

    2015-06-01

    Full Text Available Saxagliptin is a potent and selective inhibitor of the enzyme dipeptidyl peptidase 4. It is effective in the treatment of type 2 diabetes mellitus because it stimulates the pancreas to produce insulin. In the present study, a liquid chromatography method was developed and validated to quantify the drug in tablets. This method was based on the isocratic elution of saxagliptin, using a mobile phase consisting of 0.1% phosphoric acid at pH 3.0 - methanol (70: 30, v/v at a flow rate of 1 mL.min-1 with UV detection at 225 nm. The chromatographic separation was achieved in 8 minutes on a Waters XBridge C18 column (250 mm x 4.6 mm, 5µm maintained at ambient temperature. The proposed method proved to be specific and robust for the quality control of saxagliptin in pharmaceutical dosage forms, showing good linearity in the range of 15.0 - 100.0 µg.mL-1 (r>0.999, precision (RSD

  20. The dynamics of somatic indicators of basketball players under the influence of the special exercises which are directed to the increase of stability of the vestibular analyzer

    Directory of Open Access Journals (Sweden)

    Yevhen Kharchenko

    2016-06-01

    Full Text Available Purpose: to determine stability of the vestibular analyzer of basketball players of the team of KhSAPC by indicators of somatic displacements after the standard vestibular irritations on the Barany chair, after the introduction of the special exercises in the educational – training process, which are directed on the increase of stability of the vestibular sensor-based system. Material & Methods: the analysis of references, methods of definition of a functional condition of the vestibular analyzer on indicators of somatic displacements before and after the irritation on the Barany chair, methods of mathematical statistics. 12 boys – basketball players of the men's national team of KhSAPC took part in the researches. Results: somatic indicators of a functional condition of the vestibular analyzer of students – basketball players of the team of KhSAPC, and, their changes under the influence of rotary loadings before the pedagogical experiment are given in the article. Conclusions: the analysis of the results which were received after the experiment showed the considerable improvement of indicators, according to the testing of the motive test (4x9 m (s, hand dynamometry of 100% of a maximum and 50% of a maximum of the right and left hands (р0,05.

  1. Polymeric matrix membrane sensors for stability-indicating potentiometric determination of oxybutynin hydrochloride and flavoxate hydrochloride urogenital system drugs.

    Science.gov (United States)

    Heba, Mohamed; Ramadan, Nesrin; El-Laithy, Moustafa

    2008-01-01

    Four polyvinyl chloride (PVC) matrix membrane electrodes responsive to 2 drugs affecting the urogenital system--oxybutynin hydrochloride (OX) and flavoxate hydrochloride (FX)--were developed, described, and characterized. A precipitation-based technique with tungstophosphate (TP) and ammonium reineckate (R) anions as electroactive materials in a PVC matrix with an OX cation was used for electrode 1 and 2 fabrication, respectively. Electrode 3 and 4 fabrication was based on use of the precipitation technique of FX cation with tetrakis (4-chlorophenyl) borate and R anions as electroactive materials. Fast and stable Nernstian responses in the range 1 x 10(-2)-1 x 10(-6) M for the 2 drugs over the pH range 5-8 revealed the performance characteristics of these electrodes, which were evaluated according to International Union of Pure and Applied Chemistry recommendations. The method was applied to FX and OX in their pharmaceutical formulations and in human plasma samples. The 4 proposed sensors were found to be specific for the drugs in the presence of up to 60% of their degradation products. Validation of the method according to the quality assurance standards showed suitability of the proposed electrodes for use in the quality control assessment of these drugs. The recoveries for determination of the drugs by the 4 proposed selective electrodes were 99.5 +/- 0.5, 100.0 +/- 0.4, 99.9 +/- 0.4, and 100.1 +/- 0.4% for sensors 1-4, respectively. Statistical comparison between the results obtained by this method and the official method of the drugs was done, and no significant difference found.

  2. Stability of the Associations between Early Life Risk Indicators and Adolescent Overweight over the Evolving Obesity Epidemic

    DEFF Research Database (Denmark)

    Graversen, Lise; Sørensen, Thorkild I A; Petersen, Liselotte

    2014-01-01

    BACKGROUND: Pre- and perinatal factors and preschool body size may help identify children developing overweight, but these factors might have changed during the development of the obesity epidemic. OBJECTIVE: We aimed to assess the associations between early life risk indicators and overweight...... at the age of 9 and 15 years at different stages of the obesity epidemic. METHODS: We used two population-based Northern Finland Birth Cohorts including 4111 children born in 1966 (NFBC1966) and 5414 children born in 1985-1986 (NFBC1986). In both cohorts, we used the same a priori defined prenatal factors......, maternal body mass index (BMI), birth weight, infant weight (age 5 months and 1 year), and preschool BMI (age 2-5 years). We used internal references in early childhood to define percentiles of body size (90) and generalized linear models to study the association with overweight...

  3. Development and validation of hospital information system-generated indicators of the appropriateness of oral anticoagulant prescriptions in hospitalised adults: the PACHA study protocol.

    Science.gov (United States)

    Petit-Monéger, Aurélie; Thiessard, Frantz; Jouhet, Vianney; Noize, Pernelle; Berdaï, Driss; Kret, Marion; Sitta, Rémi; Salmi, Louis-Rachid; Saillour-Glénisson, Florence

    2017-08-31

    The appropriateness of oral anticoagulant prescriptions is a major challenge to improve quality and safety of care. As indicators of the appropriateness of oral anticoagulant prescriptions are lacking, the aim of the study is to develop and validate a panel of such indicators, in hospitalised adults, from the hospital information system of two university hospitals in France. The study will be carried out in four steps: (1) a literature review to identify indicators of the appropriateness of oral anticoagulant prescriptions and their conditions of appropriateness; (2) a Delphi consensus method to assess the potential utility and operational implementation of the selected indicators; (3) techniques of medical data search to implement indicators from the hospital information system and; (4) a cross-sectional study to assess the ability of indicators to detect inappropriate oral anticoagulant prescriptions, performance of medical data search techniques for tracking or retrieving information and the ability of tools to be transferred into other institutions. The fourth step will include up to 80 patient hospital stays for each indicator, depending on the prevalence of inappropriate prescriptions estimated in interim analyses. This work addresses the current lack of quality indicators of the appropriateness of oral anticoagulant prescriptions. We aim to develop and validate such indicators for integrating them into hospital clinical practice, as part of a structured approach to improve quality and safety of care. As each hospital information system is different, we will propose tools transferable to other healthcare institutions to allow an automated construction of these indicators. The PACHA study protocol was approved by institutional review boards and ethics committees (CPP Sud-Ouest et Outre Mer III-DC 2016/119; CPP Ile-de-France II-CDW_2016_0014). Clinical Trial.gov registration: NCT02898090. © Article author(s) (or their employer(s) unless otherwise stated in the

  4. Structural and thermodynamic characterization of the Escherichia coli RelBE toxin-antitoxin system: indication for a functional role of differential stability

    DEFF Research Database (Denmark)

    Cherny, Izhack; Overgaard, Martin; Borch, Jonas

    2007-01-01

    on the folding and stability of the protein pair in solution. Here we structurally and thermodynamically characterize the RelBE system components from E. coli in solution, both separately and in their complexed state. The RelB antitoxin, an alpha-helical protein according to circular dichroism and infrared.......5 degrees C, and exhibits exceptional sensitivity to heat. Complex formation, accompanied by a structural transition, leads to a 12 degrees C increase in the TM and substantial heat resistance. Moreover, in vivo interaction and protein footprint experiments indicate that the C-terminal part of Rel...

  5. Validation of the integration of technology that measures additional "vascular" indices into an ambulatory blood pressure monitoring system.

    Science.gov (United States)

    Kotovskaya, Yulia V; Kobalava, Zhanna D; Orlov, Artemy V

    2014-01-01

    The objective of this study was to validate the novel integration of oscillometric (Vasotens(®)) technology into a BPLab(®) ambulatory blood pressure (BP) monitoring system to measure central BP, the aortic augmentation index, and pulse wave velocity (PWV) compared with the recommended and widely accepted tonometric method. The ARTERY Society guidelines for comparison of PWV measurement techniques were used as the basis for recruitment of 99 individuals (mean age 44±19 years, 52 males). The standard for comparison was the conventional "classic" SphygmoCor device. Accordance of the two methods was satisfactory (r=0.98, mean difference of 2.9±3.5 mmHg for central systolic BP; r=0.98, mean difference of -1.1±2.3 mmHg for central diastolic BP; r=0.83, mean difference of -2.6%±13% for aortic augmentation index; r=0.85, mean difference of 0.69±1.4 for PWV). The performance of Vasotens algorithms using an oscillometric ambulatory BP monitoring system is feasible for accurate diagnosis, risk assessment, and evaluation of the effects of antihypertensive drugs.

  6. Validity and reproducibility of HOMA-IR, 1/HOMA-IR, QUICKI and McAuley's indices in patients with hypertension and type II diabetes.

    Science.gov (United States)

    Sarafidis, P A; Lasaridis, A N; Nilsson, P M; Pikilidou, M I; Stafilas, P C; Kanaki, A; Kazakos, K; Yovos, J; Bakris, G L

    2007-09-01

    The aim of this study was to evaluate the validity and reliability of homeostasis model assessment-insulin resistance (HOMA-IR) index, its reciprocal (1/HOMA-IR), quantitative insulin sensitivity check index (QUICKI) and McAuley's index in hypertensive diabetic patients. In 78 patients with hypertension and type II diabetes glucose, insulin and triglyceride levels were determined after a 12-h fast to calculate these indices, and insulin sensitivity (IS) was measured with the hyperinsulinemic euglycemic clamp technique. Two weeks later, subjects had again their glucose, insulin and triglycerides measured. Simple and multiple linear regression analysis were applied to assess the validity of these indices compared to clamp IS and coefficients of variation between the two visits were estimated to assess their reproducibility. HOMA-IR index was strongly and inversely correlated with the basic IS clamp index, the M-value (r=-0.572, PHOMA-IR and QUICKI indices were positively correlated with the M-value (r=0.342, PHOMA-IR was the best fit of clamp-derived IS. Coefficients of variation between the two visits were 23.5% for HOMA-IR, 19.2% for 1/HOMA-IR, 7.8% for QUICKI and 15.1% for McAuley's index. In conclusion, HOMA-IR, 1/HOMA-IR and QUICKI are valid estimates of clamp-derived IS in patients with hypertension and type II diabetes, whereas the validity of McAuley's index needs further evaluation. QUICKI displayed better reproducibility than the other indices.

  7. Validation of the bispectral index as an indicator of anesthetic depth in Thoroughbred horses anesthetized with sevoflurane.

    Science.gov (United States)

    Tokushige, Hirotaka; Kakizaki, Masashi; Ode, Hirotaka; Okano, Atsushi; Okada, Jun; Kuroda, Taisuke; Wakuno, Ai; Ohta, Minoru

    2016-01-01

    To evaluate the bispectral index (BIS) as an indicator of anesthetic depth in Thoroughbred horses, BIS values were measured at multiple stages of sevoflurane anesthesia in five horses anesthetized with guaifenesin and thiopental following premedication with xylazine. There was no significant difference between the BIS values recorded at end-tidal sevoflurane concentrations of 2.8% (median 60 ranging from 47 to 68) and 3.5% (median 71 ranging from 49 to 82) in anesthetized horses. These BIS values during anesthesia were significantly lower (Phorses (median 98 ranging from 98 to 98) or sedated horses (median 92 ranging from 80 to 93). During the recovery phase, the BIS values gradually increased over time but did not significantly increase until the horses showed movement. In conclusion, the BIS value could be useful as an indicator of awakening during the recovery period in horses, as previous reported.

  8. Comparison of credible patients of very low intelligence and non-credible patients on neurocognitive performance validity indicators.

    Science.gov (United States)

    Smith, Klayton; Boone, Kyle; Victor, Tara; Miora, Deborah; Cottingham, Maria; Ziegler, Elizabeth; Zeller, Michelle; Wright, Matthew

    2014-01-01

    The purpose of this archival study was to identify performance validity tests (PVTs) and standard IQ and neurocognitive test scores, which singly or in combination, differentiate credible patients of low IQ (FSIQ ≤ 75; n = 55) from non-credible patients. We compared the credible participants against a sample of 74 non-credible patients who appeared to have been attempting to feign low intelligence specifically (FSIQ ≤ 75), as well as a larger non-credible sample (n = 383) unselected for IQ. The entire non-credible group scored significantly higher than the credible participants on measures of verbal crystallized intelligence/semantic memory and manipulation of overlearned information, while the credible group performed significantly better on many processing speed and memory tests. Additionally, credible women showed faster finger-tapping speeds than non-credible women. The credible group also scored significantly higher than the non-credible subgroup with low IQ scores on measures of attention, visual perceptual/spatial tasks, processing speed, verbal learning/list learning, and visual memory, and credible women continued to outperform non-credible women on finger tapping. When cut-offs were selected to maintain approximately 90% specificity in the credible group, sensitivity rates were highest for verbal and visual memory measures (i.e., TOMM trials 1 and 2; Warrington Words correct and time; Rey Word Recognition Test total; RAVLT Effort Equation, Trial 5, total across learning trials, short delay, recognition, and RAVLT/RO discriminant function; and Digit Symbol recognition), followed by select attentional PVT scores (i.e., b Test omissions and time to recite four digits forward). When failure rates were tabulated across seven most sensitive scores, a cut-off of ≥ 2 failures was associated with 85.4% specificity and 85.7% sensitivity, while a cut-off of ≥ 3 failures resulted in 95.1% specificity and 66.0% sensitivity. Results are discussed in light of

  9. Investigation of Spiral Bevel Gear Condition Indicator Validation via AC-29-2C Using Fielded Rotorcraft HUMS Data

    Science.gov (United States)

    Dempsey, Paula J.; Wade, Daniel R.; Antolick, Lance J.; Thomas, Josiah

    2014-01-01

    This report presents the analysis of gear condition indicator data collected on a helicopter when damage occurred in spiral bevel gears. The purpose of the data analysis was to use existing in-service helicopter HUMS flight data from faulted spiral bevel gears as a Case Study, to better understand the differences between HUMS data response in a helicopter and a component test rig, the NASA Glenn Spiral Bevel Gear Fatigue Rig. The reason spiral bevel gear sets were chosen to demonstrate differences in response between both systems was the availability of the helicopter data and the availability of a test rig that was capable of testing spiral bevel gear sets to failure. The objective of the analysis presented in this paper was to re-process helicopter HUMS data with the same analysis techniques applied to the spiral bevel rig test data. The damage modes experienced in the field were mapped to the failure modes created in the test rig. A total of forty helicopters were evaluated. Twenty helicopters, or tails, experienced damage to the spiral bevel gears in the nose gearbox. Vibration based gear condition indicators data was available before and after replacement. The other twenty tails had no known anomalies in the nose gearbox within the time frame of the datasets. These twenty tails were considered the baseline dataset. The HUMS gear condition indicators evaluated included gear condition indicators (CI) Figure of Merit 4 (FM4), Root Mean Square (RMS) or Diagnostic Algorithm 1 (DA1) and +/- 3 Sideband Index (SI3). Three additional condition indicators, not currently calculated on-board, were calculated from the archived data. These three indicators were +/- 1 Sideband Index (SI1), the DA1 of the difference signal (DiffDA1) and the peak-to-peak of the difference signal (DP2P). Results found the CI DP2P, not currently available in the on-board HUMS, performed the best, responding to varying levels of damage on thirteen of the fourteen helicopters evaluated. Two

  10. Validation of two complementary oral-health related quality of life indicators (OIDP and OSS 0-10 in two qualitatively distinct samples of the Spanish population

    Directory of Open Access Journals (Sweden)

    Albaladejo A

    2008-11-01

    Full Text Available Abstract Background Oral health-related quality of life can be assessed positively, by measuring satisfaction with mouth, or negatively, by measuring oral impact on the performance of daily activities. The study objective was to validate two complementary indicators, i.e., the OIDP (Oral Impacts on Daily Performances and Oral Satisfaction 0–10 Scale (OSS, in two qualitatively different socio-demographic samples of the Spanish adult population, and to analyse the factors affecting both perspectives of well-being. Methods A cross-sectional study was performed, recruiting a Validation Sample from randomly selected Health Centres in Granada (Spain, representing the general population (n = 253, and a Working Sample (n = 561 randomly selected from active Regional Government staff, i.e., representing the more privileged end of the socio-demographic spectrum of this reference population. All participants were examined according to WHO methodology and completed an in-person interview on their oral impacts and oral satisfaction using the OIDP and OSS 0–10 respectively. The reliability and validity of the two indicators were assessed. An alternative method of describing the causes of oral impacts is presented. Results The reliability coefficient (Cronbach's alpha of the OIDP was above the recommended 0.7 threshold in both Validation and Occupational samples (0.79 and 0.71 respectively. Test-retest analysis confirmed the external reliability of the OSS (Intraclass Correlation Coefficient, 0.89; p Conclusion OIDP and OSS are valid and reliable subjective measures of oral impacts and oral satisfaction, respectively, in an adult Spanish population. Exploring simultaneously these issues may provide useful insights into how satisfaction and impact on well-being are constructed.

  11. Validation of newly developed and redesigned key indicator methods for assessment of different working conditions with physical workloads based on mixed-methods design: a study protocol.

    Science.gov (United States)

    Klussmann, Andre; Liebers, Falk; Brandstädt, Felix; Schust, Marianne; Serafin, Patrick; Schäfer, Andreas; Gebhardt, Hansjürgen; Hartmann, Bernd; Steinberg, Ulf

    2017-08-21

    The impact of work-related musculoskeletal disorders is considerable. The assessment of work tasks with physical workloads is crucial to estimate the work-related health risks of exposed employees. Three key indicator methods are available for risk assessment regarding manual lifting, holding and carrying of loads; manual pulling and pushing of loads; and manual handling operations. Three further KIMs for risk assessment regarding whole-body forces, awkward body postures and body movement have been developed de novo. In addition, the development of a newly drafted combined method for mixed exposures is planned. All methods will be validated regarding face validity, reliability, convergent validity, criterion validity and further aspects of utility under practical conditions. As part of the joint project MEGAPHYS (multilevel risk assessment of physical workloads), a mixed-methods study is being designed for the validation of KIMs and conducted in companies of different sizes and branches in Germany. Workplaces are documented and analysed by observations, applying KIMs, interviews and assessment of environmental conditions. Furthermore, a survey among the employees at the respective workplaces takes place with standardised questionnaires, interviews and physical examinations. It is intended to include 1200 employees at 120 different workplaces. For analysis of the quality criteria, recommendations of the COSMIN checklist (COnsensus-based Standards for the selection of health Measurement INstruments) will be taken into account. The study was planned and conducted in accordance with the German Medical Professional Code and the Declaration of Helsinki as well as the German Federal Data Protection Act. The design of the study was approved by ethics committees. We intend to publish the validated KIMs in 2018. Results will be published in peer-reviewed journals, presented at international meetings and disseminated to actual users for practical application. © Article

  12. The Validity of 21 cm Spin Temperature as a Kinetic Temperature Indicator in Atomic and Molecular Gas

    Energy Technology Data Exchange (ETDEWEB)

    Shaw, Gargi [Dept. of Physics, UM-DAE Centre for Excellence in Basic Sciences, University of Mumbai, Mumbai 400098 (India); Ferland, G. J. [Department of Physics and Astronomy, University of Kentucky, Lexington, KY 40506 (United States); Hubeny, I., E-mail: gargishaw@gmail.com, E-mail: gary@uky.edu, E-mail: hubeny@as.arizona.edu [Steward Observatory, University of Arizona, Tucson, AZ 85721 (United States)

    2017-07-10

    The gas kinetic temperature ( T {sub K} ) of various interstellar environments is often inferred from observations that can deduce level populations of atoms, ions, or molecules using spectral line observations; H i 21 cm is perhaps the most widely used, and has a long history. Usually the H i 21 cm line is assumed to be in thermal equilibrium and the populations are given by the Boltzmann distribution. A variety of processes, many involving Ly α , can affect the 21 cm line. Here we show how this is treated in the spectral simulation code Cloudy, and present numerical simulations of environments where this temperature indicator is used, with a detailed treatment of the physical processes that determine level populations within H{sup 0}. We discuss situations where this temperature indicator traces T {sub K}, cases where it fails, as well as the effects of Ly α pumping on the 21 cm spin temperature. We also show that the Ly α excitation temperature rarely traces the gas kinetic temperature.

  13. Further development and construct validation of MMPI-2-RF indices of global psychopathy, fearless-dominance, and impulsive-antisociality in a sample of incarcerated women.

    Science.gov (United States)

    Phillips, Tasha R; Sellbom, Martin; Ben-Porath, Yossef S; Patrick, Christopher J

    2014-02-01

    Replicating and extending research by Sellbom et al. (M. Sellbom, Y. S. Ben-Porath, C. J. Patrick, D. B. Wygant, D. M. Gartland, & K. P. Stafford, 2012, Development and Construct Validation of the MMPI-2-RF Measures of Global Psychopathy, Fearless-Dominance, and Impulsive-Antisociality, Personality Disorders: Theory, Research, and Treatment, 3, 17-38), the current study examined the criterion-related validity of three self-report indices of psychopathy that were derived from scores on the Minnesota Multiphasic Personality Inventory (MMPI)-2-Restructured Form (MMPI-2-RF; Y. S. Ben-Porath & A. Tellegen, 2008, Minnesota Multiphasic Personality Inventory-2-Restructured Form: Manual for Administration, Scoring, and Interpretation, Minneapolis, MN: University of Minnesota Press). We estimated psychopathy indices by regressing scores from the Psychopathic Personality Inventory (PPI; S. O. Lilienfeld & B. P. Andrews, 1996, Development and Preliminary Validation of a Self-Report Measure of Psychopathic Personality Traits in Noncriminal Populations, Journal of Personality Assessment, 66, 488-524) and its two distinct facets, Fearless-Dominance and Impulsive-Antisociality, onto conceptually selected MMPI-2-RF scales. Data for a newly collected sample of 230 incarcerated women were combined with existing data from Sellbom et al.'s (2012) male correctional and mixed-gender college samples to establish regression equations with optimal generalizability. Correlation and regression analyses were then used to examine associations between the MMPI-2-RF-based estimates of PPI psychopathy and criterion measures (i.e., other well-established measures of psychopathy and conceptually related personality traits), and to evaluate whether gender moderated these associations. The MMPI-2-RF-based psychopathy indices correlated as expected with criterion measures and showed only one significant moderating effect for gender, namely, in the association between psychopathy and narcissism. These

  14. Reliability and Validity of the Hip Stability Isometric Test (HipSIT): A New Method to Assess Hip Posterolateral Muscle Strength.

    Science.gov (United States)

    Almeida, Gabriel Peixoto Leão; das Neves Rodrigues, Helena Larissa; de Freitas, Bruno Wesley; de Paula Lima, Pedro Olavo

    2017-12-01

    Study Design Cross-sectional study. Background The Hip Stability Isometric Test (HipSIT) evaluates the strength of the hip posterolateral stabilizers in a position that favors greater activation of the gluteus maximus and gluteus medius and lower activation of the tensor fascia lata. Objectives To check the validity and reliability of the HipSIT and to evaluate the HipSIT in women with patellofemoral pain (PFP). Methods The HipSIT was evaluated with a handheld dynamometer. During testing, the participants were sidelying, with their legs positioned at 45° of hip flexion and 90° of knee flexion. Participants were instructed to raise the knee of the upper leg while keeping the upper and lower heels in contact. To establish reliability and validity, 49 women were tested with the HipSIT by 2 different evaluators on day 1, and then again 7 days later. The strength of the hip extensors, abductors, and external rotators was also evaluated. Twenty women with unilateral PFP were also evaluated. Results The HipSIT has excellent intrarater and interrater reliability. The standard error of measurement was 0.01 kgf/kg, and the minimal detectable change was 0.036 kgf/kg. The HipSIT showed good validity in isolated hip abduction, external rotation, and extension (Pstrength deficits in women with PFP. J Orthop Sports Phys Ther 2017;47(12):906-913. Epub 9 Oct 2017. doi:10.2519/jospt.2017.7274.

  15. Affect-based profiles of bulimia nervosa: The utility and validity of indicators assessed in the natural environment.

    Science.gov (United States)

    Leraas, Bethany C; Smith, Kathryn E; Utzinger, Linsey M; Cao, Li; Engel, Scott G; Crosby, Ross D; Mitchell, James E; Wonderlich, Stephen A

    2018-01-01

    Theoretical conceptualizations of bulimia nervosa (BN) emphasize the role of emotion dysregulation in the development and maintenance of symptoms, which has been supported by ecological momentary assessment studies. Given the importance of affective disturbances in BN, this study aimed to classify a sample of adult women with BN (N = 130) based on primarily momentary affective indicators, including negative and positive affect, negative and positive affective lability, and depression. Participants completed baseline assessments followed by a two-week ecological momentary assessment protocol. Latent profile analysis revealed four groups: (1) a "stable normal" group characterized by low affective lability and intensity; (2) a "stable depressed" group characterized by low affective lability and higher affect intensity; (3) an "unstable normal" group characterized by higher affective lability but lower affect intensity; and (4) an "unstable depressed" group characterized by higher affective lability and intensity. The stable depressed group evidenced the highest levels of eating psychopathology, borderline personality traits, and childhood trauma history, while the stable normal group generally evidenced the lowest levels of psychopathology. The findings demonstrate significant heterogeneity in the topography of affect experienced by individuals with BN, and suggest that chronic, intense negative affect may be particularly important to address in treatment. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. Patient dose map indications on interventional X-ray systems and validation with Gafchromic XR-RV3 film

    International Nuclear Information System (INIS)

    Bordier, C.; Klausz, R.; Desponds, L.

    2015-01-01

    To help avoiding secondary effects of interventional procedures like skin damage, a dose map method has been developed to provide an indication of the local dose on a surface representative of individual patient shapes. To minimise user interactions, patient envelope shapes are automatically determined depending on simple patient data information. Local doses are calculated in 1-cm 2 areas depending on the estimated air kerma, table and gantry positions and system settings, taking into account the table and mattress attenuations and estimated backscatter from the patient. These local doses are cumulated for each location of the patient envelope during the clinical procedure. To assess the accuracy of the method, Gafchromic XR-RV3 films have been used in several operating configurations. Good visual agreements on cumulated dose localisation were obtained within the 1-cm 2 precision of the map and the dose values agreed within 24.9 % accuracy. The resulting dose map method has been integrated into GE Healthcare X-Ray angiographic systems and should help in the management of the dose by the users during the procedure. (authors)

  17. Validation de l’indice composition IC Medit pour les eaux côtières de Corse et de la région PACA. Action 3. Indice Composition. Livrable n° B. Rapport final, juillet 2014.

    OpenAIRE

    Goffart, Anne; Andral, Bruno

    2014-01-01

    IC Medit est un nouvel indice de composition phytoplanctonique adapté aux spécificités des eaux côtières méditerranéennes. Il utilise la signature pigmentaire du phytoplancton mesurée par HPLC comme méthode de détermination rapide de la composition floristique. Le but de cette étude est de faire évoluer et de valider l’indice développé en 2010 grâce aux résultats de mesures ciblées réalisées dans des masses d’eau côtières d’eau soumises à des forces de pression bien identifiées et d’intensité...

  18. Neuro-fuzzy inference system Prediction of stability indices and Sodium absorption ratio in Lordegan rural drinking water resources in west Iran.

    Science.gov (United States)

    Takdastan, Afshin; Mirzabeygi Radfard, Majid; Yousefi, Mahmood; Abbasnia, Abbas; Khodadadia, Rouhollah; Soleimani, Hamed; Mahvi, Amir Hossein; Naghan, Davood Jalili

    2018-06-01

    According to World Health Organization guidelines, corrosion control is an important aspect of safe drinking-water supplies. Water always includes ingredients, dissolved gases and suspended materials. Although some of these water ingredients is indispensable for human beings, these elements more than permissible limits, could be endanger human health. The aim of this study is to assess physical and chemical parameters of drinking water in the rural areas of Lordegan city, also to determine corrosion indices. This cross-sectional study has carried out with 141 taken samples during 2017 with 13 parameters, which has been analyzed based on standard method and to estimate the water quality indices from groundwater using ANFIS. Also with regard to standard conditions, results of this paper are compared with Environmental Protection Agency and Iran national standards. Five indices, Ryznar Stability Index (RSI), Langlier Saturation Index (LSI), Larson-Skold Index (LS), Puckorius Scaling Index (PSI), and Aggressive Index (AI) programmed by using Microsoft Excel software. Owing to its simplicity, the program, can easily be used by researchers and operators. Parameters included Sulfate, Sodium, Chloride, and Electrical Conductivity respectively were 13.5, 28, 10.5, and 15% more than standard level. The amount of Nitrate, in 98% of cases were in permissible limits and about 2% were more than standard level. Result of presented research indicate that water is corrosive at 10.6%,89.4%,87.2%,59.6% and 14.9% of drinking water supply reservoirs, according to LSI, RSI, PSI, LS and AI, respectively.

  19. Thermostable adenylate kinase technology: a new process indicator and its use as a validation tool for the reprocessing of surgical instruments.

    Science.gov (United States)

    Hesp, J R; Poolman, T M; Budge, C; Batten, L; Alexander, F; McLuckie, G; O'Brien, S; Wells, P; Raven, N D H; Sutton, J M

    2010-02-01

    Adenylate kinase (tAK), a thermostable enzyme, was assessed as a possible means of providing a quantitative measure of cleaning efficacy suitable for validating the performance of an automated washer disinfector (AWD) during routine use. Two indicator formulations were developed using either a commercially available washer disinfector soil or a protein-based soil. Each indicator consisted of 100 microg (in test soil) of tAK dried on to a steel or plastic surface. These indicators were placed in each basket of a washer disinfector and processed alongside soiled surgical instruments during a standard day's operation. After processing, remaining tAK activity was detected using a rapid enzyme assay (2 min detection time) in a handheld hygiene monitor. The amount of tAK remaining on each indictor after a full AWD cycle was found to range from 0.1 to 0.4 ng, which represented a mean log(10) removal of 5.8+/-0.3. There was no statistical difference in the residual tAK activity between individual runs or the position of the indicator in the machine. The tAK indicator was also used to analyse the protein removal within each component of the wash cycle. These results demonstrated that all phases of the wash process contributed to the removal of the protein load, with the main wash alone being responsible for 3.6-4.0 log(10) reductions in protein activity. We propose that a quantitative cleaning index using such rapid readout indicator devices would provide a valuable addition to the methodologies for validating cleaning processes.

  20. Development and validation of an analytical method for quality control and the stability of the eyedrops 10 % Phenylephrine and the 1 % Tropicamide

    International Nuclear Information System (INIS)

    Garcia Penna, Caridad Margarita; Botet Garcia, Martha; Troche Concepcion, Yenilen

    2011-01-01

    An analytical high-performance liquid chromatography method was developed and validated applicable to quality control and to stability study of 10 % phenylephrine plus eyedrops 1 % tropicamide. To quantify simultaneously both active principles in the finished product, separation was carried out through a Lichrosorb RP-18 (15 μm) (260 x 4 mm) column chromatography, with ultraviolet detection at 253 nm using the mobile phase composed of methanol: distilled water (1:1), with 1.1 g of sodium 1-octasulfanate by litre and pH fitted to 3.0 with phosphoric acid and the quantification of this front to a reference sample using the external standard method. The analytical method developed was linear, precise, specific and accurate in the rank of study concentrations, established for the quality control and stability study of the finished product since there were not analytical methods designed for these aims

  1. Stability of 10 mg/mL cefuroxime solution for intracameral injection in commonly used polypropylene syringes and new ready-to-use cyclic olefin copolymer sterile vials using the LC-UV stability-indicating method.

    Science.gov (United States)

    Feutry, Frédéric; Simon, Nicolas; Genay, Stéphanie; Lannoy, Damien; Barthélémy, Christine; Décaudin, Bertrand; Labalette, Pierre; Odou, Pascal

    2016-01-01

    Injecting intracameral cefuroxime has been found beneficial in reducing the risk of postoperative endophthalmitis but its use has been limited through a lack of approved marketing and of ready-to-use single-units as well as the problem of aseptic compounding. Our aim was to assess a new automated primary packaging system which should ensure a higher level of sterility, thanks to its closed, sterile, ready-to-use polymer vial called "Crystal® vial". The chemical stability of a 10 mg/mL cefuroxime solution was compared in 1 mL Crystal® vials and 1 mL Luer-lock polypropylene syringes (actual reference) to eliminate any potential and specific interactions with its cyclic olefin copolymer (COC) body and elastomer stopper. Cefuroxime solution was introduced into vials and syringes and stored at -20 °C, +5 °C and +25°C/60% Relative Humidity. Cefuroxime concentration and the relative amount of the main degradation product (descarbamoyl-cefuroxime) were both determined by an HPLC/UV method indicating stability. Solutions were considered steady if the concentration remained at over 90% of the initial value. In the adapted storage conditions, the evolution of osmolality, pH and sterility was assessed. Stability profiles were identical between vials and syringes in all storage and temperature conditions. The solution was stable (cefuroxime concentration, pH and osmolality) and still sterile for 365 days at -20°C. The concentration fell below 90% after 21 days at +5 °C and after 16 h at +25°C/60%s relative humidity. The COC and thermoplastic elastomer of the vials had no impact on the degradation process confirming its possible use for a ready-to-use cefuroxime solution single-unit dose.

  2. Development of a stability-indicating high performance liquid chromatography method for assay of erythromycin ethylsuccinate in powder for oral suspension dosage form

    Directory of Open Access Journals (Sweden)

    Fahimeh Kamarei

    2014-12-01

    Full Text Available In this study an effective method was developed to assay erythromycin ethylsuccinate for an oral suspension dosage form. The chromatographic separation was achieved on an X-Terra™ C18 analytical column. A mixture of acetonitrile–ammonium dihydrogen phosphate buffer (0.025 mol L-1 (60:40, V/V (pH 7.0 was used as the mobile phase, effluent flow rate monitored at 1.0 mL min−1, and UV detection at 205 nm. In forced degradation studies, the effects of acid, base, oxidation, UV light and temperature were investigated showing no interference in the peak of drug. The proposed method was validated in terms of specificity, linearity, robustness, precision and accuracy. The method was linear at concentrations ranging from 400 to 600 μg mL−1, precise (intra- and inter-day relative standard deviations <0.65, accurate (mean recovery; 99.5%. The impurities and degradation products of erythromycin ethylsuccinate were selectively determined with good resolution in both the raw material and the final suspension forms. The method could be useful for both routine analytical and quality control assays of erythromycin ethylsuccinate in commercial powder for an oral suspension dosage form and it could be a very powerful tool to investigate the chemical stability of erythromycin ethylsuccinate.

  3. The Stability and Workload Index for Transfer score predicts unplanned intensive care unit patient readmission: initial development and validation

    NARCIS (Netherlands)

    Gajic, Ognjen; Malinchoc, Michael; Comfere, Thomas B.; Harris, Marcelline R.; Achouiti, Ahmed; Yilmaz, Murat; Schultz, Marcus J.; Hubmayr, Rolf D.; Afessa, Bekele; Farmer, J. Christopher

    2008-01-01

    OBJECTIVE: Unplanned readmission of hospitalized patients to an intensive care unit (ICU) is associated with a worse outcome, but our ability to identify who is likely to deteriorate after ICU dismissal is limited. The objective of this study is to develop and validate a numerical index, named the

  4. Validation of accuracy and stability of numerical simulation for 2-D heat transfer system by an entropy production approach

    Directory of Open Access Journals (Sweden)

    Brohi Ali Anwar

    2017-01-01

    Full Text Available The entropy production in 2-D heat transfer system has been analyzed systematically by using the finite volume method, to develop new criteria for the numerical simulation in case of multidimensional systems, with the aid of the CFD codes. The steady-state heat conduction problem has been investigated for entropy production, and the entropy production profile has been calculated based upon the current approach. From results for 2-D heat conduction, it can be found that the stability of entropy production profile exhibits a better agreement with the exact solution accordingly, and the current approach is effective for measuring the accuracy and stability of numerical simulations for heat transfer problems.

  5. Probabilistic modelling of human exposure to intense sweeteners in Italian teenagers: validation and sensitivity analysis of a probabilistic model including indicators of market share and brand loyalty.

    Science.gov (United States)

    Arcella, D; Soggiu, M E; Leclercq, C

    2003-10-01

    For the assessment of exposure to food-borne chemicals, the most commonly used methods in the European Union follow a deterministic approach based on conservative assumptions. Over the past few years, to get a more realistic view of exposure to food chemicals, risk managers are getting more interested in the probabilistic approach. Within the EU-funded 'Monte Carlo' project, a stochastic model of exposure to chemical substances from the diet and a computer software program were developed. The aim of this paper was to validate the model with respect to the intake of saccharin from table-top sweeteners and cyclamate from soft drinks by Italian teenagers with the use of the software and to evaluate the impact of the inclusion/exclusion of indicators on market share and brand loyalty through a sensitivity analysis. Data on food consumption and the concentration of sweeteners were collected. A food frequency questionnaire aimed at identifying females who were high consumers of sugar-free soft drinks and/or of table top sweeteners was filled in by 3982 teenagers living in the District of Rome. Moreover, 362 subjects participated in a detailed food survey by recording, at brand level, all foods and beverages ingested over 12 days. Producers were asked to provide the intense sweeteners' concentration of sugar-free products. Results showed that consumer behaviour with respect to brands has an impact on exposure assessments. Only probabilistic models that took into account indicators of market share and brand loyalty met the validation criteria.

  6. Large Eddy Simulation Modeling of Flashback and Flame Stabilization in Hydrogen-Rich Gas Turbines Using a Hierarchical Validation Approach

    Energy Technology Data Exchange (ETDEWEB)

    Clemens, Noel [Univ. of Texas, Austin, TX (United States)

    2015-09-30

    This project was a combined computational and experimental effort to improve predictive capability for boundary layer flashback of premixed swirl flames relevant to gas-turbine power plants operating with high-hydrogen-content fuels. During the course of this project, significant progress in modeling was made on four major fronts: 1) use of direct numerical simulation of turbulent flames to understand the coupling between the flame and the turbulent boundary layer; 2) improved modeling capability for flame propagation in stratified pre-mixtures; 3) improved portability of computer codes using the OpenFOAM platform to facilitate transfer to industry and other researchers; and 4) application of LES to flashback in swirl combustors, and a detailed assessment of its capabilities and limitations for predictive purposes. A major component of the project was an experimental program that focused on developing a rich experimental database of boundary layer flashback in swirl flames. Both methane and high-hydrogen fuels, including effects of elevated pressure (1 to 5 atm), were explored. For this project, a new model swirl combustor was developed. Kilohertz-rate stereoscopic PIV and chemiluminescence imaging were used to investigate the flame propagation dynamics. In addition to the planar measurements, a technique capable of detecting the instantaneous, time-resolved 3D flame front topography was developed and applied successfully to investigate the flow-flame interaction. The UT measurements and legacy data were used in a hierarchical validation approach where flows with increasingly complex physics were used for validation. First component models were validated with DNS and literature data in simplified configurations, and this was followed by validation with the UT 1-atm flashback cases, and then the UT high-pressure flashback cases. The new models and portable code represent a major improvement over what was available before this project was initiated.

  7. Antioxidant responses to an acute ultra-endurance exercise: impact on DNA stability and indications for an increased need for nutritive antioxidants in the early recovery phase.

    Science.gov (United States)

    Neubauer, Oliver; Reichhold, Stefanie; Nics, Lukas; Hoelzl, Christine; Valentini, Judit; Stadlmayr, Barbara; Knasmüller, Siegfried; Wagner, Karl-Heinz

    2010-10-01

    Antioxidant requirements have neither been defined for endurance nor been defined for ultra-endurance athletes. To verify whether an acute bout of ultra-endurance exercise modifies the need for nutritive antioxidants, we aimed (1) to investigate the changes of endogenous and exogenous antioxidants in response to an Ironman triathlon; (2) to particularise the relevance of antioxidant responses to the indices of oxidatively damaged blood lipids, blood cell compounds and lymphocyte DNA and (3) to examine whether potential time-points of increased susceptibility to oxidative damage are associated with alterations in the antioxidant status. Blood that was collected from forty-two well-trained male athletes 2 d pre-race, immediately post-race, and 1, 5 and 19 d later was sampled. The key findings of the present study are as follows: (1) Immediately post-race, vitamin C, α-tocopherol, and levels of the Trolox equivalent antioxidant capacity, the ferric reducing ability of plasma and the oxygen radical absorbance capacity (ORAC) assays increased significantly. Exercise-induced changes in the plasma antioxidant capacity were associated with changes in uric acid, bilirubin and vitamin C. (2) Significant inverse correlations between ORAC levels and indices of oxidatively damaged DNA immediately and 1 d post-race suggest a protective role of the acute antioxidant responses in DNA stability. (3) Significant decreases in carotenoids and γ-tocopherol 1 d post-race indicate that the antioxidant intake during the first 24 h of recovery following an acute ultra-endurance exercise requires specific attention. Furthermore, the present study illustrates the importance of a diversified and well-balanced diet to maintain a physiological antioxidant status in ultra-endurance athletes in reference to recommendations.

  8. Cross-cultural validity and measurement invariance of the Organizational Stressor Indicator for Sport Performers (OSI-SP) across three countries.

    Science.gov (United States)

    Arnold, R; Ponnusamy, V; Zhang, C-Q; Gucciardi, D F

    2017-08-01

    Organizational stressors are a universal phenomenon which can be particularly prevalent and problematic for sport performers. In view of their global existence, it is surprising that no studies have examined cross-cultural differences in organizational stressors. One explanation for this is that the Organizational Stressor Indicator for Sport Performers (OSI-SP; Arnold, Fletcher, & Daniels, 2013), which can comprehensively measure the organizational pressures that sport performers have encountered, has not yet been translated from English into any other languages nor scrutinized cross-culturally. The first purpose of this study, therefore, was to examine the cross-cultural validity of the OSI-SP. In addition, the study aimed to test the equivalence of the OSI-SP's factor structure across cultures. British (n = 379), Chinese (n = 335), and Malaysian (n = 444) sport performers completed the OSI-SP. Confirmatory factor analyses confirmed the cross-cultural validity of the factorial model for the British and Malaysian samples; however, the overall model fit for the Chinese data did not meet all guideline values. Support was provided for the equality of factor loadings, variances, and covariances on the OSI-SP across the British and Malaysian cultures. These findings advance knowledge and understanding on the cross-cultural existence, conceptualization, and operationalization of organizational stressors. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  9. Development of a stability-indicating UPLC method for determining olanzapine and its associated degradation products present in active pharmaceutical ingredients and pharmaceutical dosage forms.

    Science.gov (United States)

    Krishnaiah, Ch; Vishnu Murthy, M; Kumar, Ramesh; Mukkanti, K

    2011-03-25

    A simple, sensitive and reproducible ultra performance liquid chromatography (UPLC) coupled with a photodiode array detector method was developed for the quantitative determination of olanzapine (OLN) in API and pharmaceutical dosage forms. The method is applicable to the quantification of related substances and assays of drug substances. Chromatographic separation was achieved on Acquity UPLC BEH 100-mm, 2.1-mm, and 1.7-μm C-18 columns, and the gradient eluted within a short runtime, i.e., within 10.0 min. The eluted compounds were monitored at 250 nm, the flow rate was 0.3 mL/min, and the column oven temperature was maintained at 27°C. The resolution of OLN and eight (potential, bi-products and degradation) impurities was greater than 2.0 for all pairs of components. The high correlation coefficient (r(2)>0.9991) values indicated clear correlations between the investigated compound concentrations and their peak areas within the test ranges. The repeatability and intermediate precision, expressed by the RSD, were less than 2.4%. The accuracy and validity of the method were further ascertained by performing recovery studies via a spike method. The accuracy of the method expressed as relative error was satisfactory. No interference was observed from concomitant substances normally added to the tablets. The drug was subjected to the International Conference on Harmonization (ICH)-prescribed hydrolytic, oxidative, photolytic and thermal stress conditions. The performance of the method was validated according to the present ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, ruggedness and robustness. Copyright © 2010 Elsevier B.V. All rights reserved.

  10. A versatile, stability-indicating and high-throughput ultra-fast liquid chromatography method for the determination of isoflavone aglycones in soybeans, topical formulations, and permeation assays.

    Science.gov (United States)

    Nemitz, Marina C; Yatsu, Francini K J; Bidone, Juliana; Koester, Letícia S; Bassani, Valquiria L; Garcia, Cássia V; Mendez, Andreas S L; von Poser, Gilsane L; Teixeira, Helder F

    2015-03-01

    There is a growing interest in the pharmaceutical field concerning isoflavones topical delivery systems, especially with regard to their skin care properties and antiherpetic activity. In this context, the present work describes an ultra-fast liquid chromatography method (UFLC) for determining daidzein, glycitein, and genistein in different matrices during the development of topical systems containing isoflavone aglycones (IA) obtained from soybeans. The method showed to be specific, precise, accurate, and linear (0.1 to 5 µg mL(-1)) for IA determination in soybean acid extract, IA-rich fraction obtained after the purification process, IA loaded-nanoemulsions, and topical hydrogel, as well as for permeation/retention assays in porcine skin and porcine esophageal mucosa. The matrix effect was determined for all complex matrices, demonstrating low effect during the analysis. The stability indicating UFLC method was verified by submitting IA to acidic, alkaline, oxidative, and thermal stress conditions, and no interference of degradation products was detected during analysis. Mass spectrometry was performed to show the main compounds produced after acid hydrolysis of soybeans, as well as suggest the main degradation products formed after stress conditions. Besides the IA, hydroxymethylfurfural and ethoxymethylfurfural were produced and identified after acid hydrolysis of the soybean extract and well separated by the UFLC method. The method's robustness was confirmed using the Plackett-Burman experimental design. Therefore, the new method affords fast IA analysis during routine processes, extract purification, products development, and bioanalytical assays. Copyright © 2014 Elsevier B.V. All rights reserved.

  11. Indications for surgical stabilization of rib fractures in patients without flail chest: surveyed opinions of members of the Chest Wall Injury Society.

    Science.gov (United States)

    Pieracci, Fredric M; Agarwal, Suresh; Doben, Andrew; Shiroff, Adam; Lottenberg, Larwence; Whitbeck, Sarah Ann; White, Thomas W

    2018-02-01

    There are currently no evidence-based indications for surgical stabilization of rib fractures (SSRF) in patients without flail chest. The purpose of this survey was to identify patients for whom there is relative equipoise (operative vs. non-operative) in order to assist in designing a randomized clinical trial. Members of the Chest Wall Injury Society were sent an online survey, in which 18 patient scenarios were presented. The baseline patient had ≥ three displaced, contiguous fractures and had no other contraindications for surgery. This default scenario was then varied based upon patient age, degree of traumatic brain injury (TBI), fracture series location, and number of abnormal pulmonary physiologic variables (oxygen requirement, respiratory rate, incentive spirometry ability, cough, and numeric pain score). Thirty respondents provided a total of 540 answers. Overall, the majority of responses were in favor of SSRF (n = 413, 84.1%). Furthermore, the vast majority of responses indicated that some degree of pulmonary compromise was necessary to recommend SSRF (n = 44, 90.4%), with ≥ two abnormal parameters being the most common threshold (n = 156, 31.8%). Decision to recommend SSRF varied significantly by number of abnormal clinical variables, age, and degree of TBI, but not by fracture series location. Patients aged 85 years old and those with moderate TBI were the least likely to be recommended for SSRF, regardless of abnormal pulmonary physiologic variables. The most appropriate cutoff for equipoise appeared to be a patient aged 21-79 years old, with no or mild TBI, ≥ two abnormal pulmonary parameters, and regardless of fracture location (44.8% consensus for SSRF). SSRF was recommended for most patients with non-flail, displaced rib fractures. However, this recommendation was contingent upon patient age, degree of TBI, and pulmonary clinical status. Results of this survey may be used to inform inclusion criteria for a future randomized

  12. Medium fidelity modelling of loads in wind farms under non-neutral ABL stability conditions – a full-scale validation study

    DEFF Research Database (Denmark)

    Larsen, Gunner Chr.; Larsen, Torben J.; Chougule, A.

    2017-01-01

    The aim of the present paper is to demonstrate the capability of medium fidelity modelling of wind turbine component fatigue loading, when the wind turbines are subjected to wake affected non-stationary flow fields under non-neutral atmospheric stability conditions. To accomplish this we combine......) in description of both large- and small scale atmospheric boundary layer turbulence is facilitated by a generalization of the classical Mann spectral tensor, which consistently includes buoyancy effects. With non-stationary wind turbine inflow fields modelled as described above, fatigue loads are obtained using...... the state-of-the art aeroelastic model HAWC2. The Lillgrund offshore wind farm (WF) constitute an interesting case study for wind farm model validation, because the WT interspacing is small, which in turn means that wake effects are significant. A huge data set, comprising 5 years of blade and tower load...

  13. Co-firing straw with coal in a swirl-stabilized dual-feed burner: modelling and experimental validation

    DEFF Research Database (Denmark)

    Yin, Chungen; Kær, Søren Knudsen; Rosendahl, Lasse

    2010-01-01

    This paper presents a comprehensive computational fluid dynamics (CFD) modelling study of co-firing wheat straw with coal in a 150 kW swirl-stabilized dual-feed burner flow reactor, in which the pulverized straw particles (mean diameter of 451μm) and coal particles (mean diameter of 110.4μm...... conversion. It is found that for pulverized biomass particles of a few hundred microns in diameter the intra-particle heat and mass transfer is a secondary issue at most in their conversion, and the global four-step mechanism of Jones and Lindstedt may be better used in modelling volatiles combustion......-lean core zone; whilst the coal particles are significantly affected by secondary air jet and swirled into the oxygen-rich outer radius with increased residence time (in average, 8.1s for coal particles vs. 5.2s for straw particles in the 3m high reactor). Therefore, a remarkable difference in the overall...

  14. Validation of an in situ solidification/stabilization technique for hazardous barium and cyanide waste for safe disposal into a secured landfill.

    Science.gov (United States)

    Vaidya, Rucha; Kodam, Kisan; Ghole, Vikram; Surya Mohan Rao, K

    2010-09-01

    The aim of the present study was to devise and validate an appropriate treatment process for disposal of hazardous barium and cyanide waste into a landfill at a Common Hazardous Waste Treatment Storage Disposal Facility (CHWTSDF). The waste was generated during the process of hardening of steel components and contains cyanide (reactive) and barium (toxic) as major contaminants. In the present study chemical fixation of the contaminants was carried out. The cyanide was treated by alkali chlorination with calcium hypochlorite and barium by precipitation with sodium sulfate as barium sulfate. The pretreated mixture was then solidified and stabilized by binding with a combination of slag cement, ordinary Portland cement and fly ash, molded into blocks (5 x 5 x 5 cm) and cured for a period of 3, 7 and 28 days. The final experiments were conducted with 18 recipe mixtures of waste + additive:binder (W:B) ratios. The W:B ratios were taken as 80:20, 70:30 and 50:50. The optimum proportions of additives and binders were finalized on the basis of the criteria of unconfined compressive strength and leachability. The leachability studies were conducted using the Toxicity Characteristic Leaching Procedure. The blocks were analyzed for various physical and leachable chemical parameters at the end of each curing period. Based on the results of the analysis, two recipe mixtures, with compositions - 50% of [waste + (120 g Ca(OCl)(2) + 290 g Na(2)SO(4)) kg(-1) of waste] + 50% of binders, were validated for in situ stabilization into a secured landfill of CHWTSDF. 2010 Elsevier Ltd. All rights reserved.

  15. Validity of two recently-proposed prognostic grading indices for lung, gastro-intestinal, breast and renal cell cancer patients with radiosurgically-treated brain metastases.

    Science.gov (United States)

    Yamamoto, Masaaki; Serizawa, Toru; Sato, Yasunori; Kawabe, Takuya; Higuchi, Yoshinori; Nagano, Osamu; Barfod, Bierta E; Ono, Junichi; Kasuya, Hidetoshi; Urakawa, Yoichi

    2013-02-01

    We tested the validity of two prognostic indices for stereotactic radiosurgically (SRS)-treated patients with brain metastases (BMs) from five major original cancer categories. The two indices are Diagnosis-Specific Graded Prognostic Assessment (DS-GPA) and our Modified Recursive Partitioning Analysis (RPA). Forty-six hundred and eight BM patients underwent gamma knife SRS during the 1998-2011 period. Primary cancer categories were non-small cell lung cancer (NSCLC, 2827 patients), small cell lung cancer (SCLC, 460), gastro-intestinal cancer (GIC, 582), breast cancer (BC, 547) and renal cell cancer (RCC, 192). There were statistically significant survival differences among patients stratified into four groups based on the DS-GPA systems (p failed to reach statistical significance with this system. There were, however, statistically significant MST differences (p < 0.001) among the three groups without overlapping of 95 % CIs between any two pairs of groups with the Modified RPA system in all five categories. The DS-GPA system is applicable to our set of patients with NSCLC only. However, the Modified RPA system was shown to be applicable to patients with five primary cancer categories. This index should be considered when designing future clinical trials involving BM patients.

  16. Field Demonstration, Optimization, and Rigorous Validation of Peroxygen-Based ISCO for the Remediation of Contaminated Groundwater - CHP Stabilization Protocol

    Science.gov (United States)

    2014-05-01

    treatability testing. • Site mineralogy . If a description or characterization of the site mineralogy indicates high iron and/or manganese oxide content...document concludes with detailed descriptions of two case histories. 3 1 Introduction to Catalyzed H2O2 Propagations In situ chemical oxidation (ISCO...changes in organic matter and mineralogy , particularly iron oxides . Visual inspections can be used to help assess changes in lithology and associated

  17. Psychometric validation of the behavioral indicators of pain scale for the assessment of pain in mechanically ventilated and unable to self-report critical care patients.

    Science.gov (United States)

    Latorre-Marco, I; Acevedo-Nuevo, M; Solís-Muñoz, M; Hernández-Sánchez, L; López-López, C; Sánchez-Sánchez, M M; Wojtysiak-Wojcicka, M; de Las Pozas-Abril, J; Robleda-Font, G; Frade-Mera, M J; De Blas-García, R; Górgolas-Ortiz, C; De la Figuera-Bayón, J; Cavia-García, C

    2016-11-01

    To assess the psychometric properties of the behavioral indicators of pain scale (ESCID) when applied to a wide range of medical and surgical critical patients. A multicentre, prospective observational study was designed to validate a scale measuring instrument. Twenty Intensive Care Units of 14 hospitals belonging to the Spanish National Health System. A total of 286 mechanically ventilated, unable to self-report critically ill medical and surgical adult patients. Pain levels were measured by two independent evaluators simultaneously, using two scales: ESCID and the behavioral pain scale (BPS). Pain was observed before, during, and after two painful procedures (turning, tracheal suctioning) and one non-painful procedure. ESCID reliability was measured on the basis of internal consistency using the Cronbach-α coefficient. Inter-rater and intra-rater agreement were measured. The Spearman correlation coefficient was used to assess the correlation between ESCID and BPS. A total of 4386 observations were made in 286 patients (62% medical and 38% surgical). High correlation was found between ESCID and BPS (r=0.94-0.99; p<0.001), together with high intra-rater and inter-rater concordance. ESCID was internally reliable, with a Cronbach-α value of 0.85 (95%CI 0.81-0.88). Cronbach-α coefficients for ESCID domains were high: facial expression 0.87 (95%CI 0.84-0.89), calmness 0.84 (95%CI 0.81-0.87), muscle tone 0.80 (95%CI 0.75-0.84), compliance with mechanical ventilation 0.70 (95%CI 0.63-0.75) and consolability 0.85 (95%CI 0.81-0.88). ESCID is valid and reliable for measuring pain in mechanically ventilated unable to self-report medical and surgical critical care patients. CLINICALTRIALS.GOV: NCT01744717. Copyright © 2016 The Authors. Publicado por Elsevier España, S.L.U. All rights reserved.

  18. Quality of longer term mental health facilities in Europe: validation of the quality indicator for rehabilitative care against service users' views.

    Directory of Open Access Journals (Sweden)

    Helen Killaspy

    Full Text Available BACKGROUND: The Quality Indicator for Rehabilitative Care (QuIRC is a staff rated, international toolkit that assesses care in longer term hospital and community based mental health facilities. The QuIRC was developed from review of the international literature, an international Delphi exercise with over 400 service users, practitioners, carers and advocates from ten European countries at different stages of deinstitutionalisation, and review of the care standards in these countries. It can be completed in under an hour by the facility manager and has robust content validity, acceptability and inter-rater reliability. In this study, we investigated the internal validity of the QuIRC. Our aim was to identify the QuIRC domains of care that independently predicted better service user experiences of care. METHOD: At least 20 units providing longer term care for adults with severe mental illness were recruited in each of ten European countries. Service users completed standardised measures of their experiences of care, quality of life, autonomy and the unit's therapeutic milieu. Unit managers completed the QuIRC. Multilevel modelling allowed analysis of associations between service user ratings as dependent variables with unit QuIRC domain ratings as independent variables. RESULTS: 1750/2495 (70% users and the managers of 213 units from across ten European countries participated. QuIRC ratings were positively associated with service users' autonomy and experiences of care. Associations between QuIRC ratings and service users' ratings of their quality of life and the unit's therapeutic milieu were explained by service user characteristics (age, diagnosis and functioning. A hypothetical 10% increase in QuIRC rating resulted in a clinically meaningful improvement in autonomy. CONCLUSIONS: Ratings of the quality of longer term mental health facilities made by service managers were positively associated with service users' autonomy and experiences of care

  19. Quality of longer term mental health facilities in Europe: validation of the quality indicator for rehabilitative care against service users' views.

    Science.gov (United States)

    Killaspy, Helen; White, Sarah; Wright, Christine; Taylor, Tatiana L; Turton, Penny; Kallert, Thomas; Schuster, Mirjam; Cervilla, Jorge A; Brangier, Paulette; Raboch, Jiri; Kalisova, Lucie; Onchev, Georgi; Alexiev, Spiridon; Mezzina, Roberto; Ridente, Pina; Wiersma, Durk; Visser, Ellen; Kiejna, Andrzej; Piotrowski, Patryk; Ploumpidis, Dimitris; Gonidakis, Fragiskos; Caldas-de-Almeida, José Miguel; Cardoso, Graça; King, Michael

    2012-01-01

    The Quality Indicator for Rehabilitative Care (QuIRC) is a staff rated, international toolkit that assesses care in longer term hospital and community based mental health facilities. The QuIRC was developed from review of the international literature, an international Delphi exercise with over 400 service users, practitioners, carers and advocates from ten European countries at different stages of deinstitutionalisation, and review of the care standards in these countries. It can be completed in under an hour by the facility manager and has robust content validity, acceptability and inter-rater reliability. In this study, we investigated the internal validity of the QuIRC. Our aim was to identify the QuIRC domains of care that independently predicted better service user experiences of care. At least 20 units providing longer term care for adults with severe mental illness were recruited in each of ten European countries. Service users completed standardised measures of their experiences of care, quality of life, autonomy and the unit's therapeutic milieu. Unit managers completed the QuIRC. Multilevel modelling allowed analysis of associations between service user ratings as dependent variables with unit QuIRC domain ratings as independent variables. 1750/2495 (70%) users and the managers of 213 units from across ten European countries participated. QuIRC ratings were positively associated with service users' autonomy and experiences of care. Associations between QuIRC ratings and service users' ratings of their quality of life and the unit's therapeutic milieu were explained by service user characteristics (age, diagnosis and functioning). A hypothetical 10% increase in QuIRC rating resulted in a clinically meaningful improvement in autonomy. Ratings of the quality of longer term mental health facilities made by service managers were positively associated with service users' autonomy and experiences of care. Interventions that improve quality of care in these

  20. Pathogens and fecal indicators in waste stabilization pond systems with direct reuse for irrigation: Fate and transport in water, soil and crops

    Energy Technology Data Exchange (ETDEWEB)

    Verbyla, M.E., E-mail: verbylam@mail.usf.edu [Department of Civil and Environmental Engineering, University of South Florida, 4202 E. Fowler Avenue, Tampa, FL (United States); Iriarte, M.M.; Mercado Guzmán, A.; Coronado, O.; Almanza, M. [Centro de Aguas y Saneamiento Ambiental, Universidad Mayor de San Simón, Cochabamba (Bolivia, Plurinational State of); Mihelcic, J.R. [Department of Civil and Environmental Engineering, University of South Florida, 4202 E. Fowler Avenue, Tampa, FL (United States)

    2016-05-01

    Wastewater use for irrigation is expanding globally, and information about the fate and transport of pathogens in wastewater systems is needed to complete microbial risk assessments and develop policies to protect public health. The lack of maintenance for wastewater treatment facilities in low-income areas and developing countries results in sludge accumulation and compromised performance over time, creating uncertainty about the contamination of soil and crops. The fate and transport of pathogens and fecal indicators was evaluated in waste stabilization ponds with direct reuse for irrigation, using two systems in Bolivia as case studies. Results were compared with models from the literature that have been recommended for design. The removal of Escherichia coli in both systems was adequately predicted by a previously-published dispersed flow model, despite more than 10 years of sludge accumulation. However, a design equation for helminth egg removal overestimated the observed removal, suggesting that this equation may not be appropriate for systems with accumulated sludge. To assess the contamination of soil and crops, ratios were calculated of the pathogen and fecal indicator concentrations in soil or on crops to their respective concentrations in irrigation water (termed soil-water and crop-water ratios). Ratios were similar within each group of microorganisms but differed between microorganism groups, and were generally below 0.1 mL g{sup −1} for coliphage, between 1 and 100 mL g{sup −1} for Giardia and Cryptosporidium, and between 100 and 1000 mL g{sup −1} for helminth eggs. This information can be used for microbial risk assessments to develop safe water reuse policies in support of the United Nations' 2030 Sustainable Development Agenda. - Highlights: • Study of health risks from reclaimed wastewater irrigation from aging pond systems • Coliphages, protozoan parasites, and helminths were measured in water/soil/crops. • Sludge accumulation in

  1. Pathogens and fecal indicators in waste stabilization pond systems with direct reuse for irrigation: Fate and transport in water, soil and crops

    International Nuclear Information System (INIS)

    Verbyla, M.E.; Iriarte, M.M.; Mercado Guzmán, A.; Coronado, O.; Almanza, M.; Mihelcic, J.R.

    2016-01-01

    Wastewater use for irrigation is expanding globally, and information about the fate and transport of pathogens in wastewater systems is needed to complete microbial risk assessments and develop policies to protect public health. The lack of maintenance for wastewater treatment facilities in low-income areas and developing countries results in sludge accumulation and compromised performance over time, creating uncertainty about the contamination of soil and crops. The fate and transport of pathogens and fecal indicators was evaluated in waste stabilization ponds with direct reuse for irrigation, using two systems in Bolivia as case studies. Results were compared with models from the literature that have been recommended for design. The removal of Escherichia coli in both systems was adequately predicted by a previously-published dispersed flow model, despite more than 10 years of sludge accumulation. However, a design equation for helminth egg removal overestimated the observed removal, suggesting that this equation may not be appropriate for systems with accumulated sludge. To assess the contamination of soil and crops, ratios were calculated of the pathogen and fecal indicator concentrations in soil or on crops to their respective concentrations in irrigation water (termed soil-water and crop-water ratios). Ratios were similar within each group of microorganisms but differed between microorganism groups, and were generally below 0.1 mL g"−"1 for coliphage, between 1 and 100 mL g"−"1 for Giardia and Cryptosporidium, and between 100 and 1000 mL g"−"1 for helminth eggs. This information can be used for microbial risk assessments to develop safe water reuse policies in support of the United Nations' 2030 Sustainable Development Agenda. - Highlights: • Study of health risks from reclaimed wastewater irrigation from aging pond systems • Coliphages, protozoan parasites, and helminths were measured in water/soil/crops. • Sludge accumulation in ponds may limit

  2. Validation of noninvasive indices of global systolic function in patients with normal and abnormal loading conditions: a simultaneous echocardiography pressure-volume catheterization study.

    Science.gov (United States)

    Yotti, Raquel; Bermejo, Javier; Benito, Yolanda; Sanz-Ruiz, Ricardo; Ripoll, Cristina; Martínez-Legazpi, Pablo; del Villar, Candelas Pérez; Elízaga, Jaime; González-Mansilla, Ana; Barrio, Alicia; Bañares, Rafael; Fernández-Avilés, Francisco

    2014-01-01

    Noninvasive indices based on Doppler echocardiography are increasingly used in clinical cardiovascular research to evaluate left ventricular global systolic chamber function. Our objectives were to clinically validate ultrasound-based methods of global systolic chamber function to account for differences between patients in conditions of abnormal load, and to assess their sensitivity to load confounders. Twenty-seven patients (8 dilated cardiomyopathy, 10 normal ejection fraction, and 9 end-stage liver disease) underwent simultaneous echocardiography and left heart catheterization with pressure-conductance instrumentation. The reference index, maximal elastance (Emax), was calculated from pressure-volume loop data obtained during acute inferior vena cava occlusion. A wide range of values were observed for left ventricular systolic chamber function (Emax: 2.8±1.0 mm Hg/mL), preload, and afterload. Among the noninvasive indices tested, the peak ejection intraventricular pressure difference showed the best correlation with Emax (R=0.75). A significant but weaker correlation with Emax was observed for ejection fraction (R=0.41), midwall fractional shortening (R=0.51), global circumferential strain (R=-0.53), and strain rate (R=-0.46). Longitudinal strain and strain rate failed to correlate with Emax, as did noninvasive single-beat estimations of this index. Principal component and multiple regression analyses demonstrated that peak ejection intraventricular pressure difference was less sensitive to load, whereas ejection fraction and longitudinal strain and strain rate were heavily influenced by afterload. Current ultrasound methods have limited accuracy to characterize global left ventricular systolic chamber function in a given patient. The Doppler-derived peak ejection intraventricular pressure difference should be preferred for this purpose because it best correlates with the reference index and is more robust in conditions of abnormal load.

  3. Safety, Efficacy, Predictability and Stability Indices of Photorefractive Keratectomy for Correction of Myopic Astigmatism with Plano-Scan and Tissue-Saving Algorithms

    Directory of Open Access Journals (Sweden)

    Mehrdad Mohammadpour

    2013-10-01

    Full Text Available Purpose: To assess the safety, efficacy and predictability of photorefractive keratectomy (PRK [Tissue-saving (TS versus Plano-scan (PS ablation algorithms] of Technolas 217z excimer laser for correction of myopic astigmatismMethods: In this retrospective study one hundred and seventy eyes of 85 patients (107 eyes (62.9% with PS and 63 eyes (37.1% with TS algorithm were included. TS algorithm was applied for those with central corneal thickness less than 500 µm or estimated residual stromal thickness less than 420 µm. Mitomycin C (MMC was applied for 120 eyes (70.6%; in case of an ablation depth more than 60 μm and/or astigmatic correction more than one diopter (D. Mean sphere, cylinder, spherical equivalent (SE refraction, uncorrected visual acuity (UCVA, best corrected visual acuity (BCVA were measured preoperatively, and 4 weeks,12 weeks and 24 weeks postoperatively.Results: One, three and six months postoperatively, 60%, 92.9%, 97.5% of eyes had UCVA of 20/20 or better, respectively. Mean preoperative and 1, 3, 6 months postoperative SE were -3.48±1.28 D (-1.00 to -8.75, -0.08±0.62D, -0.02±0.57 and -0.004± 0.29, respectively. And also, 87.6%, 94.1% and 100% were within ±1.0 D of emmetropia and 68.2, 75.3, 95% were within ±0.5 of emmetropia. The safety and efficacy indices were 0.99 and 0.99 at 12 weeks and 1.009 and 0.99 at 24 weeks, respectively. There was no clinically or statistically significant difference between the outcomes of PS or TS algorithms or between those with or without MMC in either group in terms of safety, efficacy, predictability or stability. Dividing the eyes with subjective SE≤4 D and SE≥4 D postoperatively, there was no significant difference between the predictability of the two groups. There was no intra- or postoperative complication.Conclusion: Outcomes of PRK for correction of myopic astigmatism showed great promise with both PS and TS algorithms.

  4. ADAPTATION ET VALIDATION D’UN INDICE POISSON (FBI POUR L’ÉVALUATION DE LA QUALITÉ BIOLOGIQUE DES COURS D’EAU FRANÇAIS.

    Directory of Open Access Journals (Sweden)

    OBERDORFF T.

    2002-04-01

    Full Text Available La récente Directive Cadre sur l’Eau (DCE demande aux états membres de la communauté européenne la préservation et la restauration de l’état écologique des écosystèmes aquatiques au travers de leurs composantes chimiques et biologiques. Satisfaire cette demande nécessite de disposer d’indicateurs biologiques capables d’apporter une information pertinente sur l’état de santé de ces écosystèmes. Ces indicateurs doivent être scientifiquement valides, efficaces, rapides à mettre en œuvre et applicables à différentes régions géographiques. Parmi les indicateurs potentiels, les peuplements de poissons peuvent apporter une information originale en raison de la capacité qu’ont ces organismes à intégrer la variabilité environnementale à différentes échelles spatiales. Dans ce contexte, les Agences de l’Eau, le Ministère de l’Environnement et le Conseil Supérieur de la Pêche ont lancé conjointement un programme national d’adaptation d’un indice biotique fondé sur les peuplements poissons applicable à l’ensemble du réseau hydrographique. Adapter ce type d’indice à une échelle spatiale telle que le réseau hydrographique national nécessite la prise en compte des facteurs environnementaux majeurs responsables des variations des peuplements en conditions naturelles. La démarche adoptée pour l’établissement de l’indice s’établit comme suit. Dans un premier temps et en utilisant un jeu de donnée de 650 stations de référence réparties de manière homogène sur l’ensemble du réseau hydrographique national, la probabilité d’occurrence sur une station de 34 espèces les plus communes de nos cours d’eau a été modélisée en fonction d’un certain nombre de variables environnementales locales et régionales (i.e. position de la station sur le gradient longitudinal, altitude, vitesse moyenne du courant, conditions thermiques, appartenance à une unité hydrologique. Dans un deuxi

  5. Novel Validated RP-HPLC Method for Bendamustine Hydrochloride Based on Ion-pair Chromatography: Application in Determining Infusion Stability and Pharmacokinetics.

    Science.gov (United States)

    Singh, Yuvraj; Chandrashekar, Anumandla; Pawar, Vivek K; Saravanakumar, Veeramuthu; Meher, Jayagopal; Raval, Kavit; Singh, Pankaj; Kumar, R Dinesh; Chourasia, Manish K

    2017-01-01

    Ion pair chromatography was used for quantifying bendamustine hydrochloride (BH) in its marketed vial. The permissive objective was to investigate time duration for which highly susceptible drug content of the marketed vial remained stable after reconstitution. However, the method could also be used to measure extremely low levels of drug in rat plasma and a pharmacokinetic study was accordingly conducted to further showcase method's applicability. Optimized separation was achieved on C-18 Purospher ® STAR (250 mm × 4.6 mm, 5 μm particle size) column. Mobile phase flowing at 1.5 mL/min consisted of 5 mM sodium salt of octane sulfonic acid dissolved in methanol, water and glacial acetic acid (55:45:0.075) maintained at pH 6. Detection was carried out at 233 nm with BH eluting after 7.8 min. Validation parameters were determined as per ICH guidelines. Limit of detection and limit of quantification were found to be 0.1 µg/mL and 0.33 µg/mL, respectively. The recoveries were 98-102% in bulk and 85-91% in plasma. The developed method was specific for BH, and utilized for assessing its short-term stability in physiologic solvents and forced degradation products in acid, base, oxidative, light and temperature induced stress environments. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  6. Investigation of Spiral Bevel Gear Condition Indicator Validation via AC-29-2C Combining Test Rig Damage Progression Data with Fielded Rotorcraft Data

    Science.gov (United States)

    Dempsey, Paula J.

    2015-01-01

    This is the final of three reports published on the results of this project. In the first report, results were presented on nineteen tests performed in the NASA Glenn Spiral Bevel Gear Fatigue Test Rig on spiral bevel gear sets designed to simulate helicopter fielded failures. In the second report, fielded helicopter HUMS data from forty helicopters were processed with the same techniques that were applied to spiral bevel rig test data. Twenty of the forty helicopters experienced damage to the spiral bevel gears, while the other twenty helicopters had no known anomalies within the time frame of the datasets. In this report, results from the rig and helicopter data analysis will be compared for differences and similarities in condition indicator (CI) response. Observations and findings using sub-scale rig failure progression tests to validate helicopter gear condition indicators will be presented. In the helicopter, gear health monitoring data was measured when damage occurred and after the gear sets were replaced at two helicopter regimes. For the helicopters or tails, data was taken in the flat pitch ground 101 rotor speed (FPG101) regime. For nine tails, data was also taken at 120 knots true airspeed (120KTA) regime. In the test rig, gear sets were tested until damage initiated and progressed while gear health monitoring data and operational parameters were measured and tooth damage progression documented. For the rig tests, the gear speed was maintained at 3500RPM, a one hour run-in was performed at 4000 in-lb gear torque, than the torque was increased to 8000 in-lbs. The HUMS gear condition indicator data evaluated included Figure of Merit 4 (FM4), Root Mean Square (RMS) or Diagnostic Algorithm 1(DA1), + 3 Sideband Index (SI3) and + 1 Sideband Index (SI1). These were selected based on their sensitivity in detecting contact fatigue damage modes from analytical, experimental and historical helicopter data. For this report, the helicopter dataset was reduced to

  7. Qualidades psicométricas do Inventário de Habilidades Sociais (IHS: estudo sobre a estabilidade temporal e a validade concomitante Psychometric qualities of a Social Skills Inventory (IHS: a study of its temporal stability and concomitant validity

    Directory of Open Access Journals (Sweden)

    Marina Bandeira

    2000-12-01

    Full Text Available Esta pesquisa investiga as qualidades psicométricas do Inventário de Habilidades Sociais (IHS em termos de sua validade concomitante e de sua fidedignidade ou estabilidade temporal. Participaram desta pesquisa, 104 estudantes de Psicologia que foram submetidos à aplicação do IHS e da Escala de Assertividade de Rathus. Os resultados mostram uma correlação significativa entre estas duas escalas de avaliação. Os dados referentes à aplicação teste-reteste do IHS, em uma subamostra aleatória de 39 sujeitos, mostram igualmente um correlação significativa entre as duas aplicações. Estes resultados indicam que o IHS possui validade concomitante e fidedignidade ou estabilidade temporal. Estas conclusões complementam os resultados de estudos anteriores sobre as qualidades psicométricas do IHS e recomendam a utilização desta escala para avaliar as habilidades sociais de estudantes universitários no contexto brasileiro.This research investigates the psychometric properties of the Social Skills Inventory (IHS in terms of its concomitant validity and reliability. A sample of 104 psychology students participated in this research. Two scales were applied to the subjects, the IHS and the Rathus Assertiveness Scale. The results showed a significant correlation between the IHS and the Rathus Scale scores. The IHS was also reapplied to a randomized sub-sample of 39 students. The results of this test-retest application also showed a significant correlation between these scores. The results indicate that the IHS has concomitant validity and reliability or temporal stability. This study adds positive results to a previous study investigating some other psychometric properties of the IHS and recommends the use of this scale for the evaluation of college student social skills.

  8. Using an innovative combination of quality-by-design and green analytical chemistry approaches for the development of a stability indicating UHPLC method in pharmaceutical products.

    Science.gov (United States)

    Boussès, Christine; Ferey, Ludivine; Vedrines, Elodie; Gaudin, Karen

    2015-11-10

    An innovative combination of green chemistry and quality by design (QbD) approach is presented through the development of an UHPLC method for the analysis of the main degradation products of dextromethorphan hydrobromide. QbD strategy was integrated to the field of green analytical chemistry to improve method understanding while assuring quality and minimizing environmental impacts, and analyst exposure. This analytical method was thoroughly evaluated by applying risk assessment and multivariate analysis tools. After a scouting phase aimed at selecting a suitable stationary phase and an organic solvent in accordance with green chemistry principles, quality risk assessment tools were applied to determine the critical process parameters (CPPs). The effects of the CPPs on critical quality attributes (CQAs), i.e., resolutions, efficiencies, and solvent consumption were further evaluated by means of a screening design. A response surface methodology was then carried out to model CQAs as function of the selected CPPs and the optimal separation conditions were determined through a desirability analysis. Resulting contour plots enabled to establish the design space (DS) (method operable design region) where all CQAs fulfilled the requirements. An experimental validation of the DS proved that quality within the DS was guaranteed; therefore no more robustness study was required before the validation. Finally, this UHPLC method was validated using the concept of total error and was used to analyze a pharmaceutical drug product. Copyright © 2015 Elsevier B.V. All rights reserved.

  9. Validated spectrofluorimetric and spectrophotometric methods for the determination of brimonidine tartrate in ophthalmic solutions via derivatization with NBD-Cl. Application to stability study.

    Science.gov (United States)

    Ibrahim, F; El-Enany, N; El-Shaheny, R N; Mikhail, I E

    2015-05-01

    Two simple, selective and accurate methods were developed and validated for the determination of brimonidine tartrate (BT) in pure state and pharmaceutical formulations. Both methods are based on the coupling of the drug with 4-chloro-7-nitro-2,1,3-benzoxadiazole in borate buffer (pH 8.5) at 70 °C and measurement of the reaction product spectrophotometrically at 407 nm (method I) or spectrofluorimetrically at 528 nm upon excitation at 460 nm (method II). The calibration graphs were rectilinear over the concentration ranges of 1.0-16.0 and 0.1-4.0 µg/mL with lower detection limits of 0.21 and 0.03, and lower quantification limits of 0.65 and 0.09 µg/mL for methods I and II, respectively. Both methods were successfully applied to the analysis of commercial ophthalmic solution with mean recovery of 99.50 ± 1.00 and 100.13 ± 0.71%, respectively. Statistical analysis of the results obtained by the proposed methods revealed good agreement with those obtained using a comparison method. The proposed spectrofluorimetric method was extended to a stability study of BT under different ICH-outlined conditions such as alkaline, acidic, oxidative and photolytic degradation. Furthermore, the kinetics of oxidative degradation of the drug was investigated and the apparent first-order reaction rate constants, half-life times and Arrhenius equation were estimated. The proposed methods are practical and valuable for routine applications in quality control laboratories for the analysis of BT. Copyright © 2014 John Wiley & Sons, Ltd.

  10. An European concerted action investigating the validity of perinatal mortality as an outcome indicator for the quality of antenatal and perinatal care

    NARCIS (Netherlands)

    Richardus, J.H.; Graafmans, W.C.; Pal-de Bruin, K.M. van der; Amelink-Verburg, M.P.; Verloove-Vanhorick, S.P.; Mackenbach, J.P.

    1997-01-01

    In this paper the concepts, objectives, design, and data analysis procedures of the EuroNatal study are described. This sutdy started in 1996 and is a concerted action including 14 countries in Europe. The EuroNatal study aims at determining the validity of national perinatal mortality rates as an

  11. Shallow landslide stability computation using a distributed transient response model for susceptibility assessment and validation. A case study from Ribeira Quente valley (S. Miguel island, Azores)

    Science.gov (United States)

    Amaral, P.; Marques, R.; Zêzere, J. L.; Marques, F.; Queiroz, G.

    2009-04-01

    In the last 15 years, several heavy rainstorms have occurred in Povoação County (S. Miguel Island, Azores), namely in the Ribeira Quente Valley. These rainfall events have triggered hundreds of shallow landslides that killed tens of people and have been responsible for direct and indirect damages amounting to tens of millions of Euros. On the 6th March 2005 an intense rainfall episode, up to 160 mm of rain in less than 24 h, triggered several shallow landslides that caused 3 victims and damaged/blocked roads. The Ribeira Quente Valley has an area of about 9.5 km2 and is mainly constituted by pyroclastic materials (pumice ash and lapilli), that were produced by the Furnas Volcano explosive eruptions. To provide an assessment of slope-failure conditions for the 6th March 2005 rainfall event, it was applied a distributed transient response model for slope stability analysis. The adopted methodology is a modified version of Iversońs (2000) transient response model, which couple an infinite slope stability analysis with an analytic solution of the Richard's equation for vertical water infiltration in quasi-saturated soil. The validation was made on two different scales: (1) at a slope scale, using two distinct test sites where landslides were triggered; and (2) at the basin scale, using the entire landslide database and generalizing the modeling input parameters for the regional spatialization of results. At the slope scale, the obtained results were very accurate, and it was possible to predict the precise time of the slope failures. At the basin scale, the obtained results were very conservative, even though the model predicted all the observed landslide locations, in the 23.7% of the area classified as untable at the time of the slope failures. This methodology revealed to be a reasonable tool for landslide forecast for both temporal and spatial distributions, on both slope and regional scales. In the future, the model components will be integrated into a GIS

  12. Validation of Baking To Control Salmonella Serovars in Hamburger Bun Manufacturing, and Evaluation of Enterococcus faecium ATCC 8459 and Saccharomyces cerevisiae as Nonpathogenic Surrogate Indicators.

    Science.gov (United States)

    Channaiah, Lakshmikantha H; Holmgren, Elizabeth S; Michael, Minto; Sevart, Nicholas J; Milke, Donka; Schwan, Carla L; Krug, Matthew; Wilder, Amanda; Phebus, Randall K; Thippareddi, Harshavardhan; Milliken, George

    2016-04-01

    This study was conducted to validate a simulated commercial baking process for hamburger buns to destroy Salmonella serovars and to determine the appropriateness of using nonpathogenic surrogates (Enterococcus faecium ATCC 8459 or Saccharomyces cerevisiae) for in-plant process validation studies. Wheat flour was inoculated (∼6 log CFU/g) with three Salmonella serovars (Typhimurium, Newport, or Senftenberg 775W) or with E. faecium. Dough was formed, proofed, and baked to mimic commercial manufacturing conditions. Buns were baked for up to 13 min in a conventional oven (218.3°C), with internal crumb temperature increasing to ∼100°C during the first 8 min of baking and remaining at this temperature until removal from the oven. Salmonella and E. faecium populations were undetectable by enrichment (>6-log CFU/g reductions) after 9.0 and 11.5 min of baking, respectively, and ≥5-log-cycle reductions were achieved by 6.0 and 7.75 min, respectively. D-values of Salmonella (three-serovar cocktail) and E. faecium 8459 in dough were 28.64 and 133.33, 7.61 and 55.67, and 3.14 and 14.72 min at 55, 58, and 61°C, respectively, whereas D-values of S. cerevisiae were 18.73, 5.67, and 1.03 min at 52, 55, and 58°C, respectivly. The z-values of Salmonella, E. faecium, and S. cerevisiae were 6.58, 6.25, and 4.74°C, respectively. A high level of thermal lethality was observed for baking of typical hamburger bun dough, resulting in rapid elimination of high levels of the three-strain Salmonella cocktail; however, the lethality and microbial destruction kinetics should not be extrapolated to other bakery products without further research. E. faecium demonstrated greater thermal resistance compared with Salmonella during bun baking and could serve as a conservative surrogate to validate thermal process lethality in commercial bun baking operations. Low thermal tolerance of S. cerevisiae relative to Salmonella serovars limits its usefulness as a surrogate for process validations.

  13. Internet Addiction: Stability and Change

    Science.gov (United States)

    Huang, Chiungjung

    2010-01-01

    This longitudinal study examined five indices of stability and change in Internet addiction: structural stability, mean-level stability, differential stability, individual-level stability, and ipsative stability. The study sample was 351 undergraduate students from end of freshman year to end of junior year. Convergent findings revealed stability…

  14. Validity of a New Quantitative Evaluation Method that Uses the Depth of the Surface Imprint as an Indicator for Pitting Edema.

    Science.gov (United States)

    Kogo, Haruki; Murata, Jun; Murata, Shin; Higashi, Toshio

    2017-01-01

    This study examined the validity of a practical evaluation method for pitting edema by comparing it to other methods, including circumference measurements and ultrasound image measurements. Fifty-one patients (102 legs) from a convalescent ward in Maruyama Hospital were recruited for study 1, and 47 patients (94 legs) from a convalescent ward in Morinaga Hospital were recruited for study 2. The relationship between the depth of the surface imprint and circumferential measurements, as well as the relationship between the depth of the surface imprint and the thickness of the subcutaneous soft tissue on an ultrasonogram, were analyzed using a Spearman correlation coefficient by rank. There was no significant relationship between the surface imprint depth and circumferential measurements. However, there was a significant relationship between the depth of the surface imprint and the thickness of the subcutaneous soft tissue as measured on an ultrasonogram (correlation coefficient 0.736). Our findings suggest that our novel evaluation method for pitting edema, based on a measurement of the surface imprint depth, is both valid and useful.

  15. Quality of Longer Term Mental Health Facilities in Europe : Validation of the Quality Indicator for Rehabilitative Care against Service Users' Views

    NARCIS (Netherlands)

    Killaspy, Helen; White, Sarah; Wright, Christine; Taylor, Tatiana L.; Turton, Penny; Kallert, Thomas; Schuster, Mirjam; Cervilla, Jorge A.; Brangier, Paulette; Raboch, Jiri; Kalisova, Lucie; Onchev, Georgi; Alexiev, Spiridon; Mezzina, Roberto; Ridente, Pina; Wiersma, Durk; Visser, Ellen; Kiejna, Andrzej; Piotrowski, Patryk; Ploumpidis, Dimitris; Gonidakis, Fragiskos; Caldas-de-Almeida, Jose Miguel; Cardoso, Graca; King, Michael

    2012-01-01

    Background: The Quality Indicator for Rehabilitative Care (QuIRC) is a staff rated, international toolkit that assesses care in longer term hospital and community based mental health facilities. The QuIRC was developed from review of the international literature, an international Delphi exercise

  16. Quality indicators for eye bank

    Directory of Open Access Journals (Sweden)

    Manisha Acharya

    2018-01-01

    Full Text Available Purpose: The aim of this study is to identify quality indicators of the eye bank and validate their effectivity. Methods: Adverse reaction rate, discard rate, protocol deviation rate, and compliance rate were defined as Quality Indicators of the eye bank. These were identified based on definition of quality that captures two dimensions – “result quality” and “process quality.” The indicators were measured and tracked as part of quality assurance (QA program of the eye bank. Regular audits were performed to validate alignment of standard operating procedures (SOP with regulatory and surgeon acceptance standards and alignment of activities performed in the eye bank with the SOP. Prospective study of the indicators was performed by comparing their observed values over the period 2011–2016. Results: Adverse reaction rate decreased more than 8-fold (from 0.61% to 0.07%, discard rate decreased and stabilized at 30%, protocol deviation rate decreased from 1.05% to 0.08%, and compliance rate reported by annual quality audits improved from 59% to 96% at the same time. In effect, adverse reaction rate, discard rate, and protocol deviation rate were leading indicators, and compliance rate was the trailing indicator. Conclusion: These indicators fulfill an important gap in available literature on QA in eye banking. There are two ways in which these findings can be meaningful. First, eye banks which are new to quality measurement can adopt these indicators. Second, eye banks which are already deeply engaged in quality improvement can test these indicators in their eye bank, thereby incorporating them widely and improving them over time.

  17. Quality indicators for eye bank.

    Science.gov (United States)

    Acharya, Manisha; Biswas, Saurabh; Das, Animesh; Mathur, Umang; Dave, Abhishek; Singh, Ashok; Dubey, Suneeta

    2018-03-01

    The aim of this study is to identify quality indicators of the eye bank and validate their effectivity. Adverse reaction rate, discard rate, protocol deviation rate, and compliance rate were defined as Quality Indicators of the eye bank. These were identified based on definition of quality that captures two dimensions - "result quality" and "process quality." The indicators were measured and tracked as part of quality assurance (QA) program of the eye bank. Regular audits were performed to validate alignment of standard operating procedures (SOP) with regulatory and surgeon acceptance standards and alignment of activities performed in the eye bank with the SOP. Prospective study of the indicators was performed by comparing their observed values over the period 2011-2016. Adverse reaction rate decreased more than 8-fold (from 0.61% to 0.07%), discard rate decreased and stabilized at 30%, protocol deviation rate decreased from 1.05% to 0.08%, and compliance rate reported by annual quality audits improved from 59% to 96% at the same time. In effect, adverse reaction rate, discard rate, and protocol deviation rate were leading indicators, and compliance rate was the trailing indicator. These indicators fulfill an important gap in available literature on QA in eye banking. There are two ways in which these findings can be meaningful. First, eye banks which are new to quality measurement can adopt these indicators. Second, eye banks which are already deeply engaged in quality improvement can test these indicators in their eye bank, thereby incorporating them widely and improving them over time.

  18. Simplified Asset Indices to Measure Wealth and Equity in Health Programs: A Reliability and Validity Analysis Using Survey Data From 16 Countries.

    Science.gov (United States)

    Chakraborty, Nirali M; Fry, Kenzo; Behl, Rasika; Longfield, Kim

    2016-03-01

    Social franchising programs in low- and middle-income countries have tried using the standard wealth index, based on the Demographic and Health Survey (DHS) questionnaire, in client exit interviews to assess clients' relative wealth compared with the national wealth distribution to ensure equity in service delivery. The large number of survey questions required to capture the wealth index variables have proved cumbersome for programs. Using an adaptation of the Delphi method, we developed shortened wealth indices and in February 2015 consulted 15 stakeholders in equity measurement. Together, we selected the best of 5 alternative indices, accompanied by 2 measures of agreement (percent agreement and Cohen's kappa statistic) comparing wealth quintile assignment in the new indices to the full DHS index. The panel agreed that reducing the number of assets was more important than standardization across countries because a short index would provide strong indication of client wealth and be easier to collect and use in the field. Additionally, the panel agreed that the simplified index should be highly correlated with the DHS for each country (kappa ≥ 0.75) for both national and urban-specific samples. We then revised indices for 16 countries and selected the minimum number of questions and question options required to achieve a kappa statistic ≥ 0.75 for both national and urban populations. After combining the 5 wealth quintiles into 3 groups, which the expert panel deemed more programmatically meaningful, reliability between the standard DHS wealth index and each of 3 simplified indices was high (median kappa = 0.81, 086, and 0.77, respectively, for index B that included only the common questions from the DHS VI questionnaire, index D that included the common questions plus country-specific questions, and index E that found the shortest list of common and country-specific questions that met the minimum reliability criteria of kappa ≥ 0.75). Index E was the

  19. Simplified Asset Indices to Measure Wealth and Equity in Health Programs: A Reliability and Validity Analysis Using Survey Data From 16 Countries

    Science.gov (United States)

    Chakraborty, Nirali M; Fry, Kenzo; Behl, Rasika; Longfield, Kim

    2016-01-01

    ABSTRACT Background: Social franchising programs in low- and middle-income countries have tried using the standard wealth index, based on the Demographic and Health Survey (DHS) questionnaire, in client exit interviews to assess clients’ relative wealth compared with the national wealth distribution to ensure equity in service delivery. The large number of survey questions required to capture the wealth index variables have proved cumbersome for programs. Methods: Using an adaptation of the Delphi method, we developed shortened wealth indices and in February 2015 consulted 15 stakeholders in equity measurement. Together, we selected the best of 5 alternative indices, accompanied by 2 measures of agreement (percent agreement and Cohen’s kappa statistic) comparing wealth quintile assignment in the new indices to the full DHS index. The panel agreed that reducing the number of assets was more important than standardization across countries because a short index would provide strong indication of client wealth and be easier to collect and use in the field. Additionally, the panel agreed that the simplified index should be highly correlated with the DHS for each country (kappa ≥ 0.75) for both national and urban-specific samples. We then revised indices for 16 countries and selected the minimum number of questions and question options required to achieve a kappa statistic ≥ 0.75 for both national and urban populations. Findings: After combining the 5 wealth quintiles into 3 groups, which the expert panel deemed more programmatically meaningful, reliability between the standard DHS wealth index and each of 3 simplified indices was high (median kappa = 0.81, 086, and 0.77, respectively, for index B that included only the common questions from the DHS VI questionnaire, index D that included the common questions plus country-specific questions, and index E that found the shortest list of common and country-specific questions that met the minimum reliability

  20. Biomarkers of Exposure to Toxic Substances. Volume 5: Biomarker Pre-validation Studies Prevalidation of Urine and Serum Biomarkers Indicative of Subclinical Kidney Damage in a Nephrotoxin Model

    Science.gov (United States)

    2009-05-01

    patients on chronic hemodialysis versus controls (Ziegelmeier et al., 2007). This study indicates that RBP4 levels correlate with c- reactive protein in...kidney injury, as well as cancer, rheumatoid arthritis , viral infections, and other chronic inflammatory diseases (Beorchia et al., 1981; Schuster...increase in plasma in dialysis patients , thought to be caused by an inflammatory response stimulated in the kidney due to interactions with hemodialysis

  1. Cure rate is not a valid indicator for assessing drug efficacy and impact of preventive chemotherapy interventions against schistosomiasis and soil-transmitted helminthiasis

    Science.gov (United States)

    Montresor, Antonio

    2017-01-01

    Every year, in endemic countries, several million individuals are given anthelminthic drugs in the context of preventive chemotherapy programmes for morbidity control of schistosomiasis and soil-transmitted helminthiasis. The capacity of accurately evaluating the efficacy of the drugs used as well as the health impact produced by treatment is of utmost importance for the appropriate planning and implementation of these interventions. The cure rate is an indicator of drug efficacy that was originally developed for assessing the clinical efficacy of antibiotics on selected bacterial diseases. Over time, this indicator has also been widely applied to anthelminthic drugs and consequently used to monitor and evaluate preventive chemotherapy interventions. In the author's opinion, however, measurement of cure rate provides information of limited usefulness in the context of helminth control programmes. The present article analyses the peculiarities of helminth infections and those of the drugs used in preventive chemotherapy, explaining the reasons why the cure rate is not an adequate indicator in this specific public health context. PMID:21612808

  2. Cure rate is not a valid indicator for assessing drug efficacy and impact of preventive chemotherapy interventions against schistosomiasis and soil-transmitted helminthiasis.

    Science.gov (United States)

    Montresor, Antonio

    2011-07-01

    Every year in endemic countries, several million individuals are given anthelminthic drugs in the context of preventive chemotherapy programmes for morbidity control of schistosomiasis and soil-transmitted helminthiasis. The capacity to evaluate accurately the efficacy of the drugs used as well as the health impact produced by treatment is of utmost importance for appropriate planning and implementation of these interventions. Cure rate is an indicator of drug efficacy that was originally developed for assessing the clinical efficacy of antibiotics on selected bacterial diseases. Over time, this indicator has also been widely applied to anthelminthic drugs and consequently used to monitor and evaluate preventive chemotherapy interventions. In the author's opinion, however, measurement of cure rate provides information of limited usefulness in the context of helminth control programmes. The present article analyses the peculiarities of helminth infections and those of the drugs used in preventive chemotherapy, explaining the reasons why the cure rate is not an adequate indicator in this specific public health context. Copyright © 2011 Royal Society of Tropical Medicine and Hygiene. Published by Elsevier Ltd. All rights reserved.

  3. Off-line wafer level reliability control: unique measurement method to monitor the lifetime indicator of gate oxide validated within bipolar/CMOS/DMOS technology

    Science.gov (United States)

    Gagnard, Xavier; Bonnaud, Olivier

    2000-08-01

    We have recently published a paper on a new rapid method for the determination of the lifetime of the gate oxide involved in a Bipolar/CMOS/DMOS technology (BCD). Because this previous method was based on a current measurement with gate voltage as a parameter needing several stress voltages, it was applied only by lot sampling. Thus, we tried to find an indicator in order to monitor the gate oxide lifetime during the wafer level parametric test and involving only one measurement of the device on each wafer test cell. Using the Weibull law and Crook model, combined with our recent model, we have developed a new test method needing only one electrical measurement of MOS capacitor to monitor the quality of the gate oxide. Based also on a current measurement, the parameter is the lifetime indicator of the gate oxide. From the analysis of several wafers, we gave evidence of the possibility to detect a low performance wafer, which corresponds to the infantile failure on the Weibull plot. In order to insert this new method in the BCD parametric program, a parametric flowchart was established. This type of measurement is an important challenges, because the actual measurements, breakdown charge, Qbd, and breakdown electric field, Ebd, at parametric level and Ebd and interface states density, Dit during the process cannot guarantee the gate oxide lifetime all along fabrication process. This indicator measurement is the only one, which predicts the lifetime decrease.

  4. Indications of progressive desiccation of the Transvaal Lowveld over the past 100 years, and implications for the water stabilization programme in the Kruger National Park

    Directory of Open Access Journals (Sweden)

    U. De V. Pienaar

    1985-11-01

    Full Text Available All available rainfall statistics recorded for the Kruger National Park area since 1907, coupled with an analysis of all the historical climatological data on hand, appear to confirm the quasi-twenty-year rainfall oscillation in precipitation pattern for the summer rainfall area. This was first pointed out by Tyson & Dyer (1975. The dendrochronological data obtained by Hall (1976 from a study of growth rings of a very old yellowwood tree (Podocarpus falcatus in Natal, also appear to indicate a superimposed, long-term (80-100 years pattern of alternate below- average and above-average rainfall periods. The historical data relating to climate in the park, during the past century or two, seem to bear out such a pattern. If this can be confirmed, it will be an enormous aid not only in wildlife-management planning, but also to agriculturists, demographic planners and others. It would appear that the long, relatively dry rainfall period of 1860-1970, with its concomitant progressive desiccation of the @ area in question, has passed over into the next aboveverage rainfall era. This does not mean that there will be no further cataclysmic droughts during future rainfall trough periods. It is therefore wise to plan ahead to meet such contingencies. The present water distribution pattern in the park (natural plus artificial water is conspicuously still well below that which pertained, during dry seasons, at the turn of the century, when the Sabi and Shingwedzi game reserves were proclaimed. It is the declared policy of the National Parks Board of Trustees to simulate natural regulating mechanisms as closely as possible. In consequence the artificial water-for-game program is a long way from completion. The large numbers of game animals in the park (including dominant species such as elephant Loxodonta africana and buffalo Syncerus coffer can no longer migrate out of the area to escape natural catastrophes (such as the crippling droughts of 1911-1917, the

  5. Validity of the Agency for Health Care Research and Quality Patient Safety Indicators and the Centers for Medicare and Medicaid Hospital-acquired Conditions: A Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Winters, Bradford D; Bharmal, Aamir; Wilson, Renee F; Zhang, Allen; Engineer, Lilly; Defoe, Deidre; Bass, Eric B; Dy, Sydney; Pronovost, Peter J

    2016-12-01

    The Agency for Health Care Research and Quality Patient Safety Indicators (PSIs) and Centers for Medicare and Medicaid Services Hospital-acquired Conditions (HACs) are increasingly being used for pay-for-performance and public reporting despite concerns over their validity. Given the potential for these measures to misinform patients, misclassify hospitals, and misapply financial and reputational harm to hospitals, these need to be rigorously evaluated. We performed a systematic review and meta-analysis to assess PSI and HAC measure validity. We searched MEDLINE and the gray literature from January 1, 1990 through January 14, 2015 for studies that addressed the validity of the HAC measures and PSIs. Secondary outcomes included the effects of present on admission (POA) modifiers, and the most common reasons for discrepancies. We developed pooled results for measures evaluated by ≥3 studies. We propose a threshold of 80% for positive predictive value or sensitivity for pay-for-performance and public reporting suitability. Only 5 measures, Iatrogenic Pneumothorax (PSI 6/HAC 17), Central Line-associated Bloodstream Infections (PSI 7), Postoperative hemorrhage/hematoma (PSI 9), Postoperative deep vein thrombosis/pulmonary embolus (PSI 12), and Accidental Puncture/Laceration (PSI 15), had sufficient data for pooled meta-analysis. Only PSI 15 (Accidental Puncture and Laceration) met our proposed threshold for validity (positive predictive value only) but this result was weakened by considerable heterogeneity. Coding errors were the most common reasons for discrepancies between medical record review and administrative databases. POA modifiers may improve the validity of some measures. This systematic review finds that there is limited validity for the PSI and HAC measures when measured against the reference standard of a medical chart review. Their use, as they currently exist, for public reporting and pay-for-performance, should be publicly reevaluated in light of these

  6. Determination of the dissociation constant of molten Li/sub 2/CO/sub 3//Na/sub 2/CO/sub 3//K/sub 2/CO/sub 3/ using a stabilized zirconia oxide-ion indicator

    Energy Technology Data Exchange (ETDEWEB)

    Ito, Yasuhiko; Tsuru, Kiyoshi; Oishi, Jun; Miyazaki, Yoshinori; Kodama, Teruo

    1985-09-01

    An Li/sub 2/CO/sub 3//Na/sub 2/CO/sub 3//K/sub 2/CO/sub 3/ eutectic melt has been selected as an example of a molten-carbonate system and the suitability of a stabilized zirconia-air electrode as an oxide-ion concentration indicator for this melt has been confirmed. With this indicator, the dissociation constant of the reaction CO/sub 3//sup 2 -/(l)=CO/sub 2/(g)+O/sup 2 -/(l) in this melt has been determined to be Ksub(d)=P sub(CO/sub 2/) (O/sup 2 -/)=4.03 x 10/sup -3/ Pa at 873 K. Reproducible measurements were obtained throughout the experiment and this method might find further application in the study of reactions related to the oxide ion in carbonate melts. (orig.).

  7. Validation of the ICU-DaMa tool for automatically extracting variables for minimum dataset and quality indicators: The importance of data quality assessment.

    Science.gov (United States)

    Sirgo, Gonzalo; Esteban, Federico; Gómez, Josep; Moreno, Gerard; Rodríguez, Alejandro; Blanch, Lluis; Guardiola, Juan José; Gracia, Rafael; De Haro, Lluis; Bodí, María

    2018-04-01

    Big data analytics promise insights into healthcare processes and management, improving outcomes while reducing costs. However, data quality is a major challenge for reliable results. Business process discovery techniques and an associated data model were used to develop data management tool, ICU-DaMa, for extracting variables essential for overseeing the quality of care in the intensive care unit (ICU). To determine the feasibility of using ICU-DaMa to automatically extract variables for the minimum dataset and ICU quality indicators from the clinical information system (CIS). The Wilcoxon signed-rank test and Fisher's exact test were used to compare the values extracted from the CIS with ICU-DaMa for 25 variables from all patients attended in a polyvalent ICU during a two-month period against the gold standard of values manually extracted by two trained physicians. Discrepancies with the gold standard were classified into plausibility, conformance, and completeness errors. Data from 149 patients were included. Although there were no significant differences between the automatic method and the manual method, we detected differences in values for five variables, including one plausibility error and two conformance and completeness errors. Plausibility: 1) Sex, ICU-DaMa incorrectly classified one male patient as female (error generated by the Hospital's Admissions Department). Conformance: 2) Reason for isolation, ICU-DaMa failed to detect a human error in which a professional misclassified a patient's isolation. 3) Brain death, ICU-DaMa failed to detect another human error in which a professional likely entered two mutually exclusive values related to the death of the patient (brain death and controlled donation after circulatory death). Completeness: 4) Destination at ICU discharge, ICU-DaMa incorrectly classified two patients due to a professional failing to fill out the patient discharge form when thepatients died. 5) Length of continuous renal replacement

  8. [Utility and validity of indicators from the Nursing Outcomes Classification as a support tool for diagnosing Ineffective Self Health Management in patients with chronic conditions in primary health care].

    Science.gov (United States)

    Morilla-Herrera, J C; Morales-Asencio, J M; Fernández-Gallego, M C; Cobos, E Berrobianco; Romero, A Delgado

    2011-01-01

    Self-care and management of therapeutic regime (drugs adherence, preventive behaviours and development of healthy life-styles) are key components for managing chronic diseases. Nursing has standardized languages which describe many of these situations, such as the diagnosis "Ineffective Self Health Management" (ISHM) or many of the Nursing Outcomes Classification (NOC) indicators. The aims of this study were to determine the interobserver reliability of a NOC-based instrument for assessment and aid in diagnosis of the ISHM in patients with chronic conditions in Primary Health Care, to determine its diagnostic validity and to describe the prevalence of patients with this problem. Cross-sectional validation study developed in the provinces of Málaga, Cádiz and Almería from 2006 to 2009. Each patient was assessed by 3 independent observers: the first two observers evaluated scoring of the NOC indicators and the third one acted as the "gold-standard". Two hundred and twenty-eight patients were included, 37.7% of them with more than one chronic condition. NOC indicators showed a high interobserver reliability (ICC>0,70) and a consistency (Cronbach's alpha: 0.81). With a cut-point of 10.5, sensitivity was 61% and specificity 85%, and the area under the curve was 0.81 (CI95%: 0.77 to 0.85). The prevalence of patients with ISHM was 36% (CI 95%: 34 to 40). The use of NOC indicators allows evaluation of management of the therapeutic regime in people with chronic conditions with a satisfactory validity and it provides new approaches for dealing with this problem.

  9. Validity of triglyceride-glucose index as an indicator for metabolic syndrome in children and adolescents: the CASPIAN-V study.

    Science.gov (United States)

    Angoorani, Pooneh; Heshmat, Ramin; Ejtahed, Hanieh-Sadat; Motlagh, Mohammad Esmaeil; Ziaodini, Hasan; Taheri, Majzoubeh; Aminaee, Tahereh; Goodarzi, Azam; Qorbani, Mostafa; Kelishadi, Roya

    2018-02-16

    The purpose of this study was to determine the cut-off values of triglycerides and glucose (TyG) index as one of the indirect indices for metabolic syndrome (MetS) in a pediatric population. This national study was conducted in 2015 on 14400 students, aged 7-18 years. They were selected by random cluster sampling from 30 provinces of our country during the fifth survey of a national school-based surveillance program. MetS was defined based on the Adult Treatment Panel III (ATP III) criteria modified for the pediatric age group. The cut-off values of TyG index for MetS were obtained using the receiver operation characteristic (ROC) curve analysis by gender and age groups. Totally, 3843 students (52.3% boys) with mean (SD) age of 12.45 (3.04) years were assessed. The area under the ROC curve of TyG index for MetS was 0.83 in total participants. According to the ATP III criteria the cut-off values of the TyG index were 8.33 (8.21-8.45) in total students, 8.47 (8.36-8.58) in boys, and 8.33 (8.18-8.48) in girls. In the 7-12 and 13-18 years' age groups, these values were 8.47 (8.32-8.63) and 8.34 (8.22-8.45) in total, 8.39 (8.26-8.52) and 8.47 (8.33-8.61) in boys, 8.33 (8.11-8.55) and 8.35 (8.22-8.47) in girls, respectively. The findings of this study can be clinically helpful for screening MetS in children and adolescents but the effectiveness of these criteria needs to be evaluated by further longitudinal surveys. Level V, cross-sectional descriptive study (National surveillance study).

  10. Initial validation of blubber cortisol and progesterone as indicators of stress response and maturity in an otariid; the California sea lion (Zalophus californianus).

    Science.gov (United States)

    Beaulieu-McCoy, Nicole E; Sherman, Kathryn K; Trego, Marisa L; Crocker, Daniel E; Kellar, Nicholas M

    2017-10-01

    Chronic stress can have detrimental effects on an individual's health and reproductive success. The use of cortisol quantification as an indicator of stress in free-ranging cetaceans and phocids is increasing but no studies have applied this technique on blubber in otariids. We measured cortisol concentrations in blubber samples obtained from California sea lions, Zalophus californianus, stranded in San Diego County and those incidentally killed in the California drift gillnet fishery. We also measured progesterone concentrations to assess female reproductive status and, in males, as a potential secondary measure of adrenal steroid production. Blubber cortisol and progesterone values were compared across demographic groups (sex and maturity), season, and proportion blubber lipid extracted. Stranded animals (247.3±70.767 SE ng/gblubber) had significantly higher cortisol concentrations compared to fishery bycaught (8.1±2.108 SE ng/gblubber) animals. These findings are likely driven by inherent differences in the cause of death and associated nutritional state coupled with the mean duration of expiration for these two groups of animals (i.e., the duration from an animal's initial perception of the threat-to-self until death). The duration of transition from healthy state to death in stranded animals is on the order of many hours to weeks while in fishery bycaught animals, this transition occurs much more rapidly (i.e., seconds to tens of minutes). The presumed longer duration of the mortality event in stranded animals gives sufficient time for elevated cortisol to diffuse into the blubber. No significant differences between demographic groups, or season were found. However, blubber cortisol declined inversely with proportion blubber lipid extracted, suggesting utility in assessing long-term nutritional status. Blubber progesterone was significantly higher in mature females than immature females (153.8±54.546 SE ng/gblubber and 9.7±3.60 SE ng/gblubber respectively

  11. Development and Validation of an Agency for Healthcare Research and Quality Indicator for Mortality After Congenital Heart Surgery Harmonized With Risk Adjustment for Congenital Heart Surgery (RACHS-1) Methodology.

    Science.gov (United States)

    Jenkins, Kathy J; Koch Kupiec, Jennifer; Owens, Pamela L; Romano, Patrick S; Geppert, Jeffrey J; Gauvreau, Kimberlee

    2016-05-20

    The National Quality Forum previously approved a quality indicator for mortality after congenital heart surgery developed by the Agency for Healthcare Research and Quality (AHRQ). Several parameters of the validated Risk Adjustment for Congenital Heart Surgery (RACHS-1) method were included, but others differed. As part of the National Quality Forum endorsement maintenance process, developers were asked to harmonize the 2 methodologies. Parameters that were identical between the 2 methods were retained. AHRQ's Healthcare Cost and Utilization Project State Inpatient Databases (SID) 2008 were used to select optimal parameters where differences existed, with a goal to maximize model performance and face validity. Inclusion criteria were not changed and included all discharges for patients model includes procedure risk group, age (0-28 days, 29-90 days, 91-364 days, 1-17 years), low birth weight (500-2499 g), other congenital anomalies (Clinical Classifications Software 217, except for 758.xx), multiple procedures, and transfer-in status. Among 17 945 eligible cases in the SID 2008, the c statistic for model performance was 0.82. In the SID 2013 validation data set, the c statistic was 0.82. Risk-adjusted mortality rates by center ranged from 0.9% to 4.1% (5th-95th percentile). Congenital heart surgery programs can now obtain national benchmarking reports by applying AHRQ Quality Indicator software to hospital administrative data, based on the harmonized RACHS-1 method, with high discrimination and face validity. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  12. Early identification of children at-risk for academic difficulties, using standardized assessment: stability and predictive validity of preschool math and language scores

    NARCIS (Netherlands)

    Frans, Niek; Post, Wendy J.; Huisman, Mark; Oenema-Mostert, Ineke C.E.; Keegstra, Anne L.; Minnaert, Alexander E.M.G.

    2017-01-01

    Despite the claim by several researchers that variability in performance may complicate the identification of “at-risk” children, variability in the academic performance of young children remains an undervalued area of research. The goal of this study is to examine the predictive validity for future

  13. NMR investigation of acrolein stability in hydroalcoholic solution as a foundation for the valid HS-SPME/GC–MS quantification of the unsaturated aldehyde in beverages

    International Nuclear Information System (INIS)

    Kächele, Martin; Monakhova, Yulia B.; Kuballa, Thomas; Lachenmeier, Dirk W.

    2014-01-01

    Highlights: • Acrolein in hydroalcoholic solution degrades to 1,3,3-propanetriol and 3-hydroxypropionaldehyde. • Hydroquinone (0.2%) at pH 3.0 stabilizes acrolein solutions. • Quantitative HS-SPME/GC–MS determination of acrolein in alcoholic beverages was developed (LOD 14 μg L −1 ). • 6 of 117 samples had acrolein levels above the WHO threshold (1500 μg L −1 ). - Abstract: Acrolein (propenal) is found in many foods and beverages and may pose a health hazard due to its cytotoxicity. Considerable knowledge gaps regarding human exposure to acrolein exist, and there is a lack of reliable analytical methods. Hydroalcoholic dilutions prepared for calibration purposes from pure acrolein show considerable degradation of the compound and nuclear magnetic resonance (NMR) spectroscopy showed that 1,3,3-propanetriol and 3-hydroxypropionaldehyde are formed. The degradation can be prevented by addition of hydroquinone as stabilizer to the calibration solutions, which then show linear concentration-response behaviour required for quantitative analysis. The stabilized calibration solutions were used for quantitative headspace solid-phase microextraction/gas chromatography–mass spectrometry (HS-SPME/GC–MS) determination of acrolein in alcoholic beverages with a detection limit of 14 μg L −1 . Of 117 tested alcoholic beverages, 64 were tested positive with the highest incidence in grape marc spirits and whiskey (100%, mean 252 μg L −1 ), followed by fruit spirits (86%, mean 591 μg/L −1 ), tequila (86%, mean 404 μg L −1 ), Asian spirits (43%, mean 54 μg L −1 ) and wine (9%, mean 0.7 μg L −1 ). Acrolein could not be detected in beer, vodka, absinthe and bottled water. Six of the fruit and grape marc spirits had acrolein levels above the World Health Organization (WHO) provisional tolerable concentration of 1.5 mg L −1

  14. NMR investigation of acrolein stability in hydroalcoholic solution as a foundation for the valid HS-SPME/GC–MS quantification of the unsaturated aldehyde in beverages

    Energy Technology Data Exchange (ETDEWEB)

    Kächele, Martin [Chemisches und Veterinäruntersuchungsamt (CVUA) Karlsruhe, Weissenburger Strasse 3, D-76187 Karlsruhe (Germany); Hochschule Mannheim, Paul-Wittsack-Strasse 10, D-68163 Mannheim (Germany); Monakhova, Yulia B. [Chemisches und Veterinäruntersuchungsamt (CVUA) Karlsruhe, Weissenburger Strasse 3, D-76187 Karlsruhe (Germany); Bruker Biospin GmbH, Silbersteifen, 76287 Rheinstetten (Germany); Department of Chemistry, Saratov State University, Astrakhanskaya Street 83, 410012 Saratov (Russian Federation); Kuballa, Thomas [Chemisches und Veterinäruntersuchungsamt (CVUA) Karlsruhe, Weissenburger Strasse 3, D-76187 Karlsruhe (Germany); Lachenmeier, Dirk W., E-mail: lachenmeier@web.de [Chemisches und Veterinäruntersuchungsamt (CVUA) Karlsruhe, Weissenburger Strasse 3, D-76187 Karlsruhe (Germany); Ministry of Rural Affairs and Consumer Protection, Kernerplatz 10, 70182 Stuttgart (Germany)

    2014-04-01

    Highlights: • Acrolein in hydroalcoholic solution degrades to 1,3,3-propanetriol and 3-hydroxypropionaldehyde. • Hydroquinone (0.2%) at pH 3.0 stabilizes acrolein solutions. • Quantitative HS-SPME/GC–MS determination of acrolein in alcoholic beverages was developed (LOD 14 μg L⁻¹. • 6 of 117 samples had acrolein levels above the WHO threshold (1500 μg L⁻¹). Abstract: Acrolein (propenal) is found in many foods and beverages and may pose a health hazard due to its cytotoxicity. Considerable knowledge gaps regarding human exposure to acrolein exist, and there is a lack of reliable analytical methods. Hydroalcoholic dilutions prepared for calibration purposes from pure acrolein show considerable degradation of the compound and nuclear magnetic resonance (NMR) spectroscopy showed that 1,3,3-propanetriol and 3-hydroxypropionaldehyde are formed. The degradation can be prevented by addition of hydroquinone as stabilizer to the calibration solutions, which then show linear concentration-response behaviour required for quantitative analysis. The stabilized calibration solutions were used for quantitative headspace solid-phase microextraction/gas chromatography–mass spectrometry (HS-SPME/GC–MS) determination of acrolein in alcoholic beverages with a detection limit of 14 μg L⁻¹. Of 117 tested alcoholic beverages, 64 were tested positive with the highest incidence in grape marc spirits and whiskey (100%, mean 252 μg L⁻¹), followed by fruit spirits (86%, mean 591 μg/L⁻¹), tequila (86%, mean 404 μg L⁻¹), Asian spirits (43%, mean 54 μg L⁻¹) and wine (9%, mean 0.7 μg L⁻¹). Acrolein could not be detected in beer, vodka, absinthe and bottled water. Six of the fruit and grape marc spirits had acrolein levels above the World Health Organization (WHO) provisional tolerable concentration of 1.5 mg L⁻¹.

  15. Gas exchange indices how valid are they?

    African Journals Online (AJOL)

    % oxygen on intrapulmonary shunt in severely traumatized patients. J Trauma 1973; 13: 811-821. 3. Dery A, Pelletier J, Jaques A, Clavet M, Houde J. Alveolar collapse induced by denitrogenation. Can Anaesth Sac J 1965; 12: 531-544. 4.

  16. Validation of three-dimensional incompressible spatial direct numerical simulation code: A comparison with linear stability and parabolic stability equation theories for boundary-layer transition on a flat plate

    Science.gov (United States)

    Joslin, Ronald D.; Streett, Craig L.; Chang, Chau-Lyan

    1992-01-01

    Spatially evolving instabilities in a boundary layer on a flat plate are computed by direct numerical simulation (DNS) of the incompressible Navier-Stokes equations. In a truncated physical domain, a nonstaggered mesh is used for the grid. A Chebyshev-collocation method is used normal to the wall; finite difference and compact difference methods are used in the streamwise direction; and a Fourier series is used in the spanwise direction. For time stepping, implicit Crank-Nicolson and explicit Runge-Kutta schemes are used to the time-splitting method. The influence-matrix technique is used to solve the pressure equation. At the outflow boundary, the buffer-domain technique is used to prevent convective wave reflection or upstream propagation of information from the boundary. Results of the DNS are compared with those from both linear stability theory (LST) and parabolized stability equation (PSE) theory. Computed disturbance amplitudes and phases are in very good agreement with those of LST (for small inflow disturbance amplitudes). A measure of the sensitivity of the inflow condition is demonstrated with both LST and PSE theory used to approximate inflows. Although the DNS numerics are very different than those of PSE theory, the results are in good agreement. A small discrepancy in the results that does occur is likely a result of the variation in PSE boundary condition treatment in the far field. Finally, a small-amplitude wave triad is forced at the inflow, and simulation results are compared with those of LST. Again, very good agreement is found between DNS and LST results for the 3-D simulations, the implication being that the disturbance amplitudes are sufficiently small that nonlinear interactions are negligible.

  17. NMR investigation of acrolein stability in hydroalcoholic solution as a foundation for the valid HS-SPME/GC-MS quantification of the unsaturated aldehyde in beverages.

    Science.gov (United States)

    Kächele, Martin; Monakhova, Yulia B; Kuballa, Thomas; Lachenmeier, Dirk W

    2014-04-11

    Acrolein (propenal) is found in many foods and beverages and may pose a health hazard due to its cytotoxicity. Considerable knowledge gaps regarding human exposure to acrolein exist, and there is a lack of reliable analytical methods. Hydroalcoholic dilutions prepared for calibration purposes from pure acrolein show considerable degradation of the compound and nuclear magnetic resonance (NMR) spectroscopy showed that 1,3,3-propanetriol and 3-hydroxypropionaldehyde are formed. The degradation can be prevented by addition of hydroquinone as stabilizer to the calibration solutions, which then show linear concentration-response behaviour required for quantitative analysis. The stabilized calibration solutions were used for quantitative headspace solid-phase microextraction/gas chromatography-mass spectrometry (HS-SPME/GC-MS) determination of acrolein in alcoholic beverages with a detection limit of 14 μg L(-1). Of 117 tested alcoholic beverages, 64 were tested positive with the highest incidence in grape marc spirits and whiskey (100%, mean 252 μg L(-1)), followed by fruit spirits (86%, mean 591 μg/L(-1)), tequila (86%, mean 404 μg L(-1)), Asian spirits (43%, mean 54 μg L(-1)) and wine (9%, mean 0.7 μg L(-1)). Acrolein could not be detected in beer, vodka, absinthe and bottled water. Six of the fruit and grape marc spirits had acrolein levels above the World Health Organization (WHO) provisional tolerable concentration of 1.5 mg L(-1). Copyright © 2014 Elsevier B.V. All rights reserved.

  18. NRC performance indicator program

    International Nuclear Information System (INIS)

    Singh, R.N.

    1987-01-01

    The performance indicator development work of the US Nuclear Regulatory Commission (NRC) interoffice task group involved several major activities that included selection of candidate indicators for a trial program, data collection and review, validation of the trial indicators, display method development, interactions with the industry, and selection of an optimum set of indicators for the program. After evaluating 27 potential indicators against certain ideal attributes, the task group selected 17 for the trial program. The pertinent data for these indicators were then collected from 50 plants at 30 sites. The validation of the indicators consisted of two primary processes: logical validity and statistical analysis. The six indicators currently in the program are scrams, safety system actuations, significant events, safety system failures, forced outage rate, and equipment forced outages per 100 critical hours. A report containing data on the six performance indicators and some supplemental information is issued on a quarterly basis. The NRC staff is also working on refinements of existing indicators and development of additional indicators as directed by the commission

  19. Validated sensitive spectrofluorimetric method for determination of antihistaminic drug azelastine HCl in pure form and in pharmaceutical dosage forms: application to stability study.

    Science.gov (United States)

    El-Masry, Amal A; Hammouda, Mohammed E A; El-Wasseef, Dalia R; El-Ashry, Saadia M

    2017-03-01

    A highly sensitive, simple and rapid spectrofluorimetric method was developed for the determination of azelastine HCl (AZL) in either its pure state or pharmaceutical dosage form. The proposed method was based on measuring the native fluorescence of the studied drug in 0.2 M H 2 SO 4 at λ em  = 364 nm after excitation at λ ex  = 275 nm. Different experimental parameters were studied and optimized carefully to obtain the highest fluorescence intensity. The proposed method showed a linear dependence of the fluorescence intensity on drug concentration over a concentration range of 10-250 ng/mL, with a limit of detection of 1.52 ng/mL and limit of quantitation of 4.61 ng/mL. Moreover, the method was successfully applied to pharmaceutical preparations, with percent recovery values (± SD) of 99.96 (± 0.4) and 100.1 (± 0.52) for nasal spray and eye drops, respectively. The results were in good agreement with those obtained by the comparison method, as revealed by Student's t-test and the variance ratio F-test. The method was extended to study the stability of AZL under stress conditions, where the drug was exposed to neutral, acidic, alkaline, oxidative and photolytic degradation according to International Conference on Harmonization (ICH) guidelines. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  20. A validated analytical method to study the long-term stability of natural and synthetic glucocorticoids in livestock urine using ultra-high performance liquid chromatography coupled to Orbitrap-high resolution mass spectrometry.

    Science.gov (United States)

    De Clercq, Nathalie; Julie, Vanden Bussche; Croubels, Siska; Delahaut, Philippe; Vanhaecke, Lynn

    2013-08-02

    Due to their growth-promoting effects, the use of synthetic glucocorticoids is strictly regulated in the European Union (Council Directive 2003/74/EC). In the frame of the national control plans, which should ensure the absence of residues in food products of animal origin, in recent years, a higher frequency of prednisolone positive bovine urines has been observed. This has raised questions with respect to the stability of natural corticoids in the respective urine samples and their potential to be transformed into synthetic analogs. In this study, a ultra high performance liquid chromatography-high resolution mass spectrometry (UHPLC-HRMS) methodology was developed to examine the stability of glucocorticoids in bovine urine under various storage conditions (up to 20 weeks) and to define suitable conditions for sample handling and storage, using an Orbitrap Exactive™. To this end, an extraction procedure was optimized using a Plackett-Burman experimental design to determine the key conditions for optimal extraction of glucocorticoids from urine. Next, the analytical method was successfully validated according to the guidelines of CD 2002/657/EC. Decision limits and detection capabilities for prednisolone, prednisone and methylprednisolone ranged, respectively, from 0.1 to 0.5μgL(-1) and from 0.3 to 0.8μgL(-1). For the natural glucocorticoids limits of detection and limits of quantification for dihydrocortisone, cortisol and cortisone ranged, respectively, from 0.1 to 0.2μgL(-1) and from 0.3 to 0.8μgL(-1). The stability study demonstrated that filter-sterilization of urine, storage at -80°C, and acidic conditions (pH 3) were optimal for preservation of glucocorticoids in urine and able to significantly limit degradation up to 20 weeks. Copyright © 2013 Elsevier B.V. All rights reserved.

  1. The impact of pre-analytical variables on the stability of neurofilament proteins in CSF, determined by a novel validated SinglePlex Luminex assay and ELISA.

    Science.gov (United States)

    Koel-Simmelink, Marleen J A; Vennegoor, Anke; Killestein, Joep; Blankenstein, Marinus A; Norgren, Niklas; Korth, Carsten; Teunissen, Charlotte E

    2014-01-15

    Neurofilament (Nf) proteins have been shown to be promising biomarkers for monitoring and predicting disease progression for various neurological diseases. The aim of this study was to evaluate the effects of pre-analytical variables on the concentration of neurofilament heavy (NfH) and neurofilament light (NfL) proteins. For NfH an in-house newly-developed and validated SinglePlex Luminex assay was used; ELISA was used to analyze NfL. For the NfL ELISA assay, the intra- and inter-assay variation was respectively, 1.5% and 16.7%. Analytical performance of the NfH SinglePlex Luminex assay in terms of sensitivity (6.6pg/mL), recovery in cerebrospinal fluid (CSF) (between 90 and 104%), linearity (from 6.6-1250pg/mL), and inter- and intra-assay variation (<8%) were good. Concentrations of both NfL and NfH appeared not negatively affected by blood contamination, repeated freeze-thaw cycles (up to 4), delayed processing (up to 24hours) and during long-term storage at -20°C, 4°C, and room temperature. A decrease in concentration was observed during storage of both neurofilament proteins up to 21days at 37°C, which was significant by day 5. The newly developed NfH SinglePlex Luminex assay has a good sensitivity and is robust. Moreover, both NfH and NfL are stable under the most prevalent pre-analytical variations. Copyright © 2013 Elsevier B.V. All rights reserved.

  2. Empirical Productivity Indices and Indicators

    NARCIS (Netherlands)

    B.M. Balk (Bert)

    2016-01-01

    textabstractThe empirical measurement of productivity change (or difference) by means of indices and indicators starts with the ex post profit/loss accounts of a production unit. Key concepts are profit, leading to indicators, and profitability, leading to indices. The main task for the productivity

  3. Cable Stability

    Energy Technology Data Exchange (ETDEWEB)

    Bottura, L [European Organization for Nuclear Research, Geneva (Switzerland)

    2014-07-01

    Superconductor stability is at the core of the design of any successful cable and magnet application. This chapter reviews the initial understanding of the stability mechanism, and reviews matters of importance for stability such as the nature and magnitude of the perturbation spectrum and the cooling mechanisms. Various stability strategies are studied, providing criteria that depend on the desired design and operating conditions.

  4. An assessment of the validity of the nutritional indices among under-fives in the catchment area of rural health and training center of a teaching institute in Bareilly

    Directory of Open Access Journals (Sweden)

    Rashmi Katyal

    2016-01-01

    Full Text Available Context: Nutritional status is a sensitive indicator of community health and nutrition. There is a growing realization that adequate nutrition is a necessary first step in the improvement of quality of life. Malnutrition and infection are connected by a vicious cycle. It is one of the greatest international health problems and the biggest challenges being faced today. Thus, to know the magnitude of undernutrition among preschool children and to find out the sensitive tool for detection of undernutrition, this study was conducted among children under - 5 years of age. Aims: To assess the validity of the nutritional indices for screening malnutrition. Settings and Designs: The study was a community-based, cross-sectional survey carried out in the catchment area of Rural Health Training Center, Rohilkhand Medical College, Bareilly. Subjects and Methods: Various anthropometric criteria like, Kanawati, McLaren, Rao, Dugdale and weight for age according to the Indian Academy of Pediatrics (IAP (modified Gomez classification were used to define nutritional status. Statistical Analysis Used: Data were entered and analyzed in SPSS and receiver operating characteristic (ROC curves (sensitivity vs. 1 - specificity were calculated for all the above mentioned indices. Results: Age dependent criteria such as IAP (48.2% malnourished and McLaren (48.3% malnourished were followed by the age independent criteria such as Kanawati (74.3% malnourished, Dugdale (45.5% malnourished, and Rao (33.1% malnourished to classify the mild to moderate malnutrition. ROC showed Dugdale as the best index for the judgement of malnutrition showing maximum area under the curve. Conclusions: Malnutrition being a public health problem leads to morbidity which is a vicious cycle and needs proper attention to curb its detrimental effect on the children.

  5. Waste indicators

    Energy Technology Data Exchange (ETDEWEB)

    Dall, O.; Lassen, C.; Hansen, E. [Cowi A/S, Lyngby (Denmark)

    2003-07-01

    The Waste Indicator Project focuses on methods to evaluate the efficiency of waste management. The project proposes the use of three indicators for resource consumption, primary energy and landfill requirements, based on the life-cycle principles applied in the EDIP Project. Trial runs are made With the indicators on paper, glass packaging and aluminium, and two models are identified for mapping the Danish waste management, of which the least extensive focuses on real and potential savings. (au)

  6. Waste indicators

    International Nuclear Information System (INIS)

    Dall, O.; Lassen, C.; Hansen, E.

    2003-01-01

    The Waste Indicator Project focuses on methods to evaluate the efficiency of waste management. The project proposes the use of three indicators for resource consumption, primary energy and landfill requirements, based on the life-cycle principles applied in the EDIP Project. Trial runs are made With the indicators on paper, glass packaging and aluminium, and two models are identified for mapping the Danish waste management, of which the least extensive focuses on real and potential savings. (au)

  7. Quality indicators

    DEFF Research Database (Denmark)

    Hjorth-Andersen, Christian

    1991-01-01

    In recent literature it has been suggested that consumers need have no knowledge of product quality as a number of quality indicators (or signals) may be used as substitutes. Very little attention has been paid to the empirical verification of these studies. The present paper is devoted...... to the issue of how well these indicators perform, using market data provided by consumer magazines from 3 countries. The results strongly indicate that price is a poor quality indicator. The paper also presents some evidence which suggests that seller reputation and easily observable characteristics are also...

  8. Lower Length Scale Characterization and Validation of Formation and Stability of Helium Bubbles in Nano-structured Ferritic Alloys under Irradiation

    Energy Technology Data Exchange (ETDEWEB)

    Zhao, Huijuan [Clemson Univ., SC (United States); Yun, Di [Argonne National Lab. (ANL), Argonne, IL (United States); Hoelzer, David [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States). BioEnergy Science Center (BESC)

    2018-01-30

    In order to extend the operating license of current light water reactors (LWRs) in the United States and other countries to as many as 80 years or longer, it is demanding to identify potential materials for many of the internal structural components and fasteners. We proposed that 14YWT iron alloy can be adopted in such applications with its excellent material properties, such as high-temperature strength, low creep rate, and high irradiation resistance. Application with 14YWT would improve the void/helium swelling characteristics of the LWR fuels, extend the burn-up limits with the tolerant temperature up to 800oC and reduce the hydrogen production. One key feature of 14YWT material property enhancement is the ultrafine high density of 2-4nm Y-Ti-O enriched nanoclusters (NCs) within the 14YWT iron matrix. The NCs can effectively pin the ultra-fine grain boundaries and dislocations, which significantly enhance mechanical properties of the alloy. Moreover, these nanoclusters remain stable with no coarsening after a large dose of ion irradiation. After ion irradiation, the helium bubbles are observed extremely uniform in size (1nm) and quite homogeneously distributed within the 14YWT matrix, which indicates that the microstructure of 14YWT remains remarkably tolerance to radiation damage. However, there is a lack of understanding of 14YWT both theoretically and experimentally in order to understand the mechanism behind the material property enhancement and to further develop and design a new generation of advanced structural material for current LWR applications and future fusion applications.

  9. General indicators

    International Nuclear Information System (INIS)

    2003-01-01

    This document summarizes the main 2002 energy indicators for France. A first table lists the evolution of general indicators between 1973 and 2002: energy bill, price of imported crude oil, energy independence, primary and final energy consumption. The main 2002 results are detailed separately for natural gas, petroleum and coal (consumption, imports, exports, production, stocks, prices). (J.S.)

  10. Solar Indices

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Collection includes a variety of indices related to solar activity contributed by a number of national and private solar observatories located worldwide. This...

  11. Selecting clinical quality indicators for laboratory medicine.

    Science.gov (United States)

    Barth, Julian H

    2012-05-01

    Quality in laboratory medicine is often described as doing the right test at the right time for the right person. Laboratory processes currently operate under the oversight of an accreditation body which gives confidence that the process is good. However, there are aspects of quality that are not measured by these processes. These are largely focused on ensuring that the most clinically appropriate test is performed and interpreted correctly. Clinical quality indicators were selected through a two-phase process. Firstly, a series of focus groups of clinical scientists were held with the aim of developing a list of quality indicators. These were subsequently ranked in order by an expert panel of primary and secondary care physicians. The 10 top indicators included the communication of critical results, comprehensive education to all users and adequate quality assurance for point-of-care testing. Laboratories should ensure their tests are used to national standards, that they have clinical utility, are calibrated to national standards and have long-term stability for chronic disease management. Laboratories should have error logs and demonstrate evidence of measures introduced to reduce chances of similar future errors. Laboratories should make a formal scientific evaluation of analytical quality. This paper describes the process of selection of quality indicators for laboratory medicine that have been validated sequentially by deliverers and users of the service. They now need to be converted into measureable variables related to outcome and validated in practice.

  12. Synchrophasor-Assisted Prediction of Stability/Instability of a Power System

    Science.gov (United States)

    Saha Roy, Biman Kumar; Sinha, Avinash Kumar; Pradhan, Ashok Kumar

    2013-05-01

    This paper presents a technique for real-time prediction of stability/instability of a power system based on synchrophasor measurements obtained from phasor measurement units (PMUs) at generator buses. For stability assessment the technique makes use of system severity indices developed using bus voltage magnitude obtained from PMUs and generator electrical power. Generator power is computed using system information and PMU information like voltage and current phasors obtained from PMU. System stability/instability is predicted when the indices exceeds a threshold value. A case study is carried out on New England 10-generator, 39-bus system to validate the performance of the technique.

  13. Validación de métodos analíticos para los estudios de estabilidad del naproxeno en supositorios para uso infantil y adulto Validation of analytical methods for the stability studies of naproxen suppositories for infant and adult use

    Directory of Open Access Journals (Sweden)

    Yaslenis Rodríguez Hernández

    2011-12-01

    quantification limits were evaluated for the direct semi-aqueous acid-base method, which was formerly validated for the quality control and showed satisfactory results. Nevertheless, the volumetric methods were not regarded as stability indicators; therefore, this method will be used along with the chromatographic methods of choice, that is, thin-layer chromatography and high-performance liquid chromatography, to determine the degradation products.

  14. Operational indicators

    International Nuclear Information System (INIS)

    2010-01-01

    The chapter presents the operational indicators related to budget, travel costs and tickets, the evolution of the annual program for regulatory inspection, the scientific production, requested patents and the numbers related to the production of the services offered by the Institution

  15. Quality control and stability study of 100 mg/ml paracetamol oral drops

    International Nuclear Information System (INIS)

    Garcia Penna, Caridad M.; Montes de Oca Porto, Yanet; Salomon Izquierdo, Suslebys

    2013-01-01

    Paracetamol is an effective analgesic and antipyretic drug of the non-steroidal anti-inflammatory drug group. Paracetamol oral drops are indicated for use in infant population aged up to 5 years to relieve fever, headache, toothache and symptomatic relief of common cold. To validate two analytical methods for the quality control and the stability study and to study the stability of 100 mg/ml Paracetamol oral drops made in Cuba

  16. Injector of solid indicator

    Energy Technology Data Exchange (ETDEWEB)

    Chernyshev, G.I.; Luk' yanov, E.P.; Pruslin, Y.A.; Zabrodin, P.I.

    1981-04-25

    The injector can be used with remote introduction of indicators into a borehole for study in an oil well of the parameters of movement of fluid currents, control of the state of the equipment, and study of the properties of the rocks. Proposed is a method of increasing the reliability of operation of the injector by stabilizing the rate of its dispersing. Introduced to the injector of a solid indicator are auxiliary brackets and a cathode made from nonmetallic electrical conducting material and reinforced at the end by an elastic bracket. The auxillary cathode is attached to the end surface of the anode and cathode.

  17. EVALUACIÓN DE DOS MÉTODOS DE ESTABILIDAD FENOTÍPICA A TRAVÉS DE VALIDACIÓN CRUZADA EVALUATION OF TWO METHODS OF PHENOTYPIC STABILITY THROUGH CROSS-VALIDATION

    Directory of Open Access Journals (Sweden)

    Jairo Alberto Rueda Restrepo

    2009-12-01

    Full Text Available Una de las principales preocupaciones de los fitomejoradores es la evaluación de la estabilidad fenotípica mediante la realización de pruebas regionales o multiambiente. Existen numerosos métodos propuestos para el análisis de estas pruebas regionales y la estimación de la estabilidad fenotípica. En este trabajo se compara el método de regresión propuesto por Eberhart y Russell y el de componentes de varianza propuesto por Shukla, siguiendo un esquema de validación cruzada. Para ello fueron utilizados datos provenientes de 20 pruebas multiambiente de maíz, cada una con nueve genotipos, plantadas bajo un diseño en bloques completos al azar con cuatro repeticiones. Se encontró que el mejor modelo para predecir el rendimiento futuro de un genotipo en un determinado ambiente es el método de Eberhart y Russell, presentando un valor de raíz cuadrada del cuadrado medio de predicción 2,21% menos que el método de Shukla, con una consistencia en la predicción de 90,6%.One of the most important topics of plant breeders is to evaluate the phenotypic stability through regional trials or multi-environment trials. There are many methods proposed to analyze those trials and to estimate the phenotypic stability. This paper compares the regression method proposed by Eberhart and Russell and the components of variance proposed by Shukla, according to a cross-validation methodology. Data from 20 multi-environment corn tests, each one with nine genotypes, planted under a randomized complete block design with four replications, were used. It was found that the best model to predict the future performance of a genotype is the method of Eberhart and Russell, showing a root square value of the prediction medium 2,21% less than Shukla´s method , which a prediction consistence of 90.6%.

  18. Nordic eHealth Indicators

    DEFF Research Database (Denmark)

    Hyppönen, Hannele; Faxvaag, Arild; Gilstad, Heidi

    2013-01-01

    eHealth indicator and benchmarking activities are rapidly increasing nationally and internationally. The work is rarely based on a transparent methodology for indicator definition. This article describes first results of testing an indicator methodology for defining eHealth indicators, which...... was reported at the Medical Informatics Europe conference in 2012. The core elements of the methodology are illustrated, demonstrating validation of each of them in the context of Nordic eHealth Indicator work. Validation proved the importance of conducting each of the steps of the methodology, with several...

  19. Explicating Validity

    Science.gov (United States)

    Kane, Michael T.

    2016-01-01

    How we choose to use a term depends on what we want to do with it. If "validity" is to be used to support a score interpretation, validation would require an analysis of the plausibility of that interpretation. If validity is to be used to support score uses, validation would require an analysis of the appropriateness of the proposed…

  20. Indicators of sustainable tourism

    Directory of Open Access Journals (Sweden)

    Jovičić Dobrica

    2010-01-01

    Full Text Available The indicators, precisely describing the linkages between tourism and the environment, social and cultural base, are not easily available. How ever, some relevant organizations (WTO, EU, OECD, etc., institutions and experts, have been hardly working to create the indicators of sustainable tourism. Whereas the economic objectives are easily defined by the use of the traditional indicators used in national and business economics, it is very difficult to identify widely applicable environmental, social and cultural indicators. In order to stimulate and alleviate the process of sustainable tourism development, EU created the list of comparative indicators of sustainable tourism. In preparing this list, special attention is paid to identification of valid indicators of real tourism impacts on the social and cultural environment (the entire set of traditions, customs, history, hospitality and culture that characterize a given area, that is a very complex task. Assuming the fact that the related indicators have been analyzed in many European countries, this paper is focused on applying the related indicators in research of tourism development in villages of the Kosjerić community. .

  1. Dynamic respiration index as a descriptor of the biological stability of organic wastes.

    Science.gov (United States)

    Adani, Fabrizio; Confalonieri, Roberto; Tambone, Fulvia

    2004-01-01

    Analytical methods applicable to different organic wastes are needed to establish the extent to which readily biodegradable organic matter has decomposed (i.e., biological stability). The objective of this study was to test a new respirometric method for biological stability determination of organic wastes. Dynamic respiration index (DRI) measurements were performed on 16 organic wastes of different origin, composition, and biological stability degree to validate the test method and result expression, and to propose biological stability limits. In addition, theoretical DRI trends were obtained by using a mathematical model. Each test lasted 96 h in a 148-L-capacity respirometer apparatus, and DRI was monitored every hour. The biological stability was expressed as both single and cumulative DRI values. Results obtained indicated that DRI described biological stability in relation to waste typology and age well, revealing lower-stability waste characterized by a well-pronounced DRI profile (a marked peak was evident) that became practically flat for samples with higher biological stability. Fitting indices showed good model prediction compared with the experimental data, indicating that the method was able to reproduce the aerobic process, providing a reliable indication of the biological stability. The DRI can therefore be proposed as a useful method to measure the biological stability of organic wastes, and DRI values, calculated as a mean of 24 h of the highest microbial activity, of 1000 and 500 mg O(2) kg(-1) volatile solids (VS) h(-1) are proposed to indicate medium (e.g., fresh compost) and high (e.g., mature compost) biological stabilities, respectively.

  2. Chemical stability of oseltamivir in oral solutions.

    Science.gov (United States)

    Albert, K; Bockshorn, J

    2007-09-01

    The stability of oseltamivir in oral aqueous solutions containing the preservative sodium benzoate was studied by a stability indicating HPLC-method. The separation was achieved on a RP-18 ec column using a gradient of mobile phase A (aqueous solution of 50 mM ammonium acetate) and mobile phase B (60% (v/v) acetonitrile/40% (v/v) mobile phase A). The assay was subsequently validated according to the ICH guideline Q2(R1). The extemporaneously prepared "Oseltamivir Oral Solution 15 mg/ml for Adults or for Children" (NRF 31.2.) according to the German National Formulary ("Neues Rezeptur-Formularium") was stable for 84 days if stored under refrigeration. After storage at 25 degrees C the content of oseltamivir decreased to 98.4%. Considering the toxicological limit of 0.5% of the 5-acetylamino derivative (the so-called isomer I) the solution is stable for 46 days. Oseltamivir was less stable in a solution prepared with potable water instead of purified water. Due to an increasing pH the stability of this solution decreased to 14 days. Furthermore a white precipitate of mainly calcium phosphate was observed. The addition of 0.1% anhydrous citric acid avoided these problems and improved the stability of the solution prepared with potable water to 63 days. Sodium benzoate was stable in all oral solutions tested.

  3. Stabilizing Niger

    DEFF Research Database (Denmark)

    Hahonou, Eric Komlavi

    international intervention in Niger. Their main objective is to secure their own strategic, economic and political interests by strengthening the Nigerien authorities through direct intervention and capacity building activities. For western states reinforcing state security institutions and stabilizing elite...

  4. Interfacial stability with mass and heat transfer

    International Nuclear Information System (INIS)

    Hsieh, D.Y.

    1977-07-01

    A simplified formulation is presented to deal with interfacial stability problems with mass and heat transfer. For Rayleigh-Taylor stability problems of a liquid-vapor system, it was found that the effect of mass and heat transfer tends to enhance the stability of the system when the vapor is hotter than the liquid, although the classical stability criterion is still valid. For Kelvin-Holmholtz stability problems, however, the classical stability criterion was found to be modified substantially due to the effect of mass and heat transfer

  5. Validación del método analítico para el control de la calidad y el estudio de estabilidad del neolimpilen Validation of the analytical method for the quality control and the stability study of neolimpilem

    Directory of Open Access Journals (Sweden)

    Caridad M García Peña

    2004-08-01

    significativas. El método resultó específico, lineal, preciso y exacto.The analytical method developed for the quality control and for the stability study in the quantification of hydroxypropylmethylcellulose and sodium laurisulfate was validated by spectrophotometry with ultraviolet detection at 635 and 650 nm, respectively. Besides, the analytical results of the stability study conducted in the solution for cleaning and conservating rigid contact lens (neolimpilen are presented. Three batches packed in two different flasks were used to carry out the study by accelerated stability and shelf life in order to prove the phsyical and chemical stability of the solution at room temperature for 24 months. In the validation of hydroxypropylmethylcellulose, teh calibration curve in the range from 0.06 to 0.l8 mg/mL showed a lineal behavior with a correlation coefficient equal to 0.99581. The statistical test for the interval and the slope was not significant. A recovery of 99.8 % was obtained in the studied concentration range and Cochran (G and Student's (t tests were not indicative. The variation coefficient in the repeatabililty was 0.9 % for 10 tested replicas,. whereas Fischer and Student's tests were not significant in the reproducibility. The method proved to be specific, lineal, precise and exact. In the validation of sodium laurisulfate the calibration curve in the range 1.44 -3.0 mg/mL behaved in a lineal way with a correlation coefficient equal to 0.99036. The statistical test for the interval and the slope was not signficant. A recovery of 99.9% was attained in the studied concentration range and Cochran (G and Student's (t tests were not significant. The method proved to be specific, lineal, precise and exact.

  6. Transient stability risk assessment of power systems incorporating wind farms

    DEFF Research Database (Denmark)

    Miao, Lu; Fang, Jiakun; Wen, Jinyu

    2013-01-01

    fed induction generator has been established. Wind penetration variation and multiple stochastic factors of power systems have been considered. The process of transient stability risk assessment based on the Monte Carlo method has been described and a comprehensive risk indicator has been proposed......Large-scale wind farm integration has brought several aspects of challenges to the transient stability of power systems. This paper focuses on the research of the transient stability of power systems incorporating with wind farms by utilizing risk assessment methods. The detailed model of double....... An investigation has been conducted into an improved 10-generator 39-bus system with a wind farm incorporated to verify the validity and feasibility of the risk assessment method proposed....

  7. Screening for depressed mood in an adolescent psychiatric context by brief self-assessment scales -- testing psychometric validity of WHO-5 and BDI-6 indices by latent trait analyses

    DEFF Research Database (Denmark)

    Blom, Eva Henje; Bech, Per; Högberg, Göran

    2012-01-01

    of two such scales, which may be used in a two-step screening procedure, the WHO-Five Well-being Index (WHO-5) and the six-item version of Beck's Depression Inventory (BDI-6). METHOD: 66 adolescent psychiatric patients with a clinical diagnosis of major depressive disorder (MDD), 60 girls and 6 boys......, aged 14--18 years, mean age 16.8 years, completed the WHO-5 scale as well as the BDI-6. Statistical validity was tested by Mokken and Rasch analyses. RESULTS: The correlation between WHO-5 and BDI-6 was -0.49 (p=0.0001). Mokken analyses showed a coefficient of homogeneity for the WHO-5 of 0.......52 and for the BDI-6 of 0.46. Rasch analysis also accepted unidimensionality when testing males versus females (p > 0.05). CONCLUSIONS: The WHO-5 is psychometrically valid in an adolescent psychiatric context including both genders to assess the wellness dimension and applicable as a first step in screening for MDD...

  8. FACTAR validation

    International Nuclear Information System (INIS)

    Middleton, P.B.; Wadsworth, S.L.; Rock, R.C.; Sills, H.E.; Langman, V.J.

    1995-01-01

    A detailed strategy to validate fuel channel thermal mechanical behaviour codes for use of current power reactor safety analysis is presented. The strategy is derived from a validation process that has been recently adopted industry wide. Focus of the discussion is on the validation plan for a code, FACTAR, for application in assessing fuel channel integrity safety concerns during a large break loss of coolant accident (LOCA). (author)

  9. Static Voltage Stability Analysis by Using SVM and Neural Network

    Directory of Open Access Journals (Sweden)

    Mehdi Hajian

    2013-01-01

    Full Text Available Voltage stability is an important problem in power system networks. In this paper, in terms of static voltage stability, and application of Neural Networks (NN and Supported Vector Machine (SVM for estimating of voltage stability margin (VSM and predicting of voltage collapse has been investigated. This paper considers voltage stability in power system in two parts. The first part calculates static voltage stability margin by Radial Basis Function Neural Network (RBFNN. The advantage of the used method is high accuracy in online detecting the VSM. Whereas the second one, voltage collapse analysis of power system is performed by Probabilistic Neural Network (PNN and SVM. The obtained results in this paper indicate, that time and number of training samples of SVM, are less than NN. In this paper, a new model of training samples for detection system, using the normal distribution load curve at each load feeder, has been used. Voltage stability analysis is estimated by well-know L and VSM indexes. To demonstrate the validity of the proposed methods, IEEE 14 bus grid and the actual network of Yazd Province are used.

  10. External validation of the fatty liver index and lipid accumulation product indices, using 1H-magnetic resonance spectroscopy, to identify hepatic steatosis in healthy controls and obese, insulin-resistant individuals.

    Science.gov (United States)

    Cuthbertson, Daniel J; Weickert, Martin O; Lythgoe, Daniel; Sprung, Victoria S; Dobson, Rebecca; Shoajee-Moradie, Fariba; Umpleby, Margot; Pfeiffer, Andreas F H; Thomas, E Louise; Bell, Jimmy D; Jones, Helen; Kemp, Graham J

    2014-11-01

    Simple clinical algorithms including the fatty liver index (FLI) and lipid accumulation product (LAP) have been developed as surrogate markers for non-alcoholic fatty liver disease (NAFLD), constructed using (semi-quantitative) ultrasonography. This study aimed to validate FLI and LAP as measures of hepatic steatosis, as determined quantitatively by proton magnetic resonance spectroscopy (1H-MRS). Data were collected from 168 patients with NAFLD and 168 controls who had undergone clinical, biochemical and anthropometric assessment. Values of FLI and LAP were determined and assessed both as predictors of the presence of hepatic steatosis (liver fat>5.5%) and of actual liver fat content, as measured by 1H-MRS. The discriminative ability of FLI and LAP was estimated using the area under the receiver operator characteristic curve (AUROC). As FLI can also be interpreted as a predictive probability of hepatic steatosis, we assessed how well calibrated it was in our cohort. Linear regression with prediction intervals was used to assess the ability of FLI and LAP to predict liver fat content. Further validation was provided in 54 patients with type 2 diabetes mellitus. FLI, LAP and alanine transferase discriminated between patients with and without steatosis with an AUROC of 0.79 (IQR=0.74, 0.84), 0.78 (IQR=0.72, 0.83) and 0.83 (IQR=0.79, 0.88) respectively although could not quantitatively predict liver fat. Additionally, the algorithms accurately matched the observed percentages of patients with hepatic steatosis in our cohort. FLI and LAP may be used to identify patients with hepatic steatosis clinically or for research purposes but could not predict liver fat content. © 2014 European Society of Endocrinology.

  11. Macroeconomic stability

    DEFF Research Database (Denmark)

    Jespersen, Jesper

    2004-01-01

    It is demonstrated that full employment and sustainable development not necessarily are conflicting goals. On the other hand macroeconomic stability cannot be obtained without a deliberate labour sharing policy and a shift in the composition of private consumption away from traditional material...

  12. Stabilized superconductors

    International Nuclear Information System (INIS)

    Wong, J.

    1975-01-01

    The stable, high field, high current composite wire comprises multiple filaments in a depleted bronze matrix, each filament comprising a type II superconducting, beta-tungsten structure, intermetallic compound layer jacketing and metallurgically bonded to a stabilizing copper core, directly or via an intermediate layer of refractory metal

  13. Second region of stability

    International Nuclear Information System (INIS)

    Greene, J.M.; Chance, M.S.

    1980-10-01

    A new type of axisymmetric magnetohydrodynamic equilibrium is presented. It is characterized by a region of pressure and safety factor variation with a short scale length imposed as a perturbation. The equilibrium consistent with these profile variations can be calculated by means of an asymptotic expansion. The flexibility obtained by generating such equilibria allows for a close examination of the mechanisms that are relevant to ballooning instabilities - ideal MHD modes with large toroidal mode number. The so-called first and second regions of stability against these modes are seen well within the limits of validity of the asymptotic expansion. It appears that the modes must be localized in regions with small values of the local shear of the magnetic field. The second region of stability occurs where the local shear is large throughout the range where the magnetic field line curvature is destabilizing

  14. Teriparatide - Indications beyond osteoporosis

    Directory of Open Access Journals (Sweden)

    Marilyn Lee Cheng

    2012-01-01

    Full Text Available Osteoporosis is a condition of impaired bone strength that results in an increased risk of fracture. The current and most popular pharmacological options for the treatment of osteoporosis include antiresorptive therapy, in particular, oral bisphosphonates (alendronate, risedronate, ibandronate. Anabolic agents like teriparatide have widened our therapeutic options. They act by directly stimulating bone formation and improving bone mass quantity and quality. Two forms of recombinant human parathyroid hormone (PTH are available : full-length PTH (PTH 1-84; approved in the EU only and the 1-34 N-terminal active fragment of PTH (teriparatide, US FDA approved. This review aims to discuss the benefits of teriparatide beyond the currently licensed indications like fracture healing, dental stability, osteonecrosis of jaw, hypoparathyroidism, and hypocalcemia.

  15. Instrument to screen cases of pervasive developmental disorder: a preliminary indication of validity Instrumento para rastreamento dos casos de transtorno invasivo do desenvolvimento: estudo preliminar de validação

    Directory of Open Access Journals (Sweden)

    Fábio Pinato Sato

    2009-03-01

    Full Text Available OBJECTIVE: To translate into Portuguese, back-translate, culturally adapt and validate a screening instrument for pervasive developmental disorder, the Autism Screening Questionnaire, for use in Brazil. METHOD: A sample of 120 patients was selected based on three groups of 40: patients with a clinical diagnosis of pervasive developmental disorder, Down syndrome, or other psychiatric disorders. The self-administered questionnaire was applied to the patients' legal guardians. Psychometric measures of the final version of the translated questionnaire were tested. RESULTS: The score of 15 had sensitivity of 92.5% and specificity of 95.5% as a cut-off point for the diagnosis of pervasive developmental disorder. Internal validity for a total of 40 questions was 0.895 for alpha and 0.896 for KR-20, ranging from 0.6 to 0.8 for both coefficients. Test and retest reliability values showed strong agreement for most questions. CONCLUSIONS: The final version of this instrument, translated into Portuguese and adapted to the Brazilian culture, had satisfactory measurement properties, suggesting preliminary validation proprieties. It was an easy-to-apply, useful tool for the diagnostic screening of individuals with pervasive developmental disorder.OBJETIVO: Tradução, retro-versão, adaptação cultural e validação do Autism Screening Questionnaire para a língua portuguesa e para o seu uso no Brasil. MÉTODO: Foi selecionada uma amostra inicial de 120 pacientes, encaminhados de duas clínicas privadas e uma pública, divida em três grupos de 40 pacientes distintos: pacientes com diagnóstico clínico de transtornos globais do desenvolvimento ou transtornos invasivos do desenvolvimento; de síndrome de Down e de outros transtornos psiquiátricos. O questionário foi aplicado aos responsáveis legais dos pacientes seguindo os padrões de um questionário auto-aplicável. As medidas psicométricas do questionário traduzido, na sua versão final, foram

  16. Clinical assessment of hepatic functional reserve using 99mTc DTPA galactosyl human serum albumin SPECT to prognosticate chronic hepatic diseases. Validation of the use of SPECT and a new indicator

    International Nuclear Information System (INIS)

    Onodera, Yuya; Tamaki, Nagara; Miyasaka, Kazuo; Takahashi, Kazuei; Sugai, Yukio; Togashi, Tadashi

    2003-01-01

    It is generally known that scintigraphy of 99m Tc diethylenetriamine pentaacetic acid-galactosyl human serum albumin ( 99m Tc-GSA) is useful for assessing hepatic functional reserve. For hepatic functional indicators, the index of the calculated planar image has been used in previous studies. However, there have been few reports that suggest that the indicators calculated from static SPECT data would be useful for the assessment of hepatic function. The aims of this study were to establish a simple method for assessing hepatic functional reserve using the liver SPECT of 99m Tc-GSA and to apply this method for rich stratification in patients with chronic hepatic diseases. A liver phantom (a 50% concentration of 99m Tc solution) was used to compare the planar and SPECT methods. According to the definition of the new indicator, the liver SPECT of 99m Tc-GSA was divided by a syringe SPECT of 99m Tc-GSA and was called the liver uptake ratio (LUR). We correlated the LUR and the liver uptake ratio calculated according to the blood-sampling method. 99m Tc-GSA SPECT was performed in 137 patients with hepatic diseases, including chronic hepatic diseases, and 20 healthy volunteers. The LUR was correlated between the formed subtypes for all subjects. The acquired phantom-count ratio calculated by the SPECT method was more accurate than that acquired by the planar method. A good correlation was obtained between the LUR and the blood-sampling method (r=0.971). The LUR was significantly lower in subjects with severe cirrhosis than in healthy subjects or those with chronic hepatitis and mild cirrhosis, and it was significantly lower in subjects with chronic hepatitis and mild cirrhosis than in healthy subjects. The LUR was significantly correlated with other hepatic function tests. Based on LUR, the chronic hepatic diseases were divided into two groups: Group A, with LURs 30% and higher, and Group B, with LURs below 30%. An LUR of 30% marked the 25th percentile of the mild

  17. Stabilization of compactible waste

    International Nuclear Information System (INIS)

    Franz, E.M.; Heiser, J.H. III; Colombo, P.

    1990-09-01

    This report summarizes the results of series of experiments performed to determine the feasibility of stabilizing compacted or compactible waste with polymers. The need for this work arose from problems encountered at disposal sites attributed to the instability of this waste in disposal. These studies are part of an experimental program conducted at Brookhaven National Laboratory (BNL) investigating methods for the improved solidification/stabilization of DOE low-level wastes. The approach taken in this study was to perform a series of survey type experiments using various polymerization systems to find the most economical and practical method for further in-depth studies. Compactible dry bulk waste was stabilized with two different monomer systems: styrene-trimethylolpropane trimethacrylate (TMPTMA) and polyester-styrene, in laboratory-scale experiments. Stabilization was accomplished by wetting or soaking compactible waste (before or after compaction) with monomers, which were subsequently polymerized. Three stabilization methods are described. One involves the in-situ treatment of compacted waste with monomers in which a vacuum technique is used to introduce the binder into the waste. The second method involves the alternate placement and compaction of waste and binder into a disposal container. In the third method, the waste is treated before compaction by wetting the waste with the binder using a spraying technique. A series of samples stabilized at various binder-to-waste ratios were evaluated through water immersion and compression testing. Full-scale studies were conducted by stabilizing two 55-gallon drums of real compacted waste. The results of this preliminary study indicate that the integrity of compacted waste forms can be readily improved to ensure their long-term durability in disposal environments. 9 refs., 10 figs., 2 tabs

  18. Development and validation of a mass casualty conceptual model.

    Science.gov (United States)

    Culley, Joan M; Effken, Judith A

    2010-03-01

    To develop and validate a conceptual model that provides a framework for the development and evaluation of information systems for mass casualty events. The model was designed based on extant literature and existing theoretical models. A purposeful sample of 18 experts validated the model. Open-ended questions, as well as a 7-point Likert scale, were used to measure expert consensus on the importance of each construct and its relationship in the model and the usefulness of the model to future research. Computer-mediated applications were used to facilitate a modified Delphi technique through which a panel of experts provided validation for the conceptual model. Rounds of questions continued until consensus was reached, as measured by an interquartile range (no more than 1 scale point for each item); stability (change in the distribution of responses less than 15% between rounds); and percent agreement (70% or greater) for indicator questions. Two rounds of the Delphi process were needed to satisfy the criteria for consensus or stability related to the constructs, relationships, and indicators in the model. The panel reached consensus or sufficient stability to retain all 10 constructs, 9 relationships, and 39 of 44 indicators. Experts viewed the model as useful (mean of 5.3 on a 7-point scale). Validation of the model provides the first step in understanding the context in which mass casualty events take place and identifying variables that impact outcomes of care. This study provides a foundation for understanding the complexity of mass casualty care, the roles that nurses play in mass casualty events, and factors that must be considered in designing and evaluating information-communication systems to support effective triage under these conditions.

  19. SPECIES DIVERSITY AND STABILITY OF BIRD COMMUNITIES

    Directory of Open Access Journals (Sweden)

    Matsyura M.V.

    2011-12-01

    Full Text Available When comparing the suggested stability indicators, we obtained statistically significant correlations for indicators of annual stability of species and total number and standard deviation of the logarithm of the number. Annual Stability Index can be applied with a high degree of reliability as a characteristic of the averaged structure of the community and its pyramid of abundances. The results of correlation analysis confirm our assumptions about the correlation between stability over the years and indices of species diversity and relative uniformity.The final task of the study was to create a mathematical model of stability, where the independent variables are the indices of species diversity. The calculation of these indices allows forecasting birds’ community stability. According to the result of multiple regression for the indicators of diversity and stability of the breeding birds’ community highest correlation coefficients were obtained fro Shannon index and Simpson's dominance Index.Community stability could be determined by its overall species diversity. When considering the stability of community its diversity should be considered as a combination of uniformity of their total number and number of species. The most suitable predictors for the community stability were the nonparametric index of dominance and information-statistical indices, since they considered simultaneously evenness and richness. The community stability is subject of the complexity of its internal communications pattern.

  20. Number of evaluated lymph nodes and positive lymph nodes, lymph node ratio, and log odds evaluation in early-stage pancreatic ductal adenocarcinoma: numerology or valid indicators of patient outcome?

    Science.gov (United States)

    Lahat, G; Lubezky, N; Gerstenhaber, F; Nizri, E; Gysi, M; Rozenek, M; Goichman, Y; Nachmany, I; Nakache, R; Wolf, I; Klausner, J M

    2016-09-29

    We evaluated the prognostic significance and universal validity of the total number of evaluated lymph nodes (ELN), number of positive lymph nodes (PLN), lymph node ratio (LNR), and log odds of positive lymph nodes (LODDS) in a relatively large and homogenous cohort of surgically treated pancreatic ductal adenocarcinoma (PDAC) patients. Prospectively accrued data were retrospectively analyzed for 282 PDAC patients who had pancreaticoduodenectomy (PD) at our institution. Long-term survival was analyzed according to the ELN, PLN, LNR, and LODDS. Of these patients, 168 patients (59.5 %) had LN metastasis (N1). Mean ELN and PLN were 13.5 and 1.6, respectively. LN positivity correlated with a greater number of evaluated lymph nodes; positive lymph nodes were identified in 61.4 % of the patients with ELN ≥ 13 compared with 44.9 % of the patients with ELN < 13 (p = 0.014). Median overall survival (OS) and 5-year OS rate were higher in N0 than in N1 patients, 22.4 vs. 18.7 months and 35 vs. 11 %, respectively (p = 0.008). Mean LNR was 0.12; 91 patients (54.1 %) had LNR < 0.3. Among the N1 patients, median OS was comparable in those with LNR ≥ 0.3 vs. LNR < 0.3 (16.7 vs. 14.1 months, p = 0.950). Neither LODDS nor various ELN and PLN cutoff values provided more discriminative information within the group of N1 patients. Our data confirms that lymph node positivity strongly reflects PDAC biology and thus patient outcome. While a higher number of evaluated lymph nodes may provide a more accurate nodal staging, it does not have any prognostic value among N1 patients. Similarly, PLN, LNR, and LODDS had limited prognostic relevance.

  1. Validação de metodologia analítica por cromatografia líquida para doseamento e estudo da estabilidade de pantoprazol sódico Validation of analytical methodology by hplc for quantification and stability evaluation of sodium pantoprazole

    Directory of Open Access Journals (Sweden)

    Renata Platcheck Raffin

    2007-08-01

    Full Text Available Pantoprazole is a proton pump inhibitor used in the treatment of digestive ulcers, gastro-esophageal reflux disease and in the eradication of Helicobacter pylori. In this work, an analytical method was developed and validated for the quantification of sodium pantoprazole by HPLC. The method was specific, linear, precise and exact. In order to verify the stability of pantoprazole during dissolution assays, pantoprazole solution in phosphate buffer pH 7.4 was kept at room temperature and protected from light for 22 days. Pantoprazole presented less than 5% of degradation in 6 hours and the half live of the degradation was 124 h.

  2. Before Stabilization

    DEFF Research Database (Denmark)

    Plesner, Ursula; Horst, Maja

    2013-01-01

    of the communication about innovations in information and communication technology (ICT), and to contribute to an understanding of how different visions promise particular future configurations of workflows, communication processes, politics, economic models and social relations. Hereby, the paper adds...... to the literature on the relationship between ICTs and organizing, but with a distinct focus on innovation communication and distributed innovation processes taking place before ICTs are stabilized, issues which cannot be captured by studies of diffusion and adaptation of new ICTs within single organizations....

  3. Exploiting sequence and stability information for directing nanobody stability engineering.

    Science.gov (United States)

    Kunz, Patrick; Flock, Tilman; Soler, Nicolas; Zaiss, Moritz; Vincke, Cécile; Sterckx, Yann; Kastelic, Damjana; Muyldermans, Serge; Hoheisel, Jörg D

    2017-09-01

    Variable domains of camelid heavy-chain antibodies, commonly named nanobodies, have high biotechnological potential. In view of their broad range of applications in research, diagnostics and therapy, engineering their stability is of particular interest. One important aspect is the improvement of thermostability, because it can have immediate effects on conformational stability, protease resistance and aggregation propensity of the protein. We analyzed the sequences and thermostabilities of 78 purified nanobody binders. From this data, potentially stabilizing amino acid variations were identified and studied experimentally. Some mutations improved the stability of nanobodies by up to 6.1°C, with an average of 2.3°C across eight modified nanobodies. The stabilizing mechanism involves an improvement of both conformational stability and aggregation behavior, explaining the variable degree of stabilization in individual molecules. In some instances, variations predicted to be stabilizing actually led to thermal destabilization of the proteins. The reasons for this contradiction between prediction and experiment were investigated. The results reveal a mutational strategy to improve the biophysical behavior of nanobody binders and indicate a species-specificity of nanobody architecture. This study illustrates the potential and limitations of engineering nanobody thermostability by merging sequence information with stability data, an aspect that is becoming increasingly important with the recent development of high-throughput biophysical methods. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  4. The Self-esteem Stability Scale (SESS) for Cross-Sectional Direct Assessment of Self-esteem Stability

    OpenAIRE

    Tobias Altmann; Marcus Roth

    2018-01-01

    Self-esteem stability describes fluctuations in the level of self-esteem experienced by individuals over a brief period of time. In recent decades, self-esteem stability has repeatedly been shown to be an important variable affecting psychological functioning. However, measures of self-esteem stability are few and lacking in validity. In this paper, we present the Self-Esteem Stability Scale (SESS), a unidimensional and very brief scale to directly assess self-esteem stability. In four studie...

  5. Development of emotional stability scale

    Directory of Open Access Journals (Sweden)

    M Chaturvedi

    2010-01-01

    Full Text Available Background: Emotional stability remains the central theme in personality studies. The concept of stable emotional behavior at any level is that which reflects the fruits of normal emotional development. The study aims at development of an emotional stability scale. Materials and Methods: Based on available literature the components of emotional stability were identified and 250 items were developed, covering each component. Two-stage elimination of items was carried out, i.e. through judges′ opinions and item analysis. Results: Fifty items with highest ′t′ values covering 5 dimensions of emotional stability viz pessimism vs. optimism, anxiety vs. calm, aggression vs. tolerance., dependence vs. autonomy., apathy vs. empathy were retained in the final scale. Reliability as checked by Cronbach′s alpha was .81 and by split half method it was .79. Content validity and construct validity were checked. Norms are given in the form of cumulative percentages. Conclusion: Based on the psychometric principles a 50 item, self-administered 5 point Lickert type rating scale was developed for measurement of emotional stability.

  6. A Study of Method Development, Validation, and Forced Degradation for Simultaneous Quantification of Paracetamol and Ibuprofen in Pharmaceutical Dosage Form by RP-HPLC Method

    OpenAIRE

    Jahan, Md. Sarowar; Islam, Md. Jahirul; Begum, Rehana; Kayesh, Ruhul; Rahman, Asma

    2014-01-01

    A rapid and stability-indicating reversed phase high-performance liquid chromatography (RP-HPLC) method was developed for simultaneous quantification of paracetamol and ibuprofen in their combined dosage form especially to get some more advantages over other methods already developed for this combination. The method was validated according to United States Pharmacopeia (USP) guideline with respect to accuracy, precision, specificity, linearity, solution stability, robustness, sensitivity, and...

  7. Validation philosophy

    International Nuclear Information System (INIS)

    Vornehm, D.

    1994-01-01

    To determine when a set of calculations falls within an umbrella of an existing validation documentation, it is necessary to generate a quantitative definition of range of applicability (our definition is only qualitative) for two reasons: (1) the current trend in our regulatory environment will soon make it impossible to support the legitimacy of a validation without quantitative guidelines; and (2) in my opinion, the lack of support by DOE for further critical experiment work is directly tied to our inability to draw a quantitative open-quotes line-in-the-sandclose quotes beyond which we will not use computer-generated values

  8. Website quality indicators for consumers.

    Science.gov (United States)

    Griffiths, Kathleen M; Christensen, Helen

    2005-11-15

    The rating tool DISCERN was designed for use by consumers without content expertise to evaluate the quality of health information. There is some evidence that DISCERN may be a valid indicator of evidence-based website quality when applied by health professionals. However, it is not known if the tool is a valid measure of evidence-based quality when used by consumers. Since it is a lengthy instrument requiring training in its use, DISCERN may prove impractical for use by the typical consumer. It is therefore important to explore the validity of other simpler potential indicators of site quality such as Google PageRank. This study aimed to determine (1) whether the instrument DISCERN is a valid indicator of evidence-based Web content quality for consumers without specific mental health training, and (2) whether Google PageRank is an indicator of website content quality as measured by an evidence-based gold standard. This was a cross-sectional survey of depression websites using consumer and health professional raters. The main outcome measures were (1) site characteristics, (2) evidence-based quality of content as measured by evidence-based depression guidelines, (3) DISCERN scores, (4) Google PageRank, and (5) user satisfaction. There was a significant association between evidence-based quality ratings and average DISCERN ratings both for consumers (r = 0.62, P = .001) and health professionals (r = 0.80, P PageRank (r = 0.59, P = .002). However, the correlation between DISCERN scores and user satisfaction was higher than the correlation between Google PageRank and user satisfaction. DISCERN has potential as an indicator of content quality when used either by experts or by consumers. Google PageRank shows some promise as an automatic indicator of quality.

  9. Intrinsic stability of technical superconductors

    International Nuclear Information System (INIS)

    Veringa, H.J.

    1981-10-01

    For the operation of technical superconductors under high current density conditions, the superconducting wires composing high current cables should be intrinsically stabilized. In this report the various important stability criteria are derived and investigated on their validity. An experimental set up is made to check the occurrence of magnetic instabilities if the different applicable criteria are violated. It is found that the observed instabilities can be predicted on the basis of the model given in this report. Production of high current cables based upon composites made by the ECN technique seems to be possible. (Auth.)

  10. Revaluation of maturity and stability indices for compost ...

    African Journals Online (AJOL)

    BOD/COD ratio of compost was studied in conjunction with C/N ratio as commonly maturity index. Carbonaceous materials as well as nitrogenous materials declined in open-air conditions during 20 weeks. C/N ratio was correlated with BOD/COD, a couple parameters to qualify the compost was mature and stable.

  11. STABILITY-INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ...

    African Journals Online (AJOL)

    B. S. Chandravanshi

    pharmacopoeia, a careful and thorough literature review also showed absence of any reversed phase LC .... cetostearyl alcohol, petroleum jelly) of the ointment and human serum. Synthetic ... acid/base hydrolysis and oxidation. Acid-stress ...

  12. A Stability Indicating HPLC Method for the Determination of ...

    African Journals Online (AJOL)

    4–20μg/ml and the linear regression equation was y = 57257.38x + 3443.07. Accuracy ranged from 99.27 to 100.78% and the % coefficient of variation (CV) for both intra-day and inter-day precision was less than 2%. MLX showed minor degradation peak in acidic conditions at Rt of 2.24min. The LOD and LOQ values were ...

  13. Phytotoxicity as an indicator of stability of broiler production residues.

    Science.gov (United States)

    Mendes, P M; Becker, R; Corrêa, L B; Bianchi, I; Dai Prá, M A; Lucia, T; Corrêa, E K

    2016-02-01

    Beddings used for successive broiler lots act as substrate to absorb water and feed from the excreta and may be subsequently used as agricultural fertilizers. This study evaluated the physicochemical characteristics and the phytotoxicity of beddings used to raise five consecutive broiler lots in five aviaries. Samples were collected for beddings not used yet and for beddings used at each of the five broiler lots. Lettuce and cucumber seeds were considered as phytotoxicity bioindicators. As beddings were used for greater number of lots, N, Ca, K, Mg and P contents generally increased, but the C content decreased, the pH alkalinized and humidity was reduced (P lettuce and cucumber seeds was reduced with increased bedding (P seeds. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. Validation of 125I-hCG as a marker for elimination of hCG and stability of 125I-hCG after in vivo injection in humans

    OpenAIRE

    Christensen, T B; Marqversen, J; Engbaek, F; Berger, P; Bacher, T; Maase, H von der

    1999-01-01

    We have recently introduced 125I-hCG as an elimination marker in patients with human chorionic gonadotrophin (hCG) producing testicular cancer. 125I-hCG is a well-known reagent in clinical biochemistry and is used extensively in hCG assays. Previous studies have shown that the iodination process leaves the hCG molecule mainly intact. The iodination, purification and stability of 125I-hCG tracer are described. The aim of the present study was to determine whether or not 125I is associated with...

  15. Radiochemical stability of radiopharmaceutical preparations

    International Nuclear Information System (INIS)

    Martins, Patricia de A.; Silva, Jose L. da; Ramos, Marcelo P.S.; Oliveira, Ideli M. de; Felgueiras, Carlos F.; Herrerias, Rosana; Zapparoli Junior, Carlos L.; Mengatti, Jair; Fukumori, Neuza T.O.; Matsuda, Margareth M.N.

    2011-01-01

    The 'in vitro' stability studies of the radiopharmaceutical preparations are an essential requirement for routine practice in nuclear medicine and are an important parameter for evaluating the quality, safety and efficacy required for the sanitary registration of pharmaceutical products. Several countries have published guidelines for the evaluation of pharmaceutical stability. In Brazil, the stability studies should be conducted according to the Guide for Conducting Stability Studies published in the Resolution-RE n. 1, of 29th July 2005. There are also for radiopharmaceutical products, two specific resolutions: RDC-63 regulates the Good Manufacturing Practices for Radiopharmaceuticals and RDC-64 provides the Registration of Radiopharmaceuticals, both published on the 18th December 2009. The radiopharmaceutical stability is defined as the time during which the radioisotope can be safely used for the intended purpose. The radiochemical stability can be affected by a variety of factors, including storage temperature, amount of radioactivity, radioactive concentration, presence or absence of antioxidants or other stabilizing agents. The radiochemical stability studies must be established under controlled conditions determined by the effective use of the product. The aim of this work was to evaluate the radiochemical stability of labeled molecules with 131 I, 123 I, 153 Sm, 18 F, 51 Cr, 177 Lu and 111 In as well as 67 Ga and 201 Tl radiopharmaceuticals. Radiochemical purity was evaluated after production and in the validity period, with the maximum activity and in the recommended storage conditions. The analyses were carried out by thin-layer silica gel plate, paper chromatography and gel chromatography. The experimental results showed to be in accordance with the specified limits for all the analysed products. (author)

  16. Stability of rifampin in SyrSpend SF.

    Science.gov (United States)

    Sorenson, Bridget; Whaley, Paul

    2013-01-01

    Rifampin is a bactericidal antibiotic drug of the rifamycin group. It is a semisynthetic drug produced from the bacterium Streptomyces mediterranei. Rifampin is commonly manufactured in capsule, tablet, and syrup dosage solutions containing alcohol or sorbitol. The objective of this study was to determine the stability of rifampin in SyrSpend SF. The studied samples were compounded into 25-mg/mL suspensions and stored in low-actinic bottles at room temperature and refrigerated conditions. Samples were assayed at each time point out to 60 days by a stability-indicating high-performance liquid chromatography method. The method was validated for its specificity through forced-degradation studies. The sample remained within 90% to 110% of the initial concentration throughout the course of the study. Based on data collected, the beyond-use date of the preparation is at least 60 days when refrigerated or stored at room temperature and protected from light.

  17. Available transfer capability calculation considering voltage stability margin

    International Nuclear Information System (INIS)

    Pan, Xiong; Xu, Guoyu

    2005-01-01

    To make the electricity trades carry out successfully, the calculation of available transfer capability (ATC) must coordinate the relationship between the security and economic benefits. In this paper, a model for ATC calculations accorded with trade-off mechanism in electricity market was set up. The impact of branch outage contingency on the static voltage stability margin was analyzed, and contingency ranking was performed through sensitivity indices of branch flows with respect to the loading margin. Optimal power flow based on primal-dual interior point method was applied to obtain ATC when the N-1 security constraints were included. The calculation results of IEEE 30-bus and IEEE 118-bus systems show that the proposed model and method are valid. (author) (N-1 security constraints; Electricity market; Available transfer capability; Optimal power flow; Voltage stability)

  18. Stability of extemporaneously prepared preservative-free prochlorperazine nasal spray.

    Science.gov (United States)

    Yellepeddi, Venkata K

    2018-01-01

    The stability of an extemporaneously prepared preservative-free prochlorperazine 5-mg/mL nasal spray was evaluated. The preservative-free prochlorperazine nasal spray was prepared by adding 250 mg of prochlorperazine edisylate to 50 mL of citrate buffer in a low-density polyethylene nasal spray bottle. A stability-indicating high-performance liquid chromatography (HPLC) method was developed and validated using the major degradant prochlorperazine sulfoxide and by performing forced-degradation studies. For chemical stability studies, 3 100-μL samples of the preservative-free prochlorperazine from 5 nasal spray bottles stored at room temperature were collected at days 0, 20, 30, 45, and 60 and were assayed in triplicate using the stability-indicating HPLC method. Microbiological testing involved antimicrobial effectiveness testing based on United States Pharmacopeia ( USP ) chapter 51 and quantitative microbiological enumeration of aerobic bacteria, yeasts, and mold based on USP chapter 61. Samples for microbiological testing were collected at days 0, 30, and 60. The stability-indicating HPLC method clearly identified the degradation product prochlorperazine sulfoxide without interference from prochlorperazine. All tested solutions retained over 90% of the initial prochlorperazine concentration for the 60-day study period. There were no detectable changes in color, pH, and viscosity in any sample. There was no growth of bacteria, yeast, and mold for 60 days in all samples tested. An extemporaneously prepared preservative-free nasal spray solution of prochlorperazine edisylate 5 mg/mL was physically, chemically, and microbiologically stable for 60 days when stored at room temperature in low-density polyethylene bottles. Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  19. Validating Animal Models

    Directory of Open Access Journals (Sweden)

    Nina Atanasova

    2015-06-01

    Full Text Available In this paper, I respond to the challenge raised against contemporary experimental neurobiology according to which the field is in a state of crisis because of the multiple experimental protocols employed in different laboratories and strengthening their reliability that presumably preclude the validity of neurobiological knowledge. I provide an alternative account of experimentation in neurobiology which makes sense of its experimental practices. I argue that maintaining a multiplicity of experimental protocols and strengthening their reliability are well justified and they foster rather than preclude the validity of neurobiological knowledge. Thus, their presence indicates thriving rather than crisis of experimental neurobiology.

  20. BWR stability analysis: methodology of the stability analysis and results of PSI for the NEA/NCR benchmark task

    International Nuclear Information System (INIS)

    Hennig, D.; Nechvatal, L.

    1996-09-01

    The report describes the PSI stability analysis methodology and the validation of this methodology based on the international OECD/NEA BWR stability benchmark task. In the frame of this work, the stability properties of some operation points of the NPP Ringhals 1 have been analysed and compared with the experimental results. (author) figs., tabs., 45 refs

  1. Cross-Validation of Indicators of Cognitive Workload

    National Research Council Canada - National Science Library

    Marshall, Sandra P; Bartels, Mike

    2005-01-01

    .... The current study replicated the human performance findings of the previous phase of AMBR and added eye tracking analyses to enhance understanding of participants' behavior and to compare NASA TLX...

  2. Facultative Stabilization Pond: Measuring Biological Oxygen Demand using Mathematical Approaches

    Science.gov (United States)

    Wira S, Ihsan; Sunarsih, Sunarsih

    2018-02-01

    Pollution is a man-made phenomenon. Some pollutants which discharged directly to the environment could create serious pollution problems. Untreated wastewater will cause contamination and even pollution on the water body. Biological Oxygen Demand (BOD) is the amount of oxygen required for the oxidation by bacteria. The higher the BOD concentration, the greater the organic matter would be. The purpose of this study was to predict the value of BOD contained in wastewater. Mathematical modeling methods were chosen in this study to depict and predict the BOD values contained in facultative wastewater stabilization ponds. Measurements of sampling data were carried out to validate the model. The results of this study indicated that a mathematical approach can be applied to predict the BOD contained in the facultative wastewater stabilization ponds. The model was validated using Absolute Means Error with 10% tolerance limit, and AME for model was 7.38% (< 10%), so the model is valid. Furthermore, a mathematical approach can also be applied to illustrate and predict the contents of wastewater.

  3. Stability of minoxidil in Espumil foam base.

    Science.gov (United States)

    Geiger, Christine M; Sorenson, Bridget; Whaley, Paul A

    2013-01-01

    Minoxidil is a drug used to stimulate hair growth and to slow balding. It is marketed under a number of trade names, including Rogaine, and is available in varying strength dose forms from a number of generic manufacturers. Minoxidil is available in oral and topical forms. In topical form, it can be applied by a metered-spray or rub-on applicator. A hydroalcoholic compounding vehicle can minimize greasiness, itching, burning, and contact dermatitis where low concentrations of ethanol and propylene glycol are present. Espumil Foam Base contains low concentrations of these ingredients and also can form a foam on topical application. Espumil's unique delivery by foam-activating packaging assures simple application to difficult-to-treat areas, and it vanishes quickly after application, keeping it in place and avoiding health skin areas. The objective of this study was to determine the stability of minoxidil in Espumil Foam Base. The studied sample was compounded into a 50-mg/mL solution and stored in a plastic foam-activating bottle at room temperature conditions. Three samples were assayed at each time point out to 90 days by a stability-indicating high-performance liquid chromatography method. The method was validated for its specificity through forced-degradation studies. The beyond-use-date is at least 90 days, based on data collected when this formulation was stored at room temperature, protected from light.

  4. Stereotactic radiotherapy in pediatric indications

    International Nuclear Information System (INIS)

    Bernier-Chastagner, V.; Supiot, S.; Carrie, C.; Helfre, S.

    2012-01-01

    Stereotactic radiotherapy is a very high precision procedure, which has been limited to radiosurgery for a long time. Technological improvements allowed the development of radiotherapy in stereotactic conditions, leading to a lot of innovations. Previously indicated for cerebral pathologies, this procedure is now developed for extra-cerebral locations. In paediatrics, stereotactic radiotherapy is still limited, delivered precociously, due to the possibility of long-term late effects that needs to be addressed. This review reports the different useful conditions, technical evolutions, and the current validated paediatric indications, with differences from adults, and future directions. (authors)

  5. LC-mS analysis of human urine specimens for 2-oxo-3-hydroxy LSD: method validation for potential interferants and stability study of 2-oxo-3-hydroxy LSD under various storage conditions.

    Science.gov (United States)

    Klette, Kevin L; Horn, Carl K; Stout, Peter R; Anderson, Cynthia J

    2002-01-01

    2-Oxo-3-hydroxy lysergic acid diethylamide (O-H-LSD), a major LSD metabolite, has previously been demonstrated to be a superior marker for identifying LSD use compared with the parent drug, LSD. Specifically, O-H-LSD analyzed using liquid chromatography-mass spectrometry has been reported to be present in urine at concentrations 16 to 43 times greater than LSD. To further support forensic application of this procedure, the specificity of the assay was assessed using compounds that have structural and chemical properties similar to O-H-LSD, common over-the-counter products, prescription drugs and some of their metabolites, and other drugs of abuse. Of the wide range of compounds studied, none were found to interfere with the detection of O-H-LSD or the internal standard 2-oxo-3-hydroxy lysergic acid methyl propylamide. The stability of O-H-LSD was investigated from 0 to 9 days at various temperatures, pH conditions, and exposures to fluorescent light. Additionally, the effect of long-term frozen storage and pH was investigated from 0 to 60 days. There was no significant loss of O-H-LSD under both refrigerated and frozen conditions within the normal human physiological pH range of urine (4.6-8.4). However, significant loss of O-H-LSD was observed in samples prepared at pH 4.6-8.4 and stored at room temperature or higher (24-50 degrees C).

  6. Uranium mill tailings stabilization

    International Nuclear Information System (INIS)

    Hartley, J.N.; Koehmstedt, P.L.; Esterl, D.J.; Freeman, H.D.

    1980-02-01

    Uranium mill tailings pose a potential radiation health hazard to the public. Therefore, stabilization or disposal of these tailings in a safe and environmentally sound way is needed to minimize radon exhalation and other environmental hazards. One of the most promising concepts for stabilizing U tailings is the use of asphalt emulsion to contain radon and other hazardous materials within uranium tailings. This approach is being investigated at the Pacific Northwest Laboratory. Results of these studies indicate that a radon flux reduction of greater than 99% can be obtained using either a poured-on/sprayed-on seal (3.0 to 7.0 mm thick) or an admixture seal (2.5 to 12.7 cm thick) containing about 18 wt % residual asphalt. A field test was carried out in June 1979 at the Grand Junction tailings pile in order to demonstrate the sealing process. A reduction in radon flux ranging from 4.5 to greater than 99% (76% average) was achieved using a 15.2-cm (6-in.) admix seal with a sprayed-on top coat. A hydrostatic stabilizer was used to apply the admix. Following compaction, a spray coat seal was applied over the admix as the final step in construction of a radon seal. Overburden was applied to provide a protective soil layer over the seal. Included in part of the overburden was a herbicide to prevent root penetration

  7. NIKE: a new clinical tool for establishing levels of indications for cataract surgery.

    Science.gov (United States)

    Lundström, Mats; Albrecht, Susanne; Håkansson, Ingemar; Lorefors, Ragnhild; Ohlsson, Sven; Polland, Werner; Schmid, Andrea; Svensson, Göran; Wendel, Eva

    2006-08-01

    The purpose of this study was to construct a new clinical tool for establishing levels of indications for cataract surgery, and to validate this tool. Teams from nine eye clinics reached an agreement about the need to develop a clinical tool for setting levels of indications for cataract surgery and about the items that should be included in the tool. The tool was to be called 'NIKE' (Nationell Indikationsmodell för Kataraktextraktion). The Canadian Cataract Priority Criteria Tool served as a model for the NIKE tool, which was modified for Swedish conditions. Items included in the tool were visual acuity of both eyes, patients' perceived difficulties in day-to-day life, cataract symptoms, the ability to live independently, and medical/ophthalmic reasons for surgery. The tool was validated and tested in 343 cataract surgery patients. Validity, stability and reliability were tested and the outcome of surgery was studied in relation to the indication setting. Four indication groups (IGs) were suggested. The group with the greatest indications for surgery was named group 1 and that with the lowest, group 4. Validity was proved to be good. Surgery had the greatest impact on the group with the highest indications for surgery. Test-retest reliability test and interexaminer tests of indication settings showed statistically significant intraclass correlations (intraclass correlation coefficients [ICCs] 0.526 and 0.923, respectively). A new clinical tool for indication setting in cataract surgery is presented. This tool, the NIKE, takes into account both visual acuity and the patient's perceived problems in day-to-day life because of cataract. The tool seems to be stable and reliable and neutral towards different examiners.

  8. A uniform quantitative stiff stability estimate for BDF schemes

    Directory of Open Access Journals (Sweden)

    Winfried Auzinger

    2006-01-01

    Full Text Available The concepts of stability regions, \\(A\\- and \\(A(\\alpha\\-stability - albeit based on scalar models - turned out to be essential for the identification of implicit methods suitable for the integration of stiff ODEs. However, for multistep methods, knowledge of the stability region provides no information on the quantitative stability behavior of the scheme. In this paper we fill this gap for the important class of Backward Differentiation Formulas (BDF. Quantitative stability bounds are derived which are uniformly valid in the stability region of the method. Our analysis is based on a study of the separation of the characteristic roots and a special similarity decomposition of the associated companion matrix.

  9. Groundwater Model Validation

    Energy Technology Data Exchange (ETDEWEB)

    Ahmed E. Hassan

    2006-01-24

    Models have an inherent uncertainty. The difficulty in fully characterizing the subsurface environment makes uncertainty an integral component of groundwater flow and transport models, which dictates the need for continuous monitoring and improvement. Building and sustaining confidence in closure decisions and monitoring networks based on models of subsurface conditions require developing confidence in the models through an iterative process. The definition of model validation is postulated as a confidence building and long-term iterative process (Hassan, 2004a). Model validation should be viewed as a process not an end result. Following Hassan (2004b), an approach is proposed for the validation process of stochastic groundwater models. The approach is briefly summarized herein and detailed analyses of acceptance criteria for stochastic realizations and of using validation data to reduce input parameter uncertainty are presented and applied to two case studies. During the validation process for stochastic models, a question arises as to the sufficiency of the number of acceptable model realizations (in terms of conformity with validation data). Using a hierarchical approach to make this determination is proposed. This approach is based on computing five measures or metrics and following a decision tree to determine if a sufficient number of realizations attain satisfactory scores regarding how they represent the field data used for calibration (old) and used for validation (new). The first two of these measures are applied to hypothetical scenarios using the first case study and assuming field data consistent with the model or significantly different from the model results. In both cases it is shown how the two measures would lead to the appropriate decision about the model performance. Standard statistical tests are used to evaluate these measures with the results indicating they are appropriate measures for evaluating model realizations. The use of validation

  10. Euclidean distance and Kolmogorov-Smirnov analyses of multi-day auditory event-related potentials: a longitudinal stability study

    Science.gov (United States)

    Durato, M. V.; Albano, A. M.; Rapp, P. E.; Nawang, S. A.

    2015-06-01

    The validity of ERPs as indices of stable neurophysiological traits is partially dependent on their stability over time. Previous studies on ERP stability, however, have reported diverse stability estimates despite using the same component scoring methods. This present study explores a novel approach in investigating the longitudinal stability of average ERPs—that is, by treating the ERP waveform as a time series and then applying Euclidean Distance and Kolmogorov-Smirnov analyses to evaluate the similarity or dissimilarity between the ERP time series of different sessions or run pairs. Nonlinear dynamical analysis show that in the absence of a change in medical condition, the average ERPs of healthy human adults are highly longitudinally stable—as evaluated by both the Euclidean distance and the Kolmogorov-Smirnov test.

  11. Euclidean distance and Kolmogorov-Smirnov analyses of multi-day auditory event-related potentials: a longitudinal stability study

    International Nuclear Information System (INIS)

    Durato, M V; Nawang, S A; Albano, A M; Rapp, P E

    2015-01-01

    The validity of ERPs as indices of stable neurophysiological traits is partially dependent on their stability over time. Previous studies on ERP stability, however, have reported diverse stability estimates despite using the same component scoring methods. This present study explores a novel approach in investigating the longitudinal stability of average ERPs—that is, by treating the ERP waveform as a time series and then applying Euclidean Distance and Kolmogorov-Smirnov analyses to evaluate the similarity or dissimilarity between the ERP time series of different sessions or run pairs. Nonlinear dynamical analysis show that in the absence of a change in medical condition, the average ERPs of healthy human adults are highly longitudinally stable—as evaluated by both the Euclidean distance and the Kolmogorov-Smirnov test. (paper)

  12. Quantifying Stability in Complex Networks: From Linear to Basin Stability

    Science.gov (United States)

    Kurths, Jürgen

    The human brain, power grids, arrays of coupled lasers and the Amazon rainforest are all characterized by multistability. The likelihood that these systems will remain in the most desirable of their many stable states depends on their stability against significant perturbations, particularly in a state space populated by undesirable states. Here we claim that the traditional linearization-based approach to stability is in several cases too local to adequately assess how stable a state is. Instead, we quantify it in terms of basin stability, a new measure related to the volume of the basin of attraction. Basin stability is non-local, nonlinear and easily applicable, even to high-dimensional systems. It provides a long-sought-after explanation for the surprisingly regular topologies of neural networks and power grids, which have eluded theoretical description based solely on linear stability. Specifically, we employ a component-wise version of basin stability, a nonlinear inspection scheme, to investigate how a grid's degree of stability is influenced by certain patterns in the wiring topology. Various statistics from our ensemble simulations all support one main finding: The widespread and cheapest of all connection schemes, namely dead ends and dead trees, strongly diminish stability. For the Northern European power system we demonstrate that the inverse is also true: `Healing' dead ends by addition of transmission lines substantially enhances stability. This indicates a crucial smart-design principle for tomorrow's sustainable power grids: add just a few more lines to avoid dead ends. Further, we analyse the particular function of certain network motifs to promote the stability of the system. Here we uncover the impact of so-called detour motifs on the appearance of nodes with a poor stability score and discuss the implications for power grid design. Moreover, it will be shown that basin stability enables uncovering the mechanism for explosive synchronization and

  13. Decision making with environmental indices

    Science.gov (United States)

    Hoag, Dana L.; Ascough, James C.; Keske-Handley, C.; Koontz, Lynne; Burk, A.R.

    2005-01-01

    Since Ott's seminal book on environmental indices (1978), the use of indices has expanded into several natural resource disciplines, including ecological studies, environmental policymaking, and agricultural economics. However, despite their increasing use in natural resource disciplines, researchers and public decision makers continue to express concern about validity of these instruments to capture and communicate multidimensional, and sometimes disparate, characteristics of research data and stakeholder interests. Our purpose is to demonstrate how useful indices can be for communicating environmental information to decision makers. We discuss how environmental indices have evolved over four stages: 1) simple; 2) compound multicriteria; 3) the impact matrix and 4) disparate stakeholder management. We provide examples of simple and compound indices that were used by policy decision makers. We then build a framework, called an Impact Matrix (IM), that comprehensively accounts for multiple indices but lets the user decide how to integrate them. The IM was shaped from the concept of a financial risk payoff matrix and applied to ecosystem risk. While the IM offers flexibility, it does not address stakeholder preferences about which index to use. Therefore, the last phase in our evolutionary ladder includes stakeholder indices to specifically address disparate stakeholder preferences. Finally, we assert that an environmental index has the potential to increase resource efficiency, since the number of decision making resources may be reduced, and hence improve upon resource productivity

  14. Indicadores de avaliação do processamento de artigos odonto-médico-hospitalares: elaboração e validação Indicadores para la evaluación del reprocesamiento del productos medicos del hospital: construcción y validación Indicators for evaluation of processing dental-medical-hospital supplies: elaboration and validation

    Directory of Open Access Journals (Sweden)

    Kazuko Uchikawa Graziano

    2009-12-01

    realizar la validación de procesos de evaluación, independiente da existencia de criterios padrón-oro y/o a la relevancia de su repercusión en la práctica asistencial.Methodological study to elaborate and validate measures of evaluation in health contributing to an evaluation system of practices related to the control and prevention of hospital infection. It was elaborated eight dental-medical-hospital supply reprocessing conformity indicators. Indicators are described using items of the structure, process and outcomes that permitted the elaboration of conformity indicators related to the best practices (gold pattern. It was performed the content validity of the attributes of applicability and representativeness by a consensus expert judgment process using a psychometric scale. All the indicators showed to have content validity. Expert judgments, including comments and suggestions, evidenced the importance of perform validity of the evaluation processes, independently of the existence of golden pattern criteria and/or relevancies to the nursing practice.

  15. Stability analysis and stabilization strategies for linear supply chains

    Science.gov (United States)

    Nagatani, Takashi; Helbing, Dirk

    2004-04-01

    Due to delays in the adaptation of production or delivery rates, supply chains can be dynamically unstable with respect to perturbations in the consumption rate, which is known as “bull-whip effect”. Here, we study several conceivable production strategies to stabilize supply chains, which is expressed by different specifications of the management function controlling the production speed in dependence of the stock levels. In particular, we will investigate, whether the reaction to stock levels of other producers or suppliers has a stabilizing effect. We will also demonstrate that the anticipation of future stock levels can stabilize the supply system, given the forecast horizon τ is long enough. To show this, we derive linear stability conditions and carry out simulations for different control strategies. The results indicate that the linear stability analysis is a helpful tool for the judgement of the stabilization effect, although unexpected deviations can occur in the non-linear regime. There are also signs of phase transitions and chaotic behavior, but this remains to be investigated more thoroughly in the future.

  16. MATLAB Stability and Control Toolbox Trim and Static Stability Module

    Science.gov (United States)

    Kenny, Sean P.; Crespo, Luis

    2012-01-01

    MATLAB Stability and Control Toolbox (MASCOT) utilizes geometric, aerodynamic, and inertial inputs to calculate air vehicle stability in a variety of critical flight conditions. The code is based on fundamental, non-linear equations of motion and is able to translate results into a qualitative, graphical scale useful to the non-expert. MASCOT was created to provide the conceptual aircraft designer accurate predictions of air vehicle stability and control characteristics. The code takes as input mass property data in the form of an inertia tensor, aerodynamic loading data, and propulsion (i.e. thrust) loading data. Using fundamental nonlinear equations of motion, MASCOT then calculates vehicle trim and static stability data for the desired flight condition(s). Available flight conditions include six horizontal and six landing rotation conditions with varying options for engine out, crosswind, and sideslip, plus three take-off rotation conditions. Results are displayed through a unique graphical interface developed to provide the non-stability and control expert conceptual design engineer a qualitative scale indicating whether the vehicle has acceptable, marginal, or unacceptable static stability characteristics. If desired, the user can also examine the detailed, quantitative results.

  17. Study on Roll Instability Mechanism and Stability Index of Articulated Steering Vehicles

    Directory of Open Access Journals (Sweden)

    Xuefei Li

    2016-01-01

    Full Text Available This study examines the roll instability mechanism and stability index of articulated steering vehicles (ASVs by taking wheel loaders as the research object. A seven-degree-of-freedom nonlinear dynamics model of the ASVs is built on the basis of multibody dynamics. A physical prototype model of an ASV is designed and manufactured to validate the dynamic model. Test results reasonably agree with the simulation results, which indicates that the established dynamic model can reasonably describe ASV movements. Detailed analysis of the rollover stability of the wheel loader is performed with the use of the established dynamic model. Analysis results show that rollover will occur when the roll angular velocity exceeds a critical threshold, which is affected by lateral acceleration and slope angle. On this basis, a dynamic stability index applicable to the ASVs is presented.

  18. Stability and non-standard finite difference method of the generalized Chua's circuit

    KAUST Repository

    Radwan, Ahmed G.

    2011-08-01

    In this paper, we develop a framework to obtain approximate numerical solutions of the fractional-order Chua\\'s circuit with Memristor using a non-standard finite difference method. Chaotic response is obtained with fractional-order elements as well as integer-order elements. Stability analysis and the condition of oscillation for the integer-order system are discussed. In addition, the stability analyses for different fractional-order cases are investigated showing a great sensitivity to small order changes indicating the poles\\' locations inside the physical s-plane. The GrnwaldLetnikov method is used to approximate the fractional derivatives. Numerical results are presented graphically and reveal that the non-standard finite difference scheme is an effective and convenient method to solve fractional-order chaotic systems, and to validate their stability. © 2011 Elsevier Ltd. All rights reserved.

  19. Wavelet Filtering to Reduce Conservatism in Aeroservoelastic Robust Stability Margins

    Science.gov (United States)

    Brenner, Marty; Lind, Rick

    1998-01-01

    Wavelet analysis for filtering and system identification was used to improve the estimation of aeroservoelastic stability margins. The conservatism of the robust stability margins was reduced with parametric and nonparametric time-frequency analysis of flight data in the model validation process. Nonparametric wavelet processing of data was used to reduce the effects of external desirableness and unmodeled dynamics. Parametric estimates of modal stability were also extracted using the wavelet transform. Computation of robust stability margins for stability boundary prediction depends on uncertainty descriptions derived from the data for model validation. F-18 high Alpha Research Vehicle aeroservoelastic flight test data demonstrated improved robust stability prediction by extension of the stability boundary beyond the flight regime.

  20. Boundary layer stability on a yawed spinning body of revolution and its effect on the magnus force and moment

    Science.gov (United States)

    Jacobson, I. D.; Morton, J. B.

    1972-01-01

    The parameters are established which are important to the stability of a boundary layer flow over a yawed spinning cylinder in a uniform stream. It is shown that transition occurs asymmetrically in general and this asymmetry can be important for the prediction of aerodynamic forces and moments (e.g., the Magnus effect). Instability of the steady-state boundary layer flow is determined using small disturbance theory. Although the approach is strictly valid only for the calculation of the conditions for stability in the small, experimental data indicate that in many problems, it provides a good estimate for the transition to turbulence.

  1. Stability analysis of free piston Stirling engines

    Science.gov (United States)

    Bégot, Sylvie; Layes, Guillaume; Lanzetta, François; Nika, Philippe

    2013-03-01

    This paper presents a stability analysis of a free piston Stirling engine. The model and the detailed calculation of pressures losses are exposed. Stability of the machine is studied by the observation of the eigenvalues of the model matrix. Model validation based on the comparison with NASA experimental results is described. The influence of operational and construction parameters on performance and stability issues is exposed. The results show that most parameters that are beneficial for machine power seem to induce irregular mechanical characteristics with load, suggesting that self-sustained oscillations could be difficult to maintain and control.

  2. Plutonium inventories for stabilization and stabilized materials

    Energy Technology Data Exchange (ETDEWEB)

    Williams, A.K.

    1996-05-01

    The objective of the breakout session was to identify characteristics of materials containing plutonium, the need to stabilize these materials for storage, and plans to accomplish the stabilization activities. All current stabilization activities are driven by the Defense Nuclear Facilities Safety Board Recommendation 94-1 (May 26, 1994) and by the recently completed Plutonium ES&H Vulnerability Assessment (DOE-EH-0415). The Implementation Plan for accomplishing stabilization of plutonium-bearing residues in response to the Recommendation and the Assessment was published by DOE on February 28, 1995. This Implementation Plan (IP) commits to stabilizing problem materials within 3 years, and stabilizing all other materials within 8 years. The IP identifies approximately 20 metric tons of plutonium requiring stabilization and/or repackaging. A further breakdown shows this material to consist of 8.5 metric tons of plutonium metal and alloys, 5.5 metric tons of plutonium as oxide, and 6 metric tons of plutonium as residues. Stabilization of the metal and oxide categories containing greater than 50 weight percent plutonium is covered by DOE Standard {open_quotes}Criteria for Safe Storage of Plutonium Metals and Oxides{close_quotes} December, 1994 (DOE-STD-3013-94). This standard establishes criteria for safe storage of stabilized plutonium metals and oxides for up to 50 years. Each of the DOE sites and contractors with large plutonium inventories has either started or is preparing to start stabilization activities to meet these criteria.

  3. Trapped particle stability for the kinetic stabilizer

    Science.gov (United States)

    Berk, H. L.; Pratt, J.

    2011-08-01

    A kinetically stabilized axially symmetric tandem mirror (KSTM) uses the momentum flux of low-energy, unconfined particles that sample only the outer end-regions of the mirror plugs, where large favourable field-line curvature exists. The window of operation is determined for achieving magnetohydrodynamic (MHD) stability with tolerable energy drain from the kinetic stabilizer. Then MHD stable systems are analysed for stability of the trapped particle mode. This mode is characterized by the detachment of the central-cell plasma from the kinetic-stabilizer region without inducing field-line bending. Stability of the trapped particle mode is sensitive to the electron connection between the stabilizer and the end plug. It is found that the stability condition for the trapped particle mode is more constraining than the stability condition for the MHD mode, and it is challenging to satisfy the required power constraint. Furthermore, a severe power drain may arise from the necessary connection of low-energy electrons in the kinetic stabilizer to the central region.

  4. Geomagnetic Indices Bulletin (GIB)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The Geomagnetic Indices Bulletin is a one page sheet containing the magnetic indices Kp, Ap, Cp, An, As, Am and the provisional aa indices. The bulletin is published...

  5. PATRIMONIAL ANALYSIS OF FINANCIAL STABILITY

    Directory of Open Access Journals (Sweden)

    GABRIELA CORINA SLUSARIUC

    2011-01-01

    Full Text Available Patrimonial analysis of financial stability is realized with the help of some indicator determined on the balance: working capital; required working capital and net treasury. These indicators are determined and presented in evolution at two companies with different situations, and there are given conclusions and suggestions concerning achieving and maintaining the financial equilibrium or initiating corrective measures in time, before the imbalance would take irrecoverable forms.

  6. Parabolized stability equations

    Science.gov (United States)

    Herbert, Thorwald

    1994-01-01

    The parabolized stability equations (PSE) are a new approach to analyze the streamwise evolution of single or interacting Fourier modes in weakly nonparallel flows such as boundary layers. The concept rests on the decomposition of every mode into a slowly varying amplitude function and a wave function with slowly varying wave number. The neglect of the small second derivatives of the slowly varying functions with respect to the streamwise variable leads to an initial boundary-value problem that can be solved by numerical marching procedures. The PSE approach is valid in convectively unstable flows. The equations for a single mode are closely related to those of the traditional eigenvalue problems for linear stability analysis. However, the PSE approach does not exploit the homogeneity of the problem and, therefore, can be utilized to analyze forced modes and the nonlinear growth and interaction of an initial disturbance field. In contrast to the traditional patching of local solutions, the PSE provide the spatial evolution of modes with proper account for their history. The PSE approach allows studies of secondary instabilities without the constraints of the Floquet analysis and reproduces the established experimental, theoretical, and computational benchmark results on transition up to the breakdown stage. The method matches or exceeds the demonstrated capabilities of current spatial Navier-Stokes solvers at a small fraction of their computational cost. Recent applications include studies on localized or distributed receptivity and prediction of transition in model environments for realistic engineering problems. This report describes the basis, intricacies, and some applications of the PSE methodology.

  7. Audit Validation Using Ontologies

    Directory of Open Access Journals (Sweden)

    Ion IVAN

    2015-01-01

    Full Text Available Requirements to increase quality audit processes in enterprises are defined. It substantiates the need for assessment and management audit processes using ontologies. Sets of rules, ways to assess the consistency of rules and behavior within the organization are defined. Using ontologies are obtained qualifications that assess the organization's audit. Elaboration of the audit reports is a perfect algorithm-based activity characterized by generality, determinism, reproducibility, accuracy and a well-established. The auditors obtain effective levels. Through ontologies obtain the audit calculated level. Because the audit report is qualitative structure of information and knowledge it is very hard to analyze and interpret by different groups of users (shareholders, managers or stakeholders. Developing ontology for audit reports validation will be a useful instrument for both auditors and report users. In this paper we propose an instrument for validation of audit reports contain a lot of keywords that calculates indicators, a lot of indicators for each key word there is an indicator, qualitative levels; interpreter who builds a table of indicators, levels of actual and calculated levels.

  8. Study of the Rancimat test method in measuring the oxidation stability of biodiesel ester and blends

    Energy Technology Data Exchange (ETDEWEB)

    Berthiaume, D.; Tremblay, A. [Oleotek Inc., Thetford Mines, PQ (Canada)

    2006-11-15

    This paper provided details of a study conducted to examine the oxidation stability of biodiesel blends. The study tested samples of canola oil, soybean oil, fish oil, yellow grease, and tallow. The EN 14112 (Rancimat) method was used to compare oxidation stability results obtained in previous tests conducted in the United States and Europe. The aim of the study was also to evaluate the influence of peroxide value (PV), acid value (AV) and feedstock source on the the oxidative stability of different samples. The study also evaluated the possibility of developing a validated test method developed from the EN 14112 methods to specifically consider biodiesel blends. Results of the study indicated that the Rancimat method was not suitable for measuring the oxidation stability of biodiesels blended with petrodiesels. No direct correlation between oxidative stability and PV or AV was observed. It was concluded that fatty acid distribution was not a principal factor in causing changes in oxidation stability. 22 refs., 3 tabs., 1 fig.

  9. Life Span Personality Stability in Sibling Statuses.

    Science.gov (United States)

    Rosenberg, B. G.

    Personality stability and change in sibling status in the one- and two-child-family are examined in this Study. Q-sort data were analyzed for the same 33 male and 34 female subjects during four periods of their lives-- early and late adolescence and early and middle adulthood. Results indicate that stability of personality was greatest during…

  10. Liquidity and Stability of Agriculture in the Czech Republic

    Directory of Open Access Journals (Sweden)

    Lánský J.

    2017-09-01

    Full Text Available This article is based on empirical research and 2007–2012 statistical data from joint stock companies which were active in the agriculture sector of the Czech Republic. It deals with the wider aspects of liquidity and stability using suitable liquidity indicators and a vertical financial analysis over a sufficient period of time providing valid results for assessing liquidity and stability of agriculture in relation to cyclic fluctuations. The vertical financial analysis was performed to determine the liquidity structure at current assets and short term debts. Then convenient indicators of current ratio, quick ratio, and cash ratio were applied and interpreted in relation to cyclical deviations and agriculture specifics. From the viewpoint of liquidity measured using the current ratio, agriculture in the Czech Republic is stable and the current ratio values bear witness to solid liquidity, whereby the short-term assets exceed the short-term external funds. Research is to show whether the agriculture sector is liquid and whether the liquidity indicators provide the basis for solvency in the given field.

  11. Reliability and validity in a nutshell.

    Science.gov (United States)

    Bannigan, Katrina; Watson, Roger

    2009-12-01

    To explore and explain the different concepts of reliability and validity as they are related to measurement instruments in social science and health care. There are different concepts contained in the terms reliability and validity and these are often explained poorly and there is often confusion between them. To develop some clarity about reliability and validity a conceptual framework was built based on the existing literature. The concepts of reliability, validity and utility are explored and explained. Reliability contains the concepts of internal consistency and stability and equivalence. Validity contains the concepts of content, face, criterion, concurrent, predictive, construct, convergent (and divergent), factorial and discriminant. In addition, for clinical practice and research, it is essential to establish the utility of a measurement instrument. To use measurement instruments appropriately in clinical practice, the extent to which they are reliable, valid and usable must be established.

  12. Test Room Stability Plan

    International Nuclear Information System (INIS)

    1993-01-01

    This plan documents the combination of designs, installations, programs, and activities that ensures that the underground excavations at the Waste Isolation Pilot Plant (WIPP), in which transuranic (TRU) waste may be emplaced during the Test Phase, will remain sufficiently stable and safe during that time. The current ground support systems installed at the WIPP are the result of over ten years of data collection from hundreds of geomechanical instruments and thousands of hours of direct observation of the changing conditions of the openings. In addition, some of the world's most respected experts on salt rock mechanics have provided input in the design process and concurrence on the suitability of the final design. The general mine rockbolt pattern and the ground support system for the test rooms are designed to specifically address the fracture and deformation geometries observed today at the WIPP. After an introductory chapter, this plan describes the general underground design, then proceeds to an account of general ground support performance, and finally focuses on the details of the special test room ground support systems. One such system already installed in Room 1, Panel 1, is described in comprehensive detail. Other test rooms in Panel 1, whether full-size or smaller, will be equipped with systems that ensure stability to the same or equivalent extent. They will benefit from the experience gained in the first test room, which in turn benefitted from the data and knowledge accumulated during previous stages (e.g., the Site and Preliminary Design Validation program) of the project

  13. VAlidation STandard antennas: Past, present and future

    DEFF Research Database (Denmark)

    Drioli, Luca Salghetti; Ostergaard, A; Paquay, M

    2011-01-01

    designed for validation campaigns of antenna measurement ranges. The driving requirements of VAST antennas are their mechanical stability over a given operational temperature range and with respect to any orientation of the gravity field. The mechanical design shall ensure extremely stable electrical....../V-band of telecom satellites. The paper will address requirements for future VASTs and possible architecture for multi-frequency Validation Standard antennas....

  14. Stability in designer gravity

    International Nuclear Information System (INIS)

    Hertog, Thomas; Hollands, Stefan

    2005-01-01

    We study the stability of designer gravity theories, in which one considers gravity coupled to a tachyonic scalar with anti-de Sitter (AdS) boundary conditions defined by a smooth function W. We construct Hamiltonian generators of the asymptotic symmetries using the covariant phase space method of Wald et al and find that they differ from the spinor charges except when W = 0. The positivity of the spinor charge is used to establish a lower bound on the conserved energy of any solution that satisfies boundary conditions for which W has a global minimum. A large class of designer gravity theories therefore have a stable ground state, which the AdS/CFT correspondence indicates should be the lowest energy soliton. We make progress towards proving this by showing that minimum energy solutions are static. The generalization of our results to designer gravity theories in higher dimensions involving several tachyonic scalars is discussed

  15. An Investigation of Agility Issues in Scrum Teams Using Agility Indicators

    Science.gov (United States)

    Pikkarainen, Minna; Wang, Xiaofeng

    Agile software development methods have emerged and become increasingly popular in recent years; yet the issues encountered by software development teams that strive to achieve agility using agile methods are yet to be explored systematically. Built upon a previous study that has established a set of indicators of agility, this study investigates what issues are manifested in software development teams using agile methods. It is focussed on Scrum teams particularly. In other words, the goal of the chapter is to evaluate Scrum teams using agility indicators and therefore to further validate previously presented agility indicators within the additional cases. A multiple case study research method is employed. The findings of the study reveal that the teams using Scrum do not necessarily achieve agility in terms of team autonomy, sharing, stability and embraced uncertainty. The possible reasons include previous organizational plan-driven culture, resistance towards the Scrum roles and changing resources.

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