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Sample records for bioequivalence study comparing

  1. [Bioequivalence studies of pharmaceutical preparations].

    Science.gov (United States)

    Vetchý, D; Frýbortová, K; Rabisková, M; Danecková, H

    2007-01-01

    Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs. The target of such study is to evaluate the therapeutic compatibility of tested drugs (pharmaceutical equivalents or pharmaceutical alternatives). The importance of bioequivalence studies is increasing also due to the large growth of the production and consumption of generic products. Generic products represent approximately 50 % of the whole consumption in many European countries and USA. The search output of bioequivalence study is together with the pharmaceutical quality data of medical product one of the main part of the registration file submitted to a national regulatory authorities. The registration of generic products does not demand complicated and expensive clinical study contrary to original product. The comparison of the original and the generic product via bioequivalence study is suggested as sufficient. The aim of this article is to provide to a medical public a summary about the types of bioequivalence studies, their range, rules of their practise and let them gain their own attitude to this question.

  2. A comparative analysis of biopharmaceutics classification system and biopharmaceutics drug disposition classification system: a cross-sectional survey with 500 bioequivalence studies.

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    Cristofoletti, Rodrigo; Chiann, Chang; Dressman, Jennifer B; Storpirtis, Silvia

    2013-09-01

    Although policies of waiving bioequivalence studies are part of the legal framework of various regulatory agencies, there is no harmonization with regard to extension of the biowaiver to drugs other than those with high solubility and high permeability, nor is there any consensus or official endorsement of the biopharmaceutics drug disposition classification system (BDDCS). To better understand the applicability of the biowaiver, we carried out a cross-sectional survey to estimate the relative risk of obtaining nonbioequivalent (non-BE) or bioinequivalent (BIE) results for drug products containing drugs belonging to each of the biopharmaceutics classification system (BCS) and BDDCS classes. Five hundred bioequivalence studies were randomly sampled from a database of the Brazilian Health Surveillance Agency (ANVISA). The drugs were classified according to the BCS and BDDCS, to evaluate how characteristics related to drug and dosage form influence the outcome of bioequivalence studies. The relative risk of obtaining a non-BE result was approximately four times lower for drugs in classes 1 and 3 of BCS or BDDCS when compared with class 2 drugs. Thus, it seems that the final outcome of a bioequivalence study is strongly influenced by the solubility of the drug, but not by its intestinal permeability or extent of metabolism. Copyright © 2013 Wiley Periodicals, Inc.

  3. Comparative bioequivalence assessment of aspirin tablets marketed ...

    African Journals Online (AJOL)

    Purpose: In the last few years, aspirin has become a life saver against cardiovascular accidents. This investigation was carried out to determine possible bioequivalence between regular aspirin and soluble aspirin tablets marketed in Nigeria. Methods: The in vivo bioavailability profiles of three commercial brands of aspirin ...

  4. Comparative assessment of saliva and plasma for drug bioavailability and bioequivalence studies in humans

    Directory of Open Access Journals (Sweden)

    Nasir M. Idkaidek

    2017-07-01

    Conclusion: Our results suggest that there is a potential in BA/BE studies for saliva to be considered as a surrogate for plasma concentration, which goes along with drug regulations. The use of saliva instead of plasma in such studies makes them non-invasive, easy and with a lower clinical burden.

  5. Organizational aspects of conducting of bioequivalence study

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    Khokhlov A.L.

    2014-03-01

    Full Text Available Aim: to evaluate the organizational aspects of conducting bioequivalence study in Russia on the example of one of the clinical centers, Yaroslavl. Material and methods. On the basis of the Municipal Autonomous institution of health care of the Yaroslavl region Clinical hospital №2 (CH, clinical base of the Department of clinical pharmacology of YSMA was held 93 bioequivalence studies and pharmacokinetics in the period from 2011 to 2014, of which 15 studies of foreign sponsors and 78 of domestic producers. Result.: The studies involved 48 volunteers of both sexes from the database of clinical center CH №2. There were 698 females (48.6% and 739 males (51.4%. The average age of the volunteers was 26,37 years. In each study there were from 18 to 103 volunteers, depending on the design of the research Protocol. At the same time Russian studies ranged about 18-24 volunteers, about 30-103 volunteers abroad. The number of doubles in domestic studies ranged from 2 to 6 persons, and foreign — from 6 to 12 people. 10-15% from the whole number of subjects were not included into the study. Conclusion. In Russia bioequivalence of medicines for more than ten years is the main requirement of medico-biological control generic drugs. Regardless of the manufacturer to the generic drugs are exactly the same as the original drugs, must meet the following requirements: quality efficiency and safety. In connection with the increase in recent years of bioequivalence studies of medicines, require close monitoring of the quality of these studies on the territory of the Russian Federation.

  6. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Science.gov (United States)

    2013-12-05

    ...] Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted... guidance for industry entitled ``Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted... draft guidance for industry entitled ``Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

  7. Bioequivalence study of a new sildenafil 100 mg orodispersible film compared to the conventional film-coated 100 mg tablet administered to healthy male volunteers

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    Radicioni M

    2017-04-01

    Full Text Available Milko Radicioni,1 Chiara Castiglioni,1 Andrea Giori,2 Irma Cupone,3 Valeria Frangione,4 Stefano Rovati4 1CROSS Research S.A., Phase I Unit, Arzo, Switzerland; 2IBSA Farmaceutici Italia, Lodi, Italy; 3Bouty S.p.A., Strada Padana Superiore, Cassina De’ Pecchi, Italy; 4IBSA Institut Biochimique S.A., Pambio-Noranco, Switzerland Abstract: A new orodispersible film formulation of the phosphodiesterase type 5 inhibitor, sildenafil, has been developed to examine the advantages of an orally disintegrating film formulation and provide an alternative to the current marketed products for the treatment of erectile dysfunction. The pharmacokinetics of the sildenafil 100 mg orodispersible film (IBSA was compared to that of the conventional marketed 100 mg film-coated tablet (Viagra® after single-dose administration to 53 healthy male volunteers (aged 18–51 years in a randomized, open, two-way crossover bioequivalence study. Each subject received a single oral dose of 100 mg of sildenafil as test or reference formulation administered under fasting conditions at each of the two study periods according to a randomized crossover design. There was a washout interval of ≥7 days between the two administrations of the investigational medicinal products. Blood samples for pharmacokinetic analysis were collected up to 24 h post-dosing. The primary objective was to compare the rate (peak plasma concentration; Cmax and extent (area under the curve [AUC] from administration to last observed concentration time; AUC0–t of sildenafil absorption after single-dose administration of test and reference. Secondary endpoints were observed to describe the plasma pharmacokinetic profiles of sildenafil and its metabolite N-desmethyl-sildenafil relative bioavailability and safety profile after single-dose administration. The mean sildenafil and N-desmethyl-sildenafil plasma concentration–time profiles up to 24 h after single-dose administration of sildenafil 100 mg

  8. Bioequivalence study of a new sildenafil 100 mg orodispersible film compared to the conventional film-coated 100 mg tablet administered to healthy male volunteers

    Science.gov (United States)

    Radicioni, Milko; Castiglioni, Chiara; Giori, Andrea; Cupone, Irma; Frangione, Valeria; Rovati, Stefano

    2017-01-01

    A new orodispersible film formulation of the phosphodiesterase type 5 inhibitor, sildenafil, has been developed to examine the advantages of an orally disintegrating film formulation and provide an alternative to the current marketed products for the treatment of erectile dysfunction. The pharmacokinetics of the sildenafil 100 mg orodispersible film (IBSA) was compared to that of the conventional marketed 100 mg film-coated tablet (Viagra®) after single-dose administration to 53 healthy male volunteers (aged 18–51 years) in a randomized, open, two-way crossover bioequivalence study. Each subject received a single oral dose of 100 mg of sildenafil as test or reference formulation administered under fasting conditions at each of the two study periods according to a randomized crossover design. There was a washout interval of ≥7 days between the two administrations of the investigational medicinal products. Blood samples for pharmacokinetic analysis were collected up to 24 h post-dosing. The primary objective was to compare the rate (peak plasma concentration; Cmax) and extent (area under the curve [AUC] from administration to last observed concentration time; AUC0–t) of sildenafil absorption after single-dose administration of test and reference. Secondary endpoints were observed to describe the plasma pharmacokinetic profiles of sildenafil and its metabolite N-desmethyl-sildenafil relative bioavailability and safety profile after single-dose administration. The mean sildenafil and N-desmethyl-sildenafil plasma concentration–time profiles up to 24 h after single-dose administration of sildenafil 100 mg orodispersible film and film-coated tablet were nearly superimposable. The bioequivalence test was fully satisfied for sildenafil and N-desmethyl-sildenafil in terms of rate and extent of bioavailability. Adverse events occurred at similar rates for the two formulations and were of mild-to-moderate severity. The results suggest that the new orodispersible film

  9. The importance of bioequivalence study: focus on clopidogrel

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    Arini Setiawati

    2011-05-01

    Full Text Available Bioequivalence (BE study is required to show whether a generic copy product can be interchangeable with the brand innovator product. The aim of this article is to provide the rationale for conducting BE studies, the main products requiring BE studies, the design and conduct of BE studies in general, with focus on clopidogrel. All of the clopidogrel generic products in Indonesia have been shown to be BE to the innovator product Plavix® and they contain API (active pharmaceutical ingredient clopidogrel form 1 that complies with USP 30, 1997 requirements: the R-enantiomer content is not more than 1%. A proof that bioequivalence (BE means therapeutic equivalence (TE is also provided for cardiovascular drugs. Clopidogrel has 2 polymorphic forms, form 1 and form 2, which have the same indications. At least one pivotal study of clopidogrel, CAPRIE, used clopidogrel form 1. An atherothrombotic event may be associated with clopidogrel resistance, which occur in about 4 to 30% of patients treated with conventional doses of clopidogrel. (Med J Indones 2011; 20:149-53Keywords: bioequivalent, clopidogrel

  10. A limited sampling approach in bioequivalence studies: application to long half-life drugs and replicate design studies.

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    Mahmood, I; Mahayni, H

    1999-06-01

    The objectives of this study was to develop a limited sampling model (LSM) to predict the area under the curve (AUC) and the maximum plasma concentration (Cmax) for the assessment of bioequivalence studies. Two drugs (A and B) were selected for this purpose. Drug A was chosen to test bioequivalence of two formulations with a long half-life (> 35 hours), whereas drug B was chosen to test the bioequivalence of two formulations (half-life = 12 hrs) with a replicate design study. The LSM for both drugs was developed using 5 blood samples each from 15 healthy subjects. The relationship between plasma concentration (independent variable) at selected time points with the AUC or Cmax (dependent variable) was evaluated by multiple linear regression analysis. The multiple linear regression which gave the best correlation coefficient (r) for 5 sampling time vs AUC or Cmax was chosen as the LSM. The predicted AUC and Cmax from the LSM were then used to assess bioequivalence of two different formulations of each drug following a single oral dose. The model provided good estimates of both AUC and Cmax for both drugs. The 90% confidence intervals on log-transformed observed and predicted AUC and Cmax were comparable for both drugs. The method described here may be used to estimate AUC and Cmax for bioequivalence studies for drugs with long half-lives or for highly variable drugs which may require replicate design studies without detailed blood sampling.

  11. Bioequivalence study of two formulations of candesartan cilexetil tablet in healthy subjects under fasting conditions

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    Tjandrawinata RR

    2013-08-01

    Full Text Available Raymond R Tjandrawinata,1 Effi Setiawati,2 Danang Agung Yunaidi,2 Ronal Simanjuntak,2 Iwan Dwi Santoso,2 Liana W Susanto1 1Dexa Laboratories of Biomolecular Sciences (DLBS, Cikarang, Indonesia; 2Bioavailability and Bioequivalence Laboratory, PT Equilab International, Jakarta, Indonesia Introduction: The present study was conducted to compare the bioavailability of two candesartan cilexetil 16 mg tablet formulations (test and reference formulations. Materials and methods: This study was a randomized, single- blind, two-period, cross-over study which included 24 healthy adult male and female subjects under fasting conditions. The pharmacokinetic parameters were determined based on the concentrations of candesartan (CAS 139481-59-7, using ultra-pressure high-performance liquid chromatography with a tandem mass spectrometer detector. In each of the two study periods (separated by a washout period of 1 week, a single dose of test or reference product was administered. The pharmacokinetic parameters assessed were area under the plasma concentration time curve (AUC from time 0 hours to 24 hours, AUC from time zero to infinity, the peak plasma concentration of the drug (Cmax, time to achieve the Cmax, and the elimination half-life. Results: The geometric mean ratios (90% confidence interval of the test drug/reference drug for candesartan were 100.92% (92.15%–110.52% for the AUC from 0 hours to 24 hours, 100.24% (92.24%–108.95% for the AUC from time zero to infinity, and 106.71% (93.20%–122.18% for the Cmax. The differences between the test and reference product in the time to achieve Cmax values and elimination half-life values were not statistically significant (P > 0.05. The 90% confidence intervals of the test/reference AUC ratio and Cmax ratio of candesartan were within the acceptance range for bioequivalence. There was no adverse event encountered during this bioequivalence study. Conclusion: It was concluded that the two candesartan tablet

  12. Pharmacokinetic bioequivalence studies of a fixed-dose combination of tamsulosin and dutasteride in healthy volunteers.

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    Fossler, Michael J; Collins, David A; Thompson, Meg M; Nino, Antonio; Bianco, Joseph J; Chetty, Dushen

    2014-05-01

    The combination of dutasteride and tamsulosin may be more effective for the treatment of symptomatic benign prostatic hyperplasia than either treatment alone. We report the results of three pharmacokinetics and tolerability studies, which used a dutasteride/tamsulosin HCl (0.5 mg/0.2 mg) fixed-dose combination (FDC) capsules containing a small dutasteride soft gelatin capsule (smaller than commercial Avodart™) and modified-release tamsulosin pellets that have different amounts of enteric coating. These studies compared the test products to commercial Avodart™ (dutasteride 0.5 mg) and two different commercial tamsulosin HCl 0.2 mg products, Harnal™ Capsules or Harnal-D™ Tablets, which are reportedly bioequivalent to each other. All three studies were randomized single-dose studies in healthy male adults. Study 1 [N = 86 (NCT01254071)] was a two-period crossover study of a dutasteride/tamsulosin HCl FDC versus coadministered Avodart™ and Harnal-D™ Tablets. The pharmacokinetics of both dutasteride and tamsulosin were studied. Study 2 [N = 27 (NCT01471678)] was a four-period crossover study of dutasteride/tamsulosin HCl FDC formulations versus Avodart™ and Harnal™ Capsules or Harnal-D™ Tablets. Only the pharmacokinetics of tamsulosin were studied. Study 3 [N = 40 (NCT01495026)] was a two-period study of dutasteride/tamsulosin HCl FDC formulations versus coadministered Avodart™ and Harnal-D™ Tablets. In this study, only the pharmacokinetics of tamsulosin were studied. Study 2 assessed fed-state pharmacokinetics. Studies 1 and 3 assessed fed- and fasted-state pharmacokinetics. All dutasteride/tamsulosin HCl FDC formulations and coadministered treatments were well-tolerated. In Study 1, the FDC dutasteride was bioequivalent to Avodart™ coadministered with tamsulosin under fed and fasted conditions. In Study 1, the FDC tamsulosin had a slower release than commercial Harnal-D™ Tablets coadministered with dutasteride (fed and fasted

  13. Bioequivalence assessment of Lovrak (Julphar, UAE) compared with Zovirax (Glaxo Wellcome, UK)--Two brands of Acyclovir--in healthy human volunteers.

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    Najib, Naji M; Idkaidek, Nasir; Beshtawi, Muntaser; Mohammed, B; Admour, Isra'; Alam, S Mahmood; Dham, Ruwayda

    2005-01-01

    Two studies were performed to assess the relative bioavailability of Lovrak (Julphar, UAE) compared with Zovirax (Glaxo Wellcome, UK) at the International Pharmaceutical Research Center (IPRC), Amman, Jordan. One study involved acyclovir tablets and the other acyclovir suspension. Each study enrolled 24 volunteers and in both studies, after an overnight fasting, the two brands of acyclovir were administered as a single dose on 2 treatment days separated by 1 week washout period. After dosing, serial blood samples were collected for a period of 16 h. Plasma harvested from blood, was analysed for acyclovir by an HPLC method with UV detection. Various pharmacokinetic parameters including AUC0-t, AUC0-infinity, Cmax, Tmax, T1/2 and Kelm were determined from plasma concentrations for both formulations and found to be in good agreement with the reported values. AUC0-t, AUC(0-proportional to), and Cmax were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence intervals for the test/reference ratio of these parameters were found within the bioequivalence acceptance range 80%-125%. Based on these statistical inferences it was concluded that a Lovrak tablet is bioequivalent to a Zovirax tablet and that Lovrak suspension is bioequivalent to Zovirax suspension. 2004 John Wiley & Sons, Ltd.

  14. L-T4 bioequivalence and hormone replacement studies via feedback control simulations.

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    Eisenberg, Marisa; Samuels, Mary; DiStefano, Joseph J

    2006-12-01

    FDA Guidance for testing bioequivalence of levothyroxine (L-T(4)) preparations has been challenged by several groups, based on multiple issues. The efficacy of single versus combined hormone therapy also is receiving additional scrutiny. To examine these concerns, we developed a new nonlinear feedback system simulation model of whole-body regulation mechanisms involving dynamics of T(3), T(4), TSH, plasma protein binding, extravascular regulatory enzyme systems, and the hypothalamic-pituitary-thyroid axis, all quantified from human data. To address bioequivalence, we explored how to best account for varying and unmeasured endogenous T(4) following dosing with exogenous oral L-T(4) in euthyroid volunteers in required pharmacokinetic (PK) studies, by simulating various dosing scenarios and developing a new and simple correction method. We computed and assessed dosing error effects and baseline corrections using simulator-predicted endogenous T(4) level variations, due to actual closed-loop effects, and compared these with approximate corrections computed directly from PK data. Predicted dose-responses were quite linear, and for constant baseline, 7-day half-life, and our new formula-correction methods, we established some bounds on bioequivalent dosages. Simulated replacement after thyroidectomy required 141 microg L-T(4) only to normalize T(3) tissue levels and 162 microg L-T(4) to normalize plasma T(3) levels. A combined dose of approximately 103 microg L-T(4) plus approximately 6 microg T(3) ( approximately 18:1 ratio) was needed to normalize both plasma T(3) and T(4) and average tissue T(3) levels. However, simulated average tissue T(3) levels were normalized with standard L-T(4)-only therapy, and plasma T(3) levels were still within the normal range. We suggest a simple and more accurate correction for endogenous T(4) in PK studies. Current standard L-T(4)-only treatment is supported for routine replacement needs.

  15. Sensitivity of empirical metrics of rate of absorption in bioequivalence studies.

    Science.gov (United States)

    Ring, A; Tothfalusi, L; Endrenyi, L; Weiss, M

    2000-05-01

    The sensitivity and effectiveness of indirect metrics proposed for the assessment of comparative absorption rates in bioequivalence studies [Cmax, Tmax, partial AUC (AUCp), feathered slope (SLf), intercept metric (I)] were originally tested by assuming first-order absorption. The present study re-evaluates their sensitivity performances using the more realistic inverse Gaussian (IG) model characterizing the input process for oral drug administration. Simulations were performed for both the first-order or exponential model (EX) which is determined by only one parameter, the mean absorption time (MAT = 1/k(a)), and the IG model, which additionally contains a shape parameter, the relative dispersion of absorption time distribution (CV2A). Kinetic sensitivities (KS) of the indirect metrics were evaluated from bioequivalence trials (error free data) generated with various ratios of the true parameters (MAT and CV2A) of the two formulations. The behavior of the metrics was similar with respect to changes in MAT ratios with both models: KS was low with Cmax, moderate with SLf and AUCp, and high with I and Tmax following correction for apparent lag time (Tlag). Changes of the shape parameter CV2A, however, were not detectable by Cmax, Tmax, SLf, and AUCp. Changes in both MAT and CV2A were well reflected by I with CV2A - ratio > 1. I exhibited approximately full KS also with CV2A - ratio correction was first applied for the apparent lag time. The time profile of absorption rates is insufficiently characterized by only one parameter (MAT). Indirect metrics which are sensitive enough to detect changes in the scale and shape of the input profile could be useful for bioequivalence testing. Among the tested measures, I is particularly promising when a correction is applied for Tlag.

  16. Demonstrating comparative in vitro bioequivalence for animal drug products through chemistry and manufacturing controls and physicochemical characterization: a proposal.

    Science.gov (United States)

    Martinez, Marilyn N; Fahmy, Raafat

    2015-03-01

    The assessment of in vivo bioequivalence (BE) of nonsystemically absorbed drug products has been a longstanding challenge facing drug manufacturers and regulators of human or animal health products. Typically, in situations where blood level BE studies are not feasible, clinical endpoint BE trials have provided the only option for generating interproduct comparisons. Given the imprecision and logistic challenges associated with these studies, there has been an effort to identify alternative pathways that can reliably ensure the equivalence of product performance and quality. This commentary provides a proposal for an in vitro approach for evaluating the in vivo BE of veterinary drug products that are either nonsystemically absorbed or that act both locally and systemically but where the local site of action is proximal to the absorption window. The assumption underlying this approach is that equivalence in product physicochemical attributes and in vitro product performance translates to equivalence in product in vivo behavior. For sponsors with a right of reference to underlying safety and effectiveness data, this approach could be used to support pre and post-approval changes. When comparing a generic test product to the pioneer (reference listed new animal drug, RLNAD) product, a demonstration of sameness across a battery of in vitro test procedures could be used to confirm that the test and RLNAD products are bioequivalent.

  17. Bioequivalence study of two enalapril maleate tablet formulations in healthy male volunteers. Pharmacokinetic versus pharmacodynamic approach.

    Science.gov (United States)

    Ribeiro, W; Muscará, M N; Martins, A R; Moreno, H; Mendes, G B; de Nucci, G

    1996-01-01

    Two different conventional release enalapril maleate tablet formulations were evaluated for their relative bioavailability (Eupressin tablets 10 mg, Biosintética as the test formulation vs Renitec tablets 10 mg Merck Sharp & Dhome, as the reference formulation). A single 20 mg oral dose of each preparation was administered to 18 healthy male adult volunteers and their bioequivalence was assessed by comparing the serum enalaprilat and total enalapril (enalaprilat plus enalapril maleate) concentration-time curves. Angiotensin converting enzyme (ACE) activity was also quantified in each serum sample. The pharmacokinetic parameters obtained for each formation were the area under the time-concentration curve from 0 to 24 h (AUC[0-24]), maximum concentration Cmax and the time at which it occurred (tmax). When serum enalaprilat concentration-time curves were employed to assess bioequivalence, the formulations were bioequivalent in the extent but not in the rate of absorption. However, no difference in either the extent or the rate of absorption were observed when serum total enalapril vs time curves were analysed. ACE activity-time curves were similar for both formulations and showed that ACE was 90% inhibited for 3-5 h after enalapril administration, and till approximately 50% after 24 h. At that time, circulating enalaprilat and total enalapril levels were less than the tenth of Cmax. The results show that complete bioequivalence of the two formulations can be concluded from serum total enalapril concentration data, and that serum ACE activity is not a suitable pharmacodynamic variable for assessing bioequivalence.

  18. Bioequivalence evaluation of two brands of amoxicillin/clavulanic acid 250/125 mg combination tablets in healthy human volunteers: use of replicate design approach.

    Science.gov (United States)

    Idkaidek, Nasir M; Al-Ghazawi, Ahmad; Najib, Naji M

    2004-12-01

    The purpose of this study was to apply a replicate design approach to a bioequivalence study of amoxicillin/clavulanic acid combination following a 250/125 mg oral dose to 23 subjects, and to compare the analysis of individual bioequivalence with average bioequivalence. This was conducted as a 2-treatment 2-sequence 4-period crossover study. Average bioequivalence was shown, while the results from the individual bioequivalence approach had no success in showing bioequivalence. In conclusion, the individual bioequivalence approach is a strong statistical tool to test for intra-subject variances and also subject-by-formulation interaction variance compared with the average bioequivalence approach. copyright (c) 2004 John Wiley & Sons, Ltd.

  19. Bioequivalence of a Liquid Formulation of Alpha1-Proteinase Inhibitor Compared with Prolastin®-C (Lyophilized Alpha1-PI) in Alpha1-Antitrypsin Deficiency.

    Science.gov (United States)

    Barker, Alan F; Campos, Michael A; Brantly, Mark L; Stocks, James M; Sandhaus, Robert A; Lee, Douglas; Steinmann, Kimberly; Lin, Jiang; Sorrells, Susan

    2017-12-01

    This study evaluated the bioequivalence, safety, and immunogenicity of a new liquid formulation of human plasma-derived alpha 1 -proteinase inhibitor, Liquid Alpha 1 -PI, compared with the Lyophilized Alpha 1 -PI formulation (Prolastin®-C), for augmentation therapy in patients with alpha 1 -antitrypsin deficiency (AATD). In this double-blind, randomized, 20-week crossover study, 32 subjects with AATD were randomized to receive 8 weekly infusions of 60 mg/kg of Liquid Alpha 1 -PI or Lyophilized Alpha 1 -PI. Serial blood samples were drawn for 7 days after the last dose followed by 8 weeks of the alternative treatment. The primary endpoint was bioequivalence at steady state, as measured by area under the concentration versus time curve from 0 to 7 days (AUC 0-7 days ) postdose using an antigenic content assay. Bioequivalence was defined as 90% confidence interval (CI) for the ratio of the geometric least squares (LS) mean of AUC 0-7 days for both products within the limits of 0.80 and 1.25. Safety and immunogenicity were assessed. Mean alpha 1 -PI concentration versus time curves for both formulations were superimposable. Mean AUC 0-7 days was 20 320 versus 19 838 mg × h/dl for Liquid Alpha 1 -PI and Lyophilized Alpha 1 -PI, respectively. The LS mean ratio of AUC 0-7 days (90% CI) for Liquid Alpha 1 -PI versus Lyophilized Alpha 1 -PI was 1.05 (1.03-1.08), indicating bioequivalence. Liquid Alpha 1 -PI was well tolerated and adverse events were consistent with Lyophilized Alpha 1 -PI. Immunogenicity to either product was not detected. In conclusion, Liquid Alpha 1 -PI is bioequivalent to Lyophilized Alpha 1 -PI, with a similar safety profile. The liquid formulation would eliminate the need for reconstitution and shorten preparation time for patients receiving augmentation therapy for AATD.

  20. A single dose, randomized, open-label, cross-over bioequivalence study of sildenafil citrate tablets in healthy Chinese volunteers
.

    Science.gov (United States)

    Li, Dai; Wang, Yu-Lu; Xu, Su-Mei; Li, Dan; Li, Xiao-Min; Pan, Jing; Xu, Ping-Sheng

    2017-02-01

    The present study was designed to evaluate the bioequivalence of a newly developed sildenafil citrate tablet 50 mg (Jinge®, Test) and a marketed counterpart (Viagra®, 100 mg, Reference) in healthy adult male Chinese volunteers. This single-dose, randomized, open-label, four-period, and two-treatment self-crossover study included two parts: fasting and postprandial studies. In each part of the study, the subjects were randomly assigned to receive test or reference products (100 mg sildenafil) in a 1 : 1 ratio, and then received the alternative products, following a 1-week washout period. Plasma sildenafil concentrations were analyzed by liquid chromatography-tandem mass spectrometry. Tolerability was assessed during the entire study period. 32 healthy volunteers (aged 19 - 30) were enrolled in the study; 31 volunteers completed the fasting study, while 32 volunteers completed the postprandial study. The test formulation was bioequivalent to the marketed formulation as the 90% CIs for the ratio of geometric means of Cmax (fasting: 98.79 - 119.61%; fed: 94.47 - 119.65%), AUClast (fasting: 98.70 - 109.71%; fed: 96.39 - 112.89%), and AUC∞ (fasting: 98.45 - 108.87%; fed: 96.36 - 112.74%) were within equivalence limits (80 - 125%) under both fasting and postprandial conditions. When sildenafil was given with high-fat meals, mean Cmax was reduced by 23%, and median tmax ranged from 0.75 to 1.50 hours (p ≤ 0.05). However, both AUClast and AUC∞ were comparable between fasting and postprandial conditions. No serious adverse events were found among the subjects. This study confirmed that test and reference sildenafil citrate tablets were bioequivalent under fasting and postprandial conditions.
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  1. Complete dataset for 2-treatment, 2-sequence, 2-period efavirenz bioequivalence study conducted with nightly dosing

    Directory of Open Access Journals (Sweden)

    Manuel Ibarra

    2016-06-01

    Full Text Available The efavirenz pharmacokinetic raw data presented in this article was obtained in an average bioequivalence study between a local brand and Stocrin (Merck Sharp & Dohme, purchased from Australia, batch H009175, expiration date November 2013. Dose was administered at night (9:00 p.m. two hours after food intake. Fourteen healthy subjects, 8 women and 6 men, completed the study. For each subject, 15 data points until 96 h post-administration are included. Subject demographic characteristics and sequences of administration are provided along with individual pharmacokinetic profiles of efavirenz obtained for both formulations after a single oral dose of 600 mg. This data provides information in support of the research article “Sex-by-formulation interaction assessed through a bioequivalence study of efavirenz tablets” [1].

  2. Pharmacokinetic and bioequivalence studies of immediate release diclofenac potassium tablets (50mg) in healthy volunteers.

    Science.gov (United States)

    Ali, Huma; Shoaib, Muhammad Harris; Zafar, Farya; Hanif, Muhammad; Bushra, Rabia; Naz, Asia; Khursheed, Raheela

    2016-09-01

    This study was conducted with the aim to determine the pharmacokinetic and bioequivalence of diclofenac potassium 50 mg test (F4) tablet formulation with reference product (Caflam). Present study was single dose, randomized, two phase cross over design, conducted in 12 healthy Pakistani volunteers and planned in accordance with FDA guidelines. In this study a simple, selective, sensitive and reproducible HPLC procedure was developed and validated for the estimation of diclofenac potassium in plasma. The process was validated in the range of 50 - 0.05 µg.mL-1 and used in bioequivalence trial of two products. Multiple blood samples were collected at various time points (0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 14 hr after treating volunteers with test (F4) and marketed reference brand. Plasma separation and deproteination were carried out with acetonitrile; samples (20µL) were injected using the validated HPLC method. Various pharmacokinetic parameters (compartmental and noncompartmental) were estimated using KineticaTM 4.4.1 (Thermo Electron Corp. USA). Bioequivalence among the products was established by calculating the 90% CI with log and non log transformed data for Cmaxcalc, Tmaxcalc, AUC0-∞, AUCtot and AUClast using two way ANOVA and Schirmann's Two one sided t- test. No significant difference was found between log and non-log data. The 90% confidence interval values using log transformed data for AUC0-∞ (0.997-1.024), AUCtot (1.004-1.031), AUClast (0.997 -1.024), Cmaxcalc (0.994-1.007) and Tmaxcalc (0.996-1.013) for the trial and reference products were found within the FDA acceptable limits of 0.8-1.25. Results were further verified by the Schirmann's one-sided t test. Results showed the bioequivalence of test and reference formulations. Both the products were well tolerated.

  3. Piroxicam immediate release formulations: A fasting randomized open-label crossover bioequivalence study in healthy volunteers.

    Science.gov (United States)

    Helmy, Sally A; El-Bedaiwy, Heba M

    2014-11-01

    Piroxicam is a NSAID with analgesic and antipyretic properties, used for the treatment of rheumatoid diseases. The aim of this study was to evaluate the bioequivalence of two brands of piroxicam capsules (20 mg) in 24 Egyptian volunteers. The in vivo study was established according to a single-center, randomized, single-dose, laboratory-blinded, 2-period, 2-sequence, crossover study with a washout period of 3 weeks. Under fasting conditions, 24 healthy male volunteers were randomly selected to receive a single oral dose of one capsule (20 mg) of either test or reference product. Plasma samples were obtained over a 144-hour interval and analyzed for piroxicam by HPLC with UV detection. The pharmacokinetic parameters Cmax , tmax , AUC0-t , AUC0-∞ , Vd /F, Cl/F, and t1/2 were determined from plasma concentration-time profiles. The 90% confidence intervals for the ratio of log transformed values of Cmax , AUC0-t , and AUC0-∞ of the two treatments were within the acceptable range (0.8-1.25) for bioequivalence. From PK perspectives, the two piroxicam formulations were considered bioequivalent, based on the rate and extent of absorption. No adverse events occurred or were reported after a single 20-mg piroxicam and both formulations were well-tolerated. © 2014, The American College of Clinical Pharmacology.

  4. In vitro bioequivalence study of nine brands of artesunate tablets marketed in Nigeria.

    Science.gov (United States)

    Esimone, C O; Okoye, F B C; Onah, B U; Nworu, C S; Omeje, E O

    2008-03-01

    The availability of numerous brands of artesunate in our drug market today places clinicians and pharmacists in a difficult situation of choice of a suitable brand or the possibility of alternative use. The aim of the present study was to predict the bioequivalence of nine brands of artesunate tablets marketed in Nigeria using in vitro tests. The in vitro dissolution study was carried out on the nine brands of artesunate tablets using the basket method according to US Pharmacopoeia (USP) guidelines. Other general quality assessment tests like hardness and disintegration time were also determined. All the brands tested passed the British Pharmacopoeia (BP) standard for disintegration time. Only AT2, AT4, AT6 and AT9 passed the standard for hardness. There were significant differences in the dissolution profiles of the nine brands. All the brands except AT1, however, released >70% of artesunate within 30 min. Four of the brands AT5, AT6, AT7 and AT8 exhibited >90% dissolution in AT9 (innovator brand) have calculated similarity factors of 23.8, 59.8, 50, 54.8 and 100. Based on the in vitro tests, AT5, AT6, AT7 and AT8 are considered bioequivalent and interchangeable, while AT2, AT3 and AT4 are considered bioequivalent and interchangeable with the innovator brand (AT9). AT1 has very low dissolution rate, which will likely result in poor bioavailability. The results show the need for constant monitoring of new brands of artesunate introduced into the drug market to ascertain bioequivalence and conformity with pharmacopoeia standards.

  5. Bioequivalence study of a generic Risperidone (Iperdal® in healthy Thai male volunteers

    Directory of Open Access Journals (Sweden)

    Werawath Mahatthanatrakul

    2008-05-01

    Full Text Available The objective of this study was to compare the rate and extent of absorption of a generic risperidone (Iperdal® with a reference formulation (Risperdal® when given orally. The study was an open label, randomized, two-period, two-sequence,single dose cross-over design with a 2 weeks washout period in 16 healthy Thai male volunteers. Single oral dose of two 2-mg tablets of risperidone were administered and serial blood samples were collected from the antecubital vein before and at0.17, 0.33, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 and 48 hours post dose. Risperidone plasma concentrations were assayed using a validated High Performance Liquid Chromatographic (HPLC-UV method modified from Avenosoet al. (2000. Pharamcokinetic parameters i.e. Cmax, AUC0à48 and Tmax were analyzed by noncompartment analysis. Variations of the data were analyzed by “Two Way Analysis of Variance” (ANOVA. Statistics were tested as stated in USP 28 guidelinefor bioequivalence study. The maximum concentration (Cmax, ng/ml of risperidone for the innovator and the generic product were 31.11±17.24 (range 5.64-56.78 and 32.58±19.77 (range 5.29-84.56 ng/ml, respectively. The area under theplasma concentration-time curve (AUC0®48 of the innovator and the generic product were 160.64±152.89 (range 18.57- 550.32 and 144.03±127.37 (range 16.27-456.0 ng.hr/ml, respectively. The time to maximum concentration (Tmax of theinnovator and the generic product were 0.97±0.41(range 0.5-2 and 1.02±0.32 (range 0.5-1.5 hr, respectively. The 90% confidence interval of the ratio of the ln-transformed of Cmax and AUC0à48 of both preparations were 89.39-112.99% and80.02-107.28% respectively which were within the acceptance range of 80.00-125.00%. Therefore, it can be concluded that both preparations used in this study are bioequivalent in terms of both the rate and extent of absorption.

  6. Bioequivalence Study of Pantoprazole Sodium-HPBCD and Conventional Pantoprazole Sodium Enteric-Coated Tablet Formulations

    Science.gov (United States)

    Kamdi, Sandesh P.; Palkar, Prashant J.

    2013-01-01

    The objective of this study was to investigate the bioequivalence of two formulations of 40 mg pantoprazole sodium enteric-coated tablets: Tripepsa as the test and Pantocid as the reference. The two products were administered as a single oral dose according to a randomized two-phase crossover with a 1-month washout period in 25 healthy Indian volunteers. After drug administration, serial blood samples were collected over a period of 30 hours. Plasma pantoprazole concentrations were measured by high-performance liquid chromatography with UV detection. Pharmacokinetic parameters were analyzed based on noncompartmental analysis. The logarithmically transformed data of AUC0−∞ and C max were analyzed for 90% confidence intervals (CI) using ANOVA. The mean (90% CI) values for the ratio of AUC0−∞ and C max values of the test product over those of the reference product were 90.21 (83.69–97.24) and 108.68 (100.21–117.86), respectively (within the bioequivalence range of 80–125%). On the basis of pharmacokinetic parameters including AUC0−∞, AUC0−t, and C max values, both the formulations were bioequivalent. PMID:23476803

  7. A bioequivalence study of two tamsulosin sustained-release tablets in Indonesian healthy volunteers.

    Science.gov (United States)

    Prasaja, Budi; Harahap, Yahdiana; Lusthom, Windy; Setiawan, Evy C; Ginting, Mena B; Hardiyanti; Lipin

    2011-06-01

    The bioavailability of two 0.4 mg tamsulosin sustained-release film-coated tablet formulations was compared; using generic tablets (Prostam(®)) as test formulation and the originator product as reference formulation. Twenty-four subjects were included in this single-dose, open-label, randomized two-way crossover design following an overnight fasting. A one-week wash-out period was applied. Blood samples were drawn up to 72 h following drug administration. Plasma concentration of tamsulosin was determined by liquid chromatography-tandem mass spectrometry method with TurboIonSpray mode. Pharmacokinetic parameters AUC(0-t,) AUC(0-∞), C (max) and t (½) were determined and used for bioequivalence evaluation after log-transformation, whereas t (max) ratios were evaluated non-parametrically. The estimated point and 90% confidence intervals (CI) for AUC(0-t,) AUC(0-∞), C (max) and t (½) were 109.55% (96.41-124.49%), 109.94% (96.85-124.81%), 105.87% (92.88-120.67%) and 100.00% (90.56-110.43%), respectively. These results indicated that the two formulations of tamsulosin were bioequivalent; therefore they may be prescribed interchangeably.

  8. A Single-Dose, Two-Way Crossover, Open-Label Bioequivalence Study of an Amphetamine Extended-Release Oral Suspension in Healthy Adults.

    Science.gov (United States)

    Sikes, Carolyn; Stark, Jeffrey G; McMahen, Russ; Engelking, Dorothy

    2017-11-01

    The purpose of this study was to compare the pharmacokinetics of a new extended-release amphetamine oral suspension (AMP XR-OS) with a standard extended-release mixed amphetamine salts product, Adderall XR®. In this single-dose, open-label, randomized, two-period, two-treatment crossover study, 42 healthy adult volunteers received 15 mL of AMP XR-OS in one period and a 30 mg Adderall XR capsule in another period (both containing 18.8 mg of amphetamine base) under fasted conditions. Blood samples were analyzed for d- and l-amphetamine concentrations, and pharmacokinetic parameters C max , AUC 0-5 , AUC 5-last , and AUC inf were calculated to determine bioequivalence. Safety was monitored throughout the study. The 90% confidence intervals (CIs) for the log-transformed C max , AUC 0-5 , AUC 5-last , and AUC inf fell within the accepted 80% to 125% range for establishing bioequivalence for d- and l-amphetamine. The most common adverse events were nausea and decreased appetite. AMP XR-OS is bioequivalent to Adderall XR in healthy adult participants.

  9. Bioequivalence Studies of a Reformulated Dutasteride and Tamsulosin Hydrochloride Combination Capsule and a Commercially Available Formulation.

    Science.gov (United States)

    Kurczewski, Renee; Bowen, Chet; Collins, David; Zhu, John; Serbest, Gulyeter; Manyak, Michael

    2017-09-01

    A dutasteride 0.5 mg and tamsulosin hydrochloride 0.4 mg combination (DTC) capsule (Duodart ® ) was reformulated to reduce the capsule size and enhance product stability. Bioequivalence of the reformulated DTC capsule with the commercial formulation was evaluated in 2 single-dose, open-label, randomized, 2-way crossover studies in healthy adult male volunteers. Subjects in a fasted or fed state received a single oral dose of either the reformulated DTC or the commercial formulation followed by a 28-day washout period between treatments. Blood samples were taken predose and up to 72 hours postdose for pharmacokinetic (PK) analysis of dutasteride and tamsulosin serum concentrations. From the serum concentration-vs-time data, a noncompartmental method was used to calculate the maximum observed serum concentration (C max ) and area under the serum concentration-time curve (AUC 0-t ) for dutasteride and tamsulosin, and AUC 0-∞ for tamsulosin. The 90% confidence intervals for the ratios of the C max and AUC 0-t (for dutasteride and tamsulosin) and for AUC 0-∞ (for tamsulosin) were all completely contained within the range of 80% to 125%; therefore, the reformulated DTC capsule is bioequivalent to the commercial formulation under both fed and fasted states. © 2017, The American College of Clinical Pharmacology.

  10. Bioequivalence study of two enteric coated capsule formulations of ...

    African Journals Online (AJOL)

    Medical profession has realized the problem of wide variations in the therapeutic effectiveness of various brands of oral formulations containing the same active ingredient in equal amounts. The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence single-dose crossover ...

  11. Pharmacogenetic relevance of the CYP2C9*3 allele in a tenoxicam bioequivalence study performed on Spaniards.

    Science.gov (United States)

    Peiró, A M; Novalbos, J; Zapater, P; Moreu, R; López-Rodríguez, R; Rodríguez, V; Abad-Santos, F; Horga, J F

    2009-01-01

    We performed a study to quantify CYP2C9 and CYP2C8 alleles influence on the variability observed in tenoxicam pharmacokinetic (PK) and implication in a bioequivalence study design performed on Spaniards. Eighteen healthy volunteers were included in an open, randomized, crossover, phase I bioequivalence study. Significant increases were found in CYP2C9*3 alleles vs. *1 and *2 in AUC(0-infinity) (median (min-max)): 256 (230-516) vs. 150 (100-268) and 169 (124-197) microg h/mL (p<0.01) and half-life time (t1/2) 102 (79-36) vs. 56 (45-94) and 64 (60-80)h (p<0.01). Non-significant differences were observed in C(max) 1.9 (1.8-2.9) vs. 2.4 (1.7-3.4), 2.5 (1.6-2.9) microg/mL or in according to CYP2C8 alleles presence. CYP2C9*3 allele is associated to a longer elimination time of tenoxicam. PK parameters calculated in bioequivalence studies (AUC(0-infinity), t1/2) may be influenced by the presence of CYP2C9*3 allele resulting in a high variability. Thus, bioequivalence studies of tenoxicam formulations should be designed considering genotype profile.

  12. Pharmacokinetics and bioequivalence study of aniracetam after single-dose administration in healthy Chinese male volunteers.

    Science.gov (United States)

    Tian, Yuan; Zhang, Jing-Jing; Feng, Shu-Dan; Zhang, Zun-Jian; Chen, Yun

    2008-01-01

    The pharmacokinetics of aniracetam (CAS 72432-10-1) in Chinese healthy male volunteers was investigated for the first time. Twenty male volunteers were enrolled into this open, randomized, single blind two-sequence, two-period crossover study. Under fasting conditions, each subject received a single oral dose of 400 mg (2 x 200 mg/capsule) aniracetam as a test or reference formulation with a 3-day washout period between the two preparations. The plasma concentrations of aniracetam were analyzed by a sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The pharmacokinetic parameters of the test and reference formulations were estimated as follows: The maximum plasma concentrations (Cmax) were 8.75 +/- 7.82 and 8.65 +/- 8.70 ng/mL, Tmax were 0.4 +/- 0.1 and 0.4 +/- 0.1 h, and plasma elimination half-lives (t(1/2)) were 0.47 +/- 0.16 and 0.49 +/- 0.24 h, respectively. The AUC(0-t) values demonstrated nearly identical bioavailability of aniracetam from the examined formulations. AUC(0-2.5) values were 4.53 +/- 6.62 and 4.76 +/- 6.65 ng h/mL, the areas under the plasma concentration-time curve (AUC(0-infinity) were 4.62 +/- 6.66 and 4.85 +/- 6.71 ng h/mL for the test and reference formulation, respectively. No statistical differences were observed for Cmax, and AUC(0-infinity) for aniracetam. The 90% confidence limits calculated for AUC and Cmax of aniracetam were within the standard bioequivalence range (80%-125% for AUC and Cmax). Therefore, the aniracetam test formulation can be regarded as bioequivalent to the aniracetam reference formulation.

  13. Study of the trial subjects’ protection aspects in Phase I clinical trials and bioequivalence studies

    Directory of Open Access Journals (Sweden)

    K. O. Zupanets

    2016-03-01

    Full Text Available Protection of rights, health and well-being of persons who are taking the drug during the trial (trial subjects is one of the basic principles of clinical trials (CT management. Aim. In order to study key aspects of volunteer protection, determine factors that influence these indicators and estimate the importance of ensuring their proper implementation on the clinical site (CS three survey of 135 trial subjects were carried out to evaluate the importance of assessing the impact of factors such as the procedure of signing the informed consent (IC at the CS and testing procedures for HIV / AIDS, hepatitis and others. Assessment of the quality of life of trial subjects as indirect indicator of the quality of clinical trials that ensures the proper protection of their life was the subject of the third survey. Methods and results. The general model of the relationship between the key aspects of the trial subjects protection and the factors which are providing them during the clinical trials of drugs management was substantiated, which included the main aspects of the trial subjects’ protection, protective factors and basic CT management procedures, the impact of the above factors on the possibility of providing protection aspects depends on their implementation quality. It was found that trial subjects’ protection improvement can be achieved during the IC signing process. It is necessary to ensure a higher level of volunteers understanding of the terms that could be used in the IC form. Regarding the procedure of compulsory testing for HIV/AIDS in the course of screening, we can conclude that the majority of the trial subjects believe that this procedure is an additional factor in their health protection and do not consider it as an excessive psychological pressure on them. Conclusion. Assessing the quality of life during the bioequivalence study at the CS makes possible to reach a conclusion on general well-being and satisfaction with those

  14. Bioequivalence of Liposome-Entrapped Paclitaxel Easy-To-Use (LEP-ETU) formulation and paclitaxel in polyethoxylated castor oil: a randomized, two-period crossover study in patients with advanced cancer.

    Science.gov (United States)

    Slingerland, Marije; Guchelaar, Henk-Jan; Rosing, Hilde; Scheulen, Max E; van Warmerdam, Laurence J C; Beijnen, Jos H; Gelderblom, Hans

    2013-12-01

    Preclinical studies comparing paclitaxel formulated with polyethoxylated castor oil with the sonicated formulation of liposome-entrapped paclitaxel (LEP) have demonstrated that LEP was associated with reduced toxicity while maintaining similar efficacy. Preliminary studies on the pharmacokinetics in patients support earlier preclinical data, which suggested that the LEP Easy-to-Use (LEP-ETU) formulation and paclitaxel formulated with castor oil may have comparable pharmacokinetic properties. Our objectives were: (1) to determine bioequivalence of paclitaxel pharmaceutically formulated as LEP-ETU (test) and paclitaxel formulated with castor oil (reference); and (2) to assess the tolerability of LEP-ETU following intravenous administration. Patients with advanced cancer were studied in a randomized, 2-period crossover bioequivalence study. Patients received paclitaxel 175 mg/m(2) administered as an intravenous infusion over 180 minutes, either as a single-treatment cycle of the test formulation followed by a single-treatment cycle of the reference formulation, or vice versa. Thirty-two of 58 patients were evaluable and were included in the analysis for bioequivalence. Mean total paclitaxel Cmax values for the test and reference formulations were 4955.0 and 5108.8 ng/mL, respectively. Corresponding AUC0-∞ values were 15,853.8 and 18,550.8 ng·h/mL, respectively. Treatment ratios of the geometric means were 97% (90% CI, 91%-103%) for Cmax and 84% (90% CI, 80%-90%) for AUC0-∞. These results met the required 80% to 125% bioequivalence criteria. The most frequently reported adverse events after LEP-ETU administration were fatigue, alopecia, and myalgia. At the studied dose regimen, LEP-ETU showed bioequivalence with paclitaxel formulated with polyethoxylated castor oil. © 2013 Elsevier HS Journals, Inc. All rights reserved.

  15. A pharmacokinetic and bioequivalence study of Contiflo ICON 400 µg tablets in healthy Indian subjects.

    Science.gov (United States)

    Monif, T; Arora, V; Madan, S; Arora, R; Balaji, A; Jha, D; Thudi, N R

    2010-12-01

    Tamsulosin, an alpha1 adrenoceptor blocking agent, exhibits selectivity for alpha1 receptors in human prostate. Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of benign prostatic hypertrophy. A new formulation Contiflo ICON 400 µg has been developed by Ranbaxy Laboratories Limited, India similar to Flomaxtra XL 400 µg of Astellas Pharma Limited, United Kingdom. This product is specifically designed to achieve a more consistent plasma concentration over a period of 24-h, a lower maximum plasma concentration (Cmax) and an independence of pharmacokinetics (PKs) on food intake. The objective of the present study was to evaluate the pharmacokinetics and bioequivalence of the new formulation Contiflo ICON 400 µg of Ranbaxy Laboratories Limited, India and Flomaxtra XL 400 µg prolonged release tablets (containing tamsulosin hydrochloride prolonged release 400 µg) of Astellas Pharma Limited, United Kingdom. Study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, cross over, single-dose bioequivalence study in 32 adult male human subjects under fed conditions. The mean (range) age, weight and height of the study subjects were 27.03 years (19 - 40 years), 57.19 kg (48 - 72 kg) and 166.81 cm (154 - 181 cm) respectively. Blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 20, 24, 36, 48, 72, and 96 h post dose in each period. Plasma samples were analyzed for tamsulosin by using validated liquid chromatographic mass spectrometry (LC-MS/MS) method. The Mean ± SD of pharmacokinetic parameters tmax, Cmax, AUC24, AUClast and AUCinf for Tamsulosin were 11.741 ± 4.7201 and 12.155 ± 6.3077 h, 10.7614 ± 4.76709 and 10.4954 ± 5.08979 ng/ml, 171.4674 ± 77.39695 and 160.6738 ± 77.98628 ng.h/ml, 262.7771 ± 150.21432 and 250.6854 ± 156.75581 ng

  16. Pharmacokinetic, pharmacodynamic, efficacy, and safety data from two randomized, double-blind studies in patients with asthma and an in vitro study comparing two dry-powder inhalers delivering a combination of salmeterol 50 microg and fluticasone propionate 250 microg: implications for establishing bioequivalence of inhaled products.

    Science.gov (United States)

    Daley-Yates, Peter T; Parkins, David A; Thomas, Marian J; Gillett, Benjamin; House, Karen W; Ortega, Hector G

    2009-02-01

    The use of dry-powder inhalers (DPIs) to administer respiratory medicines is increasing, and new DPIs are likely to be developed because of expiring patents. However, there is considerable debate concerning the extent to which DPIs are interchangeable without altering disease control or the safety profile of the treatment. This study was designed to compare the pharmacokinetic (PK), pharmacodynamic (PD), efficacy, and safety data for 2 DPIs delivering a combination of salmeterol 50 microg plus fluticasone propionate (FP) 250 microg (SFC 50/250) to investigate assumptions of bioequivalence. Three studies compared SFC 50/250 delivery using a reservoir powder inhalation device (RPID) and a Diskus multiple-dose inhaler: an in vitro assessment of fine-particle-mass (FPM) profiles of the emitted doses; a PK/PD study of SFC 50/250 administered in two 14-day crossover treatment periods to 22 adults with moderate, persistent asthma to determine the equivalence of the RPID and Diskus inhaler in terms of drug delivery and systemic exposure; and a 12-week clinical efficacy and safety study of SFC 50/250 in 270 patients > or =12 years of age with moderate, persistent asthma to assess the equivalence of the RPID and Diskus inhaler based on peak expiratory flow (PEF) rates. FPM was summed from the quantity of active pharmaceutical ingredient deposited on stages 1 to 5 of a cascade impactor, representing an aerodynamic particle size range of 0.8 to 6.2 microm. Systemic exposure to SFC 50/250 was declared no greater with RPID than with the Diskus inhaler if the upper limit of the 90% CI for the ratio of FP AUC for the 2 devices was below the upper limit of the equivalence range (ie, <1.25). Adverse events, clinical laboratory test results, and vital signs were recorded throughout the 2 clinical studies. In vitro, mean FPM values for the RPID and Diskus inhaler, respectively, were 13.1 and 12.8 microg/dose for salmeterol (P = NS) and 66.8 and 66.2 microg/dose for FP (P = NS). The

  17. Bioequivalence of lamotrigine 50-mg tablets in healthy male volunteers: a randomized, single-dose, 2-period, 2-sequence crossover study.

    Science.gov (United States)

    Perez-Lloret, S; Olmos, L; de Mena, F; Pieczanski, P; Rodriguez Moncalvo, J J

    2012-10-01

    OBEJCTIVE: To compare the bioavailability of two 50-mg lamotrigine dispersible tablet formulations (Epilepax®, Ivax-TEVA Argentina Laboratories, Argentina, as a test formulation, and Lamictal®, GlaxoSmithKline, UK, as a reference formulation) in 24 healthy male volunteers. This study was a randomized, 2-period, 2-sequence crossover design that was open for subjects and investigators, but blind for the bioanalytical lab. Serum samples were obtained over a 120-h interval. A 9-day wash-out period was allowed between treatments. The concentrations of lamotrigine were analyzed by high-performance liquid chromatography followed by ultraviolet-visible detection. Lamotrigine time-concentrations curves were obtained and the following pharmacokinetic parameters were calculated: AUC0-t, AUC0-inf and Cmax. Bioequivalence was declared if the 90% confidence interval (CI) of the mean test/reference ratios for AUC0-t, AUC0-inf and Cmax were within 80.00-125.00%. The geometric mean and respective 90% CI of test/reference percent ratios were 100.83% (92.53-107.88%) for AUC0-t, 99.91% (93.79-108.40%) for AUC0-inf, and 95.62% (90.91-100.57%) for Cmax. No serious adverse events were observed. 1 patient reported a mild rash following the administration of each formulation. This single dose study found that the test and reference products met the regulatory criteria for bioequivalence in this sample of fasting healthy volunteers. These results suggest that bioequivalence studies evaluating 50-mg doses of Lamotrigine are feasible and recommended, since such doses may minimize the risk of severe rash or Stevens-Johnson Syndrome. This study was registered at the Argentinean Clinical Trials National Registry (www.anmat.gov.ar), No 1666/2008. © Georg Thieme Verlag KG Stuttgart · New York.

  18. Bioequivalence study of four different trademarks of enalapril maleate in spontaneously hypertensive rats.

    Science.gov (United States)

    Baracho, Nilo César do Vale; Arruda, Guilherme D'Andréa Saba; Alves, Lidinei José; Carneiro, Márcio Felipe Salomon; Siqueira, Matheus Teodoro Grilo; Arango, Héctor Gustavo; Marcos dos Reis, José

    2008-01-01

    High blood pressure is a systemic disease which has major clinical and psycho-social repercussions, involves a high morbidity-mortality rate and generates high costs for the health system. Its treatment involves the use of antihypertensive drugs, which are commercialized as trademark, generic or similar drugs. To verify the antihypertensive effect produced by a similar dose of different trademarks of enalapril maleate in spontaneously hypertensive rats (SHR). Fifteen mg/kg of enalapril maleate were administered by gavage in 50 SHR rats and their blood pressure was verified through tail plethysmography every three days in a period of 16 days. The group treated with reference drug has shown a significant reduction on blood pressure levels when compared to the control group. Thus, treatments with enalapril maleate of generic, similar-A and similar-B brands have also shown significant reduction on animals' blood pressure. The use of generic drug and similars (A and B) drugs in the same doses and for the same period of time has not shown significant difference regarding the reference drug, which suggests that the brands tested are bioequivalent.

  19. Estudio de bioequivalencia de dos formulaciones de tabletas de carbamazepina de liberación retardada Study of bioequivalence of two carbamazepine retard-release tablet formulations

    Directory of Open Access Journals (Sweden)

    2000-03-01

    Full Text Available En 12 voluntarios sanos se efectuó un estudio de bioequivalencia de dos preparados comerciales de carbamazepina en tabletas de liberación retardada. Este estudio permitió comparar la biodisponibilidad de la formulación de referencia Tegretol® Retard de Ciba Geigy elaborado en Colombia por Novartis, y la formulación de prueba Carbamazepina MK Retard, de Tecnoquímicas. Para evaluar la bioequivalencia se determinaron las curvas de concentración plasmática vs tiempo de las dos formulaciones y se calcularon las áreas bajo la curva (AUC y las concentraciones máximas (Cmáx. Para la formulación de prueba el intervalo de confianza del 90% para el AUC estuvo entre 95.7 y 100.7% y para el C(máx entre el 88.6 y el 106.1%. Para ambas determinaciones el rango de aceptación, según normas internacionales, está entre 80 y 125% de la formulación de referencia. Esto demuestra la bioequivalencia de las dos formulaciones. A study of the bioequivalence of two comercial carbamazepine retard-release formulations was carried out in 12 healthy volunteers. Studies of bioequivalence allow to compare the bioavailability of the innovator formulation with generic, alternative or branch formulations. In order to evaluate the bioequivalence, plasma carbamazepine concentration/time curves were obtained for the Tegretol® Retard Tablets –reference formulationand for the test formulation; the area under each curve and the maximum concentration were calculated. After the calculation, statistical analysis of data for the area under the curve of the Carbamazepine Retard Tablets –test formulation, was between 95.7% and 100.7 % and the maximum concentration of the test formulation was between 88.6% and 106.1%; both parameters with the 90% confidence interval. Since the acceptance range was determined to be between 80.0% and 125.0% of the reference formulation, we concluded from this study that the two formulations are bioequivalent.

  20. Meta-analysis for bioequivalence studies: interchangeability of generic drugs and similar containing Hydrochlorothiazide is possible but not with Enalapril Maleate.

    Science.gov (United States)

    Lopes, Renato Almeida; Neves, Francisco de Assis Rocha

    2010-01-01

    The generic drugs program provided a better population's access to medicines. To ensure interchangeability between a brand-name and generic or similar drugs is necessary that they are bioequivalent. With the growing number of generic drugs, it is common for patients to replace a generic to another or one similar. However, this exchange can not guarantee the maintenance of bioequivalence. To evaluate the safety interchangeability between different generic and similar drugs with Hydrochlorothiazide and Enalapril Maleate, a meta-analysis was carried out with several bioequivalence studies with these drugs. Data from bioequivalence of generic and similar drugs approved by the National Health Surveillance Agency (Anvisa) (drug regulatory agency in Brazil) were used. The compatibility of data from each study was analyzed and the determination of a confidence interval for the differences between the means of pharmacokinetic parameters, area under the curve (ASC0-t) and maximum plasma concentration (Cmax), was made for each study by meta-analysis. The interchangeability between the combinations of the three products with Hydrochlorothiazide was confirmed based on the obtained confidence intervals. For the drugs studied with Enalapril Maleate interchangeability has not been confirmed for 50% of the product comparisons. The exchange was established between the three products with hydrochlorothiazide. However, for the Enalapril Maleate half of the products studied are not interchangeable, considering they do not match the established intervals for bioequivalence tests, so the pharmacokinetics behavior and thus the effectiveness of the product may be changed.

  1. A perspective for biowaivers of human bioequivalence studies on the basis of the combination of the ratio of AUC to the dose and the biopharmaceutics classification system.

    Science.gov (United States)

    Sakuma, Shinji; Tachiki, Hidehisa; Uchiyama, Hitoshi; Fukui, Yasunobu; Takeuchi, Naohiro; Kumamoto, Kazuo; Satoh, Tomonori; Yamamoto, Yoshinobu; Ishii, Emi; Sakai, Yoshiyuki; Takeuchi, Susumu; Sugita, Masaru; Yamashita, Shinji

    2011-08-01

    The ratio of AUC to the dose (AUC/dose) was previously found as a parameter that predicts a risk of bioinequivalence of oral drug products. On the basis of the combination of this parameter and the biopharmaceutics classification system (BCS), a perspective for biowaivers of human bioequivalence studies is discussed. Databases of bioequivalence studies using immediate-release solid oral dosage forms were disclosed by 6 Japanese generic pharmaceutical companies, and the number of subjects required for demonstrating bioequivalence between generic and reference products was plotted as a function of AUC/dose for each BCS category. A small variation in the number of subjects was constantly observed in bioequivalence studies using dosage forms containing an identical BCS class 1 or class 3 drug, even though formulations of the generic product differ between companies. The variation was extremely enlarged when the drugs were substituted with BCS class 2 drugs. Rate-determining steps in oral absorption of highly water-soluble BCS class 1 and class 3 drugs are independent of formulations when there is no significant difference in the in vitro dissolution profiles between formulations. The small variation observed for both BCS categories indicates that the number of subjects converges into one value for each drug. Our analysis indicates the appropriateness of biowaiver of bioequivalence studies for immediate-release solid oral dosage forms containing not only BCS class 1 drugs but also class 3 drugs.

  2. Pharmacokinetic properties and bioequivalence of two sulfadoxine/pyrimethamine fixed-dose combination tablets: a parallel-design study in healthy Chinese male volunteers.

    Science.gov (United States)

    Liu, Yan-Mei; Zhang, Kanyin E; Liu, Yun; Zhang, Hai-Chen; Song, Yun-Xiao; Pu, Hua-Hua; Lu, Chuan; Liu, Gang-Yi; Jia, Jing-Ying; Zheng, Qing-Si; Zhu, Jian-Min; Yu, Chen

    2012-11-01

    Sulfadoxine/pyrimethamine fixed-dose combination (FDC) tablet is the long-acting portion of the antimalaria product Artecospe(®), coblister containing artesunate tablets plus sulfadoxine/pyrimethamine FDC tablets. This study was conducted to support the efficacy and tolerability of the sulfadoxine/pyrimethamine FDC tablet in the World Health Organization's (WHO) Prequalification of Medicines Programme, as well as to obtain marketing authorization in China. The aim of the present study was to compare the pharmacokinetic profiles between a new generic and the branded reference formulation of sulfadoxine/pyrimethamine FDC tablets, and to assess the bioequivalence of the 2 products in healthy Chinese volunteers. This single-dose, open-label, randomized, parallel-group study was conducted in healthy Chinese male volunteers who were randomly assigned (1:1) to receive a single 1500/75-mg dose (3 × 500/25-mg tablets) of either the test or reference formulation after a 12-hour overnight fast. Seventeen blood samples were obtained over a 168-hour interval, and plasma concentrations of sulfadoxine and pyrimethamine were determined by 2 separate validated liquid chromatography-isotopic dilution mass spectrometry methods. Pharmacokinetic properties (C(max), AUC(0-72), AUC(0-168), and T(max)) were calculated and analyzed statistically. The 2 formulations were to be considered bioequivalent if 90% CIs for the log-transformed ratios of C(max) and AUC(0-72) were within the predetermined bioequivalence range of 80% to 125%, in accordance with the guidelines of WHO and China's Food and Drug Administration (FDA). Tolerability was evaluated throughout the study by vital signs, physical examinations, clinical laboratory tests, 12-lead ECGs, and subject interviews on adverse events (AEs). Forty-six healthy subjects completed the study. The mean values of sulfadoxine C(max) (183.07 and 165.15 mg/L), AUC(0-72) (11,036.52 and 10,536.78 mg/L/h), and AUC(0-168) (22,247.05 and 21,761.02 mg

  3. Bioequivalence and x-ray visibility of a radiopaque etonogestrel implant versus a non-radiopaque implant: a 3-year, randomized, double-blind study.

    Science.gov (United States)

    Schnabel, Peter; Merki-Feld, Gabriele S; Malvy, Alice; Duijkers, Ingrid; Mommers, Ellen; van den Heuvel, Michiel W

    2012-06-01

    The etonogestrel (ENG)-releasing implant is a subdermal progestogen-only contraceptive that provides coverage for up to 3 years. This long-acting hormonal contraceptive has been available in Europe since 1998 and in the US since 2006. To date, localization of non-palpable implants at insertion and before removal has been dependent on ultrasound or magnetic resonance imaging by an experienced clinician. To facilitate localization in rare cases of non-palpable implants using widely available equipment without the need for a specialist, a radiopaque ENG implant has been developed that is detectable by two-dimensional x-ray imaging. This study aimed to establish whether the radiopaque ENG implant is bioequivalent in situ compared with the original non-radiopaque ENG implant, and to assess x-ray visibility of the radiopaque ENG implant. This was a 3-year, randomized, double-blind, parallel-group study carried out in nine international clinical trial centres. Women aged 18-40 years at the time of screening, with menstrual cycles of a usual length of 24-35 days and a body mass index of between ≥18 and ≤29 kg/m(2) were included. Women were assigned to either the radiopaque or non-radiopaque ENG implant in a 1 : 1 ratio via a block randomization by centre. Bioequivalence testing was performed based on the peak ENG concentration (C(max)), and the area under the curve (AUC) for ENG at 6, 24 and 36 months (AUC(6 mo), AUC(24 mo) and AUC(36 mo)) after insertion. For this purpose, blood sampling for pharmacokinetic determination was performed prior to insertion and for up to 3 years afterwards. Bioequivalence was defined as the 90% confidence interval (CI) of the ratio radiopaque implant/non-radiopaque implant of the geometric means (GMR) within the acceptance range of 0.80-1.25. x-Ray visibility was assessed by two-dimensional x-ray imaging after insertion and before removal of the implant. The pharmacokinetic profiles of ENG indicated that the radiopaque and non

  4. Bioequivalence of two misoprostol tablets in healthy Chinese female volunteers: a single-dose, two-period, double crossover study.

    Science.gov (United States)

    Huang, J; Chen, R; Li, R; Wei, C-M; Yuan, G-Y; Liu, X-Y; Wang, B-J; Guo, R-C

    2012-01-01

    To assess the bioequivalence of a new generic formulation of misoprostol (CAS 59122-46-2) 0.2 mg tablets (test) and the available branded tablet (reference) for the requirement of state regulatory criteria and the marketing of the test product in China. A randomized-sequence, 2-period crossover study was conducted in 20 healthy Chinese female volunteers in the fasted state. Blood samples were collected at baseline and 0.083, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 and 6 h after a single oral dose of 0.6 mg misoprostol test or reference, followed by a 7-day washout period. Misoprostol acid, the active metabolite of misoprostol, was determined by an HPLC-MS/MS method. Drug And Statistics 2.0 was used to calculate the pharmacokinetics parameters and assess bioequivalence of the 2 formulations. It was considered bioequivalent if the 90% CIs of the mean ratios (test: reference) for Tmax, Cmax and AUC0-t were all within the range from 80% to 125%. Adverse events were monitored throughout the study based on clinical parameters and patient reports. The main pharmacokinetics parameters for the test and reference were as follows: t1/2 was (0.680 ± 0.371) h and (0.650 ± 0.264) h; Tmax was (0.415 ± 0.087) h and (0.399 ± 0.097) h; Cmax was (1.941 ± 0.417) ng/mL and (2.047 ± 0.397) ng/mL; AUC0-t was (1.535 ± 0.419) ng·h/mL and (1.652 ± 0.400)ng·h/mL, and the AUC0-∞ was (1.576 ± 0.465) ng·h/mL and (1.686 ± 0.396) ng·h/mL. The mean ratios (test: reference) for Cmax, AUC0-t, and AUC0-∞ were 95.3% ±13.2%, 92.65% ± 17.31%, and 93.61%±18.97%, respectively. No significant (p>0.05) differences in pharmacokinetic parameters were found between preparations, treatments and periods. This single-dose study in healthy Chinese fasted volunteers was shown that the misoprostol test and reference met the requirement of US and China regulatory criterion, and the test and reference were bioequivalent. © Georg Thieme Verlag KG Stuttgart · New York.

  5. Evaluation of two novel tablet formulations of artemether-lumefantrine (Coartem) for bioequivalence in a randomized, open-label, two-period study.

    Science.gov (United States)

    Lefèvre, Gilbert; Bhad, Prafulla; Jain, Jay Prakash; Kalluri, Sampath; Cheng, Yi; Dave, Hardik; Stein, Daniel S

    2013-09-08

    Artemether-lumefantrine (Coartem; AL) is a standard of care for malaria treatment as an oral six-dose regimen, given twice daily over three days with one to four tablets (20/120 mg) per dose, depending on patient body weight. In order to reduce the pill burden at each dose and potentially enhance compliance, two novel fixed-dose tablet formulations (80/480 mg and 60/360 mg) have been developed and tested in this study for bioequivalence with their respective number of standard tablets. A randomized, open-label, two-period, single-dose, within formulation crossover bioequivalence study comparing artemether and lumefantrine exposure between the novel 80/480 mg tablet and four standard tablets, and the novel 60/360 mg tablet and three standard tablets, was conducted in 120 healthy subjects under fed conditions. Artemether, dihydroartemisinin, and lumefantrine were measured in plasma by HPLC/UPLC-MS/MS. Pharmacokinetic (PK) parameters were determined by non-compartmental analyses. Adjusted geometric mean AUClast for artemether were 345 and 364 ng·h/mL (geometric mean ratio (GMR) 0.95; 90% CI 0.89-1.01) and for lumefantrine were 219 and 218 μg·h/mL (GMR 1.00; 90% CI 0.93-1.08) for 80/480 mg tablet versus four standard tablets, respectively. Corresponding Cmax for artemether were 96.8 and 99.7 ng/mL (GMR 0.97; 90% CI 0.89-1.06) and for lumefantrine were 8.42 and 8.71 μg/mL (GMR 0.97; 90% CI 0.89-1.05). For the 60/360 mg tablet versus three standard tablets, adjusted geometric mean AUClast for artemether were 235 and 231 ng·h/mL (GMR 1.02; 90% CI 0.94-1.10), and for lumefantrine were 160 and 180 μg·h/mL (GMR 0.89; 90% CI 0.83-0.96), respectively. Corresponding Cmax for artemether were 75.5 and 71.5 ng/mL (GMR 1.06; 90% CI 0.95-1.18), and for lumefantrine were 6.64 and 7.61 μg/mL (GMR 0.87; 90% CI 0.81-0.94), respectively. GMR for Cmax and AUClast for artemether and lumefantrine for all primary comparisons were within the bioequivalence acceptance criteria (0

  6. International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences.

    Science.gov (United States)

    Davit, Barbara; Braddy, April C; Conner, Dale P; Yu, Lawrence X

    2013-10-01

    The objective of this article is to discuss the similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. We focused on the 13 jurisdictions and organizations participating in the International Generic Drug Regulators Pilot. These are Australia, Brazil, Canada, China, Chinese Taipei, the European Medicines Association, Japan, Mexico, Singapore, South Korea, Switzerland, the USA, and the World Health Organization. We began with a comparison of how the various jurisdictions and organizations define a generic product and its corresponding reference product. We then compared the following bioequivalence approaches: recommended bioequivalence study designs, method of pharmacokinetic calculations and bioequivalence acceptance limits, recommendations for modifying bioequivalence study designs and limits for highly variable drugs and narrow therapeutic index drugs, provisions for waiving bioequivalence study requirements (granting biowaivers), and implementation of the Biopharmaceutics Classification System. We observed that, overall, there are more similarities than differences in bioequivalence approaches among the regulatory authorities surveyed.

  7. The basic regulatory considerations and prospects for conducting bioavailability/bioequivalence (BA/BE studies – an overview

    Directory of Open Access Journals (Sweden)

    Shaik Mastan

    2011-03-01

    Full Text Available Shaik Mastan1, Thirunagari Bhavya Latha2, Sathe Ajay11Cytel Statistical Software and Services Pvt Ltd, Pune, Maharashtra, India; 2Business Development, Bioserve Clinical Research Pvt Ltd, Hyderabad, Andhra Pradesh, IndiaAbstract: Bioavailability (BA and bioequivalence (BE studies play a major role in the drug development phase for both new drug products and their generic equivalents, and thus attract considerable attention globally. BE is a strategy to introduce generic equivalents of brand-name drugs (innovator drugs to lower the cost of medication through proper assessment as directed by the international regulatory authorities. There are several approaches to assess BE and each regulatory authority has its own regulations/guidance for conducting BA/BE studies before approving generic products for marketing in their country. Therefore, a thorough understanding is required of these BA/BE concepts and basic regulatory considerations for conducting BA/BE studies. This article briefly reviews the BA/BE concepts, approaches, designs, and various basic regulatory considerations and prospects for conducting BA/BE studies. Keywords: bioavailability, bioequivalence, generic drugs, regulatory authority, pharmacokinetics, pharmacodynamics 

  8. Are marketed topical metronidazole creams bioequivalent? Evaluation by in vivo microdialysis sampling and tape stripping methodology

    DEFF Research Database (Denmark)

    Garcia Ortiz, Patricia Elodia; Hansen, S H; Shah, Surendra P.

    2011-01-01

    To evaluate the bioequivalence of 3 marketed topical metronidazole formulations by simultaneous dermal microdialysis and stratum corneum sampling by the tape stripping methodology, and to compare the techniques as tools for the determination of bioequivalence....

  9. Randomized two-way cross-over bioequivalence study of two amoxicillin formulations and inter-ethnicity pharmacokinetic variation in healthy Malay volunteers.

    Science.gov (United States)

    Liew, Kai Bin; Loh, Gabriel Onn Kit; Tan, Yvonne Tze Fung; Peh, Kok Khiang

    2014-09-01

    The objectives of this study were to develop a new deproteinization method to extract amoxicillin from human plasma and evaluate the inter-ethnic variation of amoxicillin pharmacokinetics in healthy Malay volunteers. A single-dose, randomized, fasting, two-period, two-treatment, two-sequence crossover, open-label bioequivalence study was conducted in 18 healthy Malay adult male volunteers, with one week washout period. The drug concentration in the sample was analyzed using high-performance liquid chromatography (UV-vis HPLC). The mean (standard deviation) pharmacokinetic parameter results of Moxilen® were: peak concentration (Cmax ), 6.72 (1.56) µg/mL; area under the concentration-time graph (AUC0-8 ), 17.79 (4.29) µg/mL h; AUC0-∞ , 18.84 (4.62) µg/mL h. Those of YSP Amoxicillin® capsule were: Cmax , 6.69 (1.44) µg/mL; AUC0-8 , 18.69 (3.78) µg/mL h; AUC00-∞ , 19.95 (3.81) µg/mL h. The 90% confidence intervals for the logarithmic transformed Cmax , AUC0-8 and AUC0-∞ of Moxilen® vs YSP Amoxicillin® capsule was between 0.80 and 1.25. Both Cmax and AUC met the predetermined criteria for assuming bioequivalence. Both formulations were well tolerated. The results showed significant inter-ethnicity variation in pharmacokinetics of amoxicillin. The Cmax and AUC of amoxicillin in Malay population were slightly lower compared with other populations. Copyright © 2014 John Wiley & Sons, Ltd.

  10. The advantages of combination therapy on hypertension: development of immediate release perindopril-indapamide tablet and assessment of bioequivalence studies.

    Science.gov (United States)

    Ölçer, A; Ölçer, M; İnce, I; Karasulu, E

    2016-03-01

    Hypertension has a major associated risk for organ damage and mortality, which is further heightened in patients with prior cardiovascular events, comorbid diabetes mellitus, microalbuminuria and renal impairment. Convers Plus tablet including perindopril erbumine (PE), which is an angiotensin converting enzyme (ACE) inhibitor, and indapamide, which is diuretic, was designed as a combined tablet to succes in the treatment of hypertension. Physico-pharmaceutical properties and characterization studies were evaluated in vitro conditions. Later on in vivo study was planned as a cross-designed, randomized, open-labeled, single-dose, single-center study via peroral route in 24 healthy male subjects. In this study, bioequivalence with primary pharmacokinetical target parameters reference (Bipreterax 4/1.25 mg Tablet-S.A.Servier Benelux N.V.) and test (Convers Plus 4/1.25 mg Tablet-ARGESAN Pharmaceutical Company) tablets have been found bioequivalent. The results of pharmacokinetic parameters for perindopril, perindoprilat and indapamide were found as Cmax = 23.179 µg/mL, tmax = 0.729 h, t1/2 = 1.429 h; AUC0-t = 26.998 µgs/mL, AUC0-inf = 27.117 µgs/mL; Cmax = 1.834 µg/mL, tmax = 8.792 h, t1/2 = 40.699 h; AUC0-t = 54.828 µgs/mL, AUC0-inf = 77.113 µgs/mL; Cmax = 18.994 µg/mL, tmax = 3.417 h, t1/2 = 16.626 h and AUC0-t = 385.829 µgs/mL, AUC0-inf = 410.728 µgs/mL respectively. In conclusion, physico-pharmaceutical properties and results of clinical trials show that Convers Plus tablets have been found as bioequivalent for perindopril, perindoprilat and indapamide in terms of AUC and Cmax, in 90% confidence limits.

  11. Are marketed topical metronidazole creamas bioequivalent ? Evaluation by in vivo microdialysis sampling and tape stripping methodology

    DEFF Research Database (Denmark)

    Ortiz, P. Garcia; Hansen, Steen Honore'; Shah, V. P.

    2011-01-01

    To evaluate the bioequivalence of 3 marketed topical metronidazole formulations by simultaneous dermal microdialysis and stratum corneum sampling by the tape stripping methodology, and to compare the techniques as tools for the determination of bioequivalence.......To evaluate the bioequivalence of 3 marketed topical metronidazole formulations by simultaneous dermal microdialysis and stratum corneum sampling by the tape stripping methodology, and to compare the techniques as tools for the determination of bioequivalence....

  12. Are marketed topical metronidazole creams bioequivalent? Evaluation by in vivo microdialysis sampling and tape stripping methodology

    DEFF Research Database (Denmark)

    Garcia Ortiz, Patricia Elodia; Hansen, S H; Shah, Surendra P.

    2011-01-01

    To evaluate the bioequivalence of 3 marketed topical metronidazole formulations by simultaneous dermal microdialysis and stratum corneum sampling by the tape stripping methodology, and to compare the techniques as tools for the determination of bioequivalence.......To evaluate the bioequivalence of 3 marketed topical metronidazole formulations by simultaneous dermal microdialysis and stratum corneum sampling by the tape stripping methodology, and to compare the techniques as tools for the determination of bioequivalence....

  13. Quantitative analysis of valsartan by two-dimensional liquid chromatography (2D-HPLC) and its application in a bioequivalence study in Chinese volunteers
.

    Science.gov (United States)

    Zhang, Min; Deng, Yang; Cai, Hua-Lin; Fang, Ping-Fei; Yan, Miao; Zhang, Bi-Kui; Wu, Yan-Qin

    2017-04-01

    To develop a sensitive, two-dimensional liquid chromatography (2D-LC) method for determination of valsartan, applied to investigate bioequivalence of two valsartan tablets in Chinese volunteers under fasting condition. A full automatic 2D-HPLC system was used to quantify valsartan in human plasma. The analytes were extracted by protein precipitation, using telmisartan as internal standard. The analytical method was applied in a randomized, crossover bioequivalence study of valsartan tablets; the study enrolled 18 Chinese volunteers (12 were men and 6 were women). The subjects received a single 160-mg dose of test or reference preparation with 7-days of washout under fasting state. Plasma samples were collected, pharmacokinetic parameters were obtained and the bioequivalence was evaluated. The calibration range was 9.2 - 4213.8 ng×mL-1. Inter- and intraprecision was less than 7.0%, and accuracies ranged from 99.5 to 103.8%. The extraction recovery for valsartan varied between 89.3 and 97.8%, and the stability in all conditions was excellent. The 90% CI of AUC0→36h and Cmax were 96.5 - 109.4% and 94.2 - 108.6%, respectively. The relative bioavailability was 103.9 ± 15.7%. No gender difference was observed in pharmacokinetic parameters. A sensitive 2D-HPLC method was established for the estimation of valsartan in human plasma and successfully applied in a bioequivalence study of valsartan, which suggests that these two formulations can be assumed to be bioequivalent.
.

  14. Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard.

    Science.gov (United States)

    Ting, Tricia Y; Jiang, Wenlei; Lionberger, Robert; Wong, Jessica; Jones, Jace W; Kane, Maureen A; Krumholz, Allan; Temple, Robert; Polli, James E

    2015-09-01

    To test the current U.S. Food and Drug Administration (FDA) bioequivalence standard in a comparison of generic and brand-name drug pharmacokinetic (PK) performance in "generic-brittle" patients with epilepsy under clinical use conditions. This randomized, double-blind, multiple-dose, steady-state, fully replicated bioequivalence study compared generic lamotrigine to brand-name Lamictal in "generic-brittle" patients with epilepsy (n = 34) who were already taking lamotrigine. Patients were repeatedly switched between masked Lamictal and generic lamotrigine. Intensive PK blood sampling at the end of each 2-week treatment period yielded two 12-h PK profiles for brand-name and generic forms for each patient. Steady-state area under the curve (AUC), peak plasma concentration (Cmax ), and minimum plasma concentration (Cmin ) data were subjected to conventional average bioequivalence (ABE) analysis, reference-scaled ABE analysis, and within-subject variability (WSV) comparisons. In addition, generic-versus-brand comparisons in individual patients were performed. Secondary clinical outcomes included seizure frequency and adverse events. Generic demonstrated bioequivalence to brand. The 90% confidence intervals of the mean for steady-state AUC, Cmax , and Cmin for generic-versus-brand were 97.2-101.6%, 98.8-104.5%, and 93.4-101.0%, respectively. The WSV of generic and brand were also similar. Individual patient PK ratios for generic-versus-brand were similar but not identical, in part because brand-versus-brand profiles were not identical, even though subjects were rechallenged with the same product. Few subjects had seizure exacerbations or tolerability issues with product switching. One subject, however, reported 267 focal motor seizures, primarily on generic, although his brand and generic PK profiles were practically identical. Some neurologists question whether bioequivalence in healthy volunteers ensures therapeutic equivalence of brand and generic antiepileptic drugs

  15. Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets.

    Science.gov (United States)

    Al-Tabakha, Moawia M; Fahelelbom, Khairi M S; Obaid, Dana Emad Eddin; Sayed, Sadik

    2017-05-20

    Bacterial resistance and antibiotic drug effectiveness can be related to administering generic products with a subtherapeutic dose or poor in vivo drug release. The aim of this study was to investigate whether locally marketed amoxicillin tablets have the required chemical and physical attributes, including in vitro bioequivalence performance. Five generic products (T1, T2, T3, T4, and T5) containing combination of amoxicillin trihydrate and potassium clavulanate as 1 g strength present in immediate release tablets were compared to the reference listed drug product Augmentin® (R) for weight variation, friability, resistance to crushing, and chemical content of amoxicillin. Difference (ƒ1) and similarity (ƒ2) factors were calculated to assess in vitro bioequivalence requirements. The tablets from different products have shown compliance with the pharmacopeial requirements of the performed tests. The measured resistance to crushing of tablets did not influence the dissolution time. Three generic products released more than 85% of amoxicillin by the first 15 min as did the reference product and were considered as bioequivalent products. T1 and T4 had ƒ1 values of 16.5% and 25.4% respectively and their ƒ2 values were 44.5 and 34.6 respectively, indicating failure to meet in vitro bioequivalence requirements. Tablet formulations can play an important role in achieving bioequivalence. Independent investigations such as this study serve as an important tool to reveal possible inferior or noncompliant products that may find their way to the market.

  16. Evaluation of some properties of individual bioequivalence (IBE) from replicate-design studies.

    Science.gov (United States)

    Tothfalusi, L; Endrenyi, L

    2001-04-01

    One of the claimed benefits of the individual bioequivalence (IBE) approach has been that the aggregate regulatory model rewards a test formulation when it has a within-subject variation smaller than the reference product. Hauck et al. [1996] demonstrated that, in the absence of random variations, this property of IBE was due to the tradeoff between the difference of the means and the deviation between the intrasubject variances of the two formulations. The tradeoff was a consequence of the aggregate regulatory model. However, calculations of Endrenyi and Hao [1998] showed that, in the presence of random variations, not only rewards but also penalties can arise due to chance alone. A data set of 55 investigations made public by the FDA in 1999 and containing replicate crossover designs was analyzed. Two parameters, AUC and Cmax, were determined in each investigation. The analyses of the FDA data indicate that: rewards and penalties occur at similar frequencies, large rewards and penalties are recorded quite often, and the aggregate IBE model is rather insensitive to the difference between the estimated means and is compatible with the frequent occurrence of large deviations. Rewards and penalties, apparently arising from random variations, can affect regulatory decisions on the acceptance of IBE and can lead to incorrect conclusions.

  17. Bioequivalence study of two formulations of flupirtine maleate capsules in healthy male Chinese volunteers under fasting and fed conditions

    Directory of Open Access Journals (Sweden)

    Liu YF

    2017-12-01

    Full Text Available Yanfang Liu, Hua Huo, Zhibo Zhao, Wenli Hu, Yujia Sun, Yunbiao Tang Technical Center for Clinical Pharmacy, Department of Drug Clinical Trail Management Agency, General Hospital of Shenyang Military Area Command, Shenyang, China Aim: This study developed a high-performance liquid chromatography–tandem mass spectrometry method to simultaneously determine the concentrations of flupirtine and its major active metabolite D-13223 in human plasma in order to assess the bioequivalence (BE of two flupirtine maleate capsules among healthy male Chinese volunteers under fasting and fed conditions. Materials and methods: There were two single-center, randomized, single-dose, open-label, laboratory-blinded, two-period, cross-over studies which included 24 healthy male Chinese volunteers under fasting and fed conditions, respectively. Plasma samples were collected prior to and up to 48 h after dosing. The concentrations of flupirtine and its major active metabolite D-13223 in plasma samples were determined by a validated method, that is, high-performance liquid chromatography coupled with a tandem mass spectrometry detector. Pharmacokinetic metrics of area from time zero to the last measurable concentration (AUC0-t, area under the plasma concentration–time curve from administration to infinite time (AUC0-∞, and Cmax were used for BE assessment. Results: Forty-eight healthy volunteers who met the criteria were enrolled and completed the study. According to the observation of vital signs and laboratory measurement, no volunteers had any adverse reactions. Under fasting condition, the geometric mean ratios (90% CI of the test/reference drug for flupirtine were 103.0% (98.1%–108.2% for AUC0-t, 102.9% (98.2%–107.9% for AUC0-∞, and 97.0% (85.9%–109.5% for Cmax. Under fed condition, the geometric mean ratios (90% CI of the test/reference drug for flupirtine were 101.7% (98.4%–105.1% for AUC0-t, 101.6% (98.5%–104.8% for AUC0-∞, and 103.5% (94.7%

  18. Average bioequivalence of single 500 mg doses of two oral formulations of levofloxacin: a randomized, open-label, two-period crossover study in healthy adult Brazilian volunteers

    Directory of Open Access Journals (Sweden)

    Eunice Kazue Kano

    2015-03-01

    Full Text Available Average bioequivalence of two 500 mg levofloxacin formulations available in Brazil, Tavanic(c (Sanofi-Aventis Farmacêutica Ltda, Brazil, reference product and Levaquin(c (Janssen-Cilag Farmacêutica Ltda, Brazil, test product was evaluated by means of a randomized, open-label, 2-way crossover study performed in 26 healthy Brazilian volunteers under fasting conditions. A single dose of 500 mg levofloxacin tablets was orally administered, and blood samples were collected over a period of 48 hours. Levofloxacin plasmatic concentrations were determined using a validated HPLC method. Pharmacokinetic parameters Cmax, Tmax, Kel, T1/2el, AUC0-t and AUC0-inf were calculated using noncompartmental analysis. Bioequivalence was determined by calculating 90% confidence intervals (90% CI for the ratio of Cmax, AUC0-t and AUC0-inf values for test and reference products, using logarithmic transformed data. Tolerability was assessed by monitoring vital signs and laboratory analysis results, by subject interviews and by spontaneous report of adverse events. 90% CIs for Cmax, AUC0-t and AUC0-inf were 92.1% - 108.2%, 90.7% - 98.0%, and 94.8% - 100.0%, respectively. Observed adverse events were nausea and headache. It was concluded that Tavanic(c and Levaquin(c are bioequivalent, since 90% CIs are within the 80% - 125% interval proposed by regulatory agencies.

  19. LC–MS/MS assay for olanzapine in human plasma and its application to a bioequivalence study

    Directory of Open Access Journals (Sweden)

    Dinesh S. Patel

    2012-10-01

    Full Text Available This paper describes a selective and sensitive assay for the determination of olanzapine (OLZ in human plasma based on liquid chromatography–tandem mass spectrometry (LC–MS/MS. The analyte and quetiapine as internal standard (IS were extracted from 200 μL plasma via solid phase extraction on Waters Oasis HLB cartridges. Chromatographic separation was achieved on an ACE 5C18-300 column (100 mm×4.6 mm, 5 μm under isocratic conditions in a run time of 3.5 min. Mass spectrometric detection involved electrospray ionization in the positive ion mode followed by multiple reaction monitoring (MRM of the transitions at m/z 313/256 for OLZ and m/z 384/253 for the IS. The assay was linear in the range 0.10–40.0 ng/mL with a lower limit of quantitation and limit of detection of 0.10 and 0.012 ng/mL, respectively. Intra- and inter-day precision (as coefficient of variation and relative recovery were 90%, respectively. The method was successfully applied to a bioequivalence study of 5 and 10 mg OLZ disintegrating tablets in 40 healthy Indian males with reproducibility by incurred sample reanalysis in the range −7.43 to 8.07%.

  20. Bioequivalence of two lansoprazole delayed release capsules 30 mg in healthy male volunteers under fasting, fed and fasting-applesauce conditions: a partial replicate crossover study design to estimate the pharmacokinetics of highly variable drugs.

    Science.gov (United States)

    Thota, S; Khan, S M; Tippabhotla, S K; Battula, R; Gadiko, C; Vobalaboina, V

    2013-11-01

    An open-label, 2-treatment, 3-sequence, 3-period, single-dose, partial replicate crossover studies under fasting (n=48), fed (n=60) and fasting-applesauce (n=48) (sprinkled on one table spoonful of applesauce) modalities were conducted in healthy adult male volunteers to evaluate bioequivalence between 2 formulations of lansoprazole delayed release capsules 30 mg. In all the 3 studies, as per randomization, either test or reference formulations were administered in a crossover manner with a required washout period of at least 7 days. Blood samples were collected adequately (0-24 h) to determine lansoprazole plasma concentrations using a validated LC-MS/MS analytical method. To characterize the pharmacokinetic parameters (Cmax, AUC0-t, AUC0-∞, Tmax, Kel and T1/2) of lansoprazole, non-compartmental analysis and ANOVA was applied on ln-transformed values. The bioequivalence was tested based on within-subject variability of the reference formulation. In fasting and fed studies (within-subject variability>30%) bioequivalence was evaluated with scaled average bioequivalence, hence for the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞, the 95% upper confidence bound for (μT-μR)2-θσ2 WR was ≤0, and the point estimates (test-to-reference ratio) were within the regulatory acceptance limit 80.00-125.00%. In fasting-applesauce study (within-subject variability<30%) bioequivalence was evaluated with average bioequivalence, the 90% CI of ln-transformed data of Cmax, AUC0-t and AUC0-∞ were within the regulatory acceptance limit 80.00-125.00%. Based on these aforesaid statistical inferences, it was concluded that the test formulation is bioequivalent to reference formulation. © Georg Thieme Verlag KG Stuttgart · New York.

  1. Bioequivalence of three florfenicol preparations in broilers

    Directory of Open Access Journals (Sweden)

    Husamettin Ekici

    2014-12-01

    Full Text Available This study was aimed to determine the bioequivalence of three different preparations of florfenicol using non-drugged broiler chickens. A total of 28 broiler chickens aging 30-day were divided into four equal groups; these were Group I, II, III, and IV. The birds of Group I (for effective substance were given intravenous (i.v. administration of florfenicol dosed at 40 mg/kg body weight (b.wt.. The birds of Group II (for reference drug, Group III (for test-1 drug, and Group IV (for test-2 drug received florfenicol preparations with water (dosed at 40 mg/kg b.wt. through intracrop administration. Blood samples were collected periodically from the birds of all four groups, and blood plasma was separated. Levels of florfenicol and its metabolite (florfenicol amine in the plasma were measured by High Performance Liquid Chromatography (HPLC. In this study, the limit of detection (LOD for florfenicol and florfenicol amine were recorded as 0.017 and 0.78 µg/mL, respectively. On the other hand, the recovery of florfenicol and florfenicol amine were 83.4-84.6 and 82.2-83.8%, respectively. Based on the values of area under the curve (AUC, maximum concentration (Cmax, and time to maximum concentration (Tmax, test-1 drug was found to be acceptable, whereas test-2 drug was remained below the acceptable limits (80-125% of AUC and Cmax. Thus, it was concluded that test-1 drug was bioequivalent as compared to the reference drug.

  2. Determination of levodopa in human plasma by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS: application to a bioequivalence study

    Directory of Open Access Journals (Sweden)

    Heliana F. Martins

    2013-01-01

    Full Text Available A sensitive, accurate and simple method using HPLC-MS/MS was developed and validated for levodopa quantitation in human plasma. Analysis was achieved on a pursuit® C18 analytical column (5 µm; 150 x 4.6 mm i.d. using a mobile phase (methanol and water , 90:10, v/v containing formic acid 0.5% v/v, after extracting the samples using a simple protein plasma precipitation with perchloric acid. The developed method was validated in accordance with ANVISA guidelines and was successfully applied to a bioequivalence study in 60 healthy volunteers demonstrating the feasibility and reliability of the proposed method.

  3. Rapid determination of telmisartan in human plasma by HPLC using a monolithic column with fluorescence detection and its application to a bioequivalence study.

    Science.gov (United States)

    Zhang, He; Jiang, Yunyun; Wen, Jun; Zhou, Tingting; Fan, Guorong; Wu, Yutian

    2009-11-01

    A rapid HPLC method using a monolithic column with fluorescence detection has been developed for determination of telmisartan in human plasma. Sample preparation was done by protein precipitation with acetonitrile and naproxen was used as IS. The compounds were detected by fluorescence detection, using an excitation wavelength of 300 nm and emission wavelength of 385 nm. Calibration curves of telmisartan were linear in the range of 1-200 ng/mL. The assay was high throughput, sensitive and precise, and it was successfully applied to a bioequivalence study of two formulations of telmisartan.

  4. Assessment of topical bioequivalence using dermal microdialysis and tape stripping methods.

    Science.gov (United States)

    Incecayir, Tuba; Agabeyoglu, Ilbeyi; Derici, Ulver; Sindel, Sukru

    2011-09-01

    To assess the bioequivalence of two commercial topical formulations of oxytetracycline HCl by tape stripping and microdialysis in healthy volunteers. Tape stripping study was conducted on 12 healthy volunteers. After a 30-minute application of the formulations, adhesive tapes were used to sample stratum corneum at 0.25, 0.5, 1, 1.5, 2, 3, 4 hr. Ten of these volunteers were included in the microdialysis study with a period of 4 weeks between the experiments. Microdialysis probes were inserted into the dermis of the forearm. Following the application of the test and reference simultaneously, dialysates were collected in 30-minute sampling intervals up to 4 hr. Pharmacokinetic evaluation by microdialysis yielded that the test could not be said to be bioequivalent to the reference at 90% CI. The intersubject variability of oxytetracycline content in stratum corneum was moderate when it was compared to the dermal levels. The test was found to be bioequivalent to reference according to the dermatopharmacokinetic evaluation by tape stripping. No significant correlations were found between microdialysis and tape stripping methods as regarding the topical bioequivalence of oxytetracycline HCl formulations.

  5. Integration of in vitro biorelevant dissolution and in silico PBPK model of carvedilol to predict bioequivalence of oral drug products.

    Science.gov (United States)

    Ibarra, Manuel; Valiante, Cristian; Sopeña, Patricia; Schiavo, Alejandra; Lorier, Marianela; Vázquez, Marta; Fagiolino, Pietro

    2018-06-15

    Bioequivalence implementation in developing countries where a high proportion of similar drug products are being marketed has found several obstacles, impeding regulatory agencies to move forward with this policy. Biopharmaceutical quality of these products, several of which are massively prescribed, remains unknown. In this context, an in vitro-in silico-in vivo approach is proposed as a mean to screen product performance and target specific formulations for bioequivalence assessment. By coupling in vitro biorelevant dissolution testing in USP-4 Apparatus (flow-through cell) with physiologically-based pharmacokinetic (PBPK) modeling in PK-Sim® software (Bayer, Germany), the performance of seven similar products of carvedilol tablets containing 25 mg available in the Uruguayan market were compared with the brand-name drug Dilatrend®. In silico simulations for Dilatrend® were compared with published results of bioequivalence studies performed in fasting conditions allowing model development through a learning and confirming process. Single-dose pharmacokinetic profiles were then simulated for the brand-name drug and two similar drug products selected according to in vitro observations, in a virtual Caucasian population of 1000 subjects (50% male, aged between 18 and 50 years with standard body-weights). Population bioequivalence ratios were estimated revealing that in vitro differences in drug release would have a major impact in carvedilol maximum plasma concentration, leading to a non-bioequivalence outcome. Predictions support the need to perform in vivo bioequivalence for these products of extensive use. Application of the in vitro-in silico-in vivo approach stands as an interesting alternative to tackle and reduce drug product variability in biopharmaceutical quality. Copyright © 2018 Elsevier B.V. All rights reserved.

  6. A COMPARATIVE ANALYSIS OF BIOEQUIVALENCE, CLINICAL EFFICACY AND SAFETY OF GENERIC VERSUS ORIGINAL CYCLOSPORINE AFTER KIDNEY TRANSPLANTATION

    Directory of Open Access Journals (Sweden)

    E. S. Stolyarevich

    2015-01-01

    Full Text Available The aim of the study was the evaluation of pharmacokinetic parameters and clinical efficacy of generic cyclosporine (Ecoral and Sandimmune Neoral. Materials and methods’. The pharmacokinetic parameters of different cyclosporine formulations. In 197 kidney graft recipients 319 comprehensive pharmacokinetic studies were performed. In 42 patients received in consecutive order original and generic Cyclosporine in the same dosage the complete pharmacokinetic study was perforfomed. AUC calculations based on dosing interval concentration values were fulfilled using linear trapezoidal rule. To evaluate clinical efficacy 235 short pharmacokinetic studies with concentration examination at 0, 1, 2 and 3 hours after taking Cyclosporine (Co, C1 C2 and C3 were performed in patients treated with Neoral (n = 75 or generic cyclosporine (n = 160. Clinical efficacy of generic cyclosporine was estimated by the prevalence of allograft dysfunction and biopsy proved acute rejection episodes as well as by one-years graft survival and events-free survival. The graft survival rate was calculated by Kaplan–Meyer method. Results. At 100–200 ng/ml maintenance concentration (estimated by C0 concentration pharmacokinetic parameters did not significantly differ according to Cyclosporine formulation in both complete or short pharmacokinetic studies: AUC-4265 vs. 4204 and 3834 vs. 3670 ng/ml/h respectively; (p > 0.05, Cmax (1036 vs 931 and 813 vs 741 ng/ml respectively; (p > 0.05. Allograft dysfunction occurred in 5% of patients subjected to Neoral immunosuppression and in 8% of Equoral recipients (p > 0.05. However biopsy-proven acute rejection as a cause of graft dysfunction was seen only in patients receiving Ecoral (7% vs 0; p < 0.05. One-years graft survival rate did not differ between groups (99% and 94% in generic CyA and Neoral respectively; p > 0.05, whereas events-free graft survival was significantly lower in patients, receiving generic CyA than in Neoral group

  7. Influence of a microemulsion vehicle on cutaneous bioequivalence of a lipophilic model drug assessed by microdialysis and pharmacodynamics

    DEFF Research Database (Denmark)

    Kreilgaard, Mads; Kemme, M J; Burggraaf, J

    2001-01-01

    The aim of the study was to investigate the cutaneous bioequivalence of a lipophilic model drug (lidocaine) applied in a novel topical microemulsion vehicle, compared to a conventional oil-in-water (O/W) emulsion, assessed by a pharmacokinetics microdialysis model and a pharmacodynamic method....

  8. Impact of Chiral Bioanalytical Methods on the Bioequivalence of Ibuprofen Products Containing Ibuprofen Lysinate and Ibuprofen Base.

    Science.gov (United States)

    García-Arieta, Alfredo; Ferrero-Cafiero, Juan Manuel; Puntes, Montse; Gich, Ignasi; Morales-Alcelay, Susana; Tarré, Maite; Font, Xavier; Antonijoan, Rosa Maria

    2016-05-01

    The purpose was to assess the impact of the use of a chiral bioanalytical method on the conclusions of a bioequivalence study that compared two ibuprofen suspensions with different rates of absorption. A comparison of the conclusion of bioequivalence between a chiral method and an achiral approach was made. Plasma concentrations of R-ibuprofen and S-ibuprofen were determined using a chiral bioanalytical method; bioequivalence was tested for R-ibuprofen and for S-ibuprofen separately and for the sum of both enantiomers as an approach for an achiral bioanalytical method. The 90% confidence interval (90% CI) that would have been obtained with an achiral bioanalytical method (90% CI: Cmax: 117.69-134.46; AUC0 (t) : 104.75-114.45) would have precluded the conclusion of bioequivalence. This conclusion cannot be generalized to the active enantiomer (90% CI: Cmax : 103.36-118.38; AUC0 (t) : 96.52-103.12), for which bioequivalence can be concluded, and/or the distomer (90% CI: Cmax : 132.97-151.33; AUC0 (t) : 115.91-135.77) for which a larger difference was observed. Chiral bioanalytical methods should be required when 1) the enantiomers exhibit different pharmacodynamics and 2) the exposure (AUC or Cmax ) ratio of enantiomers is modified by a difference in the rate of absorption. Furthermore, the bioequivalence conclusion should be based on all enantiomers, since the distomer(s) might not be completely inert, in contrast to what is required in the current regulatory guidelines. In those cases where it is unknown if the ratio between enantiomers is modified by changing the rate of absorption, chiral bioanalytical methods should be employed unless enantiomers exhibit the same pharmacodynamics. Chirality 28:429-433, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  9. Bioequivalence and pharmacokinetic evaluation of two formulations of risperidone 2 mg : an open-label, single-dose, fasting, randomized-sequence, two-way crossover study in healthy male Chinese volunteers.

    Science.gov (United States)

    Liu, Yun; Zhang, Meng-qi; Jia, Jing-ying; Liu, Yan-mei; Liu, Gang-yi; Li, Shui-jun; Wang, Wei; Weng, Li-ping; Yu, Chen

    2013-03-01

    Risperidone is a benzisoxazole derivate and is effective in the treatment of schizophrenia and other psychiatric illnesses in adults and children. Although there are a few reports in the literature regarding the pharmacokinetic characteristics of risperidone, insufficient data on its pharmacokinetic properties in a Chinese population are available. To meet the requirements for marketing a new generic product, this study was designed to compare the pharmacokinetic properties and bioequivalence of two 2 mg tablet formulations of risperidone: a newly developed generic formulation (test) and a branded formulation (reference) in healthy adult male Chinese volunteers. A single-dose, open-label, randomized-sequence, 2 × 2 crossover study was conducted in fasted healthy male Chinese volunteers. Eligible participants were randomly assigned in a 1:1 ratio to receive 1 tablet (2 mg each) of the test formulation (Risperidone tablet; Dr. Reddy's Laboratories Ltd., Hyderabad, India) or the reference formulation (Risperdal(®) tablet; Xian-Janssen Pharmaceutical Ltd., Xi-an, China), followed by a 2-week washout period and subsequent administration of the alternate formulation. The study drugs were administered after a 10-hour overnight fast. Plasma samples were collected over 96 hours. Plasma concentrations of the parent drug, risperidone, and its active metabolite, 9-hydroxy-risperidone, were analyzed by a liquid chromatography-tandem mass spectrometry method. The formulations would be considered bioequivalent if the 90% confidence intervals (CIs) of the natural log-transformed values were within the predetermined 80-125% equivalence range for the maximum plasma drug concentration (Cmax) and the area under the plasma concentration-time curve (AUC), in accordance with guidelines issued by the US Food and Drug Administration. Assessment of tolerability was based on recording of adverse events (AEs), monitoring of vital signs, electrocardiograms, and laboratory tests at baseline

  10. Bioequivalence of two levothyroxine tablet formulations without and with mathematical adjustment for basal thyroxine levels in healthy Argentinian volunteers: a single-dose, randomized, open-label, crossover study.

    Science.gov (United States)

    Di Girolamo, Guillermo; Keller, Guillermo A; de Los Santos, Antonio R; Schere, Daniel; Gonzalez, Claudio D

    2008-11-01

    Levothyroxine has a narrow therapeutic index; therefore, precise and accurate assessment of the bioequivalence of different levothyroxine products is critical. Bioavailability estimates of levothyroxine formulations might be affected by baseline concentrations of the hormone. The aim of this study was to assess the bioequivalence of 100 microg of a test (T4 Montpellier 100, Química Montpellier S.A., Buenos Aires, Argentina) and reference (Synthroid, Abbott Laboratories, Abbott Park, Illinois) formulation of levothyroxine. We also compared 2 methods of levothyroxine measurements: without and with baseline correction for endogenous levothyroxine. This randomized, open-label, 2-sequence, crossover study with a 65-day washout period was carried out in healthy, white, euthyroid volunteers following a single dose of sodium levothyroxine 600 microg. Blood samples were collected at 30 and 15 minutes prior to administration, and 0 (baseline), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, and 48 hours to determine thyroxine; serum thyrotropin (TSH) concentrations were determined 30 minutes before administration and 48 hours after administration. Serum concentrations of thyroxine were determined through radioimmunoassay and serum TSH concentrations were determined by a validated 2-site immunoradiometric assay. The formulations are considered to be equivalent if the 90% CI ratios for C(max) and AUC(0-last) are within 80% to 125%, per the US Food and Drug Administration (FDA). Adverse event monitoring was performed throughout the study by assessing clinical parameters (eg, blood pressure, electrocardiogram) and patient reports. A total of 24 volunteers (16 male, 8 female; mean [SD] age, 30.2 [4.6] years [range, 21-40 years]; mean [SD] weight, 71.71 [7.52] kg [range, 58-83 kg]) were included in the study. Without adjustment for baseline levels of endogenous levothyroxine, geometric mean C(max) for the test and reference formulations were 8.92 and 9.39 microg/dL, respectively

  11. Pharmacokinetic and bioequivalence study of a telmisartan/S-amlodipine fixed-dose combination (CKD-828) formulation and coadministered telmisartan and S-amlodipine in healthy subjects.

    Science.gov (United States)

    Kang, Woo Youl; Seong, Sook Jin; Ohk, Boram; Gwon, Mi-Ri; Kim, Bo Kyung; La, Sookie; Kim, Hyun-Ju; Cho, Seungil; Yoon, Young-Ran; Yang, Dong Heon; Lee, Hae Won

    2018-01-01

    A new fixed-dose combination (FDC) formulation of telmisartan 80 mg and S-amlodipine 5 mg (CKD-828) has been developed to increase convenience (as only one tablet is required per day) and improve treatment compliance. The pharmacokinetic characteristics and tolerability of an FDC of telmisartan and S-amlodipine were compared to those after coadministration of the individual agents in this randomized, open-label, single-dose, two-way, four-period, crossover study. To analyze the telmisartan and S-amlodipine plasma concentrations using a validated liquid chromatography-tandem mass spectrometry method, serial blood samples were collected up to 48 hours post-dose for telmisartan and 144 hours post-dose for S-amlodipine, in each period. Forty-eight healthy subjects were enrolled, and 43 completed the study. The mean peak plasma concentration (C max ) and the area under the plasma concentration-time curve from time 0 to the last measurement (AUC 0-t ) values of telmisartan were 522.29 ng/mL and 2,475.16 ng·h/mL for the FDC, and 540.45 ng/mL and 2,559.57 ng·h/mL for the individual agents concomitantly administered, respectively. The mean C max and AUC 0-t values of S-amlodipine were 2.71 ng/mL and 130.69 ng·h/mL for the FDC, and 2.74 ng/mL and 129.81 ng·h/mL for the individual agents concomitantly administered, respectively. The geometric mean ratio (GMR) and 90% confidence interval (CI) for the telmisartan C max and AUC 0-t (FDC of telmisartan and S-amlodipine/concomitant administration) were 0.8509 (0.7353-0.9846) and 0.9431 (0.8698-1.0226), respectively. The GMR and 90% CI for the S-amlodipine C max and AUC 0-t (FDC/concomitant administration) were 0.9829 (0.9143-1.0567) and 0.9632 (0.8798-1.0546), respectively. As the intrasubject variability of the C max for telmisartan administered individually was 42.94%, all 90% CIs of the GMRs fell within the predetermined acceptance range. Both treatments were well tolerated in this study. CKD-828 FDC tablets were shown to

  12. Bioequivalence of a biosimilar enoxaparin sodium to Clexane®after single 100 mg subcutaneous dose: results of a randomized, double-blind, crossover study in healthy volunteers.

    Science.gov (United States)

    Martínez González, Javier; Monreal, Mayte; Ayani Almagia, Ignacio; Llaudó Garín, Jordi; Ochoa Díaz de Monasterioguren, Lourdes; Gutierro Adúriz, Ibón

    2018-01-01

    To demonstrate the pharmacokinetic/pharmacodynamic (PK/PD) equivalence of a biosimilar enoxaparin to the reference drug, and to assess its safety and tolerability in healthy volunteers. A randomized, double-blind, crossover, 2-sequence, single-dose study was conducted in healthy volunteers of both sexes. Participants were sequentially and randomly administered single subcutaneous injections of enoxaparin 100 mg manufactured by Rovi (test; Madrid, Spain) and Clexane ® (enoxaparin 100 mg manufactured by Sanofi, reference) separated by a 1-week washout period. The primary PK/PD variables were maximum activity (A max ) and area under the effect curve from time 0 to the last measured activity (T) (AUEC 0-T ) and AUEC from time 0 to infinity (AUEC 0-inf ) of anti-FXa activity, and A max and AUEC 0-T of anti-FIIa activity. Secondary variables were A max and AUEC 0-T , AUEC 0-inf of tissue factor pathway inhibitor, and the ratio of AUEC 0-T anti-FXa to anti-FIIa activity. Biosimilarity would be shown when the 95% CI of the ratio of geometric least squares means (95% CI RGLSMs) of primary PK/PD parameters fell within the standard range of bioequivalence, ie, 80%-125%. The study sample consisted of 46 volunteers (33 males) aged 18-44 years and with body mass index ranging from 19.0 to 31.1 kg/m 2 . Three subjects did not complete the study. The curves of anti-FXa, anti-FIIa and tissue factor pathway inhibitor activities corresponding to administration of the test and reference products were comparable. The 95% CI RGLSMs of A max , AUEC 0-T and AUEC 0-inf for anti-FXa activity were 94.6%-105.9%, 99.8%-108.0% and 100.0%-108.6% respectively; A max and AUEC 0-T for anti-FIIa activity were 94.7%-112.6% and 90.9%-117.9% respectively. In addition, the 95% CI RGLSMs of all secondary variables fell within the range 80%-125%. The incidence and types of adverse events after administration of the test and reference drugs were similar. The results conclusively showed that the enoxaparin

  13. A sensitive and robust lc-ms/ms method with monolithic column and electrospray ionization for the quantitation of efavirenz in human plasma: application to a bioequivalence study

    Directory of Open Access Journals (Sweden)

    Danilo Cesar Galindo Bedor

    2011-01-01

    Full Text Available An LC-MS/MS method has been developed for the determination of efavirenz (EFZ in human plasma using hydrochlorothiazide as internal standard (I.S.. An ESI negative mode with multiple reaction-monitoring was used monitoring the transitions m/z 313.88→69.24 (EFZ and 296.02→204.76 (I.S.. Samples were extracted using liquid-liquid extraction. The total run time was 2.0 min. The separation was achieved with HPLC-RP using a monolithic column. The assay was linear in the concentration range of 100 - 5000 ng mL-1. The mean recovery was 83%. Intra- and inter-day precision were < 9.5% and < 8.9%, respectively and accuracy was in the range ± 8.33%. The method was successfully applied to a bioequivalence study.

  14. Bioequivalence studies for 2 different strengths of irbesartan/hydrochlorothiazide combination in healthy volunteers: 300/25 mg and 300/12.5 mg film-coated tablets.

    Science.gov (United States)

    Cánovas, M; Cabré, F; Polonio, F

    2014-05-01

    Two bioequivalence studies of irbesartan (CAS 138402-11-6) and hydrochlorothiazide (CAS 58-93-5) combination at 300/12.5 mg and 300/25 mg strengths were carried out in order to assess the bioequivalence of these film-coated tablet formulations in comparison with the marketed reference formulations.Both studies were performed with 30 healthy volunteers according to an open label, randomized, 2-period, 2-sequence, crossover, single dose and fasting conditions design. In each study, test and reference formulations were administered in 2 treatment days, separated by a washout period of 7 days. Blood samples were drawn up to 72 h following drug administration in case of irbesartan and up to 24 h in case of hydrochlorothiazide. Plasma concentrations of both analytes were obtained by a validated HPLC method using MS/MS detection. Log-transformed AUC0-t and Cmax values were tested for bioequivalence based on the ratios of the geometric LSmeans (test/reference).For both studies, the 90% confidence intervals of the geometric LSmean values for the test/reference ratios for AUC0-t [(irbesartan: 300/12.5 mgstrength: 95.33-111.74%. 300/25 mg strength: 91.27-103.93%) (hydrochlorothiazide: 300/12.5 mg strength: 99.63-107.50%. 300/25 mg strength: 95.72-102.24%)] and Cmax [(irbesartan: 300/12.5 mg strength: 98.73-115.03%. 300/25 mg strength: 97.27-112.12%) (hydrochlorothiazide: 300/12.5 mg strength: 97.34-112.06%. 300/25 mg strength: 93.29-106.38%)] were within the bio-equivalence acceptance range of 80-125%.According to the European Guideline on the Investigation of Bioequivalence it may be therefore concluded that both test formulations are bioequivalent to the corresponding reference formulations. Overall, it was judged that both studies were conducted with a good tolerance of the subjects to study drugs. © Georg Thieme Verlag KG Stuttgart · New York.

  15. 21 CFR 320.21 - Requirements for submission of bioavailability and bioequivalence data.

    Science.gov (United States)

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS... that there may be bioequivalence issues or concerns with the product, FDA may require that the... special patient population, e.g., infants, if clinical studies are required to support the new or...

  16. Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial.

    Directory of Open Access Journals (Sweden)

    Rita R Alloway

    2017-11-01

    Administration (FDA average bioequivalence (ABE acceptance criteria of a 90% confidence interval contained within the confidence limits of 80.00% and 125.00%. Within-subject variability was similar for the area under the curve (AUC (range 12.11-15.81 and the concentration maximum (Cmax (range 17.96-24.72 for all products. The within-subject variability was utilized to calculate the scaled average bioequivalence (SCABE 90% confidence interval. The calculated SCABE 90% confidence interval was 84.65%-118.13% and 80.00%-125.00% for AUC and Cmax, respectively. The more stringent SCABE acceptance criteria were met for all product comparisons for AUC and Cmax in both individuals with a kidney transplant and those with a liver transplant. European Medicines Agency (EMA acceptance criteria for narrow therapeutic index drugs were also met, with the only exception being in the case of Brand versus Generic Lo, in which the upper limits of the 90% confidence intervals were 111.30% (kidney and 112.12% (liver. These were only slightly above the upper EMA acceptance criteria limit for an AUC of 111.11%. SCABE criteria were also met for the major tacrolimus metabolite 13-O-desmethyl tacrolimus for AUC, but it failed the EMA criterion. No acute rejections, no differences in renal function in all individuals, and no differences in liver function were observed in individuals with a liver transplant using the Tukey honest significant difference (HSD test for multiple comparisons. Fifty-two percent and 65% of all individuals with a kidney or liver transplant, respectively, reported an adverse event. The Exact McNemar test for paired categorical data with adjustments for multiple comparisons was used to compare adverse event rates among the products. No statistically significant differences among any pairs of products were found for any adverse event code or for adverse events overall. Limitations of this study include that the observations were made under strictly controlled conditions that did not

  17. Estudio de bioequivalencia de clonazepam, tabletas de 2 mg, en voluntarios sanos colombianos Bioequivalence study of clonazepam 2 mg tablets in colombian healthy volunteers

    Directory of Open Access Journals (Sweden)

    Victoria Eugenia Toro Pareja

    2007-08-01

    Full Text Available Con el fin de determinar la bioequivalencia de dos formulaciones de tabletas de 2 mg de clonazepam: Sedatril®/Clonazepam MK (Tecnoquímicas S. A., Cali, Colombia como producto de prueba y Rivotril® (Roche Químicos e Farmacéuticas S. A., Río de Janeiro, Brasil, como producto de referencia, se realizó un estudio de bioequivalencia en 26 voluntarios sanos. Los productos de prueba y de referencia se administraron en condiciones de ayuno de acuerdo con un diseño cruzado aleatorio de dosis única, con dos secuencias, dos tratamientos y un período de lavado de 28 días. Las muestras de sangre se obtuvieron desde las 0 hasta las 96 horas después de la administración del medicamento. Los niveles plasmáticos de clonazepam se determinaron con un método validado por cromatografía líquida de alta eficiencia con detección ultravioleta (HPLC/UV, siglas en inglés. Los parámetros farmacocinéticos ABC0-96, ABC0-∞, Cmax, Tmax, t1/2, and ke se determinaron de los perfiles plasmáticos concentración-tiempo por el método no compartimental. El test de bioequivalencia se realizó con los datos transformados a logaritmo natural (ln de ABC0-∞and Cmax. Los intervalos de confianza del 90% para la relación producto de prueba/producto de referencia fueron de 87,9% a 103,6% y 84,4% a 104,0%, respectivamente. Estos resultados estuvieron dentro de los rangos de aceptación del 80,0% al 125%, establecidos por la FDA y se concluyó que ambos productos son bioequivalentes. In order to determine the bioequivalence of two formulations of clonazepam 2 mg tablets: Sedatril®/ Clonazepam MK (Tecnoquímicas S. A., Cali, Colombia as a test product and Rivotril® (Roche Químicos e Farmacêuticas S. A., Rio de Janeiro, Brazil as a reference product, a bioavailability study was performed in 26 healthy volunteers. Test and reference products were administered under fasting conditions following a single dose, two-sequences, two treatments, crossover randomized

  18. Bioequivalence of eslicarbazepine acetate from two different sources of its active product ingredient in healthy subjects.

    Science.gov (United States)

    Falcão, Amílcar; Lima, Ricardo; Sousa, Rui; Nunes, Teresa; Soares-da-Silva, Patrício

    2013-06-01

    To compare the bioavailability (BA) and pharmacokinetic (PK) properties and to demonstrate the bioequivalence (BE) between two active product ingredient (API) sources of eslicarbazepine acetate (ESL) in healthy volunteers. Forty healthy male and female subjects aged 18-40 years were randomized to treatment with 400 or 800 mg ESL marketed (MF) formulation [current active pharmaceutical ingredient (API) source] and 400 or 800 mg ESL to-be-marketed (TBM) formulation (new API source) under a gender-balanced, two-period, two-sequence crossover open-label study design. Subjects were assigned to receive either 400 or 800 mg ESL dose strengths, and each was randomly administered on two occasions--either a single oral tablet of MF or a single oral tablet of TBM--separated by a washout period of at least 7 days. Formulations were to be considered bioequivalent if, for both 400 or 800 mg ESL dosage strengths, the test (TBM)/reference (MF) geometric mean ratios (GMR) and 90% confidence intervals (90% CI) of the area under the plasma concentration-time curve (AUC) and peak plasma concentration (Cmax) were within the predetermined range of 80-125%. Test/reference GMR (90% CI) for the Cmax and AUC was respectively 100% (94-109%) and 96% (94-98%) following 400 mg ESL and 100% (95-105%) and 100% (97-103%) following 800 mg ESL. Oral tablet formulations of either 400 or 800 mg ESL from the new API source were found to be bioequivalent to the corresponding marketed Zebinix® formulation according to the regulatory definition of bioequivalence.

  19. Bioequivalence study between a fixed-dose single-pill formulation of nebivolol plus hydrochlorothiazide and separate formulations in healthy subjects using high-performance liquid chromatography coupled to tandem mass spectrometry.

    Science.gov (United States)

    Vespasiano, Celso Francisco Pimentel; Laurito, Tiago Luders; Iwamoto, Renan Donomae; Moreno, Ronilson Agnaldo; Mendes, Gustavo D; De Nucci, Gilberto

    2017-05-01

    Systemic arterial hypertension is a major risk factor for cerebrovascular disease. Therefore, adequate control of blood pressure is of enormous importance. One of the many fixed-dose single-pill antihypertensive formulations available on the market is the combination of nebivolol and hydrochlorothiazide. The objective of this study was to develop two distinct high-performance liquid chromatography coupled to tandem mass spectrometry methods to simultaneously quantify nebivolol and hydrochlorothiazide in human plasma. The methods were employed in a bioequivalence study, the first assay involving a nebivolol fixed-dose single-pill formulation based on healthy Brazilian volunteers. Nebilet HCT™ (nebivolol 5 mg + hydrochlorothiazide 12.5 mg tablet, manufactured by Menarini) was the test formulation. The reference formulations were Nebilet™ (nebivolol 5 mg tablet, manufactured by Menarini) and Clorana™ (hydrochlorothiazide 25 mg tablet, manufactured by Sanofi). For both analytes, liquid-liquid extraction was employed for sample preparation and the chromatographic run time was 3.5 min. The limits of quantification validated were 0.02 ng/mL for nebivolol and 1 ng/mL for hydrochlorothiazide. Since the 90% CI for C max , AUC (0-last) and AUC (0-inf) individual test/reference ratios were within the 80-125% interval indicative of bioequivalence, it was concluded that Nebilet HCT™ is bioequivalent to Nebilet™ and Clorana™. Copyright © 2016 John Wiley & Sons, Ltd.

  20. Pharmacokinetic and bioequivalence study of a telmisartan/S-amlodipine fixed-dose combination (CKD-828 formulation and coadministered telmisartan and S-amlodipine in healthy subjects

    Directory of Open Access Journals (Sweden)

    Kang WY

    2018-03-01

    Full Text Available Woo Youl Kang,1,2,* Sook Jin Seong,1,* Boram Ohk,1,2 Mi-Ri Gwon,1,3 Bo Kyung Kim,1,2 Sookie La,4 Hyun-Ju Kim,3 Seungil Cho,1 Young-Ran Yoon,1,2 Dong Heon Yang,5 Hae Won Lee1 1Clinical Trial Center, Kyungpook National University Hospital, Daegu, Republic of Korea; 2Department of Biomedical Science, BK21 Plus KNU Bio-Medical Convergence Program for Creative Talent, Kyungpook National University Graduate School, Daegu, Republic of Korea; 3Department of Molecular Medicine, Cell and Matrix Research Institute, Kyungpook National University School of Medicine, Daegu, Republic of Korea; 4Analytical Research Division, Biocore Co Ltd, Seoul, Republic of Korea; 5Division of Cardiology, Department of Internal Medicine, Kyungpook National University School of Medicine & Hospital, Daegu, Republic of Korea *These authors contributed equally to this work Purpose: A new fixed-dose combination (FDC formulation of telmisartan 80 mg and S-amlodipine 5 mg (CKD-828 has been developed to increase convenience (as only one tablet is required per day and improve treatment compliance.Methods: The pharmacokinetic characteristics and tolerability of an FDC of telmisartan and S-amlodipine were compared to those after coadministration of the individual agents in this randomized, open-label, single-dose, two-way, four-period, crossover study. To analyze the telmisartan and S-amlodipine plasma concentrations using a validated liquid chromatography–tandem mass spectrometry method, serial blood samples were collected up to 48 hours post-dose for telmisartan and 144 hours post-dose for S-amlodipine, in each period.Results: Forty-eight healthy subjects were enrolled, and 43 completed the study. The mean peak plasma concentration (Cmax and the area under the plasma concentration–time curve from time 0 to the last measurement (AUC0–t values of telmisartan were 522.29 ng/mL and 2,475.16 ng⋅h/mL for the FDC, and 540.45 ng/mL and 2,559.57 ng⋅h/mL for the individual agents

  1. Bioequivalence of a biosimilar enoxaparin sodium to Clexane® after single 100 mg subcutaneous dose: results of a randomized, double-blind, crossover study in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Martínez González J

    2018-03-01

    Full Text Available Javier Martínez González, Mayte Monreal, Ignacio Ayani Almagia, Jordi Llaudó Garín, Lourdes Ochoa Díaz de Monasterioguren, Ibón Gutierro Adúriz R&D Department, Laboratorios Farmacéuticos Rovi S.A., Madrid, Spain Purpose: To demonstrate the pharmacokinetic/pharmacodynamic (PK/PD equivalence of a biosimilar enoxaparin to the reference drug, and to assess its safety and tolerability in healthy volunteers. Patients and methods: A randomized, double-blind, crossover, 2-sequence, single-dose study was conducted in healthy volunteers of both sexes. Participants were sequentially and randomly administered single subcutaneous injections of enoxaparin 100 mg manufactured by Rovi (test; Madrid, Spain and Clexane® (enoxaparin 100 mg manufactured by Sanofi, reference separated by a 1-week washout period. The primary PK/PD variables were maximum activity (Amax and area under the effect curve from time 0 to the last measured activity (T (AUEC0–T and AUEC from time 0 to infinity (AUEC0–inf of anti-FXa activity, and Amax and AUEC0–T of anti-FIIa activity. Secondary variables were Amax and AUEC0–T, AUEC0–inf of tissue factor pathway inhibitor, and the ratio of AUEC0–T anti-FXa to anti-FIIa activity. Biosimilarity would be shown when the 95% CI of the ratio of geometric least squares means (95% CI RGLSMs of primary PK/PD parameters fell within the standard range of bioequivalence, ie, 80%–125%.Results: The study sample consisted of 46 volunteers (33 males aged 18–44 years and with body mass index ranging from 19.0 to 31.1 kg/m2. Three subjects did not complete the study. The curves of anti-FXa, anti-FIIa and tissue factor pathway inhibitor activities corresponding to administration of the test and reference products were comparable. The 95% CI RGLSMs of Amax, AUEC0–T and AUEC0–inf for anti-FXa activity were 94.6%–105.9%, 99.8%–108.0% and 100.0%–108.6% respectively; Amax and AUEC0–T for anti-FIIa activity were 94.7%–112.6% and

  2. Determination of torasemide in human plasma and its bioequivalence study by high-performance liquid chromatography with electrospray ionization tandem mass spectrometry

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    Lin Zhang

    2016-04-01

    Full Text Available A sensitive and selective method using high-performance liquid chromatography coupled with electrospray ionization tandem mass spectrometry (HPLC–ESI–MS to determine the concentration of torasemide in human plasma samples was developed and validated. Tolbutamide was chosen as the internal standard (IS. The chromatography was performed on a Gl Sciences Inertsil ODS-3 column (100 mm×2.1 mm i.d., 5.0 µm within 5 min, using methanol with 10 mM ammonium formate (60:40, v/v as mobile phase at a flow rate of 0.2 mL/min. The targeted compound was detected in negative ionization at m/z 347.00 for torasemide and 269.00 for IS. The linearity range of this method was found to be within the concentration range of 1–2500 ng/mL (r=0.9984 for torasemide in human plasma. The accuracy of this measurement was between 94.05% and 103.86%. The extracted recovery efficiency was from 84.20% to 86.47% at three concentration levels. This method was also successfully applied in pharmacokinetics and bioequivalence studies in Chinese volunteers.

  3. Development and validation of an improved method for the quantitation of sertraline in human plasma using LC-MS-MS and its application to bioequivalence studies.

    Science.gov (United States)

    Zhang, Mengliang; Gao, Feng; Cui, Xiangyong; Zhang, Yunhui; Sun, Yantong; Gu, Jingkai

    2011-02-01

    A rapid and sensitive LC-MS-MS method for the quantitation of sertraline in human plasma was developed and validated. Sertraline and the internal standard, telmisartan, were cleaned up by protein precipitation from 100 μL of plasma sample, and analyzed on a TC-C18 column (5 μm, 150 × 4.6 mm i.d.) using 70% acetonitrile and 30% 10 mM ammonium acetate (0.1% formic acid) as mobile phase. The method was demonstrated to be linear from 0.1 ng/mL to 50 ng/mL with the lower limit of quantitation of 0.1 ng/mL. Intra- and inter-day precision were below 4.40% and 3.55%. Recoveries of sertraline at low, medium, and high levels were 88.0 ± 2.3%, 88.2 ± 1.9%, and 90.0 ± 2.0%, respectively. The method was successfully applied to a bioequivalence study of sertraline after a single oral administration of 50 mg sertraline hydrochloride tablets.

  4. Simultaneous determination of irbesartan and hydrochlorothiazide in human plasma by ultra high performance liquid chromatography tandem mass spectrometry and its application to a bioequivalence study.

    Science.gov (United States)

    Qiu, Xiangjun; Wang, Zhe; Wang, Bing; Zhan, Hui; Pan, Xiaofeng; Xu, Ren-ai

    2014-04-15

    An ultra high performance liquid chromatography tandem mass spectrometry (U-HPLC-MS/MS) method was developed and validated to determine irbesartan (IRB) and hydrochlorothiazide (HCTZ) in human plasma simultaneously. Plasma samples were prepared using protein precipitation with acetonitrile, the two analytes and the internal standard losartan were separated on an Acquity U-HPLC BEH C18 column and mass spectrometric analysis was performed using a QTrap5500 mass spectrometer coupled with an electro-spray ionization (ESI) source in the negative ion mode. The MRM transitions of m/z 427.2→206.9 and m/z 296.1→204.9 were used to quantify for IRB and HCTZ, respectively. The linearity of this method was found to be within the concentration range of 5-3000ng/mL for IRB, and 0.5-300ng/mL for HCTZ in human plasma, respectively. The lower limit of quantification (LLOQ) was 5ng/mL and 0.5ng/mL for IRB and HCTZ in human plasma, respectively. The relative standard deviations (RSD) of intra and inter precision were less than 12% for both IRB and HCTZ. The analysis time of per sample was 2.5min. The developed and validated method was successfully applied to a bioequivalence study of IRB (300mg) with HCTZ (12.5mg) tablet in Chinese healthy volunteers (N=20). Copyright © 2014 Elsevier B.V. All rights reserved.

  5. Application of a rapid and sensitive liquid chromatography-tandem mass spectrometry method for determination of bumetanide in human plasma for a bioequivalence study.

    Science.gov (United States)

    Patel, Dinesh S; Sharma, Naveen; Patel, Mukesh C; Patel, Bhavin N; Shrivastav, Pranav S; Sanyal, Mallika

    2012-07-01

    A rapid, selective and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay has been proposed for the determination of bumetanide in human plasma using tamsulosin as internal standard (IS). The analyte and IS were extracted from 200 μL of human plasma via solid phase extraction and the chromatographic separation was achieved on Peerless Basic C18 (100 mm × 4.6 mm, 3 μm) column under isocratic conditions. Detection of bumetanide and IS was done by tandem mass spectrometry, operating in positive ionization and multiple reaction monitoring (MRM) acquisition mode. The protonated precursor to product ion transitions monitored for bumetanide and IS were m/z 365.2→240.2 and 409.2→228.2 respectively. The method was fully validated as per the US FDA guidelines. The limit of detection and lower limit of quantitation of the method were 0.03 and 0.30 ng/mL respectively with a linear dynamic range of 0.30-200.0 ng/mL for bumetanide. The intra-batch and inter-batch precision (% CV) was ≤6.9% while the mean extraction recovery was >90% across quality control levels. The method is selective in presence of four diuretic drugs and some commonly used medications by healthy volunteers. It was successfully applied to a bioequivalence study of 2mg bumetanide tablet formulation in 10 healthy Indian male subjects under fasting condition. The reproducibility in the measurement of study data was demonstrated by reanalysis of 42 incurred samples. Copyright © 2012 Elsevier B.V. All rights reserved.

  6. A simple and sensitive HPLC method for analysis of imipramine in human plasma with UV detection and liquid-liquid extraction: Application in bioequivalence studies.

    Science.gov (United States)

    Rezazadeh, Mahboubeh; Emami, Jaber

    2016-01-01

    High-performance liquid chromatography (HPLC) methods employing ultraviolet (UV) detector are not sufficiently sensitive to measure the low plasma concentrations following single oral dose of imipramine. Therefore, in the present study a simple, rapid and yet sensitive HPLC method with UV detection was developed and validated for quantitation of imipramine in human plasma samples. An efficient liquid-liquid extraction (LLE) of imipramine from plasma with the mixture of hexane/isoamyl alcohol (98:2) and back extraction of the drug in acidic medium concomitant with evaporation of organic phase allowed the use of UV detector to conveniently measure plasma levels of this compound as low level as 3 ng/ml. Separation was achieved on a μ-Bondapak C18 HPLC column using sodium hydrogen phosphate solution (0.01 M)/acetonitrile (60/40 v/v) at pH 3.5 ± 0.1 at 1.5 ml/min. Trimipramine was used as the internal standard for analysis of plasma samples. The retention times for imipramine and trimipramine were 4.3 and 5.2 min, respectively. Calibration curve was linear in the range of 3-40 ng/ml using human plasma with the average extraction recovery of 85 ± 5%. Imipramine was found to be stable in plasma samples with no evidence of degradation during three freeze-thaw cycles and three months storage at -70°C. The current validated method was finally applied in bioequivalence studies of two different imipramine products according to a standard two-way crossover design with a two weeks washout period.

  7. 78 FR 46965 - Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories...

    Science.gov (United States)

    2013-08-02

    ...] Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories... (BE) studies to support abbreviated new drug applications (ANDAs) for mesalamine rectal suppositories... the availability of a draft guidance on mesalamine (Draft Mesalamine Rectal Suppository BE...

  8. 78 FR 73200 - Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended...

    Science.gov (United States)

    2013-12-05

    ... Paliperidone Palmitate Extended-Release Injectable Suspension; Availability AGENCY: Food and Drug... Paliperidone Palmitate.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for paliperidone palmitate extended-release...

  9. SPE–UPLC–MS/MS assay for determination of letrozole in human plasma and its application to bioequivalence study in healthy postmenopausal Indian women

    Directory of Open Access Journals (Sweden)

    Pravin G. Vanol

    2016-08-01

    Full Text Available A rapid and sensitive ultra performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS method is described for determination of letrozole in human plasma. Following solid phase extraction (SPE of letrozole and letrozole-d4 on Orochem DVB-LP cartridges, chromatography was performed on Acquity UPLC BEH C18 (50 mm×2.1 mm, 1.7 µm column using methanol-0.1% formic acid in water (85:15, v/v as the mobile phase. Detection was carried out on a triple quadrupole mass spectrometer with an electrospray source, operated under positive ionization mode. Quantitation of letrozole and letrozole-d4 was done using multiple reaction monitoring (MRM following the transitions at m/z 286.2→217.0 and m/z 290.2→221.0, respectively. The calibration plots were linear through the concentration range of 0.10–100 ng/mL (r2≥0.9990 using 100 µL human plasma. The extraction recovery of letrozole ranged from 94.3% to 96.2% and the intra-batch and inter-batch precision was ≤5.2%. The method was successfully applied to a bioequivalence study of letrozole after oral administration of 2.5 mg tablet formulation to 16 healthy postmenopausal Indian women. The assay reproducibility was also established through incurred sample reanalysis (ISR of 74 subject samples.

  10. Application of an LC–MS/MS method for the analysis of amlodipine, valsartan and hydrochlorothiazide in polypill for a bioequivalence study

    Directory of Open Access Journals (Sweden)

    Jaivik V. Shah

    2017-10-01

    Full Text Available A sensitive and selective method has been proposed for the simultaneous determination of amlodipine (AML, valsartan (VAL and hydrochlorothiazide (HCTZ in human plasma by liquid chromatography–tandem mass spectrometry (LC–MS/MS. The analytes and their deuterated analogs were quantitatively extracted from 100 µL human plasma by solid phase extraction on Oasis HLB cartridges. The chromatographic separation of the analytes was achieved on a Chromolith RP18e (100 mm × 4.6 mm analytical column within 2.5 min. The resolution factor between AML and VAL, AML and HCTZ, and VAL and HCTZ was 2.9, 1.5 and 1.4, respectively, under isocratic conditions. The method was validated over a dynamic concentration range of 0.02–20.0 ng/mL for AML, 5.00–10,000 ng/mL for VAL and 0.20–200 ng/mL for HCTZ. Ion-suppression/enhancement effects were investigated by post-column infusion technique. The mean IS-normalized matrix factors for AML, VAL and HCTZ were 0.992, 0.994 and 0.998, respectively. The intra-batch and inter-batch precision (% CV across quality control levels was ≤ 5.56% and the recovery was in the range of 93.4%–99.6% for all the analytes. The method was successfully applied to a bioequivalence study of 5 mg AML + 160 mg VAL + 12.5 mg HCTZ tablet formulation (test and reference in 18 healthy Indian males under fasting. The mean log-transformed ratios of Cmax, AUC0–120h and AUC0-inf and their 90% CIs were within 90.2%–102.1%. The assay reproducibility was demonstrated by reanalysis of 90 incurred samples.

  11. Bioequivalence of generic alendronate sodium tablets (70 mg to Fosamax® tablets (70 mg in fasting, healthy volunteers: a randomized, open-label, three-way, reference-replicated crossover study

    Directory of Open Access Journals (Sweden)

    Zhang Y

    2017-07-01

    Full Text Available Yifan Zhang,1 Xiaoyan Chen,1 Yunbiao Tang,2 Youming Lu,1 Lixia Guo,1 Dafang Zhong1 1State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 2Department of Pharmacy, The General Hospital of Shenyang Military Region, Shenyang, People’s Republic of China Purpose: The aim of this study was to evaluate the bioequivalence of a generic product 70 mg alendronate sodium tablets with the reference product Fosamax® 70 mg tablet. Materials and methods: A single-center, open-label, randomized, three-period, three-sequence, reference-replicated crossover study was performed in 36 healthy Chinese male volunteers under fasting conditions. In each study period, the volunteers received a single oral dose of the generic or reference product (70 mg. Blood samples were collected at pre-dose and up to 8 h after administration. The bioequivalence of the generic product to the reference product was assessed using the US Food and Drug Administration (FDA and European Medicines Agency (EMA reference-scaled average bioequivalence (RSABE methods. Results: The average maximum concentrations (Cmax of alendronic acid were 64.78±43.76, 56.62±31.95, and 60.15±37.12 ng/mL after the single dose of the generic product and the first and second doses of the reference product, respectively. The areas under the plasma concentration–time curves from time 0 to the last timepoint (AUC0–t were 150.36±82.90, 148.15±85.97, and 167.11±110.87 h·ng/mL, respectively. Reference scaling was used because the within-subject standard deviations of the reference product (sWR for Cmax and AUC0–t were all higher than the cutoff value of 0.294. The 95% upper confidence bounds were -0.16 and -0.17 for Cmax and AUC0–t, respectively, and the point estimates for the generic/reference product ratio were 1.08 and 1.00, which satisfied the RSABE acceptance criteria of the FDA. The 90% CIs for Cmax and AUC0–t were 90.35%–129

  12. The steady-state serum concentration of genistein aglycone is affected by formulation: a bioequivalence study of bone products.

    Science.gov (United States)

    Bitto, Alessandra; Burnett, Bruce P; Polito, Francesca; Russo, Silvia; D'Anna, Rosario; Pillai, Lakshmi; Squadrito, Francesco; Altavilla, Domenica; Levy, Robert M

    2013-01-01

    An FDA-regulated, prescription medical food (Fosteum; 27 mg natural genistein, 200 IU cholecalciferol, 20 mg citrated zinc bisglycinate (4 mg elemental zinc) per capsule) and an over-the-counter (OTC) supplement (Citracal Plus Bone Density Builder; 27 mg synthetic genistein, 600 mg elemental calcium (calcium citrate), 400 IU vitamin D3, 50 mg magnesium, 7.5 mg zinc, 1 mg copper, 75 μ g molybdenum, 250 μ g boron per two tablets) were compared to a clinically proven bone formulation (27 mg natural genistein, 400 IU cholecalciferol, 500 mg elemental calcium (calcium carbonate) per tablet; the Squadrito formulation) in an 8-day steady-state pharmacokinetic (PK) study of healthy postmenopausal women (n = 30) randomized to receive 54 mg of genistein per day. Trough serum samples were obtained before the final dose on the morning of the ninth day followed by sampling at 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hrs. Total serum genistein, after β -glucuronidase/sulfatase digestion, was measured by time-resolved fluorometric assay. Maximal time (Tmax), concentration (Cmax), half-life (T1/2), and area under the curve (AUC) were determined for genistein in each formulation. Fosteum and the Squadrito study formulation were equivalent for genistein Tmax (2 hrs), Cmax (0.7 μM), T1/2 (18 ± 6.9 versus 21 ± 4.9 hrs), and AUC (9221 ± 413 versus 9818 ± 1370 ng·hr/mL). The OTC supplement's synthetically derived genistein, however, showed altered Tmax (6 hrs), Cmax (0.57 μ M), T1/2 (8.3 ± 1.9 hrs), and AUC (6474 ± 287 ng·hr/mL). Differences in uptake may be due to multiple ingredients in the OTC supplement which interfere with genistein absorption.

  13. Bioequivalence evaluation of two brands of aceclofenac 100 mg tablets (Aceclofar and Bristaflam) in healthy human volunteers.

    Science.gov (United States)

    Najib, Naji; Idkaidek, Nasir; Beshtawi, M; Bader, Mohammed; Admour, Isra'; Alam, S Mahmood; Zaman, Q; Dham, Ruwayda

    2004-04-01

    A randomized, two-way, crossover, bioequivalence study in 24 fasting, healthy, male volunteers was conducted to compare two brands of aceclofenac 100 mg tablets, Aceclofar (Julphar, UAE) as test and Bristaflam (Bristol Myers Squibb, Egypt) as the reference product. The drug was administered with 240 ml of water after a 10 h overnight fast on two treatment days separated by 1 week washout period. After dosing, serial blood samples were collected for a period of 24 h. Plasma harvested from blood was analysed for aceclofenac by a validated HPLC method with UV-visible detection capable of detecting aceclofenac in the range 0.2-8.0 microg/ml with the limit of quantitation as 0.2 microg/ml. Various pharmacokinetic parameters including AUC(0-t), AUC(0- infinity ), C(max), T(max), T(1/2), and lambda(Z) were determined from plasma concentrations for both formulations and found to be in good agreement with reported values. AUC(0-t), AUC(0- infinity), and C(max) were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval (100.0%-106.4% for AUC(0-t), 100.2%-106.8% for AUC(0- infinity ); 83.3%-102.8% for C(max)) of test/reference ratio for these parameters were found to be within the bioequivalence acceptance range of 80%-125%. Based on these statistical inferences, it was concluded that Aceclofar is bioequivalent to Bristaflam. Copyright 2004 John Wiley & Sons, Ltd.

  14. Scientific perspectives on extending the provision for waivers of in vivo bioavailability and bioequivalence studies for drug products containing high solubility-low permeability drugs (BCS-Class 3).

    Science.gov (United States)

    Stavchansky, Salomon

    2008-06-01

    Recently, there has been increased interest in extending the provision for waivers of in vivo bioavailability and bioequivalence (BA-BE) studies that appeared in the guidance published by the Food and Drug Administration (FDA) (1) to pharmaceutical products containing Class 3 drugs (High solubility-Low Permeability). The extension of the Biopharmaceutics Classification System (BCS) to Class 3 drugs is meritorious because of its impact on public health policy considerations. The rate limiting step in the absorption of Class 3 drugs is the permeability through the intestinal membrane. This commentary will focus its attention on the scientific considerations which need to be examined to assess the risk and the benefit prior to granting a waiver of in vivo bioavailability and/or bioequivalence studies for Class 3 drugs. It will examine the forces affecting the interconnectivity of the neuronal, immunological and hormonal systems in the gastrointestinal tract that may affect its permeability and functionality. It will also challenge the assumption that in vitro dissolution and in vitro permeability studies in tissue cultures in the presence and absence of excipients are good predictors for in vivo dissolution and in vivo permeability which are at the heart of the BCS.

  15. The Steady-State Serum Concentration of Genistein Aglycone Is Affected by Formulation: A Bioequivalence Study of Bone Products

    Directory of Open Access Journals (Sweden)

    Alessandra Bitto

    2013-01-01

    Full Text Available An FDA-regulated, prescription medical food (Fosteum; 27 mg natural genistein, 200 IU cholecalciferol, 20 mg citrated zinc bisglycinate (4 mg elemental zinc per capsule and an over-the-counter (OTC supplement (Citracal Plus Bone Density Builder; 27 mg synthetic genistein, 600 mg elemental calcium (calcium citrate, 400 IU vitamin D3, 50 mg magnesium, 7.5 mg zinc, 1 mg copper, 75 μg molybdenum, 250 μg boron per two tablets were compared to a clinically proven bone formulation (27 mg natural genistein, 400 IU cholecalciferol, 500 mg elemental calcium (calcium carbonate per tablet; the Squadrito formulation in an 8-day steady-state pharmacokinetic (PK study of healthy postmenopausal women (n=30 randomized to receive 54 mg of genistein per day. Trough serum samples were obtained before the final dose on the morning of the ninth day followed by sampling at 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hrs. Total serum genistein, after β-glucuronidase/sulfatase digestion, was measured by time-resolved fluorometric assay. Maximal time (Tmax, concentration (Cmax, half-life (T1/2, and area under the curve (AUC were determined for genistein in each formulation. Fosteum and the Squadrito study formulation were equivalent for genistein Tmax (2 hrs, Cmax (0.7 μM, T1/2 (18±6.9 versus 21±4.9 hrs, and AUC (9221±413 versus 9818±1370 ng·hr/mL. The OTC supplement’s synthetically derived genistein, however, showed altered Tmax (6 hrs, Cmax (0.57 μM, T1/2 (8.3±1.9 hrs, and AUC (6474±287 ng·hr/mL. Differences in uptake may be due to multiple ingredients in the OTC supplement which interfere with genistein absorption.

  16. Solid state NMR and bioequivalence comparison of the pharmacokinetic parameters of two formulations of clindamycin

    KAUST Repository

    Al-Talla, Zeyad

    2011-01-01

    Objective: The purpose of this study was to compare the pharmacokinetic parameters and determine the bioequivalence of a generic formulation of clindamycin that is sold in the local markets in the Middle East (Clindox® 150 mg capsule; test) with a reference formulation (Dalacin C® 150 mg capsule) in healthy adult male volunteers. Methods: A single-dose, open-label, 2-period crossover study was conducted. Healthy male volunteers were randomly assigned to oral administration of a single treatment of the reference and test formulations. The same groups were given the alternate formulation. After dosing, serial blood samples were withdrawn for a period of 24 h. Serum harvested from the blood samples was analyzed for clindamycin by high performance liquid chromatography (HPLC) with ultraviolet detection. Pharmacokinetic parameters, including AUC0-∞, AUC 0-t, Cmax, Ke, tmax and t 1/2 were determined from the serum concentrations for both formulations (test and reference). The products were tested for bioequivalence after log-transformation of the data. Results: 24 healthy adult male volunteers from Jordan (mean [SD] age, 28.8 (7.7) years (range 19-45 years); height, 175.8 (10.6) cm (range 159.0-192.0 cm); weight, 75.6 (11.0) kg (range 58-101 kg); and body mass index, 24.4 (1.8) kg/m2 (range 21.3-28 kg/m2)) were enrolled in and completed the study. The 13C NMR spectra for both Dalacin C® and Clindox® showed 18 distinct lines associated with the 18 different carbon atoms. Conclusion: The statistical comparison suggested that Clindox® capsules are bioequivalent to Dalacin C® capsules. The 13C CPMAS results confirmed that the two drugs exhibit typical clindamycin spectra. ©2011 Dustri-Verlag Dr. K. Feistle.

  17. Solid state NMR and bioequivalence comparison of the pharmacokinetic parameters of two formulations of clindamycin.

    Science.gov (United States)

    Al-Talla, Z A; Akrawi, S H; Emwas, A-H M

    2011-07-01

    The purpose of this study was to compare the pharmacokinetic parameters and determine the bioequivalence of a generic formulation of clindamycin that is sold in the local markets in the Middle East (Clindox® 150 mg capsule; test) with a reference formulation (Dalacin C® 150 mg capsule) in healthy adult male volunteers. A single-dose, open-label, 2-period crossover study was conducted. Healthy male volunteers were randomly assigned to oral administration of a single treatment of the reference and test formulations. The same groups were given the alternate formulation. After dosing, serial blood samples were withdrawn for a period of 24 h. Serum harvested from the blood samples was analyzed for clindamycin by high performance liquid chromatography (HPLC) with ultraviolet detection. Pharmacokinetic parameters, including AUC(0-∞), AUC(0-t), C(max), K(e), tmax and t(1/2) were determined from the serum concentrations for both formulations (test and reference). The products were tested for bioequivalence after log-transformation of the data. 24 healthy adult male volunteers from Jordan (mean [SD] age, 28.8 (7.7) years (range 19 - 45 years); height, 175.8 (10.6) cm (range 159.0 - 192.0 cm); weight, 75.6 (11.0) kg (range 58 - 101 kg); and body mass index, 24.4 (1.8) kg/m² (range 21.3 - 28 kg/m²) were enrolled in and completed the study. The 13C NMR spectra for both Dalacin C® and Clindox® showed 18 distinct lines associated with the 18 different carbon atoms. The statistical comparison suggested that Clindox® capsules are bioequivalent to Dalacin C® capsules. The 13C CPMAS results confirmed that the two drugs exhibit typical clindamycin spectra.

  18. Pharmacokinetic comparison and bioequivalence evaluation of losartan/ hydrochlorothiazide tablet between Asian Indian and Japanese volunteers.

    Science.gov (United States)

    Kumar, Sudershan; Monif, Tausif; Khuroo, Arshad; Reyar, Simrit; Jain, Rakesh; Singla, Ajay K; Kurachi, Kazuya

    2014-01-01

    as a single oral dose when administered to healthy adult subjects under fasted conditions. Although Asian Indian and Japanese volunteers are ethnically different, results of these studies indicate that pharmacokinetic parameters of Asian Indian and Japanese volunteers are comparable to each other in terms of bioavailability of losartan, losartan carboxylic acid and hydrochlorothiazide. Similar least square means ratios were obtained in Asian Indian and Japanese volunteers demonstrating that a bioequivalence study conducted on Japanese volunteers seems to be substituted by Asian Indian volunteers' studies.

  19. Pharmacokinetic properties and bioequivalence of two compound formulations of 1500 mg ampicillin (1167 mg)/probenecid (333 mg): a randomized-sequence, single-dose, open-label, two-period crossover study in healthy Chinese male volunteers.

    Science.gov (United States)

    Wu, Huizhe; Liu, Mingyan; Wang, Shuang; Feng, Wanyu; Yao, Weifan; Zhao, Haishan; Wei, Minjie

    2010-03-01

    Ampicillin/probenecid is an antimicrobial formulation indicated for the treatment of respiratory, urinary tract, and gastrointestinal infections. Ampicillin sodium is the active antimicrobial ingredient that can act on the phase of bacterial breeding and inhibit the biosynthesis of bacterial mucopeptide in the cell wall. Probenecid acts synergistically by competitively inhibiting an organic anion transporter in renal tubules, increasing the plasma concentrations, and thus extending the plasma elimination t(1/2). The aim of this study was to assess and compare the pharmacokinetic (PK) properties, bioavailability, and bioequivalence of a newly developed dispersible tablet formulation (test) of ampicillin/ probenecid with those of an established branded capsule formulation (reference) in healthy Chinese male volunteers. A randomized-sequence, single-dose, open-label, 2-period crossover study was conducted in fasted healthy Chinese male volunteers. Eligible participants were randomly assigned in a 1:1 ratio to receive 6 dispersible tablets (test) or branded capsules (reference) (1500 mg total; 250 mg each containing ampicillin 194.5 mg and probenecid 55.5 mg), followed by a 7-day washout period and administration of the alternate formulation. Plasma samples were collected over a 24-hour period following administration and analyzed for ampicillin and probenecid content by HPLC. PK parameters such as C(max), AUC(0-t), and AUC(0-infinity) were also determined. The formulations were considered bioequivalent if the geometric mean ratios of the log-transformed C(max) and AUC values were within the equivalence range (80%-125%) predetermined by the State Food and Drug Administration (SFDA) of the People's Republic of China. Tolerability was based on the observation of adverse events (AEs), monitoring of vital signs (blood pressure, heart rate, temperature, electrocardiography) and laboratory tests (hematology, blood biochemistry, hepatic function, urinalysis), and subject

  20. Pharmacokinetics and bioequivalence evaluation of two different atorvastatin calcium 10-mg tablets: A single-dose, randomized-sequence, open-label, two-period crossover study in healthy fasted Chinese adult males.

    Science.gov (United States)

    Liu, Yan-Mei; Pu, Hua-Hua; Liu, Gang-Yi; Jia, Jing-Ying; Weng, Li-Ping; Xu, Rong-Jing; Li, Guo-Xiu; Wang, Wei; Zhang, Meng-Qi; Lu, Chuan; Yu, Chen

    2010-07-01

    Atorvastatin calcium is a 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor indicated for the prevention of cardiovascular disease and for the treatment of dyslipidemia. Information on the pharmacokinetics of atorvastatin in a Chinese population is lacking, and regulatory requirements necessitate a bioequivalence study for the marketing of a generic product in China. The aim of the present study was to assess the pharmacokinetics and bioequivalence of a test and branded reference formulation of atorvastatin calcium 10-mg tablets in healthy fasted Chinese male volunteers. This was a single-dose, randomized-sequence, open-label, 2-period crossover study with a 2-week washout period between doses. Healthy Chinese males were randomly assigned to receive 20 mg of either the test or reference formulation, and 13 blood samples were obtained over a 48-hour interval. Plasma concentrations of parent atorvastatin and ortho-hydroxy-atorvastatin (primary active metabolite) were simultaneously determined using a validated liquid chromatography-isotopic dilution mass spectrometry method. Pharmacokinetic parameters, including C(max), T(max), t((1/2)), AUC(0-t), and AUC(0-infinity)), were calculated. The 2 formulations were to be considered bioequivalent if 90% CIs for the log transformed ratios of AUC and C(max) of atorvastatin were within the predetermined bioequivalence range (0.80-1.25 for AUC and 0.70-1.43 for C(max)) as established by the State Food and Drug Administration of China. Tolerability was evaluated throughout the study by vital signs monitoring, physical examinations, 12-lead ECGs, and subject interviews on adverse events (AEs). A total of 66 subjects were assessed for inclusion; 20 were excluded prior to study initiation. Of the 46 healthy subjects (mean [SD] age, 24.1 [2.5] years; height, 170.8 [5.1] cm; weight, 64.6 [6.4] kg; body mass index (BMI), 22.1 [1.7] kg/m(2)) who completed the study, 45 subjects (mean [SD] age, 24.1 [2.5] years; height, 171.1 [4

  1. When Bioequivalence in Healthy Volunteers May not Translate to Bioequivalence in Patients: Differential Effects of Increased Gastric pH on the Pharmacokinetics of Levothyroxine Capsules and Tablets.

    Science.gov (United States)

    Seng Yue, Corinne; Benvenga, Salvatore; Scarsi, Claudia; Loprete, Luca; Ducharme, Murray P

    2015-01-01

    Clinical studies have suggested that proton pump inhibitors may decrease levothyroxine absorption and an in vitro study suggested that the effect of pH on dissolution may differ with formulation. To determine the impact of formulation on the pharmacokinetics of levothyroxine in altered gastric pH conditions, this study compared the pharmacokinetics of levothyroxine capsules and tablets, two formulations deemed bioequivalent in healthy volunteers under fasting conditions, when taken with or without esomeprazole. Two clinical studies were conducted in healthy volunteers given single dose levothyroxine (600 mg) with a 45-day washout period. In Study 1 (parallel-design/two-way crossover), 16 subjects received either levothyroxine capsules or tablets, each group with or without prior administration of intravenous esomeprazole (maximum dose of 80 mg). In Study 2 (two-way crossover), 16 subjects received both capsules or tablets after intravenous esomeprazole. Blood samples were collected pre-dose and up to 24 hours post-dose. Baseline-adjusted pharmacokinetic parameters were calculated: Cmax (maximal concentration), Tmax (time to Cmax), AUC0-t (area under the concentration-time curve from 0 to the last detectable concentration), AUC0-6 and AUC0-12 (areas under the curve from 0 to 6 and 12 hours, respectively). Analyses of variance were conducted to compare ln-transformed Cmax and AUC. Non-parametric Tmax analyses were done. In Study 1, esomeprazole caused a greater decrease in overall levothyroxine exposure of tablets vs. capsules (13% vs 6% for Cmax, 18% vs. 14% for AUC(0-6), 17% vs. 5% for AUC(0-12) and 10% vs. 8% for AUC(0-t)). In Study 2 esomeprazole administration resulted in a 16% smaller levothyroxine exposure with tablets vs. capsules. No statistically significant differences in Tmax were found. Although both formulations are considered "bioequivalent" in healthy volunteers, they may not necessarily be bioequivalent in patients with impaired gastric pH conditions

  2. Improved simultaneous quantitation of candesartan and hydrochlorthiazide in human plasma by UPLC–MS/MS and its application in bioequivalence studies

    Directory of Open Access Journals (Sweden)

    Bhupinder Singh

    2014-04-01

    Full Text Available A validated ultra-performance liquid chromatography mass spectrometric method (UPLC–MS/MS was used for the simultaneous quantitation of candesartan (CN and hydrochlorothiazide (HCT in human plasma. The analysis was performed on UPLC–MS/MS system using turbo ion spray interface. Negative ions were measured in multiple reaction monitoring (MRM mode. The analytes were extracted using a liquid–liquid extraction (LLE method by using 0.1 mL of plasma volume. The lower limit of quantitation for CN and HCT was 1.00 ng/mL whereas the upper limit of quantitation was 499.15 ng/mL and 601.61 ng/mL for CN and HCT respectively. CN d4 and HCT-13Cd2 were used as the internal standards for CN and HCT respectively. The chromatography was achieved within 2.0 min run time using a C18 Phenomenex, Gemini NX (100 mm×4.6 mm, 5 µm column with organic mixture:buffer solution (80:20, v/v at a flow rate of 0.800 mL/min. The method has been successfully applied to establish the bioequivalence of candesartan cilexetil (CNC and HCT immediate release tablets with reference product in human subjects. Keywords: Candesartan cilexetil, Hydrochlorothiazide, UPLC–MS/MS, Bioequivalence, Candesartan cilexetil-hydrochlorothiazide (ATACAND HCT

  3. Bioequivalence assessment of two formulations of ibuprofen

    KAUST Repository

    Al-Talla, Zeyad

    2011-10-19

    Background: This study assessed the relative bioavailability of two formulations of ibuprofen. The first formulation was Doloraz , produced by Al-Razi Pharmaceutical Company, Amman, Jordan. The second forumulation was Brufen , manufactured by Boots Company, Nottingham, UK. Methods and results: A prestudy validation of ibuprofen demonstrated long-term stability, freeze-thaw stability, precision, and accuracy. Twenty-four healthy volunteers were enrolled in this study. After overnight fasting, the two formulations (test and reference) of ibuprofen (100 mg ibuprofen/5 mL suspension) were administered as a single dose on two treatment days separated by a one-week washout period. After dosing, serial blood samples were drawn for a period of 14 hours. Serum harvested from the blood samples was analyzed for the presence of ibuprofen by high-pressure liquid chromatography with ultraviolet detection. Pharmacokinetic parameters were determined from serum concentrations for both formulations. The 90% confidence intervals of the ln-transformed test/reference treatment ratios for peak plasma concentration and area under the concentration-time curve (AUC) parameters were found to be within the predetermined acceptable interval of 80%-125% set by the US Food and Drug Administration. Conclusion: Analysis of variance for peak plasma concentrations and AUC parameters showed no significant difference between the two formulations and, therefore, Doloraz was considered bioequivalent to Brufen. 2011 Al-Talla et al, publisher and licensee Dove Medical Press Ltd.

  4. Bioequivalence of a single 400-mg dose of imatinib 100-mg oral tablets and a 400-mg tablet in healthy adult Korean volunteers.

    Science.gov (United States)

    Lee, Hae Won; Seong, Sook Jin; Park, Sung Min; Lee, Joomi; Gwon, Mi-Ri; Kim, Hyun-Ju; Lim, Sung Mook; Lim, Mi-Sun; Kim, Woomi; Yang, Dong Heon; Yoon, Young-Ran

    2015-06-01

    Imatinib mesylate (IM) is a selective tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors. A new once-daily 400-mg film-coated tablet of imatinib has been developed by a pharmaceutical company in Korea. The present study was designed to assess and compare the PK parameters, bioavailability, and bioequivalence of the new imatinib 400-mg formulation (test) versus the conventional 100-mg formulation (reference) administered as a single 400-mg dose in healthy adult male volunteers. This randomized, open-label, single-dose, two-way crossover study was conducted in healthy Korean male volunteers. Eligible subjects were randomly assigned in a 1 : 1 ratio to receive 400 mg of the test (one 400-mg tablet) or reference (four 100-mg tablets) formulation, followed by a 2-week washout period and administration of the alternate formulation. Serial blood samples were collected at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours after administration. Plasma imatinib concentrations were determined using liquid chromatography coupled with tandem mass spectrometry. The formulations were to be considered bioequivalent if the 90% confidence intervals (CIs) of the adjusted geometric mean ratios for Cmax, AUC(0-t), and AUC(0-∞)ž were within the predetermined range of 0.80 - 1.25. In total, 35 subjects completed the study. No serious adverse event was reported during the study. The 90% CIs of the adjusted geometric mean ratios of the test formulation to the reference formulation for C(max), AUC(0-t) and AUC(0-∞)ž of imatinib were all within the bioequivalence criteria range of 0.8 - 1.25. The test formulation of imatinib met the Korean regulatory requirements for bioequivalence. Both imatinib formulations were well-tolerated in all subjects.

  5. Topical safety and vasoconstrictive assay-based bioequivalence of a new reformulated mometasone cream.

    Science.gov (United States)

    Krishna, Rajesh; Horowitz, Ann; Larson, Patrick; Bolognese, James; Marcantonio, Eugene E

    2017-07-01

    A new improved mometasone furoate (Elocon™) cream with an emulsification system that produces a stable emulsion has been developed. In order to register the product in various markets, it was essential to ensure the cream was topically well tolerated and that it was bioequivalent to the reference product. Phase I clinical studies were performed to assess the local safety and tolerability upon multiple dosing of this new cream as well as to assess the single-dose bioequivalence relative to the marketed product. Bioequivalence was assessed using a vasoconstrictive assay (VCA) after a dose-duration pilot study was completed with the marketed Elocon cream. The new mometasone cream and its vehicle were nonirritating in healthy subjects during 21-day patch application (MCII cream in various markets.

  6. Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.

    Science.gov (United States)

    Sullivan, Jane O'; Blake, Kevin; Berntgen, Michael; Salmonson, Tomas; Welink, Jan

    2017-12-05

    The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  7. Steady state bioequivalence of generic and innovator formulations of stavudine, lamivudine, and nevirapine in HIV-infected Ugandan adults.

    Directory of Open Access Journals (Sweden)

    Jayne Byakika-Tusiime

    Full Text Available Generic antiretroviral therapy is the mainstay of HIV treatment in resource-limited settings, yet there is little evidence confirming the bioequivalence of generic and brand name formulations. We compared the steady-state pharmacokinetics of lamivudine, stavudine and nevirapine in HIV-infected subjects who were receiving a generic formulation (Triomune or the corresponding brand formulations (Epivir, Zerit, and Viramune.An open-label, randomized, crossover study was carried out in 18 HIV-infected Ugandan subjects stabilized on Triomune-40. Subjects received lamivudine (150 mg, stavudine (40 mg, and nevirapine (200 mg in either the generic or brand formulation twice a day for 30 days, before switching to the other formulation. At the end of each treatment period, blood samples were collected over 12 h for pharmacokinetic analysis. The main outcome measures were the mean AUC(0-12h and C(max. Bioequivalence was defined as a geometric mean ratio between the generic and brand name within the 90% confidence interval of 0.8-1.25. The geometric mean ratios and the 90% confidence intervals were: stavudine C(max, 1.3 (0.99-1.71 and AUC(0-12h, 1.1 (0.87-1.38; lamivudine C(max, 0.8 (0.63-0.98 and AUC(0-12h, 0.8 (0.65-0.99; and nevirapine C(max, 1.1 (0.95-1.23 and AUC(0-12h, 1.1 (0.95-1.31. The generic formulation was not statistically bioequivalent to the brand formulations during steady state, although exposures were comparable. A mixed random effects model identified about 50% intersubject variability in the pharmacokinetic parameters.These findings provide support for the use of Triomune in resource-limited settings, although identification of the sources of intersubject variability in these populations is critical.

  8. The bootstrap and Bayesian bootstrap method in assessing bioequivalence

    International Nuclear Information System (INIS)

    Wan Jianping; Zhang Kongsheng; Chen Hui

    2009-01-01

    Parametric method for assessing individual bioequivalence (IBE) may concentrate on the hypothesis that the PK responses are normal. Nonparametric method for evaluating IBE would be bootstrap method. In 2001, the United States Food and Drug Administration (FDA) proposed a draft guidance. The purpose of this article is to evaluate the IBE between test drug and reference drug by bootstrap and Bayesian bootstrap method. We study the power of bootstrap test procedures and the parametric test procedures in FDA (2001). We find that the Bayesian bootstrap method is the most excellent.

  9. Operating characteristics of a partial-block randomized crossover bioequivalence study for dutasteride, a drug with a long half-life: investigation through simulation and comparison with final results.

    Science.gov (United States)

    Cai, Gengqian; Thiessen, Jake J; Baidoo, Charlotte A; Fossler, Michael J

    2010-10-01

    Studies to establish bioequivalence (BE) of a drug are important elements in support of drug applications. A typical BE study is conducted as a single dose, randomized, 2-period crossover design. For drugs with long half lives (≥ 48 hours) and evaluation of multiple BE objectives in 1 trial, this design may not be adequate. A parallel design may then be a more appropriate choice. However, parallel designs require increased sample size, which can become substantial. One option that is a compromise between the complete randomized block design and the parallel design is a partial-block crossover design. This approach came about during the development of a combination of dutasteride and tamsulosin. Previous experience with performing single-dose dutasteride studies suggested that 28 days of washout is needed between treatments because of its half-life of 7-9 days. Simulations were performed to assess the operating characteristics of this design using a previously developed PK model. Four scenarios were developed, and each scenario was simulated 500 times. The results showed that this design demonstrated acceptable consumer and producer risk. Partial-block crossover designs should be considered for studies when the half-life of the drug is long and there are more than 2 periods.

  10. 78 FR 66745 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2013-11-06

    ... provide product-specific guidance on the design of BE studies to support abbreviated new drug applications... industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process...,'' which explained the process that would be used to make product-specific BE recommendations available to...

  11. 77 FR 56851 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-09-14

    ... provide product-specific guidance on the design of BE studies to support abbreviated new drug applications... industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process...,'' which explained the process that would be used to make product-specific BE recommendations available to...

  12. 75 FR 33311 - Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability

    Science.gov (United States)

    2010-06-11

    ... describes a new process for making available recommendations on how to design product- specific... guidance describes a new process for making available recommendations on how to design product-specific BE... guidance on how to design product-specific bioequivalence studies to support ANDAs. It does not create or...

  13. 77 FR 16842 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-03-22

    ... provide product-specific guidance on the design of BE studies to support abbreviated new drug applications... industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process...,'' which explained the process that would be used to make product-specific BE recommendations available to...

  14. In vitro Approaches to Support Bioequivalence and Substitutability of Generic Proton Pump Inhibitors via Nasogastric Tube Administration.

    Science.gov (United States)

    Ren, Ping; Cui, Minglei; Anand, Om; Xia, Li; Zhao, Zhuojun J; Sun, Dajun; Sharp, Trueman; Conner, Dale P; Peters, John; Jiang, Wenlei; Stier, Ethan; Jiang, Xiaojian

    2017-11-01

    Administration of proton pump inhibitors (PPIs) through nasogastric tubes may present risks. If the PPI drug products are not prepared properly, clogging or obstruction of nasogastric tubes can pose a safety concern. In addition, the integrity of the enteric coating of the drug product may be damaged resulting in reduced bioavailability of the active moiety. From the perspective of administration of generic PPIs when compared to the reference drug product, differences in formulation can potentially result in a greater relative risk for the generic drug product. As part of the assessment of bioequivalence, the Office of Generic Drugs (OGD) has developed a suite of in vitro testing to compare the delivery of the generic and reference products via nasogastric tubes. These in vitro tests assess essential attributes associated with the likelihood of clogging and maintenance of the enteric coating. These in vitro tests include studies evaluating sedimentation, granule size distribution, drug recovery, and acid resistance. One of the challenges is that while the administration of PPIs through nasogastric tubes is common in clinical practice, this issue is not uniformly addressed in the FDA approved label of the reference drug products. This paper discusses the design and rationale for in vitro testing of PPI formulations with respect to bioequivalence via nasogastric tube administration and in addition, it summarizes commonly occurring deficiencies in the in vitro nasogastric tube testing of 14 recent Abbreviated New Drug Applications (ANDA) submitted for five generic PPI drug products.

  15. Topical bioequivalence of acyclovir creams using dermal microdialysis in pigs: a new model to evaluate bioequivalence for topical formulations.

    Science.gov (United States)

    Wei, Huilin; Wang, Shuqi; Xu, Feng; Xu, Lanfang; Zheng, Jiarun; Chen, Yun

    2012-07-01

    The aim was to evaluate the bioequivalence of topically applied Acyclovir (ACV) creams using dermal microdialysis (DMD) in a pig model. Three ACV creams (3%), ACV1, ACV2 and ACV3, were topically administrated on the dorsum of pigs, and the DMD sampling technique was used to continuously collect microdialysate. The concentration of ACV in microdialysate was measured by HPLC and the concentration-time profiles were used to calculate pharmacokinetic parameters. The results showed that 90% confidence interval (CI) of the ratio of AUC(0-4 h) of ACV2 and ACV3 was between 88.2 and 105.7%, which was within the acceptance range (80-125%). Ninety percent CI of the ratio of C(max) of ACV2 and ACV3 was between 87.4 and 124.4%, which was within the acceptance range (80-125%). These data indicate that ACV2 and ACV3 used in this study were bioequivalent. This study demonstrates that the pig model coupled with DMD sampling can potentially provide a cost-effective strategy to evaluate topical drug delivery and its associated pharmacokinetic studies.

  16. Bioequivalence of diclofenac sodium 2% and 1.5% topical solutions relative to oral diclofenac sodium in healthy volunteers.

    Science.gov (United States)

    Holt, Robert J; Taiwo, Tolu; Kent, Jeffrey D

    2015-08-01

    Topical formulations of nonsteroidal anti-inflammatory drugs (NSAIDs) are generally considered to be safer alternatives to oral NSAIDs due to lower systemic absorption. We conducted randomized, crossover studies that compared the pharmacokinetics (PK), bioequivalence and safety of topical diclofenac sodium 2% twice daily (BID), diclofenac sodium 1.5% four times daily (QID) and oral diclofenac sodium in healthy subjects. The results of three bioequivalence studies are reviewed. Healthy adult subjects (n = 76) applied topical diclofenac sodium 2% solution (40.4 mg/2 mL) BID; or 1.5% solution (19.3 mg/40 drops) QID to each knee for 7.5 consecutive days separated by a washout period. Subjects (n = 22) in one study also received oral diclofenac sodium 75 mg BID for 7.5 days. Plasma diclofenac concentrations were determined from serial blood samples collected on Days 1 and 8 (steady state), and diclofenac PK parameters were estimated by noncompartmental methods. The studies demonstrated comparable bioequivalence between the 2% and 1.5% topical solutions as well as lower systemic exposure compared to oral dosing (approximately 93% less). Daily systemic exposure was comparable between the two formulations with only a 12% difference in the AUCss(0-24) (p = 0.140). Furthermore, both topical solutions demonstrated delayed elimination with a t(1/2) of 4- to 6-fold longer, as compared to oral diclofenac. The 2% solution provided more consistent dosing relative to the 1.5% solution when comparing AUCss(0-24) and Cmaxss across studies. Mild application site reactions were the most common treatment-emergent adverse event reported with topical diclofenac. The steady-state PK profile of topical diclofenac 2% solution administered BID is similar to that of the 1.5% solution administered QID. Systemic exposure to diclofenac is substantially lower after topical application as compared to oral administration. (Study 2 was registered with ClinicalTrials.gov; NCT01202799; https

  17. [Pharmacokinetics and bioequivalence of atorvastatin calcium tablets in healthy male Chinese volunteers].

    Science.gov (United States)

    Shen, Yi; Zhang, Yi-fan; Chen, Xiao-yan; Guo, Li-xia; Zhong, Da-fang

    2012-03-01

    To compare the bioequivalence and pharmacokinetics of national made and imported atorvastatin in healthy male Chinese volunteers after single oral administration. This randomized sequence, open-label, two-period crossover study with a one-week washout period between doses was performed in 24 fasting healthy Chinese males. They were randomly assigned to receive 20 mg of either the test (national made) or reference (imported) formulation orally. The blood samples were collected over a 72-hour period. Plasma concentrations of parent atorvastatin (AT), ortho-hydroxy-atorvastatin (o-OAT) and para-hydroxy-atorvastatin (p-OAT) were simultaneously determined using the validated liquid chromatography-tandem mass spectrometry method, the bioequivalence was also evaluated throughout the study. The main pharmacokinetic parameters of test and reference formulations were as follows: the values of C(max) for AT were (10.6 ± 11.9) µg/L and (10.6 ± 9.8) µg/L, t(1/2z) were (11.4 ± 3.9) h and (11.4 ± 5.3) h, AUC(0-t) were (54.2 ± 37.4) µg×h(-1)×L(-1) and (51.7 ± 34.1) µg×h(-1)×L(-1), respectively. The values of C(max) for o-OAT were (7.8 ± 4.5) µg/L and (7.6 ± 4.3) µg/L, t(1/2z) were (12.3 ± 4.2) h and (11.9 ± 3.4) h, AUC(0-t) were (96.8 ± 48.2) µg×h(-1)×L(-1) and (92.3 ± 44.4) µg×h(-1)×L(-1), respectively. The values of C(max) for p-OAT were (0.5 ± 0.4) µg/L and (0.4 ± 0.3) µg/L, t(1/2z) were (18.4 ± 12.4) h and (23.3 ± 17.8) h, AUC(0-t) were (15.9 ± 12.3) µg×h(-1)×L(-1) and (13.8 ± 8.11) µg×h(-1)×L(-1), respectively. The relative bioavailability of AT and o-OAT in test formulation were (105.3 ± 20.7)% and (107.8 ± 23.2)%, respectively. The 90% confidence interval of the test/reference geometric mean ratios of AUC(0-t) for AT and o-OAT were (97.7 - 110.5)% and (98.3 - 111.3)%, C(max) for AT and o-OAT were (75.8 - 114.0)% and (90.6 - 122.9)%, they were all located within the bioequivalence criteria range (80% - 125% for AUC, and 70% - 143

  18. Preparation and Comparative Bioavailability Studies of Indomethacin-Loaded Cetyl Alcohol Microspheres

    Directory of Open Access Journals (Sweden)

    N. Vishal Gupta

    2013-01-01

    Full Text Available The purpose of the present study was to compare the in vitro release and to find out whether the bioavailability of a 75 mg indomethacin capsule (Microcid SR was equivalent to optimized formulation (indomethacin-loaded cetyl alcohol microspheres. Indomethacin-loaded cetyl alcohol microspheres were prepared by meltable emulsified cooling-induced technique. Surface morphology of microspheres has been evaluated using scanning electron microscopy. A single dose, randomized, complete cross over study of IM microspheres was carried out on 10 healthy male and female Albino sheep’s under fasting conditions. The plasma was separated and the concentrations of the drug were determined by HPLC-UV method. Plasma indomethacin concentrations and other pharmacokinetic parameters obtained were statistically analyzed. The SEM images revealed the spherical shape of fat microspheres, and more than 98.0% of the isolated microspheres were in the size range 12–32 μm. DSC, FTIR spectroscopy and stability studies indicated that the drug after encapsulation with fat microspheres was stable and compatible. Both formulations were found to be bioequivalent as evidenced by in vivo studies. Based on this study, it can be concluded that cetyl alcohol microspheres and Microcid SR capsule are bioequivalent in terms of the rate and extent of absorption.

  19. Bioequivalence Evaluations of Generic Dry Powder Inhaler Drug Products: Similarities and Differences Between Japan, USA, and the European Union.

    Science.gov (United States)

    Kuribayashi, Ryosuke; Yamaguchi, Toru; Sako, Hanaka; Takishita, Tomoko; Takagi, Kazunori

    2017-03-01

    In Japan, the development of generic oral dry powder inhaler (DPI) drug products for marketing approval has recently increased. The Pharmaceuticals and Medical Devices Agency (PMDA) considers the required data for each drug product in the consultation meeting. However, guidelines for DPI drug products have been published by the US Food and Drug Administration and the European Medicines Agency. Recently, the basic principles of bioequivalence evaluations of generic DPI drug products were published in March 2016 by the Ministry of Health, Labour and Welfare. The document mainly outlines the current understanding regarding the bioequivalence evaluations of generic DPI drug products based on knowledge from PMDA consultation meetings. In this review, we compared the bioequivalence evaluations of DPI drug products among Japan, USA, and the European Union and discuss future development of generic DPI drug products in Japan.

  20. Bioavailability and bioequivalence: focus on physiological factors and variability.

    Science.gov (United States)

    Karalis, Vangelis; Macheras, Panos; Van Peer, Achiel; Shah, Vinod P

    2008-08-01

    This is a summary report of the EUFEPS & COST B25 conference on Bioavailability and Bioequivalence which focused on physiological factors and variability. This conference was held at The Royal Olympic Hotel in the centre of Athens (Greece) during the 1-2 of October in 2007. The issues discussed in the conference involved physiological factors affecting drug absorption, the role of pre-systemic effects on bioavailability (BA), the impact of variability in bioequivalence (BE) studies, and a final closing panel session on unresolved issues in BA/BE regulations. Several important aspects of drug absorption were highlighted. It was presented how the complexity of gastrointestinal (GI) physiology and the site dependent absorption can impact on drug BA. Similarly, the effects of food and formulation were also studied. The second session focused on integrating the complexities of GI into modeling the inter-individual variability of absorption and the prediction of first-pass metabolism from in-vitro data. The necessity to measure metabolites, the value of Biopharmaceutical Classification System (BCS), and the more recently proposed Biopharmaceutical Drug Disposition Classification System (BDDCS) were assessed as well. This session closed with presentations of pharmacokinetic software delegates. In the second day of the conference, the problem of high intra-subject variability in BE studies was analyzed. Study design considerations, the use of multiple-dose studies and the role of statistics in BE were also highlighted. Finally, the current thinking of regulatory authorities (EMEA and US-FDA) was presented. The conference closed with a last session on unresolved issues in the regulatory level.

  1. Quantification of strontium in human serum by ICP-MS using alternate analyte-free matrix and its application to a pilot bioequivalence study of two strontium ranelate oral formulations in healthy Chinese subjects.

    Science.gov (United States)

    Zhang, Dan; Wang, Xiaolin; Liu, Man; Zhang, Lina; Deng, Ming; Liu, Huichen

    2015-01-01

    A rapid, sensitive and accurate ICP-MS method using alternate analyte-free matrix for calibration standards preparation and a rapid direct dilution procedure for sample preparation was developed and validated for the quantification of exogenous strontium (Sr) from the drug in human serum. Serum was prepared by direct dilution (1:29, v/v) in an acidic solution consisting of nitric acid (0.1%) and germanium (Ge) added as internal standard (IS), to obtain simple and high-throughput preparation procedure with minimized matrix effect, and good repeatability. ICP-MS analysis was performed using collision cell technology (CCT) mode. Alternate matrix method by using distilled water as an alternate analyte-free matrix for the preparation of calibration standards (CS) was used to avoid the influence of endogenous Sr in serum on the quantification. The method was validated in terms of selectivity, carry-over, matrix effects, lower limit of quantification (LLOQ), linearity, precision and accuracy, and stability. Instrumental linearity was verified in the range of 1.00-500ng/mL, corresponding to a concentration range of 0.0300-15.0μg/mL in 50μL sample of serum matrix and alternate matrix. Intra- and inter-day precision as relative standard deviation (RSD) were less than 8.0% and accuracy as relative error (RE) was within ±3.0%. The method allowed a high sample throughput, and was sensitive and accurate enough for a pilot bioequivalence study in healthy male Chinese subjects following single oral administration of two strontium ranelate formulations containing 2g strontium ranelate. Copyright © 2014 Elsevier GmbH. All rights reserved.

  2. Bioequivalence: the regulatory career of a pharmaceutical concept.

    Science.gov (United States)

    Carpenter, Daniel; Tobbell, Dominique A

    2011-01-01

    Generic drugs cannot be marketed without regulatory and clinical demonstration of "bioequivalence." The authors argue that the concept of "bioequivalence" is a joint regulatory and scientific creation, not purely a technical concept, and not purely a legal concept. It developed at the interstices of networks of pharmacologists, regulators, food and drug lawyers, and American and European policy makers interested in "generic" drugs. This article provides a situated perspective on the history of bioequivalence, which emphasizes the shaping role of the state upon scientific processes, networks of regulators and scientists, and the centrality of transnational dynamics in the formation of drug regulatory standards.

  3. Bioequivalence of 2 Formulations of Sildenafil Oral Soluble Film 100 mg and Sildenafil Citrate (Viagra) 100 mg Oral Tablets in Healthy Male Volunteers.

    Science.gov (United States)

    Dadey, Eric

    Sildenafil citrate tablets (VIAGRA; Pfizer Inc) have been used since 1998 as an oral therapy for the treatment of erectile dysfunction. However, in some cases, patients may have difficulty in swallowing tablets, and the need to use water to aid in the oral administration of the tablets has the potential to interrupt the sexual encounter, reduce spontaneity, and therefore decrease the quality of the experience. Two oral soluble film (OSF) formulations of sildenafil were developed using MonoSol Rx's proprietary PharmFilm technology. Both films were formulated to dissolve rapidly on the tongue, thereby releasing the drug into the oral cavity, whereupon it is swallowed without the use of water. From a patient perspective, it is anticipated that the film formulations of sildenafil citrate will provide a more compliant and discreet dosage form. The purpose of this clinical study was to compare the bioequivalence of the 2 sildenafil OSF 100 mg formulations (MonoSol Rx, LLC) with the sildenafil citrate 100 mg tablets. The design was a single-dose, randomized, open-label, 3-period, 6-sequence, 3-treatment, single-center, crossover study conducted in 18 healthy, nonsmoking male volunteers under fasting conditions, with each treatment period separated by a 7-day washout period. Plasma sildenafil concentrations were measured predose and then periodically to 24 hours after dosing. The 90% confidence intervals for plasma sildenafil AUC0-t, AUC0-∞, and Cmax for both sildenafil OSF formulations as compared with sildenafil citrate tablets were all within the 80%-125% range, indicating bioequivalence of both film formulations to sildenafil citrate tablets. Overall, the demonstrated bioequivalence coupled with the performance advantages of an OSF dosage form (ie, rapid dissolution in the mouth, can be taken without water, and can be dosed discreetly) suggest that the sildenafil OSF may provide an attractive alternative to sildenafil citrate oral tablets.

  4. Changing paradigms in bioequivalence trials submitted to the EMA for evaluation - A clinical and regulatory perspective.

    Science.gov (United States)

    Refalo, Nathaniel; Chetcuti, Daniel; Tanti, Amy; Serracino-Inglott, Anthony; Borg, John Joseph

    2017-02-01

    The selection of a robust bioequivalence (BE) study designs for registering a generic product remains still a hard task. This task is still challenging despite the fact that generic products are much needed by health care providers in economical terms. Thus, BE study designs could be a means to allow companies to reduce costs and reach the market earlier. We therefore investigated whether different approaches in various products assessed by the European Medicines Agency during the approval phase resulted in a reduction in resources required to show bioequivalence for different medicinal products. European Public Assessment Reports (EPARs) for off-patent medicinal products authorised within the European Union (EU) through the centralised procedure during the period 2007-2015 were retrieved and reviewed to identify the clinical studies that resulted in fewer number of subjects, the number of centres or trial duration versus the two-period crossover design. 7 studies out of 108 were considered as having benefitted from having a different design. Differences noted included having a different dose allocation scheme, having a different number of dosing periods, having a different number of treatment arms, and having one study evaluating different strengths. Benefits noted included a decrease in the number of subjects and centres required, decreases in study duration and a reduced number of studies required to demonstrate bioequivalence. Bioequivalence studies can be designed in a specific manner to require fewer resources to carry out. Fewer resources required to register a medicinal product, could impart an advantage to companies (such as to be first on the market) or could even translate to making medicines more accessible (such as cheaper) to patients.

  5. Bioequivalence: The Regulatory Career of a Pharmaceutical Concept

    OpenAIRE

    Carpenter, Daniel Paul; Tobbell, Dominique A.

    2011-01-01

    Generic drugs cannot be marketed without regulatory and clinical demonstration of "bioequivalence." The authors argue that the concept of "bioequivalence" is a joint regulatory and scientific creation, not purely a technical concept, and not purely a legal concept. It developed at the interstices of networks of pharmacologists, regulators, food and drug lawyers, and American and European policy makers interested in "generic" drugs. This article provides a situated perspective on the history o...

  6. Bio-equivalent doses of recombinant HCG and recombinant LH during ovarian stimulation result in similar oestradiol output: a randomized controlled study.

    Science.gov (United States)

    Alsbjerg, Birgit; Elbaek, Helle Olesen; Laursen, Rita Jakubcionyte; Povlsen, Betina Boel; Haahr, Thor; Yding Andersen, Claus; Humaidan, Peter

    2017-08-01

    In nature, HCG is secreted by the implanting embryo from peri-implantation and onwards. In contrast, LH is mandatory for steroidogenesis and follicular development during the follicular phase, working in synergy with FSH. Moreover, LH is mandatory for the function of the corpus luteum. Although LH and HCG bind to the same receptor, significant molecular, structural and functional differences exist, inducing differences in bioactivity. This randomized controlled study compared the effect of recombinant FSH stimulation combined with daily either micro-dose recombinant HCG or recombinant LH supplementation in a 1:1 bioactivity ratio from day 1 of stimulation in a long gonadotrophin releasing hormone agonist down regulation protocol. A total of 100 patients from a public clinic completed the study. The primary end-point was the oestradiol level on the day of ovulation trigger and the median oestradiol level in the HCG supplemented group was 8662 pmol/l versus 9203 pmol/l in the recombinant LH supplemented group; therefore, no significant difference was found. Moreover, no differences were observed in the number of oocytes retrieved or in the live birth rate. We conclude that recombinant HCG and recombinant LH are equally effective in boosting oestradiol synthesis during ovarian stimulation when used in a 1:1 bioactivity ratio. Copyright © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

  7. Comparative Studies for What?

    Directory of Open Access Journals (Sweden)

    Pedro Guedes de Carvalho

    2017-12-01

    Full Text Available ISCPES stands for International Society for Comparative Physical Education and Sports and it is going to celebrate its 40th anniversary in 2018. Since the beginning (Israel 1978 the main goals of the Society were established under a worldwide mind set considering five continents and no discrimination of any kind. The founders wanted to compare Physical Education and Sports across the world, searching for the best practices deserving consideration and applied on the purpose of improving citizen quality of life. The mission still stands for “Compare to learn and improve”. As all the organizations lasting for 39 years, ISCPES experienced several vicissitudes, usually correlated with world economic cycles, social and sports changes, which are in ISS journal articles - International Sport Studies. ISS journal is Scopus indexed, aiming to improve its quality (under evaluation to reach more qualified students, experts, professionals and researchers; doing so it will raise its indexation, which we know it is nowadays a more difficult task. First, because there are more journals trying to compete on this academic fierce competitive market; secondly, because the basic requirements are getting more and more hard to gather in the publishing environment around Physical Education and Sports issues. However, we can promise this will be one of our main strategic goals. Another goal I would like to address on this Editorial is the language issue. We have this second strategic goal, which is to reach most of languages spoken in different continents; besides the English language, we will reach Chinese, Spanish and Portuguese speaking countries. For that reason, we already defined that all the abstracts in English will be translated into Chinese, Spanish and Portuguese words so people can find them on any search browser. That will expand the demand for our journal and articles, increasing the number of potential readers. Of course this opportunity, given by

  8. Operations dashboard: comparative study

    Science.gov (United States)

    Ramly, Noor Nashriq; Ismail, Ahmad Zuhairi; Aziz, Mohd Haris; Ahmad, Nurul Haszeli

    2011-10-01

    In this present days and age, there are increasing needs for companies to monitor application and infrastructure health. Apart from having proactive measures to secure their application and infrastructure, many see monitoring dashboards as crucial investment in disaster preparedness. As companies struggle to find the best solution to cater for their needs and interest for monitoring their application and infrastructure's health, this paper summarizes the studies made on several known off-the-shelf operations dashboard and in-house developed dashboard. A few criteria of good dashboard are collected from previous studies carried out by several researchers and rank them according to importance and business needs. The finalized criteria that will be discussed in later sections are data visualization, performance indicator, dashboard personalization, audit capability and alert/ notification. Comparative studies between several popular dashboards were then carried out to determine whether they met these criteria that we derived from the first exercise. The findings hopefully can be used to educate and provide an overview of selecting the best IT application and infrastructure operations dashboard that suit business needs, thus become the main contribution of this paper.

  9. Development of novel bepotastine salicylate salt bioequivalent to the commercial bepotastine besilate in beagle dogs.

    Science.gov (United States)

    Cho, Kwan Hyung; Choi, Han-Gon

    2013-06-01

    To develop a novel salt form of bepotastine with bioequivalent to the commericial bepostastine besilate, bepostastine salicylate was prepared and its physicochemical properties were investigated. Furthermore, the bepotastine salicylate-loaded tablet was prepared by the wet granulation method, and the dissolution and bioavailability in beagle dogs were evaluated compared to the bepotastine besilate-loaded commercial product. Bepotastine salicylate improved the solubility of bepotastine, and the extent of solubility improvement by salicylate form was similar to that by besilate form. However, this novel salt exhibited negligible hygroscopicity similar to besilate form, and showed slightly higher melting point than besilate form. It was stable in various pH solutions. Furthermore, the bepotastine salicylate-loaded tablet composed of bepotastine salicylate, microcrystalline cellulose, D-mannitol, povidone, sodium starch glycolate and sodium stearyl fumarate at the weight ratio of 9.63/60.97/38/3.6/6/1.8 showed similar dissolution to the bepotastine besilate-loaded commercial product in water, pH 1.2, pH 4.0 and pH 6.8 and was bioequivalent to the commercial product in beagle dogs. Thus, this bepotastine salicylate-loaded tablet would be a promising candidate with bioequivalence to the bepotastine besilate-loaded commercial product.

  10. From drug delivery systems to drug release, dissolution, IVIVC, BCS, BDDCS, bioequivalence and biowaivers.

    Science.gov (United States)

    Karalis, Vangelis; Magklara, Eleni; Shah, Vinod P; Macheras, Panos

    2010-09-01

    This is a summary report of the conference on drug absorption and bioequivalence issues held in Titania Hotel in Athens (Greece) from the 28(th) to the 30(th) of May 2009. The conference included presentations which were mainly divided into three sections. The first section focused on modern drug delivery systems such as polymer nanotechnology, cell immobilization techniques to deliver drugs into the brain, nanosized liposomes used in drug eluting stents, encapsulation of drug implants in biocompatible polymers, and application of differential scanning calorimetry as a tool to study liposomal stability. The importance of drug release and dissolution were also discussed by placing special emphasis on camptothecins and oral prolonged release formulations. The complexity of the luminal environment and the value of dissolution in lyophilized products were also highlighted. The second session of the conference included presentations on the Biopharmaceutics Classification Scheme (BCS), the Biopharmaceutics Drug Disposition Classification System (BDDCS), and the role of transporters in the classification of drugs. The current status of biowaivers and a modern view on non-linear in vitro-in vivo (IVIVC) correlations were also addressed. Finally, this section ended with a special topic on biorelevant dissolution media and methods. The third day of the conference was dedicated to bioequivalence. Emphasis was placed on high within-subject variability and its impact on study design. Two unresolved issues of bioequivalence were also discussed: the use of generic antiepileptic drugs and the role of metabolites in bioequivalence assessment. Finally, the conference closed with a presentation of the current regulatory status of WHO and EMEA.

  11. Comparative waste forms study

    International Nuclear Information System (INIS)

    Wald, J.W.; Lokken, R.O.; Shade, J.W.; Rusin, J.M.

    1980-12-01

    A number of alternative process and waste form options exist for the immobilization of nuclear wastes. Although data exists on the characterization of these alternative waste forms, a straightforward comparison of product properties is difficult, due to the lack of standardized testing procedures. The characterization study described in this report involved the application of the same volatility, mechanical strength and leach tests to ten alternative waste forms, to assess product durability. Bulk property, phase analysis and microstructural examination of the simulated products, whose waste loading varied from 5% to 100% was also conducted. The specific waste forms investigated were as follows: Cold Pressed and Sintered PW-9 Calcine; Hot Pressed PW-9 Calcine; Hot Isostatic Pressed PW-9 Calcine; Cold Pressed and Sintered SPC-5B Supercalcine; Hot Isostatic pressed SPC-5B Supercalcine; Sintered PW-9 and 50% Glass Frit; Glass 76-68; Celsian Glass Ceramic; Type II Portland Cement and 10% PW-9 Calcine; and Type II Portland Cement and 10% SPC-5B Supercalcine. Bulk property data were used to calculate and compare the relative quantities of waste form volume produced at a spent fuel processing rate of 5 metric ton uranium/day. This quantity ranged from 3173 L/day (5280 Kg/day) for 10% SPC-5B supercalcine in cement to 83 L/day (294 Kg/day) for 100% calcine. Mechanical strength, volatility, and leach resistance tests provide data related to waste form durability. Glass, glass-ceramic and supercalcine ranked high in waste form durability where as the 100% PW-9 calcine ranked low. All other materials ranked between these two groupings

  12. Consumer's risk in the EMA and FDA regulatory approaches for bioequivalence in highly variable drugs.

    Science.gov (United States)

    Muñoz, Joel; Alcaide, Daniel; Ocaña, Jordi

    2016-05-30

    The 2010 US Food and Drug Administration and European Medicines Agency regulatory approaches to establish bioequivalence in highly variable drugs are both based on linearly scaling the bioequivalence limits, both take a 'scaled average bioequivalence' approach. The present paper corroborates previous work suggesting that none of them adequately controls type I error or consumer's risk, so they result in invalid test procedures in the neighbourhood of a within-subject coefficient of variation osf 30% for the reference (R) formulation. The problem is particularly serious in the US Food and Drug Administration regulation, but it is also appreciable in the European Medicines Agency one. For the partially replicated TRR/RTR/RRT and the replicated TRTR/RTRT crossover designs, we quantify these type I error problems by means of a simulation study, discuss their possible causes and propose straightforward improvements on both regulatory procedures that improve their type I error control while maintaining an adequate power. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  13. Metanálise de estudos de bioequivalência: a intercambiabilidade de genéricos e similares que contêm Hidroclorotiazida é possível, mas não àqueles com Maleato de Enalapril Meta-analysis for bioequivalence studies: interchangeability of generic drugs and similar containing Hydrochlorothiazide is possible but not with Enalapril Maleate

    Directory of Open Access Journals (Sweden)

    Renato Almeida Lopes

    2010-06-01

    -name and generic or similar drugs is necessary that they are bioequivalent. With the growing number of generic drugs, it is common for patients to replace a generic to another or one similar. However, this exchange can not guarantee the maintenance of bioequivalence. To evaluate the safety interchangeability between different generic and similar drugs with Hydrochlorothiazide and Enalapril Maleate, a meta-analysis was carried out with several bioequivalence studies with these drugs. METHODS: Data from bioequivalence of generic and similar drugs approved by the National Health Surveillance Agency (Anvisa (drug regulatory agency in Brazil were used. The compatibility of data from each study was analyzed and the determination of a confidence interval for the differences between the means of pharmacokinetic parameters, area under the curve (ASC0-t and maximum plasma concentration (Cmax, was made for each study by meta-analysis. RESULTS: The interchangeability between the combinations of the three products with Hydrochlorothiazide was confirmed based on the obtained confidence intervals. For the drugs studied with Enalapril Maleate interchangeability has not been confirmed for 50% of the product comparisons. CONCLUSION: The exchange was established between the three products with hydrochlorothiazide. However, for the Enalapril Maleate half of the products studied are not interchangeable, considering they do not match the established intervals for bioequivalence tests, so the pharmacokinetics behavior and thus the effectiveness of the product may be changed.

  14. Fluorescence detection of tramadol in healthy Chinese volunteers by high-performance liquid chromatography and bioequivalence assessment

    Directory of Open Access Journals (Sweden)

    Zhou X

    2015-02-01

    Full Text Available Xiao Zhou, Ji Liu Department of Anesthesia, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China Abstract: This study developed a revised high-performance liquid chromatography fluorescence method to determine plasma tramadol concentration, and thereby to examine the bioequivalence of two tramadol formulations among healthy male Chinese volunteers. The study used a double-blind, randomized, 2×2 crossover-design principle. Calculated pharmacokinetic parameters for both formulations were consistent with previous reports. According to the observation of vital signs and laboratory measurement, no subjects had any adverse reactions. The geometric mean ratios (90% confidence interval of the test drug/reference drug for tramadol were 100.2% (95.3%–103.4% for the area under the plasma concentration–time curve (AUC from time zero to the last measurable concentration, 99.6% (94.2%–102.7% for the AUC from administration to infinite time, and 100.8% (93.1%–106.4% for maximum concentration. For the 90% confidence intervals of the test/reference AUC ratio and maximum concentration ratio of tramadol, both were in the acceptance range for bioequivalence. According to the two preparations by pharmacokinetic parameter statistics, the half-life, mean residence time, and clearance values showed no significant statistical differences. Therefore, the conclusion of this study was that the two tramadol formulations (tablets and capsules were bioequivalent. Keywords: tramadol hydrochloride, in vitro release, pharmacokinetic, bioequivalence, fluorescence detector

  15. Pharmacokinetic properties and bioequivalence of two irbesartan/ hydrochlorothiazide fixed-dose combination tablets in healthy male Chinese volunteers.

    Science.gov (United States)

    Liu, Jian; Wu, Lihua; Hu, Xingjiang; Wu, Guolan; Zheng, Yunliang; Zhou, Huili; Zhai, You; Zhu, Meixiang; ShenTu, Jianzhong

    2015-07-01

    The aim of the present study was to compare the pharmacokinetic profiles between a new generic and a branded reference formulation of irbesartan/ hydrochlorothiazide FDC tablets, and to assess the bioequivalence of the two products in healthy Chinese male volunteers. 24 male healthy volunteers participated in the open-label, single-dose, randomized-sequence, 2-way crossover study. Eligible subjects were randomly assigned (1:1) to receive a single 300/12.5-mg dose of either the test or reference formulation followed by a 1-week washout. Blood samples were obtained before (0 hours) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours after dosing. Plasma concentrations of irbesartan and hydrochlorothiazide were analyzed by two separate validated liquid chromatography/tandem mass spectrometric (LC-MS/MS) methods. For irbesartan, the 90% confidence intervals (CIs) of AUC0-t, AUC0-∞, and Cmax were 103.27-116.71%, 105.01-121.47%, and 84.15-96.88%, respectively. For hydrochlorothiazide, the 90% CIs of AUC0-t, AUC0-∞, and Cmax were 96.11-109.02%, 95.15-107.35%, and 91.66-101.40%, respectively. A total of 3 mild AEs were reported in 3 subjects (12.5%). In this study, a single dose (300/12.5-mg) of the test formulation of irbesartan and hydrochlorothiazide FDC tablet in fasting healthy Chinese male volunteers met WHO's and China's FDA regulatory criteria for assumption of bioequivalence to the reference formulation based on AUC and Cmax. Both formulations were well tolerated.

  16. Bioequivalence of locally acting lozenges: Evaluation of critical in vivo parameters and first steps towards a bio-predictive in vitro test method.

    Science.gov (United States)

    Tietz, Katharina; Gutknecht, Sina I; Klein, Sandra

    2018-02-01

    Locally-acting lozenges are among the most common types of solid dosage forms applied in the oral cavity. Since no guidance on the in vitro demonstration of local bioequivalence is available, we wanted to develop a new bio-predictive test method for dissolution of lozenges based on a set of physiological parameters relevant to lozenge dissolution in the oral cavity. An in vivo sucking study determining the impact of different lozenge (candy) bases and flavours on sucking times, saliva osmolality and salivary flow rates was performed in 6 volunteers. In vivo sucking times were compared with in vitro dissolution times observed in experiments with official dissolution methods. In vitro dissolution times of all formulations were significantly longer than average in vivo sucking times (20-30 vs. hard palate during sucking. Results obtained in a first set of in vitro experiments came very close to those obtained in vivo. This novel in vitro approach is thus very promising in terms of predicting the bioequivalence of locally-acting lozenges. Copyright © 2017 Elsevier B.V. All rights reserved.

  17. Comparative Packaging Study

    Science.gov (United States)

    Perchonok, Michele H.; Oziomek, Thomas V.

    2009-01-01

    Future long duration manned space flights beyond low earth orbit will require the food system to remain safe, acceptable and nutritious. Development of high barrier food packaging will enable this requirement by preventing the ingress and egress of gases and moisture. New high barrier food packaging materials have been identified through a trade study. Practical application of this packaging material within a shelf life test will allow for better determination of whether this material will allow the food system to meet given requirements after the package has undergone processing. The reason to conduct shelf life testing, using a variety of packaging materials, stems from the need to preserve food used for mission durations of several years. Chemical reactions that take place during longer durations may decrease food quality to a point where crew physical or psychological well-being is compromised. This can result in a reduction or loss of mission success. The rate of chemical reactions, including oxidative rancidity and staling, can be controlled by limiting the reactants, reducing the amount of energy available to drive the reaction, and minimizing the amount of water available. Water not only acts as a media for microbial growth, but also as a reactant and means by which two reactants may come into contact with each other. The objective of this study is to evaluate three packaging materials for potential use in long duration space exploration missions.

  18. Blinded sample size re-estimation in crossover bioequivalence trials.

    Science.gov (United States)

    Golkowski, Daniel; Friede, Tim; Kieser, Meinhard

    2014-01-01

    In drug development, bioequivalence studies are used to indirectly demonstrate clinical equivalence of a test formulation and a reference formulation of a specific drug by establishing their equivalence in bioavailability. These studies are typically run as crossover studies. In the planning phase of such trials, investigators and sponsors are often faced with a high variability in the coefficients of variation of the typical pharmacokinetic endpoints such as the area under the concentration curve or the maximum plasma concentration. Adaptive designs have recently been considered to deal with this uncertainty by adjusting the sample size based on the accumulating data. Because regulators generally favor sample size re-estimation procedures that maintain the blinding of the treatment allocations throughout the trial, we propose in this paper a blinded sample size re-estimation strategy and investigate its error rates. We show that the procedure, although blinded, can lead to some inflation of the type I error rate. In the context of an example, we demonstrate how this inflation of the significance level can be adjusted for to achieve control of the type I error rate at a pre-specified level. Furthermore, some refinements of the re-estimation procedure are proposed to improve the power properties, in particular in scenarios with small sample sizes. Copyright © 2014 John Wiley & Sons, Ltd.

  19. Bioequivalence study of four different trademarks of enalapril maleate in spontaneously hypertensive rats Estudo da bioequivalência de quatro diferentes marcas comerciais de maleato de enalapril em ratos espontaneamente hipertensos

    Directory of Open Access Journals (Sweden)

    Nilo César do Vale Baracho

    2008-04-01

    Full Text Available INTRODUCTION: High blood pressure is a systemic disease which has major clinical and psycho-social repercussions, involves a high morbidity-mortality rate and generates high costs for the health system. Its treatment involves the use of antihypertensive drugs, which are commercialized as trademark, generic or similar drugs. PURPOSE: To verify the antihypertensive effect produced by a similar dose of different trademarks of enalapril maleate in spontaneously hypertensive rats (SHR. METHODS: Fifteen mg/kg of enalapril maleate were administered by gavage in 50 SHR rats and their blood pressure was verified through tail plethysmography every three days in a period of 16 days. RESULTS: The group treated with reference drug has shown a significant reduction on blood pressure levels when compared to the control group. Thus, treatments with enalapril maleate of generic, similar-A and similar-B brands have also shown significant reduction on animals' blood pressure. CONCLUSION: The use of generic drug and similars (A and B drugs in the same doses and for the same period of time has not shown significant difference regarding the reference drug, which suggests that the brands tested are bioequivalent.INTRODUÇÃO: A hipertensão arterial é uma doença sistêmica que traz grandes repercussões clínicas e psico-sociais, cursa com uma elevada morbi-mortalidade e gera elevados gastos para o sistema de saúde. Seu tratamento envolve a utilização de fármacos anti-hipertensivos, os quais são comercializados como remédios de marca, genéricos ou similares. PURPOSE: Verificar o efeito anti-hipertensivo produzido por dose igualitária de diferentes marcas de maleato de enalapril, em ratos naturalmente hipertensos. MÉTODOS: Foram administrados, por meio de gavagem, 15 mg/kg de maleato de enalapril em 50 ratos naturalmente hipertensos e verificada a pressão arterial, através de pletismografia de cauda, a cada três dias, em um período de 16 dias. RESULTADOS

  20. A comparative bioavailability study of two formulations of pregabalin in healthy Chilean volunteers.

    Science.gov (United States)

    Quiñones, Luis; Sasso, Jaime; Tamayo, Evelyn; Catalán, Johanna; González, Juan Paplo; Escala, Mario; Varela, Nelson; León, Jorge; Cáceres, Dante Daniel; Saavedra, Iván

    2010-07-01

    The aim of this study was to compare the pharmacokinetic parameters between two brands of pregabalin in healthy Chilean volunteers. A randomized, single-dose, two-period, two-sequence, crossover study design with a 2-week washout period was conducted in healthy Chilean males. Plasma samples were collected over a 12-hour period after administration of 150 mg pregabalin in each period. A validated ultra-performance liquid chromatography with positive ionization mass spectrometric detection method was used to analyze pregabalin concentration in plasma. Pharmacokinetic parameters were determined using a noncompartmental method. Bioequivalence between the test and reference products was determined when the ratio for the 90% confidence intervals (CIs) of the difference in the means of the log-transformed area under the curve (AUC)(0-t), AUC(0-∞), and maximum concentration (C(max)) of the two products were within 0.80 and 1.25. The study was carried out on 22 healthy Chilean volunteers. The mean (SD) C(max), AUC(0-t) and AUC(0-∞) of the test formulation (Pregobin™) of pregabalin were 2.10 (0.56) μg/ml, 10.35 (2.00) μgxh/ml and 13.92 (2.74) μgxh/ml, respectively. The mean (SD) C(max), AUC(0-t) and AUC(0-∞) of the reference formulation (Lyrica™) of pregabalin were 2.15 (0.52) μg/ml, 10.31 (1.85) μgxh/ml and 13.78 (2.25) μgxh/ml, respectively. The parametric 90% CIs for C(max), AUC(0-t), and AUC(0-∞) were 0.97-1.13, 1.01-1.04, and 0.98-1.02, respectively. These results suggest that both products are bioequivalent and can be used as interchangeable options in the clinical setting.

  1. Characterization of a Murine Model of Bioequivalent Bladder Wound Healing and Repair Following Subtotal Cystectomy.

    Science.gov (United States)

    Zarifpour, Mona; Andersson, Karl-Erik; Kelkar, Sneha S; Mohs, Aaron; Mendelsohn, Cathy; Schneider, Kerry; Marini, Frank; Christ, George J

    2017-01-01

    Previous work demonstrated restoration of a bioequivalent bladder within 8 weeks of removing the majority of the bladder (subtotal cystectomy or STC) in rats. The goal of the present study was to extend our investigations of bladder repair to the murine model, to harness the power of mouse genetics to delineate the cellular and molecular mechanisms responsible for the observed robust bladder regrowth. Female C57 black mice underwent STC, and at 4, 8, and 12 weeks post-STC, bladder repair and function were assessed via cystometry, ex vivo pharmacologic organ bath studies, and T 2 -weighted magnetic resonance imaging (MRI). Histology was also performed to measure bladder wall thickness. We observed a time-dependent increase in bladder capacity (BC) following STC, such that 8 and 12 weeks post-STC, BC and micturition volumes were indistinguishable from those of age-matched non-STC controls and significantly higher than observed at 4 weeks. MRI studies confirmed that bladder volume was indistinguishable within 3 months (11 weeks) post-STC. Additionally, bladders emptied completely at all time points studied (i.e., no increases in residual volume), consistent with functional bladder repair. At 8 and 12 weeks post-STC, there were no significant differences in bladder wall thickness or in the different components (urothelium, lamina propria, or smooth muscle layers) of the bladder wall compared with age-matched control animals. The maximal contractile response to pharmacological activation and electrical field stimulation increased over time in isolated tissue strips from repaired bladders but remained lower at all time points compared with controls. We have established and validated a murine model for the study of de novo organ repair that will allow for further mechanistic studies of this phenomenon after, for example, genetic manipulation.

  2. Comparative Canadian-American Studies.

    Science.gov (United States)

    Ezell, Macel D.

    1988-01-01

    Outlines topics for comparative study of Canada and the United States. Includes geography, politics, settlement patterns, economics, education, religion, and sports. Suggests materials to aid teachers in formulating comparative approaches to Canadian and U.S. studies. (DB)

  3. Bioequivalence of ciprofloxacin tablet formulations assessed in Indonesian volunteers.

    Science.gov (United States)

    Harahap, Y; Prasaja, B; Indriati, E; Lusthom, W; Lipin

    2007-06-01

    Determination of the bioequivalence of two ciprofloxacin tablet formulations (test formulation manufactured by Novell Pharmaceutical Laboratories, Indonesia, reference formulation from Quimica Farmaceutica Bayer, Spain). 24 healthy volunteers received each of the two ciprofloxacin formulations at a dose of 500 mg in a 2-way crossover design. Blood samples were obtained prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and24h after drug administration. Plasma concentrations of ciprofloxacin were monitored using high-performance liquid chromatography over a period of 24 h after administration. The pharmacokinetics parameter AUC0-24h, AUC0-infinity and Cmax were tested for bioequivalence after log-transformation of data and ratios of tmax were evaluated non-parametrically. The point estimates and 90% confidence intervals for AUC0-24h, AUC0-infinity and Cmax were 97.55% (92.71 - 102.6%), 97.63% (92.90 - 102.59%) and 95.84% (89.95 - 102.10%), respectively, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration guidelines. These results indicate that two medications of ciprofloxacin are bioequivalent and, thus, may be prescribed interchangeably.

  4. Bioequivalence of budesonide plus formoterol (BF) Spiromax® and BF Turbohaler® (with and without charcoal block) in healthy volunteers.

    Science.gov (United States)

    Weisfeld, Lori; Shu, Youyi; Shah, Tushar P

    2015-07-01

    Budesonide formoterol (BF) Spiromax® is a breath-actuated dry-powder inhaler designed to deliver similar combinations of budesonide and formoterol as Symbicort® Turbohaler®. We performed two studies to demonstrate pharmacokinetic (PK) equivalence of BF Spiromax with BF Turbohaler. Two single-center, open-label, randomized, 5-period crossover studies were performed. The first study compared BF Spiromax 160/4.5 μg with BF Turbohaler 200/6 μg, while the second study compared BF Spiromax 320/9 μg with BF Turbohaler 400/12 μg. All treatments were administered with and without charcoal. PK parameters were calculated by measuring plasma drug concentrations from blood samples taken pre-dose and up to 24 hours post-dose. In each study, 90 healthy volunteers were randomized. Bioequivalence of BF Spiromax with BF Turbohaler was demonstrated for budesonide and formoterol (AUC0-t and Cmax (90% confidence intervals of the geometric mean between-device ratios for both parameters were within the predefined range of 0.80-1.25 in both studies)). Equivalence was observed without use of charcoal (overall absorption post-inhalation) and with charcoal (pulmonary absorption). There were no major differences between treatments in tmax for either budesonide or formoterol. All study treatments were well tolerated (one treatment-emergent adverse event (TEAE) in the medium-dose study and four TEAEs in the high-dose study). These studies indicate that BF Spiromax (±charcoal block) is bioequivalent to BF Turbohaler with respect to the PK parameters assessed. Single doses of BF Spiromax were well tolerated; the overall safety profile of BF Spiromax and BF Turbohaler was similar.

  5. A comparative bioavailability study of two ibuprofen formulations after single-dose administration in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Metta S.S. Wiria

    2007-09-01

    Full Text Available This study was aimed to investigate the bioequivalence of ibuprofen 125 mg suppository formulation (Ibukal®, test formulation from PT. Kalbe Farma, Tbk., Jakarta and the ibuprofen suppository comparative formulation (Proris®, from PT. Pharos Indonesia, Jakarta in 12 healthy volunteers. The pharmacokinetic parameters used in this study were the area under the concentration-time curve from time zero to hour 10 (AUC0-t, the area under the concentration-time curve from time zero to infinite (AUC0-inf, the maximum concentration (Cmax, and the time needed to reach the maximum concentration (tmax. The study was designed as a random cross-over fashion, single-blinded which included 12 healthy adult volunteers. The volunteers were fasted overnight and in the morning they received a suppository of the test drug (Ibukal® or a suppository of the comparative drug (Proris®. Blood samples were withdrawn on hour 0 (control, 20 min; 40 min; 1; 1.5; 2; 2.5; 3; 4; 6; 8; and 10 time points after the administration of the drug. Following a wash-out period of 1 week, this procedure was repeated using the other drug. The serum concentration of the drug was determined by means of high-performance liquid chromatography with ultraviolet detection. The results of the study showed that, the mean (SD of AUC0-t, AUC0-inf, Cmax and tmax of the test drug were, respectively, 28.59(3.37 μg.h.mL-1, 30.47(3.56 μg.h.mL-1, 8.24(1.44 μg/mL, and 1.33(0.44 h. The mean (SD of AUC0-t, AUC0-inf, Cmax and tmax of the comparative drug were, respectively, 28.13(8.14 μg.h.mL-1, 30.56(8.05 μg.h.mL-1, 8.27(2.88 μg/mL, and 1.79(0.33 h. The geometric means ratio of the test to the comparative drug were 104.38% (CI 90%: 90.38-120.54% for AUC0-t, 101.97% (CI 90%: 89.51-116.16% for AUC0-inf, and 104.02% (CI 90%: 85.73-126.16% for Cmax. There was no side effect of the drug detected in this study. From the results we can conclude that the 125 mg of ibuprofen suppository of PT Kalbe Farma

  6. "Pharmacodynamically evaluated bioequivalence of two preparations of Enalapril Maleate "

    Directory of Open Access Journals (Sweden)

    "Tajerzadeh H

    2001-07-01

    Full Text Available The bioequivalence of two preparations of enalapril maleate (20 mg tablets manufactured in Iran has been exploited in reference to a standard preparation (Xanef 20 tablets, MSD, Germany in 14 healthy volunteers. Following oral dosing of a single tablet of each of test and standard products, as a randomized crossover design with 10-day washout intervals, the blood samples were collected in predetermined time points and using a synthetic substrate, Hippuryl-Histidy-Leucine (HHL, the release of hippuric acid from the substrate was determined as Angiotensin-Converting-Enzyme (ACE activity of serum fractions. The percent of ACE inhibition in each sample was calculated and plotted against time, from which three pharmacodynamic parameters, i.e. Emax, tmax and AUC0-24 were derived. The results of statistical comparison of these parameters showed that both of the test preparations are bioequivalent with reference standard preparation.

  7. Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyond.

    Science.gov (United States)

    Polli, James E; Abrahamsson, Bertil S I; Yu, Lawrence X; Amidon, Gordon L; Baldoni, John M; Cook, Jack A; Fackler, Paul; Hartauer, Kerry; Johnston, Gordon; Krill, Steve L; Lipper, Robert A; Malick, Waseem A; Shah, Vinod P; Sun, Duxin; Winkle, Helen N; Wu, Yunhui; Zhang, Hua

    2008-06-01

    The workshop "Bioequivalence, Biopharmaceutics Classification System, and Beyond" was held May 21-23, 2007 in North Bethesda, MD, USA. This workshop provided an opportunity for pharmaceutical scientists to discuss the FDA guidance on the Biopharmaceutics Classification System (BCS), bioequivalence of oral products, and related FDA initiatives such as the FDA Critical Path Initiative. The objective of this Summary Workshop Report is to document the main points from this workshop. Key highlights of the workshop were (a) the described granting of over a dozen BCS-based biowaivers by the FDA for Class I drugs whose formulations exhibit rapid dissolution, (b) continued scientific support for biowaivers for Class III compounds whose formulations exhibit very rapid dissolution, (c) scientific support for a number of permeability methodologies to assess BCS permeability class, (d) utilization of BCS in pharmaceutical research and development, and (e) scientific progress in in vitro dissolution methods to predict dosage form performance.

  8. "Pharmacodynamically evaluated bioequivalence of two preparations of Enalapril Maleate "

    OpenAIRE

    "Tajerzadeh H; Hamidi M; Rouini MR; Shahverdi M; Ghaiumi A "

    2001-01-01

    The bioequivalence of two preparations of enalapril maleate (20 mg tablets) manufactured in Iran has been exploited in reference to a standard preparation (Xanef 20 tablets, MSD, Germany) in 14 healthy volunteers. Following oral dosing of a single tablet of each of test and standard products, as a randomized crossover design with 10-day washout intervals, the blood samples were collected in predetermined time points and using a synthetic substrate, Hippuryl-Histidy-Leucine (HHL), the release ...

  9. Interactions between active pharmaceutical ingredients and excipients affecting bioavailability: impact on bioequivalence.

    Science.gov (United States)

    García-Arieta, Alfredo

    2014-12-18

    The aim of the present paper is to illustrate the impact that excipients may have on the bioavailability of drugs and to review existing US-FDA, WHO and EMA regulatory guidelines on this topic. The first examples illustrate that small amounts of sorbitol (7, 50 or 60mg) affect the bioavailability of risperidone, a class I drug, oral solution, in contrast to what is stated in the US-FDA guidance. Another example suggests, in contrast to what is stated in the US-FDA BCS biowaivers guideline, that a small amount of sodium lauryl sulphate (SLS) (3.64mg) affects the bioavailability of risperidone tablets, although the reference product also includes SLS in an amount within the normal range for that type of dosage form. These factors are considered sufficient to ensure that excipients do not affect bioavailability according to the WHO guideline. The alternative criterion, defined in the WHO guideline and used in the FIP BCS biowaivers monographs, that asserts that excipients present in generic products of the ICH countries do not affect bioavailability if used in normal amounts, is shown to be incorrect with an example of alendronate (a class III drug) tablets, where 4mg of SLS increases bioavailability more than 5-fold, although a generic product in the USA contains SLS. Finally, another example illustrates that a 2mg difference in SLS may affect bioavailability of a generic product of a class II drug, even if SLS is contained in the comparator product, and in all cases its amount was within the normal range. Therefore, waivers of in vivo bioequivalence studies (e.g., BCS biowaivers, waivers of certain dosage forms in solution at the time of administration and variations in the excipient composition) should be assessed more cautiously. Copyright © 2014 Elsevier B.V. All rights reserved.

  10. Evaluation of statistical power function for various diclofenac bioequivalence trials with different subject numbers.

    Science.gov (United States)

    Popović, Jovan; Mikov, Momir; Sabo, Ana; Jakovljević, Vida

    2009-01-01

    This study presents application of statistical power function for the t-test and ANOVA F-test on the evaluation of diclofenac bioequivalence in trials with the wide variations in sample sizes (N = 12, 18 and 24). The power function, together with appropriate equations tables and figures, is used to calculate the power of the ANOVA for crossover design, the number of subjects for a given value of power and the minimum detectable difference in treatment means for different pharmacokinetic parameters of the formulations. The power of the trial with a small, sample size (N = 12) to detect 20% differences between diclofenac formulations is shown to be more than 0.9 and almost the same as the power of the trial with a large sample size (N = 24). In all trials for all pharmacokinetic parameters the power to detect 20% difference is shown to be more than 0.8. For the power of 0.8, the needed subject number to detect 20% difference in treatment means is the same or smaller than used and the minimum detectable difference is smaller than 20% in all our trials. This investigation shows that bioequivalence studies with small number of subjects (N = 12) may be quite adequate for valid conclusions.

  11. Bioequivalence evaluation of two brands of fluoxetine 20 mg capsules (Flutin and Prozac) in healthy human volunteers.

    Science.gov (United States)

    Najib, Naji M; Idkaidek, Nasir; Beshtawi, Muntaser; Mohammed, B; Admour, Isra; Alam, S Mahmood; Dham, Ruwayda; Qumaruzaman

    2005-09-01

    A bioequivalence study of two oral formulations of 20 mg fluoxetine was carried out in 24 healthy volunteers following a single dose, two-sequence, crossover randomized design at International Pharmaceutical Research Centre (IPRC), Amman, Jordan. The two formulations were Flutin capsules (Julphar, UAE) as test and Prozac capsules (Eli Lilly, UK) as reference product. Test and reference capsules were administered to each subject after an overnight fasting on two treatment days separated by a 28 day washout period. After dosing, serial blood samples were collected for a period of 360 h. Plasma harvested from blood was analysed for fluoxetine by a sensitive, reproducible and accurate LC-MS method. Various pharmacokinetic parameters including AUC(0-t), AUC(0-infinity), C(max), T(max), T(1/2), and lambda(Z) were determined from plasma concentrations for both formulations and found to be in good agreement with reported values. AUC(0-t), AUC(0-infinity) and C(max) were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval (94.60%-106.41% for AUC(0-t), 94.6%-108.14% for AUC(0-infinity); 91.88%-103.65% for C(max)) for test/reference ratio of these parameters were found within FDA acceptance range of 80%-125%. Based on these statistical inferences, it was concluded that Flutin is bioequivalent to Prozac and can be used interchangeably in medical practice. Copyright 2005 John Wiley & Sons, Ltd

  12. Percutaneous penetration of methyl nicotinate from ointments using the laser Doppler technique: bioequivalence and enhancer effects.

    Science.gov (United States)

    Remane, Yvonne; Leopold, Claudia S; Maibach, Howard I

    2006-12-01

    Laser Doppler flowmetry (LDF) may be used to quantify erythema response as a result of an increased cutaneous microcirculation induced by methyl nicotinate (MN). Bioequivalence of a test and a standard preparation (vehicles: light mineral oil and medium chain triglycerides, respectively) was confirmed according to the pilot study of the FDA Guidance for Industry "Topical dermatologic corticosteroids: In Vivo bioequivalence" applying the staggered application and synchronized removal method for one defined concentration. Furthermore, the influence of penetration enhancers (5% w/w Dimethylsulfoxide (DMSO) and 10% w/w diethylene glycol monoethyl ether) on MN penetration was investigated. It was shown that DMSO and diethylene glycol monoethyl ether altered cutaneous microcirculation and thus MN penetration in comparison to the standard formulation. However, true penetration enhancement could only be proved with diethylene glycol monoethyl ether resulting from an improved drug solubility in the skin which was confirmed by attenuated total reflectance fourier transform infrared spectroscopy (ATR-FTIR). Increased MN penetration by DMSO was only caused by thermodynamic effects, i.e. a decreased drug solubility in the vehicle.

  13. A randomized, single-blind, Phase I trial (INVICTAN-1) assessing the bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects.

    Science.gov (United States)

    Hettema, Willem; Wynne, Christopher; Lang, Benjamin; Altendorfer, Mario; Czeloth, Niklas; Lohmann, Ragna; Athalye, Sandeep; Schliephake, Dorothee

    2017-08-01

    This Phase I trial (INVICTAN®-1) evaluated three-way bioequivalence and safety of BI 695502 a bevacizumab biosimilar candidate, and reference product bevacizumab from two sources (US-approved Avastin®, Genentech; EU-approved Avastin, Roche). Healthy male subjects (N = 91) were randomized 1:1:1 to receive a single intravenous infusion of 1 mg/kg of BI 695502 or US- or EU-approved Avastin. An interim analysis was planned when ~50% of subjects were evaluable for the primary end point to determine if the prespecified criteria for bioequivalence were achieved; if demonstrated, the study could be stopped early. The primary end point was area under the concentration-time curve (AUC) of the analyte in plasma from time zero extrapolated to infinity (AUC 0-∞ ). Other pharmacokinetic (PK) parameters, safety, and in vitro binding affinity were also evaluated. The interim analysis demonstrated three-way bioequivalence for all comparisons. The confidence intervals around the geometric mean ratios of the primary and secondary PK parameters were within the predefined acceptance ranges. Study drugs were well tolerated with no clinically relevant differences in safety. BI 695502 and US- and EU-approved Avastin showed three-way bioequivalence with similar safety profile. NCT01608087.

  14. Time in internationally comparative studies

    NARCIS (Netherlands)

    Scheerens, Jaap; Luyten, Johannes W.; Glas, Cornelis A.W.; Scheerens, J

    2014-01-01

    In this chapter, illustrative internationally comparative data about time at school, time spent in out-of-school programs, and homework/ individual study time are presented. In the first section this is done in a more descriptive way, while in the second and third sections, the association between

  15. Comparative study of mountain sickness

    OpenAIRE

    Cuba Caparó, Alberto

    2014-01-01

    In order to make a comparative study of Mountain Sickness affecting humans and cattle and sheep has been reviewed briefly the clinical, hematologic and pathologic aspects found in the literature. The anatomic correlation of clinical symptoms and major injuries in the bovine and ovine, emphasizing, among other things, the similarity of symptoms and lesions observed in the myocardium and the adrenal cortex does. Mountain Sickness In the three species considered in this study polycythemia is one...

  16. Determination of bioequivalence of lomefloxacin tablets using urinary excretion data.

    Science.gov (United States)

    Shah, Shailesh A; Rathod, Ishwarsinh S; Savale, Shrinivas S; Patel, Dharmesh B

    2002-11-07

    The present study describes development of a sensitive and simple HPTLC method for estimation of lomefloxacin (LMF) in human urine. The drug was extracted using chloroform after adjusting the pH of urine to 7.0. Chloroform extract was spotted on silica gel 60 F(254) TLC plate and was developed in a mixture of n-butanol-methanol-ethyl acetate-6 M ammonia (4:2:3:2, v/v/v/v) as the mobile phase and scanned at 290 nm. The peak for LMF resolved at R(F) of 0.40+/-0.02. The method was validated in terms of linearity (50-600 microgram/ml), precision, specificity and accuracy. The limit of detection and limit of quantification for LMF in urine were found to be 20 and 50 microgram/ml, respectively. The average recovery of LMF from urine was 91.93%. The proposed method was applied to generate urinary excretion data for LMF after administration of two market LMF tablet formulations (400 mg, Formulation R and Formulation T) to six healthy human volunteers in a two-treatment, open, crossover design. Various pharmacokinetic parameters like peak excretion rate ((dAU/dt)(max)), time for peak excretion rate (t(max)), AUC(0-48), AUC(0- infinity ), cumulative amount and % cumulative amount of LMF excreted, elimination half-life (t(1/2)), terminal elimination rate constant (k(el)) and overall elimination rate constant (K), were calculated for both the formulations. The average cumulative amounts of LMF excreted in urine after administration of Formulation R and Formulation T were found to be 321.60 mg (80.40% of dose) and 296.51 mg (74.13% of dose), respectively. The urinary excretion profiles of LMF upto 48 h for both the formulations were found to be similar. Statistical comparison (90% confidence intervals of ratio) of various pharmacokinetic parameters of Formulation T with that of Formulation R revealed that Formulation T is bioequivalent with Formulation R.

  17. Levothyroxine soft capsules demonstrate bioequivalent pharmacokinetic exposure with the European reference tablets in healthy volunteers under fasting conditions.

    Science.gov (United States)

    Al-Numani, Dina; Scarsi, Claudia; Ducharme, Murray P

    2016-02-01

    To assess the bioequivalence (BE) potential under fasting conditions between levothyroxine soft capsules and the European reference tablet formulation. Two studies were conducted to assess the BE potential as per European regulations. Study 1 was a two-way crossover BE study comparing a high strength of levothyroxine soft capsules versus levothyroxine tablets (200 μg), while study 2 was a three-way crossover dosage form proportionality study between low, medium, and high strengths of soft capsules. 70 healthy adult subjects participated in the two studies. Each treatment consisted of a 600-μg dose of levothyroxine sodium, administered under fasting conditions. Blood samples were collected for levothyroxine (T4) assay prior to dosing and up to 72 hours post dose. A washout of 35 days separated treatments in each study. Pharmacokinetics was assessed using noncompartmental methods. A total of 61 subjects completed the studies. Baseline-adjusted total T4 ratios (test/reference) and 90% confidence intervals (CIs) between soft capsules and tablets were within 80.00 - 125.00%. Comparison of the three strengths of soft capsules indicated pharmacokinetic equivalence between them (ratios and 90% CIs were contained within 80.00 - 125.00%). Overall, levothyroxine sodium was well tolerated with all products when given as single oral doses of 600 μg, except for 1 serious adverse event of secondary bacteremia reported in study 2, deemed not to be related to treatment. Levothyroxine soft capsules meet BE criteria in terms of systemic exposure when compared to a European reference tablet under fasting conditions in healthy volunteers.

  18. Bioequivalence of a fixed-dose repaglinide/metformin combination tablet and equivalent doses of repaglinide and metformin tablets
.

    Science.gov (United States)

    Cho, Hea-Young; Ngo, Lien; Kim, Sang-Ki; Choi, Yoonho; Lee, Yong-Bok

    2018-04-12

    This study was conducted to determine whether a fixed-dose combination (FDC) tablet of repaglinide/metformin (2/500 mg) is equivalent to coadministration of equivalent doses of individual (EDI) tablets of repaglinide (2 mg) and metformin (500 mg) in healthy Korean male subjects. This study was conducted as an open-label, randomized, single-dose, two-period, two-sequence crossover design in 50 healthy Korean male subjects who received an FDC tablet or EDI tablets. Plasma concentrations of repaglinide and metformin were determined for up to 24 hours using a validated UPLC-MS/MS method. Bioequivalence was assessed according to current guidelines issued by the U.S. Food and Drug Administration (FDA) and Korean legislation. Tolerability was also evaluated throughout the study via subject interview, vital signs, and blood sampling. Point estimates (90% CIs) for AUC0-t, AUC0-∞, and Cmax based on EDI tablets were 110.07 (102.25 - 118.49), 109.90 (101.70 - 118.39), and 112.60 (101.49 - 124.85), respectively, for repaglinide. They were 95.18 (89.62 - 101.05), 95.00 (89.74 - 100.65), and 98.44 (92.72 - 104.50), respectively, for metformin. These results satisfied the bioequivalence criteria of 80.00 - 125.00% proposed by the FDA and Korean legislation. Results of pharmacokinetic analysis suggested that repaglinide and metformin in FDC tablets were bioequivalent to EDI tablets of repaglinide (2 mg) and metformin (500 mg) in healthy Korean male subjects. Both formulations appeared to be well tolerated.
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  19. Bioequivalence and adhesion evaluation of transdermal clonidine following a change in excipient supplier.

    Science.gov (United States)

    Ehrlich, Jerome; Beck, Bonnie; Thiedmann, Ralf; Marzin, Kristell; MacGregor, Thomas

    2016-10-01

    To evaluate the bioequivalence (BE), safety, tolerability, and adhesion of Oppanol® polyisobutylene (PIB)-containing transdermal therapeutic system (TTS) formulation (test treatment, T) with VistanexTM PIB-containing TTS formulation (reference treatment, R) of clonidine. This randomized, double-blind, 2-way crossover study comprised a 7-day treatment with 0.3 mg clonidine/24 h (T1/R1), a 7-day washout, and another 7-day treatment (R1/T1) period. After a 3-day washout period, subjects used T2 and R2 (each 0.1 mg clonidine/24 h) simultaneously in the 7-day adhesion phase. Primary endpoints were AUC0-168 and Cavg. Secondary endpoints were AUC0-∞ and Cmax. Additional endpoints included adhesion properties for all phases. For the primary endpoint, the geometric mean (gMean) ratios for test/reference treatment were calculated with BE defined as 90% confidence interval (CI) between 80 and 125%. 58 subjects (mean age, 41.3 years) received treatment (T1/R1, n = 29; R1/T1, n = 29); 55 completed the adhesion phase. BE criteria were met for the primary and secondary endpoints. Adjusted gMean ratios for T1/R1 were 102.3% (90% CI: 95.7%, 109.4%) for AUC0-168; 104.3% (90% CI: 98.4%, 110.5%) for Cavg; 102.8% (90% CI: 97.3%, 108.6%) for AUC0-∞; and 104.0% (90% CI: 98.2%, 110.3%) for Cmax. Mean adhesion was greater than 90% for all four patch types when data from all assessment times were included. Most frequently reported adverse events were general disorders and local irritation. Clonidine Oppanol® PIB-containing TTS formulation was bioequivalent to VistanexTM PIB-containing TTS formulation and had similar adhesive properties. Both doses and formulations of clonidine-TTS were well tolerated.

  20. 77 FR 10535 - Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations...

    Science.gov (United States)

    2012-02-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability... drug products containing the following active ingredients: A Acetaminophen; Caffeine; Dihydrocodeine...

  1. Paracetamol suppositories: a comparative study.

    Science.gov (United States)

    Cullen, S; Kenny, D; Ward, O C; Sabra, K

    1989-01-01

    Paracetamol suppositories in two different bases were given to children who had fever after operations. Plasma concentrations and the effect on temperature were compared. There was a significant correlation between peak plasma concentrations and maximum drop in temperature. A lipophilic base produced better results than a hydrophilic base. PMID:2817936

  2. Paracetamol suppositories: a comparative study.

    OpenAIRE

    Cullen, S; Kenny, D; Ward, O C; Sabra, K

    1989-01-01

    Paracetamol suppositories in two different bases were given to children who had fever after operations. Plasma concentrations and the effect on temperature were compared. There was a significant correlation between peak plasma concentrations and maximum drop in temperature. A lipophilic base produced better results than a hydrophilic base.

  3. Complexity of intravenous iron nanoparticle formulations: implications for bioequivalence evaluation.

    Science.gov (United States)

    Pai, Amy Barton

    2017-11-01

    Intravenous iron formulations are a class of complex drugs that are commonly used to treat a wide variety of disease states associated with iron deficiency and anemia. Venofer® (iron-sucrose) is one of the most frequently used formulations, with more than 90% of dialysis patients in the United States receiving this formulation. Emerging data from global markets outside the United States, where many iron-sucrose similars or copies are available, have shown that these formulations may have safety and efficacy profiles that differ from the reference listed drug. This may be attributable to uncharacterized differences in physicochemical characteristics and/or differences in labile iron release. As bioequivalence evaluation guidance evolves, clinicians should be educated on these potential clinical issues before a switch to the generic formulation is made in the clinical setting. © 2017 New York Academy of Sciences.

  4. Bioequivalencia entre dos formulaciones comerciales de gliclazida en Colombia Bioequivalence between two commercial formulations of gliclazide in Colombia

    Directory of Open Access Journals (Sweden)

    Gloria Holguín Martínez

    2001-01-01

    Full Text Available Los formulaciones comerciales de Gliclazida de 80 mg – tabletas, los productos Glidiab® de Tecnoquímicas y Diamicron® de Euroetika-Elsevier, fueron sometidos a estudio para evaluar la equivalencia farmacéutica y la equivalencia biológica. Después de comprobar la equivalencia farmacéutica se llevó a cabo el estudio de la equivalencia biológica en 14 voluntarios sanos; la cuantificación de Gliclazida en plasma se realizó por la técnica de cromatografía líquida de alta resolución (HPLC. Los parámetros farmacocinéticos evaluados fueron: área bajo la curva (AUC de 0-60 horas, concentración máxima (Cmáx y el tiempo máximo (tmáx los cuales se analizaron estadísticamente con intervalos de confianza del 90.0% y un rango de aceptación para bioequivalencia del 80.0% al 125.0% para AUC y Cmáx y del 80.0% al 120.0% para el tmáx. Ambas formulaciones presentaron alta variabilidad inter e intrasujeto y se encontró que son bioequivalentes con respecto a AUC, pero no lo son con respecto a Cmáx y tmáx. Two commercial formulations of Gliclazide 80 mg tablets were studied in order to evaluate both pharmaceutical and biological equivalence, Glidiab® Tecnoquímicas Laboratories and Diamicron® Euroetika-Elsevier Laboratories. After proving the pharmaceutical equivalence, a bioequivalence was tested in 14 healthy volunteers and the determination of gliclazide in plasma was carried out by high-performance liquid chromatography (HPLC. The evaluated pharmacokinetic parameters were: area under the curve (AUC from 0 to 60 hours, maximum concentration (Cmax and time to maximum concentration (Tmax. In statistical analysis the 90.0% confidence intervals for AUC, Cmax and Tmax, and acceptance range for bioequivalence of 80.0%-125.0% to AUC and Cmax and acceptance range of 80:0%-120.0% to Tmax, were applied. Both formulations presented inter and intra subject high variability and it was found that they are bioequivalent in relation to AUC but

  5. Comparative Studies of Acculturative Stress.

    Science.gov (United States)

    Berry, J. W.; And Others

    1987-01-01

    Studies of acculturative stress are reported from Canada. The reduction in health status among people undergoing acculturation has psychological, somatic, and social aspects. The stress varies across types of groups and individual differences. Further study is needed to determine variations across host societies. (VM)

  6. Bioequivalence evaluation of two amlodipine salts, besylate and orotate, each in a fixed-dose combination with olmesartan in healthy subjects

    Directory of Open Access Journals (Sweden)

    Lee SY

    2015-06-01

    Full Text Available Soo-Yun Lee,1 Jung-Ryul Kim,2,3 Jin Ah Jung,4 Wooseong Huh,2,5 Mi Young Bahng,6 Jae-Wook Ko1,2 1Department of Health Sciences and Technology, SAIHST, Sungkyunkwan University, Seoul, Republic of Korea; 2Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea; 3Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, Republic of Korea; 4Department of Clinical Pharmacology, Inje University, Busan Paik Hospital, Busan, Republic of Korea; 5Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; 6Dong-A ST Co., Ltd., Seoul, Republic of Korea Abstract: A fixed-dose combination of amlodipine and olmesartan is used to treat high blood pressure in patients whose hypertension is not sufficiently controlled with either drug alone. The objective of this study was to evaluate the bioequivalence of two fixed-dose combinations, ie, amlodipine orotate/olmesartan medoxomil 10/40 mg and amlodipine besylate/olmesartan medoxomil 10/40 mg, in healthy subjects. A randomized, open-label, single-dose, two-sequence, two-period, crossover study was conducted in 30 healthy adult volunteers. Blood samples were collected for up to 72 hours post-dose in each period. Safety data included the results of physical examinations, clinical laboratory tests, vital signs, an electrocardiogram, and adverse events. For both amlodipine and olmesartan, the 90% confidence intervals for the geometric mean ratios of AUClast and time to peak plasma concentration fell within the bioequivalence acceptance criteria. The two fixed-dose combinations showed similar safety profiles. Amlodipine orotate/olmesartan medoxomil 10/40 mg was bioequivalent to amlodipine besylate/olmesartan medoxomil 10/40 mg. Keywords: amlodipine orotate, amlodipine besylate, olmesartan medoxomil, fixed-dose combination, bioequivalence

  7. Benchmarked Library Websites Comparative Study

    KAUST Repository

    Ramli, Rindra M.

    2015-01-01

    This presentation provides an analysis of services provided by the benchmarked library websites. The exploratory study includes comparison of these websites against a list of criterion and presents a list of services that are most commonly deployed by the selected websites. In addition to that, the investigators proposed a list of services that could be provided via the KAUST library website.

  8. COMPARATIVE STUDY ON CORPORATE GOVERNANCE

    Directory of Open Access Journals (Sweden)

    Gavrea Corina

    2011-12-01

    Full Text Available Corporate governance is a key element of today’s economic reality being more and more present in many countries around the world. This paper has two main objectives. The first one is to offer more insight into the concept of corporate governance by a thorough literature review and by presenting and analyzing a framework of corporate governance. The second objective of this paper is to investigate the corporate governance situation in three developing economies (Romania, Bulgaria and Hungary. The World Bank and the European Bank for Reconstruction and Development published a series of reports on corporate governance. The present study uses data from these reports in order to illustrate how these developing economies are dealing with corporate governance. Based on ROSC Reports a corporate governance score was calculated. As this score shows, there is room for improvement for all three developing economies. This study is important because it shows the differences in corporate governance among developing economies and the need to study these nations at the individual country level. Corporate governance has many benefits for developing economies. It helps developing economies to register sustainable growth rates, to increases investors’ confidence in the national economy, and to increase the ability of capital markets to mobilize savings.

  9. A Comparative Study of the Pharmacokinetics of Conventional and ...

    African Journals Online (AJOL)

    Purpose: To examine the pharmacokinetics of a formulated aceclofenac sustained release tablet formulation and determine if it is bioequivalent to a commercial brand of aceclofenac immediate release tablet (Zerodol® 100 mg). Methods: Each of two groups of twelve fasting volunteers received either the reference standard ...

  10. The biowaiver extension for BCS class III drugs: the effect of dissolution rate on the bioequivalence of BCS class III immediate-release drugs predicted by computer simulation.

    Science.gov (United States)

    Tsume, Yasuhiro; Amidon, Gordon L

    2010-08-02

    The Biopharmaceutical Classification System (BCS) guidance issued by the FDA allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release (IR) solid oral dosage forms only for BCS class I drugs. However, a number of drugs within BCS class III have been proposed to be eligible for biowaivers. The World Health Organization (WHO) has shortened the requisite dissolution time of BCS class III drugs on their Essential Medicine List (EML) from 30 to 15 min for extended biowaivers; however, the impact of the shorter dissolution time on AUC(0-inf) and C(max) is unknown. The objectives of this investigation were to assess the ability of gastrointestinal simulation software to predict the oral absorption of the BCS class I drugs propranolol and metoprolol and the BCS class III drugs cimetidine, atenolol, and amoxicillin, and to perform in silico bioequivalence studies to assess the feasibility of extending biowaivers to BCS class III drugs. The drug absorption from the gastrointestinal tract was predicted using physicochemical and pharmacokinetic properties of test drugs provided by GastroPlus (version 6.0). Virtual trials with a 200 mL dose volume at different drug release rates (T(85%) = 15 to 180 min) were performed to predict the oral absorption (C(max) and AUC(0-inf)) of the above drugs. Both BCS class I drugs satisfied bioequivalence with regard to the release rates up to 120 min. The results with BCS class III drugs demonstrated bioequivalence using the prolonged release rate, T(85%) = 45 or 60 min, indicating that the dissolution standard for bioequivalence is dependent on the intestinal membrane permeability and permeability profile throughout the gastrointestinal tract. The results of GastroPlus simulations indicate that the dissolution rate of BCS class III drugs could be prolonged to the point where dissolution, rather than permeability, would control the overall absorption. For BCS class III drugs with intestinal absorption patterns

  11. Survey of international regulatory bioequivalence recommendations for approval of generic topical dermatological drug products.

    Science.gov (United States)

    Braddy, April C; Davit, Barbara M; Stier, Ethan M; Conner, Dale P

    2015-01-01

    The objective of this article is to discuss the similarities and differences in accepted bioequivalence (BE) approaches for generic topical dermatological drug products between international regulatory authorities and organizations. These drug products are locally applied and not intended for systemic absorption. Therefore, the BE approaches which serve as surrogates to establish safety and efficacy for topical dosage forms tend to differ from the traditional solid oral dosage forms. We focused on 15 different international jurisdictions and organizations that currently participate in the International Generic Drug Regulators Pilot Project. These are Australia, Brazil, Canada, China, Chinese Taipei, the European Medicines Association (EMA), Japan, Mexico, New Zealand, Singapore (a member of the Association of Southeast Asian Nations), South Africa, South Korea, Switzerland, the USA and the World Health Organization (WHO). Upon evaluation, we observed that currently only Canada, the EMA, Japan, and the USA have specific guidance documents for topical drug products. Across all jurisdictions and organizations, the three approaches consistently required are (1) BE studies with clinical endpoints for most topical drug products; (2) in vivo pharmacodynamic studies, in particular the vasoconstrictor assay for topical corticosteroids; and (3) waivers from BE study requirements for topical solutions. Japan, South Africa, the USA, and the WHO are also making strides to accept other BE approaches such as in vivo pharmacokinetic studies for BE assessment, in vivo dermatopharmacokinetic studies and/or BE studies with in vitro endpoints.

  12. Physics studies in Europe; a comparative study

    NARCIS (Netherlands)

    Steenstrup, S; dalle Rose, LFD; Jones, WG; Tugulea, L; van Steenwijk, FJ

    What are the differences and similarities between physics studies at different universities across Europe (here the definition of Europe is broad)? How much does a student have to work to obtain a degree in physics? Questions like those prompted EUPEN (European Physics Education Network) to make a

  13. Microdialysis sampling for investigations of bioavailability and bioequivalence of topically administered drugs: current state and future perspectives

    DEFF Research Database (Denmark)

    Holmgaard, R; Nielsen, J B; Benfeldt, E

    2010-01-01

    of instrumentation, calibration and experimental procedures are discussed along with the analytical considerations necessary for successful sampling. Clinical MD studies in the skin are reviewed with emphasis on pharmacokinetic studies of topically applied drugs with or without impairment of skin barrier function...... development, improvement and validation during the last decade and has proved to be a versatile, safe and valuable tool for pharmacokinetic and pharmacodynamic studies. This review gives an overview of the current state and future perspectives of dermal MD sampling. Methodological issues such as choice...... is concluded by the current regulatory point of view. The future perspective includes further expansion and validation of the use of MD in the experimental and clinical setting as well as in the optimization of the method for regulatory purposes, i.e. the commercialization of bioequivalent, generic drug...

  14. Randomized, interventional, prospective, comparative study to ...

    African Journals Online (AJOL)

    Randomized, interventional, prospective, comparative study to evaluate the antihypertensive efficacy and tolerability of ramipril versus telmisartan in stage 1 hypertensive patients with diabetes mellitus.

  15. Comparative studies on pectinases obtained from Aspergillus ...

    African Journals Online (AJOL)

    Comparative studies on pectinases obtained from Aspergillus fumigatus and Aspergillus niger in submerged fermentation system using pectin extracted from mango, orange and pineapple peels as carbon sources.

  16. bioequivalence study on two 10% enrofloxacin oral formulations

    African Journals Online (AJOL)

    AONDOVER

    African grey parrots following single and multiple doses. J. Vet. Pharmacol. Therapeut., 14: 359-. 366. HARITOVA, A., DJENEVA, H.,. LASHEV, L., SOTIROVA, P.,. GYUROV,. B. and. STEFANOVA, M. (2004):. Pharmacokinetics and PK/PD modeling of enrofloxacin in. Meleagris Gallopavo and Gallus. Domesticus. Bulg. J. Vet.

  17. 78 FR 52777 - Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection...

    Science.gov (United States)

    2013-08-26

    ... on Bioequivalence Recommendations for Risperidone Injection; Availability AGENCY: Food and Drug... availability of a revised draft guidance for industry entitled ``Draft Guidance on Risperidone.'' The guidance... drug applications (ANDAs) for risperidone injection. DATES: Although you can comment on any guidance at...

  18. 21 CFR 320.30 - Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by...

    Science.gov (United States)

    2010-04-01

    ... appropriate. (3) The proposed chemical and statistical analytical methods are adequate. (c)(1) General... and Drug Administration, Center for Drug Evaluation and Research, Office of Clinical Pharmacology, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. (2) General inquiries relating to bioequivalence...

  19. Application of dermal microdialysis for the evaluation of bioequivalence of a ketoprofen topical gel

    DEFF Research Database (Denmark)

    Tettey-Amlalo, Ralph Nii Okai; Kanfer, Isadore; Skinner, Michael F

    2008-01-01

    The purpose was to investigate dermal microdialysis (DMD) for the assessment of the bioavailability of a ketoprofen topical gel formulation and to evaluate this technique as a tool for the determination of bioequivalence. Four microdialysis probes were inserted into the dermis on the volar aspect...

  20. Bioequivalent UV detectors based on cholesteric liquid crystals: effects of spectral composition and quantitative account for intensity of UV radiation

    Science.gov (United States)

    Lisetski, Longin N.; Panikarskaya, Valentina D.; Kasyan, Natalya A.; Grishchenko, Leonid V.; Terenetskaya, Irina P.

    2005-11-01

    Response of cholesteric sensor materials to biologically active UV radiation has been studied. The sensor mixture comprised a cholesteric liquid crystalline matrix doped with provitamin D, and changes in the maximum selective reflection wavelength λ max caused by the photochemical reaction of provitamin D --> vitamin D transformation were recorded. Using a UV source (DRT-240 lamp) calibrated accounting for the specific irradiation geometry, λ max shifts were obtained as function of UV illuminance dose (in J/cm2). Using a set of optical filters cutting off specified parts of the provitamin D absorption spectrum, effects of the spectral composition of UV radiation upon the response characteristics of sensor were determined. The results obtained support our earlier considerations of the developed sensor material as "bioequivalent".

  1. A Comparative Study on Error Analysis

    DEFF Research Database (Denmark)

    Wu, Xiaoli; Zhang, Chun

    2015-01-01

    of the grammatical errors with using comparative sentences is developed, which include comparative item-related errors, comparative result-related errors and blend errors. The results further indicate that these errors could attribute to negative L1 transfer and overgeneralization of grammatical rule and structures......Title: A Comparative Study on Error Analysis Subtitle: - Belgian (L1) and Danish (L1) learners’ use of Chinese (L2) comparative sentences in written production Xiaoli Wu, Chun Zhang Abstract: Making errors is an inevitable and necessary part of learning. The collection, classification and analysis...... the occurrence of errors either in linguistic or pedagogical terms. The purpose of the current study is to demonstrate the theoretical and practical relevance of error analysis approach in CFL by investigating two cases - (1) Belgian (L1) learners’ use of Chinese (L2) comparative sentences in written production...

  2. COMPARATIVE STUDY ON SPECIFIC AND EARLY DETECTION ...

    African Journals Online (AJOL)

    The objective of this study was to compare the sensitivity and specificity of smear and culture methods with rapid serological EIA myco kits manufactured by Omega diagnostics, for the early detection of Mycobacterium tuberculosis (MTB) complex. Sera from various categories of smear and culture results were compared ...

  3. Pharmacokinetics and bioequivalence of a liquid formulation of hydroxyurea in children with sickle cell anemia.

    Science.gov (United States)

    Estepp, Jeremie H; Melloni, Chiara; Thornburg, Courtney D; Wiczling, Paweł; Rogers, Zora; Rothman, Jennifer A; Green, Nancy S; Liem, Robert; Brandow, Amanda M; Crary, Shelley E; Howard, Thomas H; Morris, Maurine H; Lewandowski, Andrew; Garg, Uttam; Jusko, William J; Neville, Kathleen A

    2016-03-01

    Hydroxyurea (HU) is a crucial therapy for children with sickle cell anemia, but its off-label use is a barrier to widespread acceptance. We found HU exposure is not significantly altered by liquid vs capsule formulation, and weight-based dosing schemes provide consistent exposure. HU is recommended for all children starting as young as 9 months of age with sickle cell anemia (SCA; HbSS and HbSβspan(0) thalassemia); however; a paucity of pediatric data exists regarding the pharmacokinetics (PK) or the exposure-response relationship of HU. This trial aimed to characterize the PK of HU in children and to evaluate and compare the bioavailability of a liquid vs capsule formulation. This multicenter; prospective; open-label trial enrolled 39 children with SCA who provided 682 plasma samples for PK analysis following administration of HU. Noncompartmental and population PK models are described. We report that liquid and capsule formulations of HU are bioequivalent; weight-based dosing schemes provide consistent drug exposure; and age-based dosing schemes are unnecessary. These data support the use of liquid HU in children unable to swallow capsules and in those whose weight precludes the use of fixed capsule formulations. Taken with existing safety and efficacy literature; these findings should encourage the use of HU across the spectrum of age and weight in children with SCA; and they should facilitate the expanded use of HU as recommended in the National Heart; Lung; and Blood Institute guidelines for individuals with SCA. © 2015, The American College of Clinical Pharmacology.

  4. A double-blind, randomized, comparative study of Dysport vs. Botox in primary palmar hyperhidrosis.

    Science.gov (United States)

    Simonetta Moreau, M; Cauhepe, C; Magues, J P; Senard, J M

    2003-11-01

    Intradermal injections of type A botulinum toxin have been reported to reduce excessive sweating in patients with primary palmar hyperhidrosis. Two preparations are commercially available in Europe: Botox (Allergan; 100 U per vial) and Dysport (Beaufour Ipsen Biotech; 500 U per vial), which are not bioequivalent. A few studies have tried to find an appropriate conversion factor between the two preparations in dystonic patients but results remain controversial. To compare the efficacy of Botox and Dysport in palmar hyperhidrosis using a conversion factor of 1 : 4. In a double-blind, randomized study, eight patients with severe primary palmar hyperhidrosis received in the same session intradermal injections of Dysport in one palm and Botox in the other, after regional median and ulnar nerve blocks. Quantification of sweat production was performed by Minor's iodine starch test at baseline, 1, 3 and 6 months after the treatment. Subjective assessment of sweat production was performed using a visual analogue scale. The mean +/- SD number of injection sites (28 +/- 1), mean volume of reconstituted solution injected (2.8 mL) and mean sweating area at baseline (BSA) were similar in each palm group. The mean +/- SD dose injected was 69.3 +/- 3.1 U for the Botox-treated palms and 283.7 +/- 11.3 U for the Dysport-treated palms (1 : 4). At 1 month, Minor's test revealed significant decreases in mean sweating area for each preparation (Dysport palms: -78.6% vs. BSA, P = 0.0002; Botox palms: -56.6% vs. BSA, P = 0.003). The percentage of decrease was more pronounced in Dysport palms compared with Botox palms but the difference did not reach statistical significance. At 3 months, the decrease in sweating area remained significant for Dysport palms (-69.4% vs. BSA, P = 0.008) but not for Botox palms (-48.8% vs. BSA). Self-evaluation showed a similar amount of improvement in both palm groups at 1 and 3 months (77% and 75% for Dysport; 68% and 72% for Botox). Local side-effects were

  5. Mathematics education and comparative historical studies

    Directory of Open Access Journals (Sweden)

    Wagner RODRIGUES VALENTE

    2013-11-01

    Full Text Available This paper has as its aims: to characterize the area of research «history of mathematics education» and to defend the idea that mathematics education has constituted a privileged research theme within the field of comparative historical studies. To achieve these aims, the text includes references to a review of the literature concerning comparative studies, the analysis of two fundamental moments focused on attempts to internationalize the mathematics curriculum, both of which occurred during the 20th century, and, to end, a case study emanating from an international cooperation between researchers in Brazil and Portugal.

  6. Comparative studies in Chelicerata III. Opilionida

    NARCIS (Netherlands)

    Hammen, van der L.

    1985-01-01

    A comparative study is made of the three groups (Cyphophthalmi, Laniatores and Palpatores) into which Opilionida are currently subdivided. Methods, principles and terminology, adopted in this paper, correspond with those of parts I and II of the present series of studies in Chelicerata. Special

  7. Comparative study of bioethanol production from sugarcane ...

    African Journals Online (AJOL)

    The study was designed to compare the bioethanol production from Zymomonas mobilis and Saccharomyces cerevisiae using molasses as production medium. The focus was on the retention time at lab scale. Bioethanol and petroleum blend can be used in existing gasoline engines. Present study showed a more ...

  8. Supplementary data: Comparative studies on sequence ...

    Indian Academy of Sciences (India)

    Unknown

    Supplementary data: Comparative studies on sequence characteristics around translation initiation codon in four eukaryotes. Qingpo Liu and Qingzhong Xue. J. Genet. 84, 317–322. Table 1. Spearman's rank correlation coefficients of 39 base positions around the AUG codon in the four eukaryotic species studied. – 30.

  9. Regulatory framework on bioequivalence criteria for locally acting gastrointestinal drugs: the case for oral modified release mesalamine formulations.

    Science.gov (United States)

    Sferrazza, Gianluca; Siviero, Paolo D; Nicotera, Giuseppe; Turella, Paola; Serafino, Annalucia; Blandizzi, Corrado; Pierimarchi, Pasquale

    2017-09-01

    Bioequivalence testing for locally acting gastrointestinal drugs is a challenging issue for both regulatory authorities and pharmaceutical industries. The international regulatory framework has been characterized by the lack of specific bioequivalence tests that has generated a negative impact on the market competition and drug use in clinical practice. Areas covered: This review article provides an overview of the European Union and United States regulatory frameworks on bioequivalence criteria for locally acting gastrointestinal drugs, also discussing the most prominent scientific issues and advances that has been made in this field. A focus on oral modified release mesalamine formulations will be also provided, with practical examples of the regulatory pathways followed by pharmaceutical companies to determine bioequivalence. Expert commentary: The development of a scientific rationale to demonstrate bioequivalence in this field has been complex and often associated with uncertainties related to scientific and regulatory aspects. Only in recent years, thanks to advanced knowledge in this field, the criteria for bioequivalence assessment are undergoing substantial changes. This new scenario will likely result in a significant impact on pharmaceutical companies, promoting more competition through a clearer regulatory approach, conceived for streamlining the demonstration of therapeutic equivalence for locally acting gastrointestinal drugs.

  10. A Comparative Study on Error Analysis

    DEFF Research Database (Denmark)

    Wu, Xiaoli; Zhang, Chun

    2015-01-01

    Title: A Comparative Study on Error Analysis Subtitle: - Belgian (L1) and Danish (L1) learners’ use of Chinese (L2) comparative sentences in written production Xiaoli Wu, Chun Zhang Abstract: Making errors is an inevitable and necessary part of learning. The collection, classification and analysis...... of errors in the written and spoken production of L2 learners has a long tradition in L2 pedagogy. Yet, in teaching and learning Chinese as a foreign language (CFL), only handful studies have been made either to define the ‘error’ in a pedagogically insightful way or to empirically investigate...... the occurrence of errors either in linguistic or pedagogical terms. The purpose of the current study is to demonstrate the theoretical and practical relevance of error analysis approach in CFL by investigating two cases - (1) Belgian (L1) learners’ use of Chinese (L2) comparative sentences in written production...

  11. Comparative bioavailability of ferrous succinate tablet formulations without correction for baseline circadian changes in iron concentration in healthy Chinese male subjects: a single-dose, randomized, 2-period crossover study.

    Science.gov (United States)

    Cao, Guo-Ying; Li, Ke-Xin; Jin, Peng-Fei; Yue, Xiang-Yang; Yang, Chen; Hu, Xin

    2011-12-01

    Ferrous succinate is used for the treatment of iron deficiency anemia. Determining the bioavailability of iron products is a challenge, because iron is naturally present in the blood and some tissues. Therefore, bioequivalence evaluation of ferrous formulations can be affected by the presence of endogenous iron species. Little information regarding the pharmacokinetics of ferrous supplements is available in the healthy Chinese population. The aim of the study was to assess the comparative bioavailability of 200-mg of a test (ferrous succinate,100 mg × 2, Hunan Huana Pharmaceutical Co., Ltd., Hunan, China) and reference (Sulifei, 100 mg × 2, Nanjing Jinling Pharmaceutical Co., Ltd., Nanjing, China) formulation in healthy Chinese male subjects. The study was conducted to meet Chinese State Food and Drug Administration regulatory requirements for approval of a generic formulation of ferrous succinate. This study utilized a single-dose randomized, 2-period, crossover design with alternate assignment of subjects to treatment (a single 200-mg [100 mg × 2]) or reference formulation groups. Both groups underwent a 4-day diet equilibration before 2 days of treatment and, finally, a 4-day washout period for the bioequivalence study. Blood samples were collected at 8:00 am on every diet equilibration day, 0 (baseline), 1, 2, 3, 4, 4.5, 5, 6, 9, 12, 24, and 36 hours after drug administration. Iron concentrations were determined using an inductively coupled plasma mass spectrometry. Subjects in both groups were given a standardized diet, with known amounts of iron and calories. The formulations were assumed to be bioequivalent if the 90% CI ratios for C(max) were within 70% to 143% and AUC(0-last) were within 80% to 125%-criteria established by the Chinese Food and Drug Administration. Tolerability was monitored throughout the study by assessing clinical parameters (vital signs, chemistry laboratory) and subject reports. Twenty healthy Han Chinese male subjects (mean age, 26

  12. Comparative Fasting Bioavailability of 2 Different Betahistine Dihydrochloride 24-mg Tablets: A Single- Dose, Randomized-Sequence, Open-Label, 2-Period Crossover Study in Healthy Thai Volunteers

    Directory of Open Access Journals (Sweden)

    Pinpilai Jutasompakorn

    2016-05-01

    Full Text Available Objective: To evaluate the bioequivalence of 24 mg betahistine dihydrochloride tablets between the test product (Stei® and the reference product (Serc® in healthy Thai volunteers. Methods: This was an open-label, randomized sequence, single-dose, two-period crossover study in 24 healthy volunteers. Half of the volunteers received a single dose of test product 24 mg and then reference product 24 mg after a minimum 7-day washout period. The remaining half of volunteers received the reference product first and then the test product with the same washout period. Blood samples were obtained at pre-dose and over 14 hours after dosing. Plasma concentrations of 2-pyridylacetic acid (2-PAA, a major metabolite of betahistine were quantified by using liquid chromatography with tandem mass spectrometry (LC-MS/MS. Tolerability in volunteers were assessed during the study. Results: Statistical comparison of the main pharmacokinetic parameters showed no significant difference between test and reference. The geometric mean ratios of 2-PAA between the test and reference products were 96.44%, 96.99%, and 94.56% for Cmax, AUC0-t, and AUC0-∞, respectively. These pharmacokinetic parameter values lie within the FDA and European Medicines Agency specified bioequivalence limit (80-125%. No serious adverse events related to the studied drugs were found. Conclusion: It can be concluded that these two betahistine dihydrochloride products were considered bioequivalent.

  13. A comparative study of microbiological and physicochemical ...

    African Journals Online (AJOL)

    A comparative study of microbiological and physicochemical characteristics of water distributed from two water treatment plants in Rwanda. ... Thus, as recommendation to WASAC authority, there is a need for improvement in the water management strategy for better water quality especially along the distribution network.

  14. A Comparative Study of Probabilistic Roadmap Planners

    NARCIS (Netherlands)

    Geraerts, R.J.; Overmars, M.H.

    2004-01-01

    The probabilistic roadmap approach is one of the leading motion planning techniques. Over the past eight years the technique has been studied by many different researchers. This has led to a large number of variants of the approach, each with its own merits. It is difficult to compare the different

  15. A comparative study of map use

    DEFF Research Database (Denmark)

    Bouvin, Niels Olof; Brodersen, Ann Christina; Bødker, Susanne

    2006-01-01

    We present a study comparing the handling of three kinds of maps, each on a physical device: a paper map, a tablet-PC based map, and a cellular phone based one. Six groups of users were asked to locate eight landmarks, looking out a window, and using a particular map. We have begun analyzing video...

  16. Tolerability, pharmacokinetics, and bioequivalence of the tablet and syrup formulations of lacosamide in plasma, saliva, and urine: saliva as a surrogate of pharmacokinetics in the central compartment.

    Science.gov (United States)

    Cawello, Willi; Bökens, Hilmar; Nickel, Brunhild; Andreas, Jens-Otto; Halabi, Atef

    2013-01-01

    To test for bioequivalence of 200 mg lacosamide oral tablet and syrup formulations. Additional objectives were to compare the pharmacokinetic profile of lacosamide in saliva and plasma, and to evaluate its tolerability. This open-label, randomized, two-way crossover trial was conducted in 16 healthy Caucasian male participants in Germany. The bioequivalence of 200 mg lacosamide tablet and syrup was evaluated using plasma to determine maximum measured concentration (C(max)) and area under the curve from zero to the last time point (AUC)(0-tz). Plasma and saliva samples for evaluation of pharmacokinetic parameters of lacosamide and the major metabolite O-desmethyl lacosamide (SPM 12809) were taken over 15 time points (0.5-72 h) and used to statistically compare bioavailability of the two. Urine samples were collected predose and over five time points (0-48 h) to evaluate the cumulative amount of unchanged drug and metabolite. Lacosamide median time to reach C(max) (t(max)) was 1 h for tablet and 0.5 h for syrup in plasma and saliva. Mean terminal half life (t(½)) for tablet and syrup was 12.5 and 12.4 h in plasma, and 13.1 and 13.3 h in saliva, respectively. Tablet and syrup mean plasma AUC(0-tz) was 84.5 and 83.3 μg/mL*h, respectively. Mean AUC(0-tz) in saliva was 93.2 μg/mL*h for tablet and syrup. Mean C(max) for tablet was 5.26 μg/mL in plasma and 5.63 μg/mL in saliva. Syrup mean C(max) was 5.14 and 8.32 μg/mL in plasma and saliva, respectively. Within 2 h of syrup administration, elevated lacosamide concentration in saliva compared to plasma was observed. The ratio of lacosamide syrup to tablet was 0.98 for C(max) and 0.99 for AUC(0-tz) in plasma, and 1.00 for AUC((0-tz)) in saliva; the 90% confidence intervals (CIs) for these parameters were within the range of 0.80-1.25, which meets accepted bioequivalence criteria. The syrup-to-tablet ratio for C(max) in saliva was 1.48, and the 90% CIs exceeded the accepted upper boundary for bioequivalence (1

  17. A comparative study of Averrhoabilimbi extraction method

    Science.gov (United States)

    Zulhaimi, H. I.; Rosli, I. R.; Kasim, K. F.; Akmal, H. Muhammad; Nuradibah, M. A.; Sam, S. T.

    2017-09-01

    In recent year, bioactive compound in plant has become a limelight in the food and pharmaceutical market, leading to research interest to implement effective technologies for extracting bioactive substance. Therefore, this study is focusing on extraction of Averrhoabilimbi by different extraction technique namely, maceration and ultrasound-assisted extraction. Fewplant partsof Averrhoabilimbiweretaken as extraction samples which are fruits, leaves and twig. Different solvents such as methanol, ethanol and distilled water were utilized in the process. Fruit extractsresult in highest extraction yield compared to other plant parts. Ethanol and distilled water have significant role compared to methanol in all parts and both extraction technique. The result also shows that ultrasound-assisted extraction gave comparable result with maceration. Besides, the shorter period on extraction process gives useful in term of implementation to industries.

  18. Comparative Study of Bancruptcy Prediction Models

    Directory of Open Access Journals (Sweden)

    Isye Arieshanti

    2013-09-01

    Full Text Available Early indication of bancruptcy is important for a company. If companies aware of  potency of their bancruptcy, they can take a preventive action to anticipate the bancruptcy. In order to detect the potency of a bancruptcy, a company can utilize a a model of bancruptcy prediction. The prediction model can be built using a machine learning methods. However, the choice of machine learning methods should be performed carefully. Because the suitability of a model depends on the problem specifically. Therefore, in this paper we perform a comparative study of several machine leaning methods for bancruptcy prediction. According to the comparative study, the performance of several models that based on machine learning methods (k-NN, fuzzy k-NN, SVM, Bagging Nearest Neighbour SVM, Multilayer Perceptron(MLP, Hybrid of MLP + Multiple Linear Regression, it can be showed that fuzzy k-NN method achieve the best performance with accuracy 77.5%

  19. Linear pneumatic motors – a comparative study

    Directory of Open Access Journals (Sweden)

    Deaconescu Tudor

    2017-01-01

    Full Text Available The paper presents a comparative study of the performance of single-acting cylinders, diaphragm cylinders and pneumatic muscles, and offers users information that allows the selection of an optimum technical solution. Such a study was necessary, in view of the numerous papers on pneumatic muscle applications found in literature, that assert the superiority of pneumatic muscles over other pneumatic linear motors in relation to quantities like dimensions, mass, developed force or energy-to-mass ratios, however without offering concrete data.

  20. EFQPSK Versus CERN: A Comparative Study

    Science.gov (United States)

    Borah, Deva K.; Horan, Stephen

    2001-01-01

    This report presents a comparative study on Enhanced Feher's Quadrature Phase Shift Keying (EFQPSK) and Constrained Envelope Root Nyquist (CERN) techniques. These two techniques have been developed in recent times to provide high spectral and power efficiencies under nonlinear amplifier environment. The purpose of this study is to gain insights into these techniques and to help system planners and designers with an appropriate set of guidelines for using these techniques. The comparative study presented in this report relies on effective simulation models and procedures. Therefore, a significant part of this report is devoted to understanding the mathematical and simulation models of the techniques and their set-up procedures. In particular, mathematical models of EFQPSK and CERN, effects of the sampling rate in discrete time signal representation, and modeling of nonlinear amplifiers and predistorters have been considered in detail. The results of this study show that both EFQPSK and CERN signals provide spectrally efficient communications compared to filtered conventional linear modulation techniques when a nonlinear power amplifier is used. However, there are important differences. The spectral efficiency of CERN signals, with a small amount of input backoff, is significantly better than that of EFQPSK signals if the nonlinear amplifier is an ideal clipper. However, to achieve such spectral efficiencies with a practical nonlinear amplifier, CERN processing requires a predistorter which effectively translates the amplifier's characteristics close to those of an ideal clipper. Thus, the spectral performance of CERN signals strongly depends on the predistorter. EFQPSK signals, on the other hand, do not need such predistorters since their spectra are almost unaffected by the nonlinear amplifier, Ibis report discusses several receiver structures for EFQPSK signals. It is observed that optimal receiver structures can be realized for both coded and uncoded EFQPSK

  1. CURRICULAR OFFER INFLUENCING STUDENTS’ SATISFACTION: COMPARATIVE STUDY

    Directory of Open Access Journals (Sweden)

    Oana DUMITRASCU

    2014-11-01

    Full Text Available The main objective of the study is the determination of students’ satisfaction regarding curricular activities. The study has been accomplished using the qualitative and quantitative research, using the bibliographic study, various secondary sources and different primary sources. The study is developed with a marketing research and accomplished using the survey method. 699 students from four universities have been questioned. Due to a comparative study the University of Applied Sciences Worms, University of Applied Sciences Wiesbaden Rüsselsheim, University of Applied Sciences Frankfurt am Main and Nürtingen-Geislingen University have been analysed and their similarities and differences have been identified. The collected data, based on the established sample, is evaluated through univariate and bivariate analysis. In accordance with the evaluated sample, specific gaps from each region are identified regarding the curricular offer of the analysed universities. As a result to the conducted study, recommendations for the University of Applied Sciences Worms regarding the student’s satisfaction concerning the curricular offer are presented.

  2. A multicentre, prospective, non-randomized, sequential, open-label trial to demonstrate the bioequivalence between intravenous immunoglobulin new generation (IGNG) and standard IV immunoglobulin (IVIG) in adult patients with primary immunodeficiency (PID).

    Science.gov (United States)

    Viallard, J-F; Brion, J-P; Malphettes, M; Durieu, I; Gardembas, M; Schleinitz, N; Hoarau, C; Lazaro, E; Puget, S

    2017-09-01

    To demonstrate the bioequivalence between 2 intravenous immunoglobulin (IVIG) preparations, TEGELINE ® and ClairYg ® , a ready-to-use 5% IVIG, in primary immunodeficiency (PID). Secondary objectives were to assess the efficacy, safety and pharmacokinetics of ClairYg ® . Twenty-two adult PID patients receiving stable doses of TEGELINE ® (5% lyophilized IVIG) were switched to ClairYg ® for 6 months. ClairYg ® was administered under the same conditions as TEGELINE ® , either every 3 or 4 weeks. The primary endpoint was mean average total IgG trough level at steady state with ClairYg ® versus TEGELINE ® . Clinical efficacy was also assessed in terms of infections and associated events. Bioequivalence was established with a mean average total IgG trough level at steady state being 8.05g/L with TEGELINE ® and 9.17g/L with ClairYg ® (i.e. geometric mean for the difference between ClairYg ® and TEGELINE ® was 1.136; [90% CI: 1.092-1.181] P4-6g/L) throughout the study. No patient was hospitalized for infection or had serious bacterial infections while receiving ClairYg ® . The median annualized infections rate per patient was similar for both products: 4.35 [0; 21.8] for TEGELINE ® and 4.30 [0; 15.1] for ClairYg ® . Infections were less common with higher IgG trough levels (>8.16g/L). ClairYg ® showed good safety, in particular good hepatic and renal tolerance, and did not induce hemolysis. ClairYg ® pharmacokinetics profile was comparable to that of TEGELINE ® . ClairYg ® is safe and effective in the treatment of adult PID. Copyright © 2017 Société Nationale Française de Médecine Interne (SNFMI). Published by Elsevier SAS. All rights reserved.

  3. A comparative study of teenage pregnancy.

    Science.gov (United States)

    Mahavarkar, S H; Madhu, C K; Mule, V D

    2008-08-01

    Teenage pregnancy is a global problem and is considered a high-risk group, in spite of conflicting evidence. Our objective was to compare obstetric outcomes of pregnancy in teenagers and older women. This was a retrospective study of case records of pregnancies from August 2000 to July 2001. Girls aged pregnancy outcomes in older women (19-35 years) in the same hospital. The study took place in the Government General Hospital, Sangli, India, a teaching hospital in rural India, with an annual delivery rate of over 3,500. A total of 386 teenage pregnancies were compared with pregnancies in 3,326 older women. Socioeconomic data, age, number of pregnancies, antenatal care and complications, mode of delivery, and neonatal outcomes were considered. The incidence of teenage pregnancy in the study was 10%. A significant proportion of teenage pregnant mothers were in their first pregnancies. The teenage mothers were nearly three times more at risk of developing anaemia (OR = 2.83, 95% CI = 2.2-3.7, p Teenage mothers were twice as likely to develop hypertensive problems in pregnancy (OR = 2.2, 95% CI = 1.5-3.2, p teenage pregnancies are still a common occurrence in rural India in spite of various legislations and government programmes and teenage pregnancy is a risk factor for poor obstetric outcome in rural India. Cultural practices, poor socioeconomic conditions, low literacy rate and lack of awareness of the risks are some of the main contributory factors. Early booking, good care during pregnancy and delivery and proper utilisation of contraceptive services can prevent the incidence and complications in this high-risk group.

  4. A single-dose, randomized, two-way crossover study comparing two olanzapine tablet products in healthy adult male volunteers under fasting conditions.

    Science.gov (United States)

    Elshafeey, Ahmed H; Elsherbiny, Mohamed A; Fathallah, Mohsen M

    2009-03-01

    Olanzapine is a psychotropic agent that belongs to the thienobenzodiazepine class. The aim of this study was to assess the bioequivalence of 2 commercial 10-mg tablet formulations of olanzapine by statistical analysis of the pharmacokinetic parameters C(max), AUC from 0 to 72 hours after dosing (AUC(0-72)), and AUC(0-infinity) as required by the Egyptian health authority for the marketing of a generic product. This bioequivalence study was carried out in healthy male volunteers using a single-dose, randomized, 2-way crossover design under fasting conditions. Statistical analysis of the pharmacokinetic parameters C(max), AUC(0-72), and AUC(0-infinity) was conducted to determine bioequivalence (after log-transformation of data using analysis of variance and 90% CIs) and to gain marketing approval in Egypt. The formulations were considered to be bioequivalent if the log-transformed ratios of the 3 pharmacokinetic parameters were within the predetermined bioequivalence range (ie, 80%-125%), as established by the US Food and Drug Administration (FDA). Both the test product (Trademark: Integrol((R)) [Global Napi Pharmaceuticals, Cairo, Egypt]) and the reference product (Trademark: Zyprexa((R)) [Eli Lilly and Company, Basingstoke, Hampshire, United Kingdom]) were administered as 10-mg tablets with 240 mL of water after an overnight fast on 2 treatment days, separated by a 2-week washout period. After dosing, serial blood samples were collected for 72 hours. Plasma samples were analyzed using a sensitive, reproducible, and accurate liquid chromatography-tandem mass spectrometry method capable of quantitating olanzapine in the range of 0.167 to 16.7 ng/mL, with a lower limit of quantitation of 0.167 ng/mL. Adverse events were reported by the volunteers as instructed or observed by the resident physician, and were recorded, tabulated, and evaluated. Twenty-four healthy adult male volunteers participated in this study. Their mean (SD) age was 24.7 (6.2) years (range, 19

  5. A comparative study of bike lane injuries.

    Science.gov (United States)

    Wee, Jung Hee; Park, Jeong Ho; Park, Kyu Nam; Choi, Seung Pill

    2012-02-01

    Because of the increased number of bicycle riders and governmental promotions, a recent increase in the construction of bicycle lanes has occurred. We aimed to characterize injuries specific to bicycle lane accidents by comparing them with injuries that occurred on regular roadways. On the basis of our findings, we provide suggestions on proper preventive strategies. We performed a retrospective study on 408 cases obtained between January 1, 2009, and December 31, 2010. Of these cases, 387 met the criterion that the location of the injury could be confirmed by telephone or via review of the patient's chart. Data regarding age, gender, Injury Severity Score, time of the accident, location of the accident, and other characteristics were collected. Data were analyzed using SPSS 12.0K. Of the 387 cases, 204 (52.7%) patients were injured in bicycle lanes and 183 (47.3%) were injured on regular roadways. Comparing cases of bicycle lane injuries and non-bicycle lane injuries, there were no differences in age, day of the week, season, or the time at which the accident occurred. Bicycle helmets were used more frequently in bicycle lane injuries (33.2% vs. 13.7%; p gear or preventing the use of bicycle lanes by pedestrians. More safety education programs are also needed. III.

  6. Comparative study of different fuel cell technologies

    International Nuclear Information System (INIS)

    Alvarado-Flores, J.

    2013-01-01

    Fuel cells generate electricity and heat during electrochemical reaction which happens between the oxygen and hydrogen to form the water. Fuel cell technology is a promising way to provide energy for rural areas where there is no access to the public grid or where there is a huge cost of wiring and transferring electricity. In addition, applications with essential secure electrical energy requirement such as uninterruptible power supplies (UPS), power generation stations and distributed systems can employ fuel cells as their source of energy. The current paper includes a comparative study of basic design, working principle, applications, advantages and disadvantages of various technologies available for fuel cells. In addition, techno-economic features of hydrogen fuel cell vehicles (FCV) and internal combustion engine vehicles (ICEV) are compared. The results indicate that fuel cell systems have simple design, high reliability, noiseless operation, high efficiency and less environmental impact. The aim of this paper is to serve as a convenient reference for fuel cell power generation reviews. (Author)

  7. Comparative microscopy study of Vibrio cholerae flagella

    Science.gov (United States)

    Konnov, Nikolai P.; Baiburin, Vil B.; Zadnova, Svetlana P.; Volkov, Uryi P.

    1999-06-01

    A fine structure of bacteria flagella is an important problem of molecular cell biology. Bacteria flagella are the self-assembled structures that allow to use the flagellum protein in a number of biotechnological applications. However, at present, there is a little information about high resolution scanning probe microscopy study of flagellum structure, in particular, about investigation of Vibrio cholerae flagella. In our lab have been carried out the high resolution comparative investigation of V. cholerae flagella by means of various microscopes: tunneling (STM), scanning force (SFM) and electron transmission. As a scanning probe microscope is used designed in our lab versatile SPM with replaceable measuring heads. Bacteria were grown, fixed and treated according to the conventional techniques. For STM investigations samples were covered with Pt/Ir thin films by rotated vacuum evaporation, in SFM investigations were used uncovered samples. Electron microscopy of the negatively stained bacteria was used as a test procedure.

  8. [Anxiety in eating disorders: a comparative study].

    Science.gov (United States)

    Solano Pinto, Natalia; Cano Vindel, Antonio

    2012-01-01

    Scientific literature shows that anxiety is an important factor in eating disorders. The aim of this case-control study was to compare the anxiety manifestations obtained by means of the Anxiety Situations and Responses Inventory of in a clinical sample of 74 females (46, anorexia nervosa; 28, bulimia) to those obtained by a control group (130 girls without disorders). The between-group ANOVA results showed higher anxiety scores in the clinical group with a medium effect size for the anxiety trait, finding a flat profile (within-group ANOVA) for the three response systems (cognitive, physiological and motor) and the four specific anxiety traits (test, interpersonal, phobic, and daily life situations). Moreover, high scores in anxiety involved a greater risk of being diagnosed with an eating disorder in the 8 bivariate comparisons. The estimations were more precise for cognitive anxiety and for the specific interpersonal anxiety trait.

  9. Transdermal fentanyl matrix patches Matrifen and Durogesic DTrans are bioequivalent

    DEFF Research Database (Denmark)

    Kress, Hans G; Boss, Hildegard; Delvin, Thomas

    2010-01-01

    AIM: The pharmacokinetic profiles of the two commercially available transdermal fentanyl patches Matrifen (100 microg/h) and Durogesic DTrans (100 microg/h), used to manage severe chronic pain, were compared regarding their systemic exposure, rate of absorption, and safety. METHODS: Transdermal...... matrix fentanyl patches [Matrifen or Durogesic DTrans (100 microg/h)] were applied for 72 h to 30 healthy male subjects in a randomized, four-period (two replicated treatment sequences), crossover study; 28 subjects completed the study. The pharmacokinetic parameters of fentanyl were determined for 144 h...... after application using plasma samples. Safety of the patches (adverse events) and performance (adhesion, skin irritation, residual fentanyl content in the patch) were evaluated. RESULTS: The plasma concentration-time curves of Matrifen (Test) and Durogesic DTrans (Reference) were similar. The geometric...

  10. Comparative studies of groundwater vulnerability assessment

    Science.gov (United States)

    Maria, Rizka

    2018-02-01

    Pollution of groundwater is a primary issue because aquifers are susceptible to contamination from land use and anthropogenic impacts. Groundwater susceptibility is intrinsic and specific. Intrinsic vulnerability refers to an aquifer that is susceptible to pollution and to the geological and hydrogeological features. Vulnerability assessment is an essential step in assessing groundwater contamination. This approach provides a visual analysis for helping planners and decision makers to achieve the sustainable management of water resources. Comparative studies are applying different methodologies to result in the basic evaluation of the groundwater vulnerability. Based on the comparison of methods, there are several advantages and disadvantages. SI can be overlaid on DRASTIC and Pesticide DRASTIC to extract the divergence in sensitivity. DRASTIC identifies low susceptibility and underestimates the pollution risk while Pesticide DRASTIC and SI represents better risk and is recommended for the future. SINTACS method generates very high vulnerability zones with surface waters and aquifer interactions. GOD method could be adequate for vulnerability mapping in karstified carbonate aquifers at small-moderate scales, and EPIK method can be used for large scale. GOD method is suitable for designing large area such as land management while DRASTIC has good accuracy and more real use in geoenvironmental detailed studies.

  11. COMPARATIVE STUDY ON ACCOUNTING AND FISCAL AMORTIZATION

    Directory of Open Access Journals (Sweden)

    MARIANA GURAU

    2012-05-01

    Full Text Available Placed in the international trend, Romanian accounting had experienced various changes, especially as regards of progress on disconnection between accounting and fiscality. In the present, fiscal rules should not have any role in accounting decisions, because accounting rules are applied to produce accounting information that is useful in making decisions and to provide a "true and fair view" upon financial reality of the entity. However, the barrier in the habit of accounting to thinking for fiscal point of view all economic transactions remains insurmountable, yet. Starting from this perspective on disconnection between accounting and fiscality would mean that amortization recorded in the accounting, as a result of management policy, to be different from fiscality amortization, to calculate income tax. Although formally accepted, disconnect between accounting and fiscality continues to meet many difficulties. In this sense, it is usual in practice to use the same method of amortization for accounting purposes and for fiscal purposes to prevent complications of double track amortization and prevent wandering in the rules in this field. Accounting rule is deliberately eluded in favor of the fiscal rules. This is the reason we proposed to make in this paper a comparative study between norms and rules on accounting and fiscal amortization, paper in which we intend to show the benefits of applying accounting and fiscal rules separately.

  12. Comparative study on Charpy specimen reconstitution techniques

    International Nuclear Information System (INIS)

    Bourdiliau, B.; Decroix, G.-M.; Averty, X.; Wident, P.; Bienvenu, Y.

    2011-01-01

    Highlights: → Welding processes are used to reconstitute previously tested Charpy specimens. → Stud welding is preferred for a quick installation, almost immediately operational. → Friction welding produces better quality welds, but requires a development effort. - Abstract: Reconstitution techniques are often used to allow material from previously fractured Charpy-V specimens to be reused for additional experiments. This paper presents a comparative experimental study of various reconstitution techniques and evaluates the feasibility of these methods for future use in shielded cells. The following techniques were investigated: arc stud welding, 6.0 kW CO 2 continuous wave laser welding, 4.5 kW YAG continuous wave laser welding and friction welding. Subsize Charpy specimens were reconstituted using a 400 W YAG pulsed wave laser. The best result was obtained with arc stud welding; the resilience of the reconstituted specimens and the load-displacement curves agreed well with the reference specimens, and the temperature elevation caused by the welding process was limited to the vicinity of the weld. Good results were also obtained with friction welding; this process led to the best quality welds. Laser welding seems to have affected the central part of the specimens, thus leading to different resilience values and load-displacement curves.

  13. A Bioequivalence Test by the Direct Comparison of Concentration-versus-Time Curves Using Local Polynomial Smoothers

    Directory of Open Access Journals (Sweden)

    Suyan Tian

    2016-01-01

    Full Text Available In order to test if two chemically or pharmaceutically equivalent products have the same efficacy and/or toxicity, a bioequivalence (BE study is conducted. The 80%/125% rule is the most commonly used criteria for BE and states that BE cannot be claimed unless the 90% CIs for the ratio of selected pharmacokinetics (PK parameters of the tested to the reference drug are within 0.8 to 1.25. Considering that estimates of these PK parameters are derived from the concentration-versus-time curves, a direct comparison between these curves motivates an alternative and more flexible approach to test BE. Here, we propose to frame the BE test in terms of an equivalence of concentration-versus-time curves which are constructed using local polynomial smoother (LPS. A metric is presented to quantify the distance between the curves and its 90% CIs are calculated via bootstrapping. Then, we applied the proposed procedures to data from an animal study and found that BE between a generic drug and its brand name cannot be concluded, which was consistent with the results by applying the 80%/125% rule. However, the proposed procedure has the advantage of testing only on a single metric, instead of all PK parameters.

  14. Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I drugs.

    Science.gov (United States)

    Kortejärvi, H; Shawahna, R; Koski, A; Malkki, J; Ojala, K; Yliperttula, M

    2010-02-01

    Currently, the EMEA, FDA, and WHO as regulatory authorities accept rapidly dissolving (>85% dissolved in 30 min) biopharmaceutics classification system (BCS) I drug products for biowaiver candidates. In the draft EMEA guideline the requirement has been set tighter, that is, the drug product should be very rapidly dissolving (>85% dissolved in 15 min) to be eligible for a biowaiver. Pharmacokinetic modeling of 32 BCS I drugs was performed to demonstrate that very rapid dissolution is not necessary to guarantee bioequivalence for them. Rapid dissolution and similar dissolution profiles are sufficient criteria for all BCS I drugs. (c) 2009 Wiley-Liss, Inc. and the American Pharmacists Association.

  15. 21 CFR 320.27 - Guidelines on the design of a multiple-dose in vivo bioavailability study.

    Science.gov (United States)

    2010-04-01

    ... vivo bioavailability study. 320.27 Section 320.27 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products § 320.27...

  16. Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs

    Energy Technology Data Exchange (ETDEWEB)

    Szebeni, Janos, E-mail: jszebeni2@gmail.com [Nanomedicine Research and Education Center, Semmelweis University, Budapest & SeroScience Ltd, Budapest (Hungary); Storm, Gert [Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht (Netherlands)

    2015-12-18

    Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequivalence evaluations of generic liposomal drug candidates. This review highlights the adverse consequences of C activation, the unique symptoms of CARPA triggered by essentially all i.v. administered liposomal drugs, and the various features of vesicles influencing this adverse immune effect. For the case of Doxil, we also address the mechanism of C activation and the opsonization vs. long circulation (stealth) paradox. In reviewing the methods of assessing C activation and CARPA, we delineate the most sensitive porcine model and an algorithm for stepwise evaluation of the CARPA risk of i.v. liposomes, which are proposed for standardization for preclinical toxicology evaluation of liposomal and other nanoparticulate drug candidates. - Highlights: • Outlining of difficulties in generic development of liposomal drugs. • New regulatory requirements to evaluate CARPA in preclinical studies. • Review of complement activation by liposomes and its adverse consequences (CARPA). • Assays of C activation in vitro and CARPA in vivo, with the porcine test in focus. • Decision tree how to handle the risk of CARPA assessed by a battery of tests.

  17. COMPARATIVE PHARMACOKINETICS AND EFFECT ON THE HEMODYNAMICS OF ORIGINAL AND GENERIC NEBIVOLOL IN HEALTHY VOLUNTEERS

    Directory of Open Access Journals (Sweden)

    E. I. Bambysheva

    2016-01-01

    Full Text Available Beta-blockers are an important part of modern pharmacotherapy in cardiology. The introduction of generics into clinical practice requires clear evidence of bioequivalence to the original drug.Aim. To study the pharmacokinetics and effect on hemodynamic parameters of the original and a generic nebivolol in healthy volunteers in the fasting state. Material and methods. 18 healthy volunteers were included into the randomized open study on cross-balanced design. They received single dose (5 mg of two compared preparations of nebivolol under fasting condition. The concentration of unchanged nebivolol in blood plasma was determined by gas chromatography-tandem mass spectrometry. Calculation of pharmacokinetic parameters and assessment of the hemodynamic were performed.Results. The concentrations of nebivolol after the original and generic drugs intake did not differ significantly in any time point (AUC0-∞ 41.09±46.82 vs 47.16±66.58 ng•hr/mL and T1/2 30.84±10.78 vs 29.59±12.08 hours, respectively. Blood pressure reduction was slightly more pronounced when taking generic nebivolol, while the reduction in heart rate at 2 and 4 hours – after original nebivolol intake.Conclusion. A comparative pharmacokinetic study of the genetic nebivolol showed its bioequivalence to the original drug. The effect on hemodynamic parameters with single dose (5 mg of generic and original nebivolol in healthy volunteers was comparable.

  18. Investigation of the bioequivalence of montelukast chewable tablets after a single oral administration using a validated LC-MS/MS method

    Directory of Open Access Journals (Sweden)

    Zaid AN

    2015-09-01

    Full Text Available Abdel Naser Zaid,1 Murad N Abualhasan,1 David G Watson,2 Ayman Mousa,3 Nadia Ghazal,4 Rana Bustami5 1Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine; 2Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK; 3R&D Department, Avalon Pharma (Middle East Pharmaceutical Industries Co. Ltd., Riyadh, Kingdom of Saudi Arabia; 4Naratech Pharmaceutical Consultancy, 5Pharmaceutical Research Unit, Amman, Jordan Background: Montelukast (MT is a leukotriene D4 antagonist. It is an effective and safe medicine for the prophylaxis and treatment of chronic asthma. It is also used to prevent acute exercise-induced bronchoconstriction and as a symptomatic relief of seasonal allergic rhinitis and perennial allergic rhinitis.Objective: The aim of this study was to evaluate the bioequivalence (BE of two drug products: generic MT 5 mg chewable tablets versus the branded drug Singulair® pediatric 5 mg chewable tablets among Mediterranean volunteers.Methods: An open-label, randomized two-period crossover BE design was conducted in 32 healthy male volunteers with a 9-day washout period between doses and under fasting conditions. The drug concentrations in plasma were quantified by using a newly developed and fully validated liquid chromatography tandem mass spectrometry method, and the pharmacokinetic parameters were calculated using a non-compartmental model. The ratio for generic/branded tablets using geometric least squares means was calculated for both the MT products.Results: The relationship between concentration and peak area ratio was found to be linear within the range 6.098–365.855 ng/mL. The correlation coefficient (R2 was always greater than 0.99 during the course of the validation. Statistical comparison of the main pharmacokinetic parameters showed no significant difference between the generic and branded products. The point estimates (ratios of

  19. Old people in pain : a comparative study

    OpenAIRE

    Jakobsson, Ulf; Klevsgård, Rosemarie; Westergren, Albert; Rahm Hallberg, Ingalill

    2003-01-01

    To investigate the prevalence of pain in older people (75+), compare those in pain to those without regarding demographics, social network, functional limitations, fatigue, sleeping problems, depressed mood and quality of life (QOL), and identify variables associated with pain, a cross-sectional, prospective survey was conducted in an age-stratified sample of 4,093 people aged 75-105 years old. Those reporting pain (n=1,654) were compared with those who did not (n=2,439). Pain was more common...

  20. Comparative studies on organoleptic and nutritional characteristics ...

    African Journals Online (AJOL)

    Low consumption of meat is associated with high poverty level, and protein deficiency in Nigeria. Meat analogue (Texturized Vegetable Protein – TVP) was processed from protein concentrate and defatted soybean flour, and was flavoured as beef and compared to beef from animal source. The nutritional composition of ...

  1. Comparative Studies on Some Physicochemical Properties of ...

    African Journals Online (AJOL)

    Industrial and nutritional processes have increased the demands for oil and this in turn has led to the search for oils from different types of seeds. It is in this vein that baobab seed oil was extracted, analyzed and some of it physicochemical properties compared with those of vegetable, peanut and palm oils. The percentage ...

  2. A COMPARATIVE STUDY OF THE STARCH PASTING ...

    African Journals Online (AJOL)

    Past~ng properties (gelatinization temperature, gelatinization time, viscosity, ease of cooking and starch stat;ility) of cassava, plantain and banana flours have been found to be affected by processing. Roasting and boiling, reduced peak .... and compare the effect of the afore mentioned processing methods on the pasting ...

  3. Energy band offset extraction - a comparative study

    NARCIS (Netherlands)

    van der Steen, J.P.J.; Hueting, Raymond Josephus Engelbart; Schmitz, Jurriaan

    2008-01-01

    Structural quantum confinement in thin silicon double-gate MOSFETs has been quantified using the temperature dependence of the subthreshold current. The results were compared with the shifts in threshold voltage. Data was obtained from simulations after initial verification with experimental data.

  4. Comparative study of environmental impact assessment methods ...

    African Journals Online (AJOL)

    STORAGESEVER

    2009-07-20

    Jul 20, 2009 ... components (in the construction or operation of the pro- ject). iv) Lack of unity. v) Lack of consideration of the comparative impacts of the components result from the changes happened in the environment. vi) Lack of possibility of benefiting from aggregative opi- nions of experts. In fact, there is no unity ...

  5. Comparative Studies on Some Physicochemical Properties of ...

    African Journals Online (AJOL)

    ABSTRACT: Industrial and nutritional processes have increased the demands for oil and this in turn has led to the search for oils from different types of seeds. It is in this vein that baobab seed oil was extracted, analyzed and some of it physicochemical properties compared with those of vegetable, peanut and palm oils.

  6. Counseling in Costa Rica: A Comparative Study

    Science.gov (United States)

    Collier, Crystal

    2013-01-01

    With one of the world's most comprehensive universal healthcare systems, medical tourism in Costa Rica has increased significantly over the past few decades. American tourists save up to 80% of comparative costs for procedures, from heart surgery to root canal treatment. Although many Costa Rican healthcare professionals receive training in North…

  7. A Comparative Study of Navigation Meshes

    NARCIS (Netherlands)

    van Toll, W.G.; Triesscheijn, Roy; Kallmann, Marcelo; Oliva, Ramon; Pelechano, Nuria; Pettré, Julien; Geraerts, R.J.

    2016-01-01

    A navigation mesh is a representation of a 2D or 3D virtual environment that enables path planning and crowd simulation for walking characters. Various state-of-the-art navigation meshes exist, but there is no standardized way of evaluating or comparing them. Each implementation is in a different

  8. Comparative study of some new EPR dosimeters

    International Nuclear Information System (INIS)

    Alzimami, K.S.; Maghraby, Ahmed M.; Bradley, D.A.

    2014-01-01

    Investigations have been made of four new radiation dosimetry EPR candidates from the same family of materials: sulfamic acid, sulfanillic acid, homotaurine, and taurine. Mass energy attenuation coefficients, mass stopping power values and the time dependence of the radiation induced radicals are compared. Also investigated are the microwave saturation behavior and the effect of applied modulation amplitude on both peak-to-peak line width (W PP ) and peak-to-peak signal height (H PP ). The dosimeters are characterized by simple spectra and stable radiation-induced radicals over reasonable durations, especially in taurine dosimeters. Sulfamic acid dosimeters possessed the highest sensitivity followed by taurine and homotaurine and sulfanillic. - Highlights: ► Several EPR dosimeters were suggested based on SO 3 − radical. ► Taurine, homotaurine, sulfanilic, and sulfamic acid all possess simple EPR spectra. ► Dosimeters were compared to each other in terms of the dosimetric point of view. ► Energy dependence curves of the selected dosimeters were compared to eachother

  9. Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA.

    Science.gov (United States)

    Bate, Roger; Mathur, Aparna; Lever, Harry M; Thakur, Dinesh; Graedon, Joe; Cooperman, Tod; Mason, Preston; Fox, Erin R

    2016-03-01

    The regulations for assessing the quality of generic drugs and their bioequivalence to innovator products are outdated and need to be substantially modernized. There are multiple reasons why these changes are needed, including: (i) the regulations remain largely unchanged since the passage of the Hatch-Waxman Act in 1984; (ii) medication therapies have become substantially more complex over the three decades since the passage of the Act; (iii) a switch from an innovator drug to a generic drug, or switching from one generic to another, is not a benign process - there is substantial clinical professional judgment involved and in some instances these decisions should be better informed; and (iv) pharmaceutical ingredients for finished products, whether innovator or generic, are from multiple sources of supply, adding variability in their production, and which may not be accounted for in specification tolerances. When these elements are viewed together, they clearly suggest that more transparency of responsible manufacturers in product labels and updated standards for bioequivalence are required. Copyright © 2015 Elsevier Ltd. All rights reserved.

  10. Comparative study of some new EPR dosimeters

    Science.gov (United States)

    Alzimami, K. S.; Maghraby, Ahmed M.; Bradley, D. A.

    2014-02-01

    Investigations have been made of four new radiation dosimetry EPR candidates from the same family of materials: sulfamic acid, sulfanillic acid, homotaurine, and taurine. Mass energy attenuation coefficients, mass stopping power values and the time dependence of the radiation induced radicals are compared. Also investigated are the microwave saturation behavior and the effect of applied modulation amplitude on both peak-to-peak line width (WPP) and peak-to-peak signal height (HPP). The dosimeters are characterized by simple spectra and stable radiation-induced radicals over reasonable durations, especially in taurine dosimeters. Sulfamic acid dosimeters possessed the highest sensitivity followed by taurine and homotaurine and sulfanillic.

  11. Comparative transport studies of ''1212'' superconductors

    International Nuclear Information System (INIS)

    Gapud, Albert; Wu, Judy; Yan, Shaolin; Xie, Yi-Yuan; Kang, Byeongwon; Siegal, Michael P.; Overmyer, Donald L.

    2000-01-01

    HgBa 2 CaCu 2 O 6+δ (Hg-1212) thin films were fabricated by exchanging the TI cations in TlBa 2 CaCu 2 O 7-δ (Tl-1212) thin films with Hg cations, causing a 30-K increase in Tc. To determine how this exchange effects such a Tc increase, the irreversibility lines, temperature dependence of critical current density, and temperature dependence of Hall angle of Hg-1212 and T1-1212 thin films were measured and then compared. The results strongly suggest that the Tc shift is caused by a doubling of charge carrier density

  12. Comparative study of emphathy in adolescents

    Directory of Open Access Journals (Sweden)

    Racu Iulia

    2016-11-01

    Full Text Available The problem of empathy is an important one in modern psychology. Empathy is reliving states, thoughts and actions of others like yours. The present research is focused on empathy at adolescents. So we can mention that 23,3 % of adolescents presents low level of empathy, 66,7% - moderate level of empathy and 10% - high level of empathy. Comparative analyzes permit to establish that high school adolescents and adolescent in conflict with laws are characterized by different levels of empathy. Adolescents in conflict with laws present a lower level of empathetic tendencies than high school adolescents.

  13. Comparative studies on different molecular methods for ...

    African Journals Online (AJOL)

    The present study aims to evaluate two molecular methods for epidemiological typing of multi drug resistant Klebsiella pneumoniae isolated from Mansoura Hospitals. In this study, a total of 300 clinical isolates were collected from different patients distributed among Mansoura Hospitals, Dakahlia governorate, Egypt.

  14. Advertisement Analysis: A Comparative Critical Study

    Science.gov (United States)

    Abdelaal, Noureldin Mohamed; Sase, Amal Saleh

    2014-01-01

    This study aimed at analyzing two advertisements, and investigating how advertisers use discourse and semiotics to make people and customers buy into their ideas, beliefs, or simply their products. The two advertisements analyzed are beauty products which have been selected from internet magazines. The methodology adopted in this study is…

  15. Child Labor in Africa: A Comparative Study

    DEFF Research Database (Denmark)

    Canagarajah, Sudharshan; Nielsen, Helena Skyt

    2001-01-01

    This paper analyzes the determinants of child labor in Africa as inferred from recent empirical studies. The empirical analysis is based upon five country studies undertaken in three different African countries, namely Côte d'Ivoire, Ghana, and Zambia. Some support is found for the popular belief...

  16. The significance of pharmacodynamic measurements in the assessment of bioavailability and bioequivalence of psychotropic drugs using CEEG and dynamic brain mapping.

    Science.gov (United States)

    Itil, T M; Itil, K Z

    1986-09-01

    There are a variety of problems in evaluating the bioavailability of psychotropic drugs. Psychotropics have many metabolites; there are discrepancies between peripheral plasma levels and therapeutic effects, and psychotropics must penetrate the blood-brain barrier to have an effect on their target organ. Therefore, "classical" pharmacokinetic evaluation may not be sufficient to determine the bioavailability and bioequivalence of these drugs. Additional and more precise information may be obtained by adding pharmacodynamic procedures to these evaluations. Quantitative pharmaco-EEG (QPEEG), which uses the computer-analyzed electroencephalogram (CEEG), may be the method of choice for determining the pharmacodynamic profiles of psychotropic drugs at the central nervous system (CNS) level. The difficulties in evaluating the bioavailability of psychotropics, as well as the results of several studies that confirm the significance of CEEG as a pharmacodynamic measure, are discussed.

  17. Comparative study of void fraction models

    International Nuclear Information System (INIS)

    Borges, R.C.; Freitas, R.L.

    1985-01-01

    Some models for the calculation of void fraction in water in sub-cooled boiling and saturated vertical upward flow with forced convection have been selected and compared with experimental results in the pressure range of 1 to 150 bar. In order to know the void fraction axial distribution it is necessary to determine the net generation of vapour and the fluid temperature distribution in the slightly sub-cooled boiling region. It was verified that the net generation of vapour was well represented by the Saha-Zuber model. The selected models for the void fraction calculation present adequate results but with a tendency to super-estimate the experimental results, in particular the homogeneous models. The drift flux model is recommended, followed by the Armand and Smith models. (F.E.) [pt

  18. Clinical methods of goniometry: a comparative study.

    Science.gov (United States)

    Goodwin, J; Clark, C; Deakes, J; Burdon, D; Lawrence, C

    1992-01-01

    This investigation compared the reliability and interchangeable use of three currently available goniometers--a universal goniometer, a fluid goniometer, and an electrogoniometer. Three consecutive readings of the active range of movement of the right elbow joint were taken from each of 23 healthy female volunteers; three experienced observers each used each type of goniometer on two occasions. A balanced experimental design was used to eliminate order effects with respect to subject, tester, or goniometer, and a rigid protocol was employed to reduce error due to diurnal or methodological variations. The results show that there are significant differences between the goniometers used, the testers, and the replications. Significant interaction effects also exist between the goniometers and the occasion, the goniometers and the testers, and the testers and replications. The data suggest that the interchangeable use of different types of goniometer in a clinical setting is inadvisable.

  19. COMPARATIVE STUDY OF LIGHT SOURCES FOR HOUSEHOLD

    Directory of Open Access Journals (Sweden)

    Andrzej PAWLAK

    2017-01-01

    Full Text Available The article describes test results that provided the ground to define and evaluate basic photometric, colorimetric and electric parameters of selected, widely available light sources, which are equivalent to a traditional incandescent 60-Watt light bulb. Overall, one halogen light bulb, three compact fluorescent lamps and eleven LED light sources were tested. In general, it was concluded that in most cases (branded products, in particular the measured and calculated parameters differ from the values declared by manufacturers only to a small degree. LED sources prove to be the most beneficial substitute for traditional light bulbs, considering both their operational parameters and their price, which is comparable with the price of compact fluorescent lamps or, in some instances, even lower.

  20. Bioequivalence of two film-coated tablets of imatinib mesylate 400 mg: a randomized, open-label, single-dose, fasting, two-period, two-sequence crossover comparison in healthy male South American volunteers.

    Science.gov (United States)

    Parrillo-Campiglia, Susana; Ercoli, Mónica Cedres; Umpierrez, Ofelia; Rodríguez, Patricia; Márquez, Sara; Guarneri, Carolina; Estevez-Parrillo, Francisco T; Laurenz, Marilena; Estevez-Carrizo, Francisco E

    2009-10-01

    Imatinib is a tyrosine kinase inhibitor that has been established as a highly effective therapy for chronic myelogenous leukemia and gastrointestinal stromal tumors. A new generic, once-daily 400-mg tablet of imatinib has been developed by a pharmaceutical company in Argentina, where the regulatory standard for marketing authorization of an imatinib generic is in vitro dissolution testing. The aim of this study was to assess the bioequivalence of a new generic film-coated test tablet formulation versus a film-coated reference tablet formulation of imatinib 400 mg. The local manufacturer seeks to validate the in vitro performance of this new formulation with a bioequivalence study. A randomized, open-label, single-dose, fasting, 2-period, 2-sequence crossover design with a 2-week washout period was used in this study. The study population consisted of healthy male South American (Uruguayan) volunteers, who were assigned in a 1:1 ratio to a randomized sequence (test-reference or reference-test). In each period, the test or reference formulation was administered after an overnight fast. During the 72-hour follow-up period, participants were monitored for vital signs and symptoms. Blood samples were collected at 15 time points, including baseline, until 72 hours. Physical examination and laboratory tests (blood, urine) were repeated 1 week after study completion. A noncompartmental model was used to determine the pharmacokinetic parameters of imatinib. The 90% CIs of the test/reference ratios for AUC(0-infinity) and C(max) were determined; the test and reference formulations were considered bioequivalent if the 90% CIs were between 0.80 and 1.25. Adverse events were assessed by a nurse who administered a questionnaire while the healthy volunteers were admitted in the unit. The bioequivalence study was conducted in 30 Uruguayan male volunteers. Demographic characteristics (mean [SD]) included age, 27.8 (6.5) years; weight, 71.2 (9.8) kg; height, 1.71 (0.09) m; and body

  1. Comparative study of connectivity in telemedicine.

    Science.gov (United States)

    Singh, Indra Pratap; Kapoor, Lily; Daman, Repu; Mishra, Saroj Kanta

    2008-10-01

    Communication links are the lifelines for telemedicine practice. Various terrestrial and satellite media can be used; however, each has its own plus and minus side. The current study was designed to evaluate three types of telecommunication media used for telemedical videoconference at the Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow Telemedicine program over a period of 20 months. The evaluation was based on analysis of technical parameters recorded in a prescribed proforma designed for the study purpose and maintained prospectively after completion of each event. Only technical issues were addressed. At the end of the study period, analysis of data revealed that leased line-based terrestrial Internet Protocol (IP) was better than Sky IP. Integrated Services Digital Network media were found technically less acceptable for telemedical videoconference.

  2. Child Labor in Africa: A Comparative Study

    DEFF Research Database (Denmark)

    Nielsen, Helena Skyt; Canagarajah, Sudharshan

    1999-01-01

    This paper analyzes the determinants of child labor in Africa as inferred from recent empirical studies. The empirical analysis is based upon five country studies undertaken in three different African countries, namely Côte d'Ivoire, Ghana, and Zambia. Some support is found for the popular belief...... of poverty as a determinant of child labor, however other determinants are of similar importance. Among school costs, transportation costs have the greatest effect on child labor and school attendance, whereas the hypothesis of imperfect capital markets and that of household composition generally find some...

  3. A Comparative Study of Orthodontic Coil Springs

    OpenAIRE

    Deepak Kumar Agarwal; Anup Razdan; Abhishek Agarwal; Preeti Bhattacharya; Ankur Gupta; D N Kapoor

    2011-01-01

    Several types of force delivering system are used to carry out tooth movement in orthodontics. Coil springs being one of them are used for the same thus requiring minimal operator manipulation. Aims and objectives : The purpose of this study was to determine the effect of wire diameter, lumen size and length of coil spring on the load produced as a function of displacement of SS and NiTi coil spring. Materials and methods : The study consisted of 60 samples of open and closed coil sprin...

  4. Child Labor in Africa: A Comparative Study

    DEFF Research Database (Denmark)

    Canagarajah, Sudharshan; Nielsen, Helena Skyt

    2001-01-01

    This paper analyzes the determinants of child labor in Africa as inferred from recent empirical studies. The empirical analysis is based upon five country studies undertaken in three different African countries, namely Côte d'Ivoire, Ghana, and Zambia. Some support is found for the popular belief...... of poverty as a determinant of child labor, however other determinants are of similar importance. Among school costs, transportation costs have the greatest effect on child labor and school attendance, whereas the hypothesis of imperfect capital markets and that of household composition generally find some...

  5. Advertisement Analysis: A Comparative Critical Study

    Directory of Open Access Journals (Sweden)

    Noureldin Mohamed Abdelaal

    2014-12-01

    Full Text Available This study aimed at analyzing two advertisements, and investigating how advertisers use discourse and semiotics to make people and customers buy into their ideas, beliefs, or simply their products. The two advertisements analyzed are beauty products which have been selected from internet magazines. The methodology adopted in this study is qualitative method. The first advertisement is analyzed qualitatively in terms of content; there was no focus on a specific theoretical frame work, while the second advertisement analysis is based on Fairclough’s framework, the critical discourse analysis framework.

  6. Comparative study on software development methodologies

    Directory of Open Access Journals (Sweden)

    Mihai Liviu DESPA

    2014-12-01

    Full Text Available This paper focuses on the current state of knowledge in the field of software development methodologies. It aims to set the stage for the formalization of a software development methodology dedicated to innovation orientated IT projects. The paper starts by depicting specific characteristics in software development project management. Managing software development projects involves techniques and skills that are proprietary to the IT industry. Also the software development project manager handles challenges and risks that are predominantly encountered in business and research areas that involve state of the art technology. Conventional software development stages are defined and briefly described. Development stages are the building blocks of any software development methodology so it is important to properly research this aspect. Current software development methodologies are presented. Development stages are defined for every showcased methodology. For each methodology a graphic representation is illustrated in order to better individualize its structure. Software development methodologies are compared by highlighting strengths and weaknesses from the stakeholder's point of view. Conclusions are formulated and a research direction aimed at formalizing a software development methodology dedicated to innovation orientated IT projects is enunciated.

  7. Comparative Anticonvulsant Study of Epoxycarvone Stereoisomers

    Directory of Open Access Journals (Sweden)

    Paula Regina Rodrigues Salgado

    2015-10-01

    Full Text Available Stereoisomers of the monoterpene epoxycarvone (EC, namely (+-cis-EC, (−-cis-EC, (+-trans-EC, and (−-trans-EC, were comparatively evaluated for anticonvulsant activity in specific methodologies. In the pentylenetetrazole (PTZ-induced anticonvulsant test, all of the stereoisomers (at 300 mg/kg increased the latency to seizure onset, and afforded 100% protection against the death of the animals. In the maximal electroshock-induced seizures (MES test, prevention of tonic seizures was also verified for all of the isomers tested. However, the isomeric forms (+ and (−-trans-EC showed 25% and 12.5% inhibition of convulsions, respectively. In the pilocarpine-induced seizures test, all stereoisomers demonstrated an anticonvulsant profile, yet the stereoisomers (+ and (−-trans-EC (at 300 mg/kg showed a more pronounced effect. A strychnine-induced anticonvulsant test was performed, and none of the stereoisomers significantly increased the latency to onset of convulsions; the stereoisomers probably do not act in this pathway. However, the stereoisomers (+-cis-EC and (+-trans-EC greatly increased the latency to death of the animals, thus presenting some protection. The four EC stereoisomers show promise for anticonvulsant activity, an effect emphasized in the isomers (+-cis-EC, (+-trans-EC, and (−-trans-EC for certain parameters of the tested methodologies. These results serve as support for further research and development of antiepileptic drugs from monoterpenes.

  8. Comparative study of telmisartan tablets prepared via the wet granulation method and pritor™ prepared using the spray-drying method.

    Science.gov (United States)

    Park, Junsung; Park, Hee Jun; Cho, Wonkyung; Cha, Kwang-Ho; Yeon, Wonki; Kim, Min-Soo; Kim, Jeong-Soo; Hwang, Sung-Joo

    2011-03-01

    The wet granulation method was successfully used to manufacture amorphous telmisartan tablets (CNU) for comparison with the spray-drying method, used for Pritor™. Drug crystallinity in the tablet was characterized using differential scanning calorimetry and powder X-ray diffraction, and pharmaceutical properties of the tablets such as hardness, friability, water absorption, and in vitro dissolution in pH 1.2, 4.0, 6.8 and 7.5 were characterized. Especially with regard to the water absorption feature, the CNU tablets showed better performance by maintaining their original structures and by absorbing less water. Since both Pritor™ and CNU tablets had similar physical properties of crystallinity, hardness, friability, and > 50 f(2) value in an in vitro dissolution study, the bioequivalence of CNU tablets should be analyzed in a future in vivo study. Therefore, telmisartan tablets can be produced using a more economical and easier method than that used to produce Pritor™ tablets.

  9. Bilingual Language Proficiency : A comparative study

    NARCIS (Netherlands)

    Duarte, Joana

    2011-01-01

    his book investigates the role native language plays in the process of acquiring a second language within a bilingual educational model. The research presented is based on a 2 year longitudinal study of students in a bilingual school. Particular attention is paid to the development of academic

  10. Comparative study of two treatment planning systems

    International Nuclear Information System (INIS)

    Ramos Caballero, L. J.; Quinones Rodriguez, L. A.; Lupiani Castellanos, J.

    2013-01-01

    In this study of the comparison of the clinical dosimetry between planners can deduce that the differences are in the majority of the cases below 3%, and only in cases where the field size is small, we found significant discrepancies, although justifiable. On the one hand it is different calculation algorithm and implementation on the other, the modeling of the accelerator. (Author)

  11. Comparative study of different Schlieren diffracting elements

    Indian Academy of Sciences (India)

    Raj Kumar et al test studies on transparent objects such as depicting deviations in light beams in- duced by density, temperature or refractive index gradients in combustion research, laminar and turbulent fluid .... The results presented in this paper have been captured using a Canon S-50 Power Shot digital camera (1024.

  12. A Comparative Study of Pycnodysostosis, Cleidocranial Dysostosis ...

    African Journals Online (AJOL)

    A radiological study of cases of pycnodysostosis, osteopetrosis, cleidocranial dysostosis and acro-osteolysis revealed an interwoven relationship as regards the X-ray findings with numerous identical signs that these conditions had in common. Open fontanelles and sutures as well as metopic sutures were found in all 4 ...

  13. Comparative study of environmental impact assessment methods ...

    African Journals Online (AJOL)

    Environmental Impacts Assessment has been developed as a critically substantial approach to determine, predict and interpret the ecological impact on the environment, public hygiene and healthy ecosystems. This study aims to introduce and systematically investigate the environmental issues during important ...

  14. Children's Friendship Development: A Comparative Study

    Science.gov (United States)

    Yu, SeonYeong; Ostrosky, Michaelene M.; Fowler, Susan A.

    2011-01-01

    Establishing friendships is an important developmental goal of early childhood, but little research has addressed ways in which parents support the friendship development of their young children with disabilities. The purpose of this survey study was to explore the support strategies that parents use to facilitate their children's friendships.…

  15. Earthquake correlations and networks: A comparative study

    International Nuclear Information System (INIS)

    Krishna Mohan, T. R.; Revathi, P. G.

    2011-01-01

    We quantify the correlation between earthquakes and use the same to extract causally connected earthquake pairs. Our correlation metric is a variation on the one introduced by Baiesi and Paczuski [M. Baiesi and M. Paczuski, Phys. Rev. E 69, 066106 (2004)]. A network of earthquakes is then constructed from the time-ordered catalog and with links between the more correlated ones. A list of recurrences to each of the earthquakes is identified employing correlation thresholds to demarcate the most meaningful ones in each cluster. Data pertaining to three different seismic regions (viz., California, Japan, and the Himalayas) are comparatively analyzed using such a network model. The distribution of recurrence lengths and recurrence times are two of the key features analyzed to draw conclusions about the universal aspects of such a network model. We find that the unimodal feature of recurrence length distribution, which helps to associate typical rupture lengths with different magnitude earthquakes, is robust across the different seismic regions. The out-degree of the networks shows a hub structure rooted on the large magnitude earthquakes. In-degree distribution is seen to be dependent on the density of events in the neighborhood. Power laws, with two regimes having different exponents, are obtained with recurrence time distribution. The first regime confirms the Omori law for aftershocks while the second regime, with a faster falloff for the larger recurrence times, establishes that pure spatial recurrences also follow a power-law distribution. The crossover to the second power-law regime can be taken to be signaling the end of the aftershock regime in an objective fashion.

  16. Comparative biochemical studies of type 3 poliovirus.

    OpenAIRE

    Minor, P D

    1980-01-01

    A study of the biochemistry of type 3 poliovirus strains which involves the examination of the virus-coded polypeptides in infected cells and the preparation of oligonucleotide maps is reported. The polypeptide patterns were shown to be a relatively stable property of virus strains and distinguished Sabin vaccine strains from wild strains of poliovirus type 3. This approach may be of value in deciding the origin (vaccine or nonvaccine) of field isolates of poliovirus. Oligonucleotide maps wer...

  17. Conjunctivitis in the newborn- A comparative study

    Directory of Open Access Journals (Sweden)

    Meenakshi Wadhwani

    2011-01-01

    Full Text Available Background: Conjunctivitis of the newborn is defined as hyperemia and eye discharge in the neonates and is a common infection occurring in the neonates in the first month of life. In the United States, the incidence of neonatal conjunctivitis ranges from 1-2%, in India, the prevalence is 0.5-33% and varies in the world from 0.9-21% depending on the socioeconomic status. Aim: To study the organisms causing conjunctivitis of the newborn and to correlate the etiology with the mode of delivery. Design: Single center, prospective, observational study. Materials and Methods: A total of 300 mothers and their newborns, born over a period of one year, were included in the study. Of these 200 newborns were delivered through vaginal route (Group A and 100 (Group B delivered by lower segment caesarean section (LSCS. At the time of labour, high vaginal swabs were taken from the mothers. Two conjunctival swabs each from both eyes of the newborn were collected at birth and transported to Microbiology department in a candle jar immediately. Results: Eight babies in Group A, developed conjunctivitis at birth. None of the babies in Group B developed conjunctivitis, this difference was statistically highly significant (P<0.000. The organisms found in the conjunctiva of the newborns in Group A were Coagulase negative Staphylococcus, α hemolytic Streptococcus, Escherichia coli and Pseudomonas spps. However, the commonest organism leading to conjunctivitis in the newborn in this study was Coagulase negative Staphylococcus. It was observed that the mothers of 5 out of 8 babies (60% developing conjunctivitis gave history of midwife interference and premature rupture of membranes so the presence of risk factors contribute to the occurrence of conjunctivitis in the newborn. Conclusions: It is inferred that the mode of delivery and the presence of risk factors is responsible for conjunctivitis in the newborn.

  18. Comparative study of radon in Sudan

    International Nuclear Information System (INIS)

    Gharbi, Shaza Ismail Mohammed

    2014-07-01

    This study was conducted primarily to contribute radon data for radon map in Sudan and identify regions with elevated radon levels and improve data collection and analysis for the future radon levels evaluation. This study partially covered three states of Sudan ( Red Sea - Khartoum - South Khordofan). Previous work done has been considered in this study which focused and investigated the levels of radon concentration in ( indoor radon gas and water) by using gamma spectrometry equipped with ( HPGe detector) or (Na1 (T1) detector). The results obtained are within the acceptable levels and dose not poses any risk from radiation protection point of view. Red Sea state ( port-sudan): (124.39±6.21) Bq/m 3 . Khartoum state ( Suba): (151.52) Bq/m 3 . (Omdurman): ( 127±23) Bq/m 3 . Radon in water: (59) Bq/L. South Kordofan State: (102.8) Bq/m 3 . In water (Kadugli): (3 1 39)) Bq/L.(Author)

  19. Agoraphobia and Panic Disorder: A Comparative Study

    Directory of Open Access Journals (Sweden)

    Ayse Kart

    2016-01-01

    Full Text Available Aim: In this study we aim to get more information about agoraphobia (AG which is an independent diagnosis in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5 and to evaluate overlaps or differences between agoraphobia and panic disorder (PD upon sociodemographic features and comorbidity with considering relation of these two disorders. Material and Method: Sociodemographic Data Form was given and Structural Clinical Interview for DSM Axis I Disorders (SCID-I was applied to 33 patients diagnosed as AG and 34 patients diagnosed as PD with AG (PDA.Results: AG group consisted of 21 females (63.1%, 12 males (36%, totally 33 patients and PDA group consisted of 23 females (67.6%, 11 males (32.4%, totally 34 patients. Mean age of onset was 32.4±10.2 in PDA group and 31.1±12.1 in AG group. According to sociodemographic features, violence in family and smoking rates were significantly higher in PDA group than AG group. Major Depressive Disorder (MDD as a comorbidity was higher in PDA group. Discussion: In this study, we tried to identify the overlaps and differences of PDA and AG. For a better recognition of AG, further studies are needed.

  20. A comparative study of various decalcification techniques

    Directory of Open Access Journals (Sweden)

    Prathibha Prasad

    2013-01-01

    Full Text Available Background : Study of fibrilar, cellular and sub cellular structures of mineralized tissues is only possible after the removal of the calcium apatite of these tissues by the process of demineralization. Aims: The present study aims to evaluate six commonly used demineralizing agents to identify the best decalcifying agent. Materials and Methods: The present study included six different decalcifying solutions: 10% formal nitric acid, 8% formal nitric acid, 10% formic acid, 8% formic acid, Perenyi′s fluid and Ethylene Di-Amine Tetra Acetic Acid. eight samples of posterior mandible of rat were decalcified in each of the decalcifying solutions and subjected to chemical end-point test. Ehrlich′s Hematoxylin stain was used. Statistical Analysis Used: One way ANOVA was used for multiple group comparisons and Chi-square test was used for analyzing categorical data. P value of 0.05/less was set for statistical significance. Results: Samples treated with EDTA showed the best overall histological impression and the tissue integrity were well preserved. Formal nitric of both the percentages 10 and 8% gave fairly good cellular detail and were rapid in their action. Conclusion: The final impression led to the proposition that EDTA was indeed the best decalcifying agent available. However, with time constraint, the use of formal nitric acid is advocated.

  1. Comparative study on dermatoglyphics in alcoholic patients.

    Science.gov (United States)

    Devcić, Sanja; Mihanović, Mate; Milicić, Jasna; Glamuzina, Ljubomir; Silić, Ante

    2009-12-01

    According to the world's prevalence rate, alcoholism is in the third place after heart and blood vessel diseases and malignant tumors. With the development of neuroscience, the causes of alcoholism's biological etiologic sources are still being studied. Considering that dermatoglyphics are highly determined by heritage, we contemplated the possibilities of their discrimination in alcoholic patients in relation to phenotypically healthy subjects. We analyzed the quantitative and qualitative dermatoglyphics properties of 100 alcoholic patients without psychiatric comorbidity, who have been cured in the Psychiatric Hospital Sveti Ivan two or more times, and those of 100 phenotypically healthy men. Through the t-test we evaluated the heterogeneity of the examined groups. Results showed a statistically significant difference on five examined variables. In the calculation of fluctuating asymmetry measure, we found no statistically significant differences in the correlation of values of the right and the left hand on the tested variables, beside one. Chi-square tests showed that there is no relation between the dermatoglyphic qualitative properties of alcoholic patients and those of the examinees from the comparison group. Despite the indisputable genetic role in the genesis of alcoholism, the analysis of the dermatoglyphics carried out in our study did not show any etiological connection between the results of the test on dermatoglyphics and the appearance of alcoholism.

  2. The effect of food on the pharmacokinetic properties and bioequivalence of two formulations of pitavastatin calcium in healthy Chinese male subjects.

    Science.gov (United States)

    Shang, Dewei; Deng, Shuhua; Yao, Zhenhong; Wang, Zhanzhang; Ni, Xiaojia; Zhang, Ming; Hu, Jinqing; Lu, Haoyang; Zhu, Xiuqing; Huang, Wencan; Qiu, Chang; Wen, Yuguan

    2016-01-01

    1. Pitavastatin is an effective treatment for primary hyperlipidemia and mixed dyslipidemia. The aim of the present study was to investigate the effect of food on the pharmacokinetic properties and bioequivalence of the original, branded, formulation of pitavastatin calcium and a new generic formulation in healthy Chinese male subjects under fasting and fed conditions. 2. Under fasting and fed conditions, 90% CIs of the geometric mean of generic/branded AUC0-48 h ratios were 92.2-102.4%, 93.1-104.5%, the ratios of ln(AUC0-∞) were 92.6-103.7%, 93.2-103.5%, and ln(Cmax) ratios were 90.7-110.3%, 84.7-100.8%, respectively. The generic and branded formulations were bioequivalent in terms of rate and extent of absorption under both the conditions. The average values of AUC0-48 h, AUC0-∞ and Cmax decreased noticeably following a high-fat breakfast. Values for AUC0-48 h were 87.69% and 83.7%, values for AUC0-∞ were 87.5% and 84.6%, and values for Cmax were 45.0% and 50.4% in subjects given the generic and branded preparations, respectively. The absorption of pitavastatin calcium tablets was delayed following a high-fat meal, with Tmax increasing by up to 2.43-fold. 3. Both formulations were generally well tolerated, with no serious adverse reactions reported. The newly developed generic formulation may provide a reliable alternative to the branded tablets for patients with primary hyperlipidemia or mixed dyslipidemia.

  3. A Comparative Study in Communication Texts & Theories

    Directory of Open Access Journals (Sweden)

    Mahdi Mohsenian Rad

    2011-04-01

    Full Text Available The present article is to study the characteristics and general nature of audience and is described it as "Audience phantasm" in developing countries. It firstly notes that there will be consequences such as audience distancing themselves from local and official media if policy makers and media officials' imaginations of audiences become far from related bare facts have happened in the era of global media and the nature of audiences. Knowing and analyzing the image of audiences presented in new communication theories. Accordingly, as the abovementioned authorities’ viewpoint of audiences exposed to media messages keeps distance from the true nature of media activities, media‐message receivers and their current position in the booming market of media, as termed by Mohsenyan Rad as “Message Bazaar”, there will possibly be disastrous social, cultural, political, and even economic consequences with regard to media uses.Then the history and definitions of “audience”, "uses & gratifications theory" and the concept of "Audience Phantasm" is described. After that, based on those and the increased options as well as the right of selecting of today-audience in the situation of message bazaar, as a result the characteristics of them are explained.

  4. Field study of the comparative efficacy of gamithromycin and tulathromycin for the treatment of undifferentiated bovine respiratory disease complex in beef feedlot calves.

    Science.gov (United States)

    Torres, Siddartha; Thomson, Dan U; Bello, Nora M; Nosky, Bruce J; Reinhardt, Chris D

    2013-06-01

    To compare the efficacy of gamithromycin with that of tulathromycin for the treatment of undifferentiated bovine respiratory disease complex (BRDC) in feedlot calves. 1,049 weaned crossbred beef calves. At each of 6 feedlots, newly arrived calves with BRDC were administered a single dose of gamithromycin (6.0 mg/kg, SC; n = 523) or tulathromycin (2.5 mg/kg, SC; 526). Case-fatality and BRDC retreatment rates during the first 120 days after treatment, final body weight, and average daily gain (ADG), were compared between treatments. At 2 feedlots, calves were assigned clinical scores for 10 days after treatment to determine recovery rates for each treatment. Bioequivalence limits for gamithromycin and tulathromycin were calculated for outcomes for which there was no significant difference between treatments. Mean BRDC retreatment rate (17.7%) for calves administered gamithromycin was greater than that (9.0%) for calves administered tulathromycin. Mean case-fatality rate, final body weight, ADG, and clinical score 10 days after treatment did not differ significantly between treatments. Limits for mean differences within which gamithromycin was bioequivalent to tulathromycin were ± 2.4% for case-fatality rate, ± 13 kg for final body weight, and ± 0.1 kg/d for ADG. Calves administered gamithromycin had a higher BRDC retreatment rate than did calves administered tulathromycin; otherwise, the clinical efficacy did not differ between the 2 treatments for the treatment of BRDC in feedlot calves.

  5. Clinical utility of topiramate extended-release capsules (USL255): Bioequivalence of USL255 sprinkled and intact capsule in healthy adults and an in vitro evaluation of sprinkle delivery via enteral feeding tubes.

    Science.gov (United States)

    Clark, Annie M; Pellock, John M; Holmay, Mary; Anders, Bob; Cloyd, James

    2016-04-01

    The objectives of these two studies were to determine if beads from extended-release topiramate capsules sprinkled onto soft food are bioequivalent to the intact capsule and if beads from the capsule can be passed through enteral gastrostomy (G-) and jejunostomy (J-) feeding tubes. Bioequivalence of 200-mg USL255 (Qudexy XR [topiramate] extended-release capsules) sprinkled onto soft food (applesauce) versus the intact capsule was evaluated in a phase 1, randomized, single-dose, crossover study (N=36). Pharmacokinetic evaluations included area under the curve (AUC), maximum plasma concentration (Cmax), time to Cmax (Tmax), and terminal elimination half-life (t1/2). If 90% confidence intervals (CI) of the ratio of geometric least-squares means were between 0.80 and 1.25, AUC and Cmax were considered bioequivalent. In separate in vitro experiments, 100-mg USL255 beads were passed through feeding tubes using gentle syringe pressure to develop a clog-free bead-delivery method. Multiple tube sizes (14- to 18-French [Fr] tubes), dilutions (5 mg/15 mL-25 mg/15 mL), and diluents (deionized water, apple juice, Ketocal, sparkling water) were tested. Area under the curve and Cmax for USL255 beads sprinkled onto applesauce were bioequivalent to the intact capsule (GLSM [90% CI]: AUC0-t 1.01 [0.97-1.04], AUC0-∞ 1.02 [0.98-1.05]; Cmax 1.09 [1.03-1.14]). Median Tmax was 4h earlier for USL255 sprinkled versus the intact capsule (10 vs 14 h; p=0.0018), and t1/2 was similar (84 vs 82 h, respectively). In 14-Fr G-tubes, USL255 beads diluted in Ketocal minimized bead clogging versus deionized water. Recovery of USL255 beads diluted in deionized water was nearly 100% in 16-Fr G-, 18-Fr G-, and 18-Fr J-tubes. For patients with difficulty swallowing pills, USL255 sprinkled onto applesauce offers a useful once-daily option for taking topiramate. USL255 beads were also successfully delivered in vitro through ≥14-Fr G- or J-tubes, with tube clogging minimized by portioning the dose and

  6. Comparative oral bioavailability of non-fixed and fixed combinations of artesunate and amodiaquine in healthy Indian male volunteers.

    Science.gov (United States)

    Fortin, Anny; Verbeeck, Roger K; Jansen, Frans H

    2011-03-01

    The aim of the present study was to compare the pharmacokinetic properties, bioavailability and tolerability of artesunate (AS) and amodiaquine (AQ) administered as a fixed-dose combination (Amonate FDC tablets; Dafra Pharma, Turnhout, Belgium) or as a non-fixed dose combination of separate AS tablets (Arsuamoon; Guilin Pharmaceutical Co, Shanghai, China) and AQ tablets (Flavoquine; Sanofi-Aventis, Paris, France). This was a randomized, open label, two-period, two-treatment, two-sequence, cross-over study in which 60 healthy male Indian volunteers were given a single total oral dose of 100 mg AS and 400 mg AQ hydrochloride either as two tablets of Amonate FDC (AS 50 mg and AQ hydrochloride 200 mg) or as two AS tablets of the co-blister Arsuamoon (50 mg AS) together with two Flavoquine tablets (200 mg AQ hydrochloride). Plasma AS and blood AQ concentrations, as well as those of their respective active metabolites dihydroartemisinin (DHA) and desethylamodiaquine (DEAQ), were measured by high-performance liquid chromatography-tandem spectrometry. The pharmacokinetic parameters of AS, DHA, AQ and DEAQ were determined by non-compartmental analysis. Bioequivalence assessment was performed by analysis of variance (ANOVA), and calculation of the 90% confidence intervals of the geometric mean ratio test (fixed)/reference (non-fixed) for AUC(0-t) and C(max) for AS, AQ, DHA and DEAQ. Interim analysis showed that both treatments were not bioequivalent; therefore, statistical analysis was carried out on the results of all subjects for whom blood/plasma concentrations were available for all four analytes (n=26). The C(max) (maximum plasma/blood concentration) of AS was 67.0 ± 37.1 and 154.8 ± 116.2 ng/mL for the fixed-dose and non-fixed dose administration, respectively. The AUC(0-t) (area under the plasma concentration-time curve from time zero to the last measurable concentration) of AS was 60.1 ± 27.5 and 81.8 ± 44.3 ng h/mL for the fixed-dose and non-fixed dose

  7. A comparative study of the defluoridation efficiency of synthetic ...

    African Journals Online (AJOL)

    A comparative study of the defluoridation efficiency of synthetic dicalcium phosphate dihydrate (DCPD) and lacunar hydroxyapatite (L-HAp): An application of synthetic solution and Koundoumawa field water.

  8. How Australian and Indonesian Universities Treat Plagiarism: a Comparative Study

    OpenAIRE

    Cahyono, Bambang Yudi

    2005-01-01

    This article is a part of a larger study comparing various aspects of policies on plagiarism in two university contexts. It compares policies on plagiarism in universities in Australia and Indonesia. The results of this comparative study showed that Australian and Indonesian universities treat plagiarism differently. Australian universities treat plagiarism explicitly in their university policies. In Australian universities, plagiarism is defined clearly and forms of plagiarism are explained ...

  9. A prospective, observational study comparing the PK/PD relationships of generic Meropenem (Mercide® to the innovator brand in critically ill patients

    Directory of Open Access Journals (Sweden)

    Mer M

    2016-11-01

    , the upper limit of the area under the curve for the ratio comparator/innovator exceeded the 1.25-point estimate, i.e., 4% higher for comparator meropenem. Conclusion: This observational, in-practice study demonstrates similar ex vivo activity and in vivo plasma concentration time curves for the products under observation. Assay sensitivity is also confirmed. Current registration status of generic small molecules is in place. The products are therefore clinically interchangeable based on registration status as well as bioassay results, demonstrating sufficient overlap for clinical comfort. The slightly higher observed comparator meropenem concentration (4% is still clinically acceptable due to the large therapeutic index and should ally fears of inferiority. Keywords: bioequivalence, antimicrobial, multisource products, Meropenem, ­pharmacokinetics, pharmacodynamics

  10. COMPAR

    International Nuclear Information System (INIS)

    Kuefner, K.

    1976-01-01

    COMPAR works on FORTRAN arrays with four indices: A = A(i,j,k,l) where, for each fixed k 0 ,l 0 , only the 'plane' [A(i,j,k 0 ,l 0 ), i = 1, isub(max), j = 1, jsub(max)] is held in fast memory. Given two arrays A, B of this type COMPAR has the capability to 1) re-norm A and B ind different ways; 2) calculate the deviations epsilon defined as epsilon(i,j,k,l): =[A(i,j,k,l) - B(i,j,k,l)] / GEW(i,j,k,l) where GEW (i,j,k,l) may be chosen in three different ways; 3) calculate mean, standard deviation and maximum in the array epsilon (by several intermediate stages); 4) determine traverses in the array epsilon; 5) plot these traverses by a printer; 6) simplify plots of these traverses by the PLOTEASY-system by creating input data blocks for this system. The main application of COMPAR is given (so far) by the comparison of two- and three-dimensional multigroup neutron flux-fields. (orig.) [de

  11. Comparative study of casual and regular workers' job satisfaction ...

    African Journals Online (AJOL)

    This study investigated the comparative study of regular and casual workers' job satisfaction and commitment in two selected banks in Lagos State, A descriptive survey research design was adopted for the study. A total of 145 respondents were selected for the study using proportionate stratified sampling technique.

  12. Case studies of extreme wave analysis: A comparative study

    Energy Technology Data Exchange (ETDEWEB)

    Vledder, G. van; Goda, Y.; Hawkes, P.; Mansard, E.; Martin, M.J.; Mathiesen, M.; Peltier, E.; Thompson, E.

    1993-07-01

    Several methods of extreme wave analysis have been applied to two sets of deep water extreme wave data. One set consisted of three-hourly sea-state records collected during a nine year period with a wave buoy at Haltenbanken off the Norwegian cost. The other set comprised a 20-year period of storm peak wave heights, obtained via a numerical hindcast of historical storms. For both data sets, 100-year return wave heights with corresponding 90% confidence intervals were computed with a variety of extremal analysis techniques, including the Initial Distribution Method, the Annual Maxima Method, and the Peak over Threshold Method. FT-I, Weibull and other probability distributions were fitted to the data by the Method of Moments, Least Squares Method, and the Maximum Likelihood Method. The results of the study show that for both data sets the estimated 100-year return wave heights differ less than 10% of one another. It was also found that the effect of choices in the data selection, e.g. the choice of the threshold, has a significant effect on the estimated wave heights. 13 refs., 4 figs., 5 tabs.

  13. Field study of the comparative efficacy of gamithromycin and tulathromycin for the control of undifferentiated bovine respiratory disease complex in beef feedlot calves at high risk of developing respiratory tract disease.

    Science.gov (United States)

    Torres, Siddartha; Thomson, Dan U; Bello, Nora M; Nosky, Bruce J; Reinhardt, Chris D

    2013-06-01

    To compare the efficacy of gamithromycin with that of tulathromycin for control of undifferentiated bovine respiratory disease complex (BRDC) in feedlot calves. 2,529 weaned crossbred beef calves. At each of 2 feedlots, calves at risk of developing BRDC were administered a single dose of gamithromycin (6.0 mg/kg, SC; n = 1,263) or tulathromycin (2.5 mg/kg, SC; 1,266) metaphylactically. Health (BRDC morbidity, mortality, case-fatality, and retreatment rates) and performance (average daily gain, dry matter intake, and feed-to-gain ratio) outcomes were compared between treatments via classical hypothesis testing. Bioequivalence limits for gamithromycin and tulathromycin were established for outcomes for which no significant difference between treatments was detected. Mean BRDC morbidity rate (31.0%) for calves administered gamithromycin was greater than that (22.9%) for calves administered tulathromycin; otherwise, health and performance did not differ between treatments. Limits for mean differences within which gamithromycin was considered bioequivalent to tulathromycin were ± 10% for BRDC retreatment rate, ± 3.5% for BRDC mortality rate, ± 16% for case-fatality rate, ± 37 kg for final body weight, ± 0.1 kg/d for average daily gain, ± 0.3 kg/d for dry matter intake, and ± 0.7 for feed-to-gain ratio. The efficacy of gamithromycin did not differ from that of tulathromycin for all outcomes except morbidity rate; calves administered gamithromycin had a higher BRDC morbidity rate than did calves administered tulathromycin. On the basis of the bioequivalence limits established for this dataset, gamithromycin was considered equivalent to tulathromycin for the control of BRDC.

  14. From Comparative Education to Comparative Pedagogy: A Physical Education Case Study

    Science.gov (United States)

    Georgakis, Steve; Graham, Jessica

    2016-01-01

    In the last two decades forces of globalization and the rise of and access to information technology have transformed the nature of educational research. Traditional disciplines such as comparative education have not been immune to these transformational impacts. Although one might expect globalization to promote the study of comparative…

  15. Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: In Vitro Cellular Uptake

    Directory of Open Access Journals (Sweden)

    Min Wu

    2017-12-01

    Full Text Available Iron deficiency anemia is a common clinical consequence for people who suffer from chronic kidney disease, especially those requiring dialysis. Intravenous (IV iron therapy is a widely accepted safe and efficacious treatment for iron deficiency anemia. Numerous IV iron drugs have been approved by U.S. Food and Drug Administration (FDA, including a single generic product, sodium ferric gluconate complex in sucrose. In this study, we compared the cellular iron uptake profiles of the brand (Ferrlecit® and generic sodium ferric gluconate (SFG products. We used a colorimetric assay to examine the amount of iron uptake by three human macrophage cell lines. This is the first published study to provide a parallel evaluation of the cellular uptake of a brand and a generic IV iron drug in a mononuclear phagocyte system. The results showed no difference in iron uptake across all cell lines, tested doses, and time points. The matching iron uptake profiles of Ferrlecit® and its generic product support the FDA’s present position detailed in the draft guidance on development of SFG complex products that bioequivalence can be based on qualitative (Q1 and quantitative (Q2 formulation sameness, similar physiochemical characterization, and pharmacokinetic bioequivalence studies.

  16. Comparative study of intestine length, weight and digestibility on ...

    African Journals Online (AJOL)

    Comparative study of intestine length, weight and digestibility on different body weight chickens. HM Yang, W Wang, ZY Wang, J Wang, YJ Cao, YH Chen. Abstract. This experiment was conducted to compare the difference of digestibility on different body weight chickens. Twenty-seven (27) 58-week-old New Yangzhou ...

  17. Comparative Study of Biogas Yield Pattern in Some Animal and ...

    African Journals Online (AJOL)

    This research was a laboratory based work which compared Biogas yield patterns in some animal and household wastes. The parameters studied included dilution and concentration of substrates, the effect of available space in the digester, and the comparative biogas yield from different wastes. The method of research ...

  18. A comparative study between all-electron scalar relativistic ...

    Indian Academy of Sciences (India)

    Abstract. A comparative study between all-electron relativistic (AER) calculation and all-electron (AE) cal- culation on the H2 molecule adsorption onto small gold clusters has been performed. Compared with the corres- ponding AunH2 cluster obtained by AE method, the AunH2 cluster obtained by AER method has much ...

  19. Comparative studies in Chelicerata IV. Apatellata, Arachnida, Scorpionida, Xiphosura

    NARCIS (Netherlands)

    Hammen, van der L.

    1986-01-01

    A comparative study is made of four chelicerate classes: Apatellata (Solifugae and Pseudoscorpionida), Arachnida s. str. (both groups of Uropygi, i.e. Holopeltida and Schizomida, Amblypygi and Araneida), Scorpionida and Xiphosura. Methods, principles and terminology, adopted in this paper,

  20. Comparative bioavailability study of a new quinine suppository and ...

    African Journals Online (AJOL)

    user

    QN) administration in complicated and severe malaria. The purpose of this study is to compare the bioavailability (BA) of a new quinine suppository made from theobroma oil to that of an existing tablet formulation in healthy volunteers.

  1. Comparative study of gabapentin and isoflavone in menopausal vasomotor symptoms

    OpenAIRE

    Savita Rani Singhal; Wansalan Kuru Shullai

    2016-01-01

    Objective: This study was planned to compare the effects of gabapentin and isoflavones in menopausal vasomotor symptoms. Materials and Methods: This prospective comparative study was conducted on 100 patients with complaints of hot flashes, divided into two groups of 50 each. Group I received 900 mg of gabapentin and Group II received 60 mg of isoflavones daily for 3 months. The patients were interviewed to calculate hot flash, global and depression scores and were rescored after 2, 4, 8, and...

  2. A comparative study of the hematological values in the ovulation ...

    African Journals Online (AJOL)

    This study compares the hematological values of the ovulation phase with the luteal phase of the menstrual cycle. Sixty subjects with 30 subjects each in the ovulation and luteal phases of the menstrual cycle were studied. Ethical clearance and informed consent were obtained for the study. Hematological parameters of ...

  3. Comparative Study of Vlasov and Euler Instabilities of Axially ...

    African Journals Online (AJOL)

    In this study, Vlasov's displacement model with modification by Varbanov and Euler's elastica model were used in a comparative study to determine the flexural buckling strength of single-cell doubly symmetric thin-walled box columns with different boundary conditions. The study involved a theoretical formulation based on ...

  4. Comparative study on the pathogenic effects of Diminazine ...

    African Journals Online (AJOL)

    The study was conducted in goats to compare the pathogenic effects of Trypanosome congolense known to be resistant and ... Water supply was ad libitum. Study isolates. The study was done with two ... Accordingly, blood was taken in a capillary tube and centrifuged at 1200 rpm for 5 minutes. The tube was cut 1mm below ...

  5. Comparative morphological and ecological studies of two Stachys ...

    African Journals Online (AJOL)

    In this study, comparative morphological and ecological studies of Stachys balansae and S. carduchorum were investigated. Morphologically, general views of taxa and micromorphological features of the trichomes were studied. S. balansae differs from S. carduchorum in its leaves sericeouspilose on the upper surface and ...

  6. A Comparative Study of Depression among Fertile and Infertile ...

    African Journals Online (AJOL)

    Background: Studies have identified a high prevalence of depression among women with infertility; few studies have explored this association in this environment. Aims and objectives: the study is aimed at evaluating depression in a group of infertile women; compare the prevalence of depression among this group with ...

  7. Comparative Study of Internal Efficiency in Private and Public ...

    African Journals Online (AJOL)

    The education sector has been undergoing regular reviews so that to improve efficiency and cost effectiveness in resource utilization. This study was designed to make a comparative study of internal efficiency in both private and public primary schools of Manga Division, Nyamira District, Kenya. Specifically, the study not ...

  8. Effects of Coaching on Instructional Practices: A Comparative Case Study

    Science.gov (United States)

    Carlson, Rosie M.

    2017-01-01

    This comparative case study analyzed two styles of coaching, team and individual, and the perceived impact each style has on instructional practices. This study was conducted in two elementary schools that are part of the same charter organization in California. The study identified the challenges and benefits of each style through interviews with…

  9. Comparative steady-state pharmacokinetic study of an extended-release formulation of itopride and its immediate-release reference formulation in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Yoon S

    2014-01-01

    Full Text Available Seonghae Yoon,1,* Howard Lee,2,* Tae-Eun Kim,1 SeungHwan Lee,1 Dong-Hyun Chee,3 Joo-Youn Cho,1 Kyung-Sang Yu,1 In-Jin Jang1 1Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, 2Clinical Trials Center, Seoul National University Hospital, 3AbbVie Ltd., Seoul, Republic of Korea *These authors contributed equally to this work Background: This study was conducted to compare the oral bioavailability of an itopride extended-release (ER formulation with that of the reference immediate-release (IR formulation in the fasting state. The effect of food on the bioavailability of itopride ER was also assessed. Methods: A single-center, open-label, randomized, multiple-dose, three-treatment, three-sequence, crossover study was performed in 24 healthy male subjects, aged 22–48 years, who randomly received one of the following treatments for 4 days in each period: itopride 150 mg ER once daily under fasting or fed conditions, or itopride 50 mg IR three times daily in the fasting state. Steady-state pharmacokinetic parameters of itopride, including peak plasma concentration (Cmax and area under the plasma concentration versus time curve over 24 hours after dosing (AUC0–24h, were determined by noncompartmental analysis. The geometric mean ratio of the pharmacokinetic parameters was derived using an analysis of variance model. Results: A total of 24 healthy Korean subjects participated, 23 of whom completed the study. The geometric mean ratio and its 90% confidence interval of once-daily ER itopride versus IR itopride three times a day for AUC0–24h were contained within the conventional bioequivalence range of 0.80–1.25 (0.94 [0.88–1.01], although Cmax was reached more slowly and was lower for itopride ER than for the IR formulation. Food delayed the time taken to reach Cmax for itopride ER, but AUC0–24h was not affected. There were no serious adverse events and both formulations were

  10. Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop

    Science.gov (United States)

    Duan, J; Kesisoglou, F; Novakovic, J; Amidon, GL; Jamei, M; Lukacova, V; Eissing, T; Tsakalozou, E; Zhao, L; Lionberger, R

    2017-01-01

    On May 19, 2016, the US Food and Drug Administration (FDA) hosted a public workshop, entitled “Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation.”1 The topic of mechanistic oral absorption modeling, which is one of the major applications of physiologically based pharmacokinetic (PBPK) modeling and simulation, focuses on predicting oral absorption by mechanistically integrating gastrointestinal transit, dissolution, and permeation processes, incorporating systems, active pharmaceutical ingredient (API), and the drug product information, into a systemic mathematical whole‐body framework.2 PMID:28571121

  11. Important Questions Of Comparative Studies In Asian Countries

    OpenAIRE

    Pazyura Natalia

    2015-01-01

    The issue of the “identity” of comparative education as a field of study or a discipline has been discussed for decades. Yet a kind of systematic structure that provides the basic principles for a coherent exposition of the field remains open. “Comparative education” is no longer conceived as an imaginary field’s coherence but, rather in terms of distinct branches of comparative and international studies in education and their underlying issues. Such an understanding is fostered through a dee...

  12. Sustaining and Improving Study Abroad Experiences Through Comparative Evaluation.

    Science.gov (United States)

    Johanson, Linda S

    Researchers have related participation in study abroad experiences to many positive outcomes for nursing students; however, educators are faced with the task of not only developing meaningful study abroad opportunities but sustaining and improving them as well. Educators can evaluate repeat study abroad programs by comparing experiences, looking for trends, and conjecturing rationales. To illustrate this process, an example of a study abroad opportunity that has been repeated over 11 years is presented. The first six years have been compared to the most recent five years, revealing three categories of change for evaluation and the resulting course improvements.

  13. Comparative Study of Bio-implantable Acoustic Generator Architectures

    International Nuclear Information System (INIS)

    Christensen, D; Roundy, S

    2013-01-01

    This paper is a comparative study of the design spaces of two bio-implantable acoustically excited generator architectures: the thickness-stretch-mode circular piezoelectric plate and the bending-mode unimorph piezoelectric diaphragm. The generators are part of an acoustic power transfer system for implanted sensors and medical devices such as glucose monitors, metabolic monitors, drug delivery systems, etc. Our studies indicate that at small sizes the diaphragm architecture outperforms the plate architecture. This paper will present the results of simulation studies and initial experiments that explore the characteristics of the two architectures and compare their performance

  14. Comparative study of serum lipid levels in normotensive and pre ...

    African Journals Online (AJOL)

    Aim : This study was performed to compare the serum lipid levels of pregnant normotensive and pre-eclamptic women. Methods: It was a case control study involving 50 normotensive and 50 preeclamptic women at the University College Hospital, Ibadan, making a total of 100 participants. Their venous blood (5mls) was ...

  15. Comparative study of three methods of propagation of Jatropha ...

    African Journals Online (AJOL)

    Objective: Jatropha curcas L. is an Euphorbiaceae known for its oleaginous seed characters. Its propagation following a specific technical route is not yet established. This study aimed at comparing the growth of seedlings through three methods of propagation in southeastern of Gabon. Methodology and Results: This study ...

  16. A Prospective Comparative Study of the Bacterial Flora of the ...

    African Journals Online (AJOL)

    A qualitative comparative study of the bacterial flora of the vagina and cervix of 90 non-pregnant women of childbearing age (18-35 years) in Calabar was undertaken. The study revealed that both aerobic and microaerophilic organisms as well as the strictly anaerobic bacteria constituted the microflora of the lower genital of ...

  17. Comparative study of atrial fibrillation and AV conduction in mammals

    NARCIS (Netherlands)

    Meijler, F.L.; Tweel, I. van der

    1987-01-01

    Atrial fibrillation is one ofthe most common cardiac arrhythmias in humans. It a1so occurs quite frequent1y in dogs and horses. Comparative study of this arrhythmia may contribute to better understanding of the pathophysiologica1 mechanisms involved. In this study, we present a quantitative

  18. Comparative studies in Chelicerata II. Epimerata (Palpigradi and Actinotrichida)

    NARCIS (Netherlands)

    Hammen, van der L.

    1982-01-01

    A comparative study is made of two groups of Chelicerata (Palpigradi and Actinotrichid mites, together constituting the Epimerata, a chelicerate class), and models of the evolution of epimerate characters are prepared. The study is based on the same methods and principles as the first part of the

  19. A Comparative Study of Learning Organisation Practices of Indian Businesses

    Science.gov (United States)

    Bhattacharya, Sonali; Neelam, Netra; Behl, Abhishek; Acharya, Sabyasachi

    2017-01-01

    Purpose: In this study we compared the learning organisation practices of Indian Businesses across sectors. Methodology: The study is based on a sample of 406 managers of banking, information technology and information technology enabled services (IT/ITES), manufacturing, hotel & hospitality and hospital and healthcare sectors. Learning…

  20. Comparative study on the level of bacteriological contamination of ...

    African Journals Online (AJOL)

    Comparative study on the level of bacteriological contamination of automatic teller machines, public toilets and public transport commercial motorcycle crash ... Conclusion: This study has revealed the ability of these public devices to serve as vehicle of transmission of microorganisms with serious health implications.

  1. Importance of comparative study of CT dose between different centers

    International Nuclear Information System (INIS)

    Ramos Amores, D.; Serna Berna, A.; Mata Colodro, F.; Puchades Puchades, V.

    2013-01-01

    This work aims to show the importance of comparative analysis to get CT study can be made with fewer doses without impeding optimal image quality for diagnosis. With this work we can see that statistical studies on the dose given at two different sites can have beneficial consequences for patients because scanners can work with fewer doses and optimal image quality for diagnosis. (Author)

  2. Comparative study of ICT use by researchers in selected private ...

    African Journals Online (AJOL)

    The main objective of this study was to compare ICT use by researchers in private universities and research institutes and also to determine to what extent to which the use of ICT facilities ha s impacted their research works. The study adopted the descriptive survey design. Questionnaire was the research instrument used to ...

  3. A Comparative Study of the Gastro-Intestinal Helminth Parasites ...

    African Journals Online (AJOL)

    A comparative study of the gastro-intestinal helminth parasites infection of fresh and brackish water fishes from Warri river, Southern Nigeria, was undertaken. Eight hundred (800) fishes examined during the investigation belong to 30 families, 45 genera and 56 species. The study revealed a highly significant relationship (P ...

  4. International comparative studies of education and large scale change

    NARCIS (Netherlands)

    Howie, Sarah; Plomp, T.; Bascia, Nina; Cumming, Alister; Datnow, Amanda; Leithwood, Kenneth; Livingstone, David

    2005-01-01

    The development of international comparative studies of educational achievements dates back to the early 1960s and was made possible by developments in sample survey methodology, group testing techniques, test development, and data analysis (Husén & Tuijnman, 1994, p. 6). The studies involve

  5. A comparative study of organizational citizenship behaviour in ...

    African Journals Online (AJOL)

    This study compares the degree of organizational citizenship behaviour (OCB), OCB-Organization (OCB-O) and OCB-Individual (OCB-I) in service and manufacturing organizations. Design of this study was cross-sectional survey and data were collected with a standardized scale that was presented in questionnaire form.

  6. Comparative study of some mechanical and release properties of ...

    African Journals Online (AJOL)

    The mechanical and release properties of paracetamol tablets formulated with cashew gum (CAG), povidone (PVP) and gelatin (GEL) as binders were studied and compared. The parameters studied were tensile strength (TS), brittle fracture index (BFI), friability (F), disintegration time (DT) and percentage drug released ...

  7. Comparative Studies of Population Synthesis Models in the ...

    Indian Academy of Sciences (India)

    Comparative Studies of Population Synthesis Models in the Framework of Modified Strömgren Filters ... The study conveys a good agreement of GALEV models with modified Strömgren colours but with poor UV model predictions and observed globular cluster data, while the spectroscopic models perform badly because of ...

  8. A comparative study of chromosome morphology among some ...

    African Journals Online (AJOL)

    USER

    2010-02-15

    Feb 15, 2010 ... genetic source of wheat, some cytogenetic analysis reported (Chennaveeraiah, 1960; Badaeva et al., 1998,. 2001) and indicated that all A. crassa chromosomes can be identified by their morphology and C-banding patterns. Cytogenetical studies have been carried out on A. crassa but a comparative study ...

  9. ulous and comparative study on the use of specific and ...

    African Journals Online (AJOL)

    Sudhanshu

    2014-02-19

    Feb 19, 2014 ... Comparison of genetic diversity indices of heterologous and species-specific microsatellite loci within a species may provide a panel of appropriate markers for genetic studies, but few studies have carried out such comparisons. We examined and compared the genetic characteristics of tiger-specific and.

  10. Comparative ultrasound study of acute lateral ankle ligament ...

    African Journals Online (AJOL)

    The purpose of this study was to establish the difference in rehabilitation outcomes between the Jump Stretch Flex Band (JSFB) programme and conventional ankle rehabilitation programmes of acute lateral ankle ligament injuries. This study compares the process of healing under the guidance of ultrasound in both groups.

  11. A Comparative Study of Students' Achievement in Botany and Zoology

    Science.gov (United States)

    Tamir, P.

    1974-01-01

    A comparative study of student achievement in botany and zoology based on data of 10 studies conducted in 20 countries. Up to age 14, students achieve better in zoology; after age 14, students achieve better in botany. Based on the findings, recommendations are suggested regarding curriculum planning, laboratory work and the need for specific…

  12. A Comparative Study of the Block Characteristics of Spinal ...

    African Journals Online (AJOL)

    For most of the study period, group D exhibited significantly lower mean blood pressures compared to group B. The differences in the occurrence of adverse etfects were not statistically signiticant in both groups. Conclusion: This study has shown that spinal anaesthesia using hyperbaric bupivacaine plus dexrnedetomid ine ...

  13. Comparative Study on the Effects of Crude Extracts of Pterocarpus ...

    African Journals Online (AJOL)

    A comparative study on the effects of crude extracts of pterocarpus soyauxii and Telfairia occidentalis on haematological parameters of albino wistar rats was carried out. Forty nine albino rats of both sexes, weighing between 150 and 250 g were used for the study. The rats were divided into seven groups of seven rats each.

  14. A COMPARATIVE STUDY OF LAPAROSCOPIC VERSUS OPEN CHOLECYSTECTOMY

    OpenAIRE

    Gopal Rao; Suryanarayana; Srinivas; Satish

    2015-01-01

    The model era of Laparoscopic Surgery has evoked remarkable changes in approaches to surgical diseases. The trend toward minimal access surgery (MAS) has prompted General surgeons to scrutinize nearly all operations for possible convention to Laparoscopic techniques. AIM OF THE STUDY : Our aim of the study is to compare Laparoscopic Cholecystectomy with that of open cholecystectomy. MATERIALS AND METHODS : ...

  15. [Comparative biometric studies of school children from Kenya and Braunschweig].

    Science.gov (United States)

    May, E; Indiatsy, I; Hannemann, K

    1994-09-01

    Constitution and growth biology of 6 to 7 years old children from a European city ("Braunschweiger Längsschnitt") and a country with rather original habits (extreme rural area of Kenya, "Abaluya"--administrative name of Bantuid tribes from W-Kenya--out of the region of Idakho and Tiriki, elevated in spring 1990) were comparatively studied. To achieve comparability in physique and body height, the elevated data were "allometrically standardized". The statistical parameters and the results of correlation statistics were shown by comparing the two groups of children. This paper is thought to be the first attempt of a more extensive study in which further more comparative data from other age groups of children and different ecological factors as climate or nutrition should be involved in the analysis. At least the knowledge of standardized data is a cogent assumption to judge about constitution, typology and health of populations.

  16. A Comparative Study of Spreadsheet Applications on Mobile Devices

    Directory of Open Access Journals (Sweden)

    Veera V. S. M. Chintapalli

    2016-01-01

    Full Text Available Advances in mobile screen sizes and feature enhancement for mobile applications have increased the number of users accessing spreadsheets on mobile devices. This paper reports a comparative usability study on four popular mobile spreadsheet applications: OfficeSuite Viewer 6, Documents To Go, ThinkFree Online, and Google Drive. We compare them against three categories of usability criteria: visibility; navigation, scrolling, and feedback; and interaction, satisfaction, simplicity, and convenience. Measures for each criterion were derived in a survey. Questionnaires were designed to address the measures based on the comparative criteria provided in the analysis.

  17. Comparative study of wavelets of the first and second generation

    International Nuclear Information System (INIS)

    Ososkov, G.A.; Shitov, A.B.; Stadnik, A.V.

    2001-01-01

    In order to compare efficiency a comprehensive set of benchmarking tests is developed, which is used to compare abilities of continuous wavelet transform of the vanishing momenta type as well as the second generation wavelets constructed on the basis of the lifting scheme. It is based on processing of various types of pure and contaminated harmonic signals, delta-function, study of the signal phase dependence and the gain-frequency characteristics. The results of a comparative multiscale analysis allow one to reveal advantages and flaws of the considered types of wavelets

  18. Anonymity communication VPN and Tor: a comparative study

    Science.gov (United States)

    Ramadhani, E.

    2018-03-01

    VPN and Tor is a technology based on anonymity communication. These two technologies have their advantage and disadvantage. The objective of this paper is to find the difference between VPN and Tor technologies by comparing their security of communication on the public network based on the CIA triad concept. The comparative study in this paper is based on the survey method. At last, the result of this paper is a recommendation on when to use a VPN and Tor to secure communication

  19. Comparative study of experimental signals for multipactor and breakdown.

    CERN Document Server

    Dehler, Micha; Wuensch, Walter; Faus-Golfe, Angeles; Gimeno Martinez, Benito; Kovermann, Jan; Boria, Vicente; Raboso, David

    2012-01-01

    Performance limiting high-power rf phenomenon occur in both transmitter systems in satellites and high-gradient accelerating structures in particle accelerators. In satellites the predominant effect is multipactor while in accelerators it is breakdown. Both communities have studied their respective phenomena extensively and developed particular simulation tools and experimental techniques. A series of experiments to directly compare measurements made under multipactor and breakdown conditions has been initiated with the objective to crosscheck and compare the physics, simulation tools and measurement techniques.

  20. Comparing distance education and conventional education: observations from a comparative study of post-registration nurses

    Directory of Open Access Journals (Sweden)

    Tim Duffy

    2002-12-01

    Full Text Available This retrospective study presents a comparison of assessment results achieved by distancelearning students and classroom-based students undertaking the same module in a degree course. The purpose of the comparison is to provide some objective measurement of the quality of distance education in relation to conventional classroom-based education. The authors have selected three groups of students, who have all undertaken the same module in the B. Sc Health Studies degree programme offered by the University of Paisley. One group (in Paisley undertook their studies by means of conventional classroom-based education, the second (in Hong Kong by supported distance learning with face-to-face contact in the form of tutorials, and the third (in a geographically dispersed group in the United Kingdom and other countries by supported distance learning with no face-to-face contact. The results obtained by these three groups of students were analysed. Because of the differences in the size of the groups, the Kruskal- Wallis 1- Way Anova test was applied to validate the face value findings. The authors include findings from the literature comparing distance education with conventional education and from cross-cultural studies to present their data in context. Analysis of the assessment results showed that students from all three groups were successful in their studies, but the students studying by distance learning obtained significantly higher end-of-module results than their classroom-based colleagues. This latter finding reflects the conclusion that other investigators have reached In their discussion the authors identify educational, cultural and personal factors that may help to explain their findings. A limitation in the study is that it concerns only one module in the degree programme. The research now moves on to comparing students who have undertaken the whole degree programme by the means described

  1. Methods and models used in comparative risk studies

    International Nuclear Information System (INIS)

    Devooght, J.

    1983-01-01

    Comparative risk studies make use of a large number of methods and models based upon a set of assumptions incompletely formulated or of value judgements. Owing to the multidimensionality of risks and benefits, the economic and social context may notably influence the final result. Five classes of models are briefly reviewed: accounting of fluxes of effluents, radiation and energy; transport models and health effects; systems reliability and bayesian analysis; economic analysis of reliability and cost-risk-benefit analysis; decision theory in presence of uncertainty and multiple objectives. Purpose and prospect of comparative studies are assessed in view of probable diminishing returns for large generic comparisons [fr

  2. Social Capital in Russia and Denmark: A Comparative Study

    DEFF Research Database (Denmark)

    Hjøllund, Lene; Paldam, Martin; Svendsen, Gert Tinggaard

    2001-01-01

    This paper has three purposes: (p1) To study the relation between the main social capital definitions using empirical data. (p2) To compare the level of social capital in a new democracy (Russia) and an old one (Denmark). (p3) To show whether social capital matters for income generation and event......This paper has three purposes: (p1) To study the relation between the main social capital definitions using empirical data. (p2) To compare the level of social capital in a new democracy (Russia) and an old one (Denmark). (p3) To show whether social capital matters for income generation...

  3. A comparative pharmacokinetic study of a fixed dose combination for essential hypertensive patients: a randomized crossover study in healthy human volunteers.

    Science.gov (United States)

    Gorain, B; Choudhury, H; Halder, D; Sarkar, A K; Sarkar, P; Biswas, E; Ghosh, B; Pal, T K

    2013-04-01

    This study was aimed to investigate the relative bioavailability of fixed-dose-combination (FDC) product of amlodipine, telmisartan and hydrochlorothiazide with individual marketed products in healthy male volunteers. Control of blood pressure with fixed dose combination of the above drugs acting through different mechanism have a benefit of convenient dosing in terms of compliance, lower the dose and subsequently reduce the side effects. The authors investigated the relative bioavailability under a fasting state of the 3 drugs in a randomized, open-label, 2-treatment, 2-period, 2-sequence, crossover bioequivalence study with a washout period of 21 days. Plasma concentration of the analytes were assayed in timed samples with a simple, highly sensitive and rapid validated method using HPLC coupled to tandem mass spectrometry that had a lower limit of quantification of 1 ng/mL for all the 3 components. Test and reference formulations gave a mean Cmax of 5.234±0.914 ng/mL and 4.991±0.563 ng/mL, 108.839±13.601 ng/mL and 114.783±12.315 ng/mL and 97.814±10.779 ng/mL and 93.731±10.018 ng/mL for amlodipine, telmisartan and hydrochlorothiazide respectively. The AUC0-t of amlodipine, telmisartan and hydrochlorothiazide was 161.484 ng.h/mL, 1 917.644 ng.h/mL and 822.847 ng.h/mL for test formulation and 162.108 ng.h/mL, 2 014.764 ng.h/mL and 829.323 ng.h/mL for reference in the fasting state. The 90% confidence intervals for the test/reference ratio of the pharmacokinetic parameters in fasting state (mean Cmax, AUC0-t, and AUC0-∞) were within the acceptable range of 80.00-125.00. Thus, these findings clearly indicate that the FDC product is bioequivalent with the individual marketed products in terms of rate and extent of drug absorption and is well tolerated with no significant adverse reactions. © Georg Thieme Verlag KG Stuttgart · New York.

  4. How Australian and Indonesian Universities Treat Plagiarism: A Comparative Study

    Directory of Open Access Journals (Sweden)

    Bambang Yudi Cahyono

    2016-02-01

    Full Text Available This article is a part of a larger study comparing various aspects of policies on plagiarism in two university contexts. It compares policies on plagiarism in universities in Australia and Indonesia. The results of this comparative study showed that Australian and Indonesian universities treat plagiarism differently. Australian universities treat plagiarism explicitly in their university policies. In Australian universities, plagiarism is defined clearly and forms of plagiarism are explained thoroughly, policies on plagiarism are informed to all university academic members, and there are mechanisms to manage cases related to plagiarism. In contrast, not all Indonesian universities treat plagiarism directly. Some universities depend on religious morality and academic ethics in dealing with plagiarism. Accordingly, this article recommends the explicit treatment of plagiarism in Indonesian universities.

  5. Comparative religion as an academic study in contemporary India

    Directory of Open Access Journals (Sweden)

    Asha MUKHERJEE

    2016-06-01

    Full Text Available The paper aims to argue that the different forms of ‘academic study of religion’ in the West hardly have core characteristics on which there is a consensus of scholars. Moreover, it may not be the only way of doing Academic Study of Religion. In Indian tradition, in its own way there have been religious studies. Religion is a way of living. The presence of a large diverse religious population constitutes myriad human exemplars of and witnesses to what it means to be religious and to act religiously. It furnishes a diversity of backgrounds, sensitivities and language competences on the part of Indians who choose to be trained as scholars in the field. Typically for an Indian, ‘living religion’ is more important than studying, describing, or knowing religion. One does not have the time or money for such ‘luxuries’; religion is a ‘bracketed existence’ in normal circumstances, but in crises it is the basic or fundamental identity of an individual. Further, in the Indian context only the serious academic studycomparative reli‑ gion’ has relevance, and this brings an interesting methodology to the study. Contemporary attempts and distinctive contributions on comparative methodology of study of religion would be discussed as well as how far its application in the Asian context would be possible. The paper concludes by answering what it means to do ‘comparative religion’ of an authentic sort among diverse pressures, expectations, challenges and opportunities.

  6. Comparative studies on the skeletogenic mesenchyme of echinoids.

    Science.gov (United States)

    Minokawa, Takuya

    2017-07-15

    Skeletogenic mesenchyme cells in echinoids are suitable for studying developmental mechanisms, and have been used extensively. Most of these studies have been performed on species in the order Camarodonta, which are modern echinoids (subclass Euechinoidea) and are considered "model" echinoid species. In contrast, species belonging to other orders are studied less frequently, especially investigations of their molecular developmental biology such as gene regulatory networks. Recent studies on mesenchyme development in non-camarodont species suggest that these species are potential sources of comparative information to elucidate the mechanisms underlying skeletogenic mesenchyme development. In this review, the importance of using comparative data to understand development and evolution is discussed. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Reverse Engineering of Gene Regulatory Networks: A Comparative Study

    Directory of Open Access Journals (Sweden)

    Hendrik Hache

    2009-01-01

    Full Text Available Reverse engineering of gene regulatory networks has been an intensively studied topic in bioinformatics since it constitutes an intermediate step from explorative to causative gene expression analysis. Many methods have been proposed through recent years leading to a wide range of mathematical approaches. In practice, different mathematical approaches will generate different resulting network structures, thus, it is very important for users to assess the performance of these algorithms. We have conducted a comparative study with six different reverse engineering methods, including relevance networks, neural networks, and Bayesian networks. Our approach consists of the generation of defined benchmark data, the analysis of these data with the different methods, and the assessment of algorithmic performances by statistical analyses. Performance was judged by network size and noise levels. The results of the comparative study highlight the neural network approach as best performing method among those under study.

  8. A comparative study assessing a new tool for occluding ...

    African Journals Online (AJOL)

    0.630, p=0.068 and p=0.047, respectively) (Table 2). A comparative study assessing a new tool for occluding parenchymal blood flow during liver resection for hepatocellular carcinoma. S Zhou, X-J Xue, R-R Li, D-F Chen, W-Y Chen, G-X Liu, ...

  9. Comparative study of percentage yield of pulp from various Nigerian ...

    African Journals Online (AJOL)

    Comparative study of percentage yield of pulp from various Nigerian wood species using the kraft process. ... African Journal of Environmental Science and Technology ... The infra red analysis of the pulp obtained from the various wood species confirmed the chemical integrity of the pulps obtained from all the hard wood ...

  10. A Prospective, Randomized Study Comparing 7-day and 14-day ...

    African Journals Online (AJOL)

    2018-02-07

    Feb 7, 2018 ... H. pylori infection in Turkey. KEYWORDS: Duodenum, dyspepsia, Helicobacter pylori, gastritis, stomach. A Prospective, Randomized Study Comparing 7-day and 14-day. Quadruple Therapies as First-line Treatments for Helicobacter pylori. Infection in Patients with Functional Dyspepsia. A Yağbasan, DÖ ...

  11. A comparative study on physicochemical properties of Chinese-type ...

    African Journals Online (AJOL)

    hope&shola

    2010-10-04

    Oct 4, 2010 ... A comparative study on physicochemical properties of. Chinese-type soy sauces prepared using .... chemical properties between soy sauces prepared using. A. oryzae koji (SSAO) and mixed kojis .... by gel permeation chromatography on a. Superdex peptide 10/300 GL column (Amersham Biosciences ...

  12. Comparative study between purse–string suture and peritoneal ...

    African Journals Online (AJOL)

    Comparative study between purse–string suture and peritoneal disconnection with ligation techniques in the laparoscopic repair of inguinal hernia in infants and ... The main outcome measurement was recurrence, and secondary outcome measurements were operative time, hospital stay, intraoperative complications, ...

  13. Comparative Study of Teenage Pregnancy in Lagos State University ...

    African Journals Online (AJOL)

    This informed a comparative study of the obstetric performance of primiparous teenagers and nonteenage primiparas within a two-year period (1st January, 2006-31st December, 2007) in Lagos State University Teaching Hospital,Ikeja. Fifty six(56) case notes of teenagers who delivered in this hospital were available for ...

  14. A comparative study of group versus individual diabetes education ...

    African Journals Online (AJOL)

    Methods: A comparative study consisting of two hundred consenting type 2 diabetics receiving care at the general outpatient department of Bingham University Teaching Hospital was done. Subjects were recruited by systematic random sampling and randomly allocated into intervention (group education) and control (one- ...

  15. Comparative study of the inhibition effects of alkaloid and non ...

    African Journals Online (AJOL)

    The Alkaloid and Non- alkaloid fractions of the ethanolic extracts from Costus afer (AECA and NAECA) were comparatively studied for their inhibitive properties on the corrosion of mild steel in 5 M HCl solution using Gravimetric and Gasometric techniques. The results revealed that both extracts inhibited the corrosion of ...

  16. Comparative Studies on the Biosurfactant Production Capacity of ...

    African Journals Online (AJOL)

    The study was carried out to compare the the production capabilities and the biosurfactant activity of the bacteria, Bacillus subtilis and Pseudomonas aeruginosa using engine oil and diesel as the substrates respectively. The test organisms were isolated from engine oil contaminated soil as in the case of the Bacillus subtilis ...

  17. Comparative studies between FRAPCON-1 and FRAPCON-3 programs

    International Nuclear Information System (INIS)

    Silva, Antonio Teixeira e; Castanheira, Myrthes; Terremoto, Luis Antonio Albiac; Silva, Cecilia C. Guedes e

    2005-01-01

    This paper presents a comparative study between the steady-state calculation results of a LWR fuel rod with the computer codes FRAPCON-1 and FRAPCON-3. FRAPCON-3 is the third released code of the FRAPCON series, and is intended to replace the earlier codes FRAPCON-1 and FRAPCON-2. (author)

  18. A comparative study of Interactions between chronic Alcohol ...

    African Journals Online (AJOL)

    Methods: The effects of drinking 10% alcohol solution for 12 weeks on daily body weight, and drinking and feeding behaviour were studied in Sprague – Dawley rats of both sexes. Daily measurement of body weight, fluid intake and food consumption were recorded and compared. Multiple linear regression analysis was ...

  19. Comparative study of the therapeutic effects of brands of ...

    African Journals Online (AJOL)

    Objectives: To compare the therapeutic effects of two brands of Paracetamol: Panadol® (paracetamol 1000mg) and Panadol-Extra®( paracetamol 1000mg and 60mg caffeine) on the perception of dental pain. Method: The setting for the study was the Oral Diagnosis Unit of the Dental Hospital, Obafemi Awolowo University ...

  20. A Comparative Study on Lognormal and Gamma Distributions for ...

    African Journals Online (AJOL)

    A comparative study on Lognormal and Gamma distributions for failure times, t, of kamag machine was undertaken to identify an appropriate distribution for the failure times, t, of the machine. The Gamma distribution of the random variable, failure times, t, has a smaller variance, σ = 24.335 than the variance, σ= 86.490 of the ...

  1. Comparative study of Heavy Metals Distribution in a Mechanic ...

    African Journals Online (AJOL)

    A comparative study of heavy metals; Lead, Chromium, Arsenic, Nickel, Cadmium and Mercury distribution was carried out in Oluku and Otofure both in Metropolitan Benin City, Edo State Nigeria with the view to determine the level of concentration and contribution of each site investigated. Thirty eight (38) soil samples were ...

  2. A comparative study of the flow enhancing properties of bentonite ...

    African Journals Online (AJOL)

    A comparative study of granule flow enhancing property of bentonite, magnesium stearate, talc and microcrystalline cellulose (MCC) was undertaken. Bentonite was processed into fine powder. A 10 %w/w of starch granules was prepared and separated into different sizes (˂180, 180-500, 500-710 and 710-850 μm).

  3. Comparative study of physical activity patterns among school ...

    African Journals Online (AJOL)

    Examination of the timing and patterns of daily activity are crucial in understanding when children accumulate the highest levels of physical activity. The objectives of this study were to examine moderate-to-vigorous physical activity (MVPA) patterns accrued by time of day among Kenyan children, and compare activity ...

  4. A comparative study regarding effects of interfacial ferroelectric ...

    Indian Academy of Sciences (India)

    A comparative study regarding effects of interfacial ferroelectric. Bi4Ti3O12 (BTO) layer on electrical characteristics of Au/n-Si structures. M YILDIRIM and M GÖKÇEN. ∗. Department of Physics, Faculty of Arts & Science, Düzce University, 81620 Düzce, Turkey. MS received 11 July 2012; revised 7 January 2013. Abstract.

  5. A comparative study on heat dissipation, morphological and ...

    Indian Academy of Sciences (India)

    Home; Journals; Bulletin of Materials Science; Volume 35; Issue 7. A comparative study on heat dissipation, morphological and magnetic properties of hyperthermia suitable nanoparticles prepared by co-precipitation and hydrothermal methods. Md Shariful Islam Yoshihumi Kusumoto Junichi Kurawaki Md ...

  6. A comparative study on isotopic composition of precipitation in wet ...

    Indian Academy of Sciences (India)

    A comparative study on isotopic composition of precipitation in wet tropic and semi-arid stations across southern India. C Unnikrishnan Warrier∗ and M Praveen Babu. Isotope Hydrology Division, Centre for Water Resources Development and Management,. Kunnamangalam P.O., Kozhikode 673 571, Kerala, India. ∗.

  7. Comparative Study Of Asbestos And Rice Husk As Roofing Materials

    African Journals Online (AJOL)

    The need to get a replacement for asbestos as a roofing material cannot be overemphasized. Therefore, the researcher in this study critically analyses the characteristics of rice husk as compared to the characteristics of asbestos. Series of tests were carried out on rice husk roofing sheet while the results of tests carried out ...

  8. Homeless Adolescents' Perceptions of Positive Development: A Comparative Study

    Science.gov (United States)

    Nott, Brooke Dolenc; Vuchinich, Samuel

    2016-01-01

    Background: While some recent research has addressed homeless youth from a strengths-based approach, comparative studies of homeless and non-homeless youth from a strengths perspective are few; research that includes youth's views on positive youth development are also limited. Objective: Addressing these gaps and using an inductive approach,…

  9. Suicides in two Scandinavian capitals--a comparative study

    DEFF Research Database (Denmark)

    Rogde, S; Hougen, H P; Poulsen, K

    1996-01-01

    Suicides from the city and county of Copenhagen, Denmark, and from the two police districts Oslo and Asker and Baerum, Norway, two comparable Scandinavian capital populations, were studied with regard to age, gender, suicide methods, marital status, nationality, month of year, somatic and psychia...

  10. Comparative study of methods for extraction and purification of ...

    African Journals Online (AJOL)

    DNA extraction from wastewater sludge (COD 50000 and BOD 25000 mg/l) was conducted using nine different methods normally used for environmental samples including a procedure used in this study and the results obtained were compared. The quality of the differently extracted DNAs was subsequently assessed by ...

  11. Comparative study of spectroscopic properties of the low-lying ...

    Indian Academy of Sciences (India)

    985–994. c Indian Academy of Sciences. Comparative study of spectroscopic properties of the low-lying electronic states of 2,4-pentadien-1-iminium cation and its N-substituted analogues. ANJAN CHATTOPADHYAY. Department of Chemistry, Birla Institute of Technology and Science (BITS), Pilani –KK Birla Goa Campus,.

  12. A comparative study of the spectra recorded at RRCAT synchrotron ...

    Indian Academy of Sciences (India)

    2013-01-09

    Jan 9, 2013 ... E-mail: abhijeetgaur9@gmail.com. MS received 13 February 2012; revised 3 July 2012; accepted 24 July 2012. Abstract. The aim of the present work is to make a comparative study of the EXAFS spectra recorded at the BL-8 dispersive EXAFS beamline at 2 GeV Indus-2 synchrotron source at RRCAT,.

  13. Comparative study between the use of Macintosh Laryngoscope ...

    African Journals Online (AJOL)

    Comparative study between the use of Macintosh Laryngoscope and Airtraq in patients with cervical spine immobilization. ... Conclusion: The Airtraq Laryngoscope offers a new approach for the management of difficult airway like patients with potential cervical spine injury, it is fast, easy to use, gets an easy view of the ...

  14. an example of studies comparing artificial disc replacement with ...

    African Journals Online (AJOL)

    2015-07-22

    Jul 22, 2015 ... Cervical artificial disc replacement (C-ADR) is now an alternative to anterior cervical discectomy and fusion. (ACDF). Many studies have evaluated the efficacy of C-ADR compared with ACDF. This led to a series of systematic reviews and meta-analyses to evaluate the evidence of the superiority of one ...

  15. A comparative study on the aphrodisiac activity of food plants ...

    African Journals Online (AJOL)

    Background: Any substance that increases erectile function, sexual performance and enjoyment is considered an aphrodisiac. The aim of this study was to compare the effects of food plants Mondia whitei, Chenopodium album, Cucurbita pepo and Sclerocarya birrea extracts at a fixed dose of 200mg/kg body weight on ...

  16. Quality of systematic reviews: an example of studies comparing ...

    African Journals Online (AJOL)

    Cervical artificial disc replacement (C-ADR) is now an alternative to anterior cervical discectomy and fusion (ACDF). Many studies have evaluated the efficacy of C-ADR compared with ACDF. This led to a series of systematic reviews and meta-analyses to evaluate the evidence of the superiority of one intervention against ...

  17. Comparative phytochemical and growth inhibitory studies on the leaf ...

    African Journals Online (AJOL)

    Comparative phytochemical and growth inhibitory studies on the leaf and root bark extracts of securinega Virosa (roxb ex. Willd) baill ... The growth inhibitory tests were carried out between 1-30 mg/ in a period of 24-96 h while the phytochemical screening was carried out on the plant parts using standard methods. At 24 h ...

  18. Comparative study of the physiochemical and structural properties of ...

    African Journals Online (AJOL)

    A comparative analysis of some physiochemical and structural parameters of brown (mature) and green (immature) coconut fibre as adsorbents was studied. The physiochemical and structural properties evaluated were surface area, moisture content, pH, bulk density, pore volume, porosity, ash content, tortuocity and metal ...

  19. Comparative and Interactive Studies of Aqueous Leaf Extracts of ...

    African Journals Online (AJOL)

    The present study was designed to investigate the comparative effects of aqueous leaf extract of Ocimum gratissimum Linn. (Lamiaceae), vitamin C and vitamin E on the basal serum phosphatases- alkaline phosphatase (ALP), total acid phosphatase (ACPT) and prostatic acid phosphatase (ACPP) of the male guinea-pig.

  20. Comparative Study on Wind Power using Meteorological Data and ...

    African Journals Online (AJOL)

    The power efficiency of a wind turbine may be influenced by several parameters such as wind speed and type and age of the turbine and its accessories. This study was conducted at Ashogoda village to compare the theoretically predicted power from the wind speed of Ashogoda area with electrical power generated from ...

  1. COMPARATIVE-STUDY OF 3 SEMIAUTOMATED SPECULAR MICROSCOPES

    NARCIS (Netherlands)

    LANDESZ, M; SIERTSEMA, JV; VANRIJ, G

    We compared two clinical video-assisted specular microscopes (Zeiss, noncontact, and the wide-field Keeler Konan sp 3300, contact) with an autofocus microscope (Konan noncon Robo-ca sp 8000, noncontact) with built-in analyzing software by studying the morphometry of the central corneal endothelium

  2. Comparative studies on the growth and survival of African catfish ...

    African Journals Online (AJOL)

    Comparative studies on the growth and survival of African catfish, Clarias gariepinus (Burchell, 1822) juveniles reared in cages suspended in concrete tank and earthen pond in Umudike, Abia State. E E Oti, C D Nwani. Abstract. No Abstract. Bio-Research Vol. 5 (1) 2007: pp. 210-215. Full Text: EMAIL FULL TEXT EMAIL ...

  3. A Comparative Study of The Economic Performance of Farmers ...

    African Journals Online (AJOL)

    This study determined the better irrigation method between large scale and motorised pump to recommend to farmers in Katsina state of Nigeria. The target populations were Farmers Under Large Scale (FULS) and Farmers Using Motorised Pumps (FUMP) and were compared along their socio-economic characteristics, ...

  4. A Comparative Study of Job Satisfaction between Cataloguers in ...

    African Journals Online (AJOL)

    The study aimed at comparing job satisfaction among cataloguers in federal and private university libraries in Nigeria and to identify what cataloguers are satisfied and dissatisfied with. The instrument used for data collection was the questionnaire. Data was collected from cataloguers in federal and private university ...

  5. Spanish and American Turn-Taking Styles: A Comparative Study.

    Science.gov (United States)

    Berry, Anne

    A comparative study of turn-taking in North American and Spanish conversation investigated (1) differences in styles for the two cultures and (2) any resulting misinterpretation of communicative intentions. Data for the first were drawn from two dinner parties, one with four American women, conducted in English, and one with four Spanish-speaking…

  6. Comparative study of Aspergillus niger and Penicillium sp. in the ...

    African Journals Online (AJOL)

    STORAGESEVER

    2010-06-14

    Jun 14, 2010 ... The comparative study of Aspergillus niger and Penicillium sp. in the biodegradation of automotive gas oil (AGO) and premium motor spirit (PMS) was carried out to ascertain the effectiveness of using these microorganisms in cleaning and restoring the ecosystem when polluted by petroleum products.

  7. Comparative study of Aspergillus niger and Penicillium sp. in the ...

    African Journals Online (AJOL)

    The comparative study of Aspergillus niger and Penicillium sp. in the biodegradation of automotive gas oil (AGO) and premium motor spirit (PMS) was carried out to ascertain the effectiveness of using these microorganisms in cleaning and restoring the ecosystem when polluted by petroleum products. These fungi were ...

  8. Comparative studies on the neurohypophysial extracts from tropical ...

    African Journals Online (AJOL)

    Comparative studies on the neurohypophysial extracts from tropical mammalian and non-mnammalian vetebrates on rat blood pressure. R.A Elegbe. Abstract. No Abstract. Full Text: EMAIL FULL TEXT EMAIL FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL TEXT · http://dx.doi.org/10.4314/wajpdr.v6i1.53369.

  9. A Comparative Study Of Source Location And Depth Estimates From ...

    African Journals Online (AJOL)

    A Comparative Study Of Source Location And Depth Estimates From Total Intensity And Reduced-To-The Pole Magnetic Data. ... Ife Journal of Science ... analysed to show that estimates of source location and depth can be improved significantly by reducing the data to the pole prior to the application of the HGM, ASA and ...

  10. Accessing powerful knowledge: a comparative study of two first year ...

    African Journals Online (AJOL)

    This paper presents a case study of two first year sociology courses run at an elite South African university in order to speak to student perspectives on the sociology curriculum. The paper provides a comparative analysis of the academic experiences of extended degree (ED) students registered on two first year courses, ...

  11. Comparative study of the properties of ordinary portland cement ...

    African Journals Online (AJOL)

    The study explored metakaolin as alternative material to cement. It compares the properties of Ordinary Portland Cement (OPC) concrete and binary concrete containing metakaolin as partial replacement of OPC. Two set of concrete samples; one with 10% Metakaolin (MK) replacing OPC by weight, and the other without ...

  12. Comparative feed intake and deigestibility studies with sheep and ...

    African Journals Online (AJOL)

    Comparative feed intake and deigestibility studies with sheep and cattle on roughages. EAN Engels, B Ferreira, JA Swart, PJ Nieman. Abstract. No Abstract. Full Text: EMAIL FREE FULL TEXT EMAIL FREE FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL TEXT · AJOL African Journals Online. HOW TO USE AJOL.

  13. comparative study of thermal insulation boards from leaf and bark ...

    African Journals Online (AJOL)

    HOD

    environmentally friendly thermal insulation products. The aim of this study was to compare the performance of insulation boards made from leave and bark fibres of Piliostigma thonningii L.in terms of density, water absorption, apparent thermal conductivity, specific heat and thermal diffusivity. The leave and the bark fibres ...

  14. Comparative study on calcium, magnesium and cobalt in diabetic ...

    African Journals Online (AJOL)

    Comparative study on calcium, magnesium and cobalt in diabetic and non diabetic patients (males) in Punjab, Pakistan. A Anjum, M Yousaf, M Zuber, HB Ahmad, AF Zahoor, ZI Khan, K Ahmad, S Naheed, KG Ali, A Jabbar, TH Bukhari, S Hina, S Ahmad, MK Mukhtar, M Arshad, A Hussain ...

  15. Comparative study of genetic influence on the susceptibility of exotic ...

    African Journals Online (AJOL)

    This study investigated comparatively the genetic influence on the susceptibility of exotic cockerels, pullets and broilers to natural infection with infectious bursal disease (IBD) virus in a flock of 150 seven-week-old exotic breed of chickens comprising of 50 Black Harco cockerels, 50 Black Harco pullets and 50 White ...

  16. Scandinavian Approaches to Gender Equality in Academia: A Comparative Study

    Science.gov (United States)

    Nielsen, Mathias Wullum

    2017-01-01

    This study investigates how Denmark, Norway, and Sweden approach issues of gender equality in research differently. Based on a comparative document analysis of gender equality activities in six Scandinavian universities, together with an examination of the legislative and political frameworks surrounding these activities, the article provides new…

  17. Comparative Studies on the Biosurfactant Production Capacity of ...

    African Journals Online (AJOL)

    Windows User

    Abdulsalam et al: Comparative Studies on the Biosurfactant Production Capacity of ……………….. 104 and morphological characterizations carried out were: pigmentation on cetrimide agar and growth at 40C. A loopful of 24hrs broth culture of the isolate was streaked on fresh Cetrimide agar and incubated at 370C for ...

  18. Comparative study of classical controllers for LFC of an isolated ...

    African Journals Online (AJOL)

    Comparative study of classical controllers for LFC of an isolated hybrid distributive generation system. ... generation system. Tarkeshwar Kumar, V Mukherjee, Almoataz Y. Abdelaziz ... of the PID controller. Keywords: Harmony search algorithm; isolated hybrid distributive generation; load frequency control; PID controller ...

  19. Comparative study of growth and linear body measurements in Anak ...

    African Journals Online (AJOL)

    The study was designed to compare the performance of two different breeds of broilers (Anak and Hubbard) using body weight and body linear measurements. Data on a total of 200 (100 each) Anak and Hubbard broiler breeds were collected weekly and the experiment lasted for 8 weeks. The parameters investigated ...

  20. Comparative studies of ginger ( Zingiber officinale ) and black pepper

    African Journals Online (AJOL)

    Comparative studies of ginger ( Zingiber officinale ) and black pepper ( Piper guinenses ) extracts at different concentrations on the microbial quality of soymilk and ... African Journal of Biotechnology ... 3.6% black pepper extract in soymilk and kunuzaki had a microbial load of 3.20 × 106d and 2.90 × 106c, respectively.

  1. A comparative study of proton transport properties of zirconium ...

    Indian Academy of Sciences (India)

    TECS

    A comparative study of proton transport properties of zirconium phosphate and its metal exchanged phases. RAKESH THAKKAR, HEEMANSHU PATEL and UMA CHUDASAMA*. Applied Chemistry Department, Faculty of Technology and Engineering, M.S. University of Baroda,. Vadodara 390 001, India. MS received 26 ...

  2. A comparative study of multiple regression analysis and back ...

    Indian Academy of Sciences (India)

    Home; Journals; Sadhana; Volume 41; Issue 5. A comparative study of multiple regression analysis and back propagation neural network approaches on plain carbon steel in submerged-arc welding. ABHIJIT SARKAR PRASENJIT DEY R N RAI SUBHAS CHANDRA SAHA. Volume 41 Issue 5 May 2016 pp 549-559 ...

  3. A Comparative Study Of The Phytochemical And Anti-Microbial ...

    African Journals Online (AJOL)

    A comparative study of the phytochemical and anti-microbial properties of leaves of Loranthus micranthus harvested from six host trees, namely, Irvingia gabonensis, Pentaclethra macrophylla, Kola acuminata, Baphia nitida, Persea americana and Azadirachta indica, was carried out using standard methods. The result ...

  4. A Comparative Study of Psychopathology among Pastors, Mental ...

    African Journals Online (AJOL)

    The study was carried out to compare levels of psychopathology among three groups, namely Pastors, Patients and Police men: 60 participants made up of 30 males and 30 females from each group were administered Stress Checklist 90 SCL - 90 and Religious Affiliation scale. Although, a 2 x 3 ANOVA showed significant ...

  5. A Prospective, Randomized Study Comparing 7-day and 14-day ...

    African Journals Online (AJOL)

    Objective: Standard triple therapy for Helicobacter pylori has a low eradication rate in Turkey. The aim of this study was to evaluate and compare the effectiveness of 7-day and 14-day lansoprazole, amoxicillin, clarithromycin, and bismuth subsalicylate (LACB) treatment regimens as first-line H. pylori eradication therapies.

  6. Comparative study of the electronic structure of natural and synthetic ...

    Indian Academy of Sciences (India)

    Comparative study of the electronic structure of natural and synthetic rubies using XAFS and EDAX analyses ... Electronics and Engineering Research Institute, Pilani 333 031, India; Dipartimento di Fisica, Universita di Roma, “La Sapienza”, 00185 P,le A.Moro, Roma, Italy; Gem Testing Laboratory, Jaipur 302 003, India ...

  7. A Comparative Study of the Effect of Hydrogen Peroxide and ...

    African Journals Online (AJOL)

    Contact lens cases contaminated with Pseudomonas aeruginosa are a major risk factor in ocular infections. A comparative study of the effect of 0.6% hydrogen peroxide and 0.0005% polyhexamethlylene biguanide on Pseudomonas aerugunosa isolated from three different sources, and cultured on nutrient agar plates and ...

  8. Sources for comparative studies of placentation I. Embryological collections

    DEFF Research Database (Denmark)

    Carter, Anthony Michael

    2008-01-01

    A rich source of material for comparative studies of the placenta is the collections made by pioneers in the field such as H.W. Mossman, A.A.W. Hubrecht and J.P. Hill. This overview gives a brief description of collections known to be available and information on how each can be accessed. Include...

  9. Comparative milk production and prevalence study of parasites and ...

    African Journals Online (AJOL)

    Comparative study on prevalence of gastrointestinal parasites, ticks and subclinical mastitis as well as milk yield was conducted on local zebu lactating dairy cows exposed to different feeding regimes in dry seasons at Sululta and Mukaturi districts of North Shewa zone, central Ethiopia. A total of 15 households at each ...

  10. Comparative study of thermal insulation boards from leaf and bark ...

    African Journals Online (AJOL)

    The aim of this study was to compare the performance of insulation boards made from leave and bark fibres of Pilios tigma thonningii L.in terms of density, water absorption, apparent thermal conductivity, specific heat and thermal diffusivity. The leave and the bark fibres were prepared in form of squared boards of 200 mm x ...

  11. Comparative Study Of Breakfast Intake Among School Children In ...

    African Journals Online (AJOL)

    A comparative study of the breakfast intake of school children between the ages of 10-12yeras in Nsukka urban and rural areas was investigated. Sixty urban and thirty rural school children were randomly selected from three primary schools. Data was collected using a structured; pre tested and validated questionnaire ...

  12. Comparative studies on chemical, hot and cold water treatments of ...

    African Journals Online (AJOL)

    study was to compare cold and hot water treatment with chemical treatment of banana planting material for the control of the banana weevil, and to validate the effect of paring on weevil and nematode removal from banana suckers. Materials and methods. The experiment was conducted at Kawanda Agricultural research ...

  13. Comparative study of the influence of cement and lime stabilization ...

    African Journals Online (AJOL)

    Comparative study of the influence of cement and lime stabilization on geotechnical properties of lateritic soil derived from pegmatite in Ago-Iwoye area, southwestern Nigeria. MO Oloruntola, GO Adeyemi, OC Oduneye. Abstract. No Abstract. Journal of Mining and Geology Vol. 44 (1) 2008: pp. 95-105. Full Text:.

  14. Africa and Ethnic Conflict Management: A Comparative Study of ...

    African Journals Online (AJOL)

    Relying on the comparative study of Nigeria and South Africa, it is the contention in this paper that ethnic conflict which has been at the heart of African countries development problem is a product of skewed economy, authoritarian governance and religious bigotry. There is no gainsaying the fact that African countries in ...

  15. Different Underlying Neurocognitive Deficits in Developmental Dyslexia: A Comparative Study

    Science.gov (United States)

    Menghini, D.; Finzi, A.; Benassi, M.; Bolzani, R.; Facoetti, A.; Giovagnoli, S.; Ruffino, M.; Vicari, S.

    2010-01-01

    The aim of this study was to investigate the role of several specific neurocognitive functions in developmental dyslexia (DD). The performances of 60 dyslexic children and 65 age-matched normally reading children were compared on tests of phonological abilities, visual processing, selective and sustained attention, implicit learning, and executive…

  16. Comparative studies of the nutritional indices of rural and urban ...

    African Journals Online (AJOL)

    Malnutrition is a major health problem among young children in third World countries. In the present study, a comparative assessment of the nutritional indices of rural and urban school children in Umuahia North Local Government Area of Abia State, Nigeria was undertaken by assessing both anthropometric and ...

  17. Level structures of Mo – A comparative study

    Indian Academy of Sciences (India)

    Level structures of. 95,97. Mo – A comparative study. J M CHATTERJEE, M SAHA SARKAR, S BHATTACHARYA, P BANERJEE,. S SARKAR£, R P SINGHÝ, S MURULITHARÝ and R K BHOWMIKÝ. Saha Institute of Nuclear Physics, 1/AF, Bidhannagar, Kolkata 700 064, India. *Department of Physics, Burdwan University, ...

  18. A Comparative Study of Igala and Igbo Culture and Communication ...

    African Journals Online (AJOL)

    A Comparative Study of Igala and Igbo Culture and Communication Systems in Ata Igala Coronation and Ofala Festival, 2013. ... I adopted particpant observation as an instrument of ethnographic design of fact finding, hence, my physical presence at both ceremonies. Pictoral description was also adopted to bring home ...

  19. Comparative Noise Pollution Study Of Some Major Towns In Delta ...

    African Journals Online (AJOL)

    Comparative noise pollution studies have been carried out in some major towns in Delta State, Nigeria using a PIONneer 65 noise dosimeter. The noise measurements were taken at ten points within each of the towns at an interval of 30 minutes during the peak period of the day and at the cool of the night. The results ...

  20. Newton series, coinductively : a comparative study of composition

    NARCIS (Netherlands)

    Basold, Henning; Hansen, H.H.; Pin, Jean Éric; Rutten, Jan

    We present a comparative study of four product operators on weighted languages: (i) the convolution, (ii) the shuffle, (iii) the infiltration and (iv) the Hadamard product. Exploiting the fact that the set of weighted languages is a final coalgebra, we use coinduction to prove that an operator of

  1. A comparative study assessing a new tool for occluding ...

    African Journals Online (AJOL)

    Background. The aim of this study was to compare the efficacy of a new tool (the hepatic section vascular blocker, HSVB) with hepatic pedicle clamping and hemihepatic vascular exclusion to control bleeding during liver resection for cancer. Methods. Clinical data on 117 patients who underwent liver resection from 2004 to ...

  2. A comparative study of voluntarily reported medication errors among ...

    African Journals Online (AJOL)

    A comparative study of voluntarily reported medication errors among adult patients in intensive care (IC) and non- IC settings in Riyadh, Saudi Arabia. Shmeylan A. Al Harbi, Nasser Mahdi Al-Qhtani, Rami Bustami, Hind Almodaimegh, Abdulmalik M. Alkatheri, Hind A. Al Badali, Yousef H. Al Awlah, Saleh Aldekhael, Waleed ...

  3. A comparative study on zero tillage with bulldozing as land ...

    African Journals Online (AJOL)

    A comparative study on zero tillage and bulldozing, as land preparations for oil palm seedling transplanted into the field was conducted at Ayip Eku Oil Palm Estate between 1993 and 1997. The experimental site was a five-year fallow land in which Panicum maximum (Guinea grass) and Centresoma pubescence were ...

  4. Comparative study of the influence of lecture and demonstration ...

    African Journals Online (AJOL)

    Teaching methods are teacher's skills and manipulations on the subject matter and the desired responses from the learner. With the application of effective method, the teaching of agricultural science will be facilitated. The study compared the influence of lecture method and demonstration method on the teaching of ...

  5. A comparative study of the performances of some estimators of ...

    African Journals Online (AJOL)

    These estimators are compared using the finite properties of estimators' criteria namely; sum of biases, sum of variances and sum of the mean squared error of the estimated parameter of the model at different levels of autocorrelation and sample size through Monte – Carlo studies. Results show that at each level of ...

  6. A comparative study on different BMI category and physical fitness ...

    African Journals Online (AJOL)

    A comparative study on different BMI category and physical fitness health related component of sedentary male youth in Terengganu. V Eswaramoorthi, M.R. Abdullah, H Juahir, A.B.H.M. Maliki, R.M. Musa, N.A. Kosni, N Alias, N.B. Raj, S.M.M. Rasid, A Adnan ...

  7. A comparative study of compressed earth bricks (ceb's) and ...

    African Journals Online (AJOL)

    This study examined the production and testing of sandcrete bricks and compressed earth bricks (CEB's) with a view to comparing their strength and moisture content of materials used. Some units of sandcrete bricks and laterite bricks were made using machine vibrated sandcrete brick mould and hydraulic brick making ...

  8. Comparative Study Of Two Non-Selective Cyclooxygenase ...

    African Journals Online (AJOL)

    The comparative study of the effects of two non-selective cyclooxygenase inhibitors ibuprofen and paracetamol on maternal and neonatal growth was conducted using 15 Sprague dawley rats, with mean body weight ranging between 165 and 179g. The rats were separated at random into three groups (A, B and C).

  9. Comparative study of hygrothermal properties of five thermal insulation materials

    OpenAIRE

    Laure Ducoulombier; Zoubeir Lafhaj

    2017-01-01

    The objective of this article is to carry out a comparative study of the main hygrothermal properties of five thermal insulation materials for buildings. These properties are necessary for a correct prediction of heat and moisture transfers through the walls and the selection of the most appropriate materials according to the specific buildings. The studied materials were glass wool, rock wool, expanded polystyrene, wood fiberboard and polyester fiberfill. The article is divided into three pa...

  10. Comparative Study of Algorithms (MPPT) Applied to Photovoltaic Systems

    OpenAIRE

    DRIS, MIDA; DJILANI, BEN ATTOUS; DJILANI, Benattous

    2016-01-01

    This work presents a theoretical study of maximum power point tracking (MPPT) for photovoltaic (PV) system. The study includes discussion of three MPPT algorithms (the Perturbation and Observation, Incremental Conductance and the Fractional open circuit voltage) and perform comparative tests between them using actual irradiance data. First the PV system with resistive load is discussed, the modelling and the simulation of the PV generator, the DC/DC converter and the three MPPT algorithms are...

  11. The efficacy of primary care chaplaincy compared with antidepressants: a retrospective study comparing chaplaincy with antidepressants.

    Science.gov (United States)

    Macdonald, Gordon

    2017-07-01

    Aim To determine the effectiveness of primary care chaplaincy (PCC) when used as the sole intervention, with outcomes being compared directly with those of antidepressants. This was to be carried out in a homogenous study population reflective of certain demographics in the United Kingdom. Increasing numbers of patients are living with long-term conditions and 'modern maladies' and are experiencing loss of well-being and depression. There is an increasing move to utilise non-pharmacological interventions such as 'talking therapies' within this context. Chaplaincy is one such 'talking therapy' but within primary care its evidence base is sparse with only one quantitative study to date. There is therefore a need to evaluate PCC excluding those co-prescribed antidepressants, as this is not evidenced in the literature as yet. PCC also needs to be directly compared with the use of antidepressants to justify its use as a valid alternative treatment for loss of well-being and depression. This was a retrospective observational study based on routinely collected data. There were 107 patients in the PCC group and 106 in the antidepressant group. Socio-demographic data were collected. Their pre- and post-intervention (either chaplaincy or antidepressant) well-being was assessed, by the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) which is a validated Likert scale. Findings The majority of both groups were female with both groups showing marked ethnic homogeneity. PCC was associated with a significant and clinically meaningful improvement in well-being at a mean follow-up of 80 days. This treatment effect was maintained after those co-prescribed antidepressants were removed. PCC was associated with an improvement in well-being similar to that of antidepressants with no significant difference between the two groups.

  12. Important Questions Of Comparative Studies In Asian Countries

    Directory of Open Access Journals (Sweden)

    Pazyura Natalia

    2015-06-01

    Full Text Available The issue of the “identity” of comparative education as a field of study or a discipline has been discussed for decades. Yet a kind of systematic structure that provides the basic principles for a coherent exposition of the field remains open. “Comparative education” is no longer conceived as an imaginary field’s coherence but, rather in terms of distinct branches of comparative and international studies in education and their underlying issues. Such an understanding is fostered through a deepened awareness of the basic problems, and successive solutions, constitutive of the emergence and further conformations of the comparative approach in education and the social sciences. Thus, academic journal publications of the past decade to shape education policy research within an Asia-Pacific context have been analyzed. Facts of increasing research collaboration, growing policy evaluation research, and growing attention to higher education have been presented. Significant difference in research impact and diffusion between Asia-Pacific and American education policy studies has been shown. Perspectives for future research directions in education policy research in an Asia-Pacific context have been suggested.

  13. Comparative study of three methods of esophageal anastomosis in dogs

    Directory of Open Access Journals (Sweden)

    Z. T. Abd Al-Maseeh

    2009-01-01

    Full Text Available This study was performed to compare three methods of esophageal anastomosis. Twenty four healthy adult dogs were used in this study. The animals were divided into three groups; each one consisted of 8 animals. In group 1; two layers were used to perform the esophageal anastomosis. The first layer represented simple interrupted suture to close the mucosa with knot inside the lumen, and the second layer represented horizontal mattress interrupted suture to close the other layers of esophagus. While in group 2; one layer of cross interrupted mattress suture was used to close all layers of esophageal wall, and in group 3; one layer of Schmieden's suture was used to close all layers of esophageal wall. The results of clinical, radiological and histopathological studies after 15 and 30 days of surgical operation revealed that most of the animals showed different degrees of difficulty concerning the moderate dysphagia and regurgitation. The radiological study showed significant difference of stenosis. The best results were recorded in the second group where the mean degree of stenosis was 7.69%, however the mean degree of stenosis was 42.80% in the first group, while the mean degree of stenosis in the third groups was 37.81%, through 30 days. The histopathological study of group 2 showed rapid healing of the site of anastomosis, lack of granulation tissue and consequently the less degree of stricture and other complications as compared with groups 1 and 3. The Schmieden's suture was characterized by its standard short time as compared with group 1 and 2, although accompanied by some complications. In conclusion this study revealed that the cross mattress suture used in the second group characterized by faster healing and minimal amount of fibrous tissue formation manifested by decrease in moderate degree of stenosis as compared with the two other suture patterns used in the first and third groups.

  14. Maxillary sinusitis - a comparative study of different imaging diagnosis methods

    International Nuclear Information System (INIS)

    Hueb, Marcelo Miguel; Borges, Fabiano de Almeida; Pulcinelli, Emilte; Souza, Wandir Ferreira; Borges, Luiz Marcondes

    1999-01-01

    We conducted prospective study comparing different methods (plain X-rays, computed tomography and ultrasonography mode-A) for the initial diagnosis of maxillary sinusitis. Twenty patients (40 maxillary sinuses) with a clinical history suggestive of sinusitis included in this study. The results were classified as abnormal or normal, using computed tomography as gold standard. The sensitivity for ultrasonography and plain X-rays was 84.6% and 69.2%, respectively. The specificity of both methods was 92.6%. This study suggests that ultrasonography can be used as a good follow-up method for patients with maxillary. sinusitis. (author)

  15. Recognition of Faces in Unconstrained Environments: A Comparative Study

    Directory of Open Access Journals (Sweden)

    Javier Ruiz-del-Solar

    2009-01-01

    Full Text Available The aim of this work is to carry out a comparative study of face recognition methods that are suitable to work in unconstrained environments. The analyzed methods are selected by considering their performance in former comparative studies, in addition to be real-time, to require just one image per person, and to be fully online. In the study two local-matching methods, histograms of LBP features and Gabor Jet descriptors, one holistic method, generalized PCA, and two image-matching methods, SIFT-based and ERCF-based, are analyzed. The methods are compared using the FERET, LFW, UCHFaceHRI, and FRGC databases, which allows evaluating them in real-world conditions that include variations in scale, pose, lighting, focus, resolution, facial expression, accessories, makeup, occlusions, background and photographic quality. Main conclusions of this study are: there is a large dependence of the methods on the amount of face and background information that is included in the face's images, and the performance of all methods decreases largely with outdoor-illumination. The analyzed methods are robust to inaccurate alignment, face occlusions, and variations in expressions, to a large degree. LBP-based methods are an excellent election if we need real-time operation as well as high recognition rates.

  16. Challenges in Doctoral Research Project Management: A Comparative Study

    Directory of Open Access Journals (Sweden)

    Reuven Katz

    2016-03-01

    Full Text Available This paper presents quantitative results of a comparative study evaluating the management skills of doctoral candidates working toward a PhD and additional information related to their lifestyles. We conducted a survey among enrolled doctoral candidates at five universities in Israel and three technological universities in Western Europe. 1013 Israeli candidates and 457 Western European candidates replied to our survey. In our analysis, we compared the answers of Israeli Science and Engineering candidates to those of Social Sciences and Humanities candidates; in addition, we compared the answers of Israeli Science and Engineering students to their Western European peers. Our analysis focused on finding significant patterns by comparing these groups of students. In order to identify such patterns, we analyzed each question using the Pearson chi-square test. The current study’s main finding is that the majority of candidates, regardless of their chosen academic field or the region where they study, have no training or expertise in managing a doctoral research project. Based on these findings, we suggest that all doctoral candidates be taught basic research-project management. We believe that such training will provide them with a powerful tool for better managing their research as they advance towards successful completion of their doctorate.

  17. A simulation study comparing aberration detection algorithms for syndromic surveillance

    Directory of Open Access Journals (Sweden)

    Painter Ian

    2007-03-01

    Full Text Available Abstract Background The usefulness of syndromic surveillance for early outbreak detection depends in part on effective statistical aberration detection. However, few published studies have compared different detection algorithms on identical data. In the largest simulation study conducted to date, we compared the performance of six aberration detection algorithms on simulated outbreaks superimposed on authentic syndromic surveillance data. Methods We compared three control-chart-based statistics, two exponential weighted moving averages, and a generalized linear model. We simulated 310 unique outbreak signals, and added these to actual daily counts of four syndromes monitored by Public Health – Seattle and King County's syndromic surveillance system. We compared the sensitivity of the six algorithms at detecting these simulated outbreaks at a fixed alert rate of 0.01. Results Stratified by baseline or by outbreak distribution, duration, or size, the generalized linear model was more sensitive than the other algorithms and detected 54% (95% CI = 52%–56% of the simulated epidemics when run at an alert rate of 0.01. However, all of the algorithms had poor sensitivity, particularly for outbreaks that did not begin with a surge of cases. Conclusion When tested on county-level data aggregated across age groups, these algorithms often did not perform well in detecting signals other than large, rapid increases in case counts relative to baseline levels.

  18. Latin America and Beyond: The Case for Comparative Area Studies

    Directory of Open Access Journals (Sweden)

    Bert Hoffmann

    2015-12-01

    Full Text Available Comparative Area Studies (CAS emerges as a new approach in which scholars of Latin American Studies engage systematically with scholars working on other world regions. Adopting a focus on intra-, inter- and cross area comparisons, CAS builds on the traditional strengths of area studies. At the same time it enables scholars to have a stronger impact on overarching conceptual debates and it may provide new bridges between area studies scholars and the academic communities in the regions studied. However, a comparative area studies approach requires systematic cooperation among scholars of different world regions, and adequate organizational and institutional structures to support them. Resumen: Latinoamérica y más allá: El caso de los estudios regionales comparativos Los Estudios Regionales Comparativos (Comparative Area Studies – CAS surgen como un enfoque nuevo dentro del cual académicos de Estudios Latinoamericanos colaboran sistemáticamente con académicos que investigan sobre otras regiones del mundo. Tomando como punto de partida comparaciones intrarregionales, interregionales y transregionales, los ERC se basan en los puntos fuertes tradicionales de los estudios regionales. Al mismo tiempo, este enfoque permite a los académicos tener un impacto mayor en los debates conceptuales más amplios y puede tender nuevos puentes entre los académicos de estudios regionales y las comunidades académicas de las regiones estudiadas. Sin embargo, un enfoque de estudios regionales comparativos exige una cooperación sistemática entre académicos de distintas regiones del mundo y unas estructuras organizativas e institucionales adecuadas para apoyarles.

  19. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    OBJECTIVE: The goals for maintenance dialysis treatment are to improve patient survival, reduce patient morbidity, and improve patient quality of life. This is the first randomized prospective study comparing automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD......) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included...... were assessed at baseline and after 6 months by the self-administered short-form SF-36 generic health survey questionnaire supplemented with disease- and treatment-specific questions. Therapy costs were compared by evaluating dialysis-related expenses. MAIN OUTCOME MEASURES: Quality-of-life parameters...

  20. MRI Compatibility of Robot Actuation Techniques – A Comparative Study

    OpenAIRE

    Fischer, Gregory S.; Krieger, Axel; Iordachita, Iulian; Csoma, Csaba; Whitcomb, Louis L.; Fichtinger, Gabor

    2008-01-01

    This paper reports an experimental evaluation of the following three different MRI-compatible actuators: a Shinsei ultrasonic motor, a Nanomotion ultrasonic motor and a pneumatic cylinder actuator. We report the results of a study comparing the effect of these actuators on the signal to noise ratio (SNR) of MRI images under a variety of experimental conditions. Evaluation was performed with the controller inside and outside the scanner room and with both 1.5T and 3T MRI scanners. Pneumatic cy...

  1. Comparative Study on Mechanical Properties between Pure and Recycled Polypropylenes

    OpenAIRE

    Ariadne L. Juwono; Bernadeth Jong Hiong Jun

    2010-01-01

    Polypropylene (PP) is one type of thermoplastics that is widely used in our daily activities. A combination of the high demand and the easiness of recycling process, the recycled PP has been generally applied. In this study, the structure and the mechanical properties of the as-received PPs, recycled PPs, and commercial recycled PPs were compared, especially for cloth hanger application. DSC test results showed that recycling process did not cause a significant change to the material's meltin...

  2. Comparative study of ozonized olive oil and ozonized sunflower oil

    OpenAIRE

    Díaz,Maritza F.; Hernández,Rebeca; Martínez,Goitybell; Vidal,Genny; Gómez,Magali; Fernández,Harold; Garcés,Rafael

    2006-01-01

    In this study the ozonized olive and sunflower oils are chemical and microbiologically compared. These oils were introduced into a reactor with bubbling ozone gas in a water bath at room temperature until they were solidified. The peroxide, acidity and iodine values along with antimicrobial activity were determined. Ozonization effects on the fatty acid composition of these oils were analyzed using Gas-Liquid Chromatographic Technique. An increase in peroxidation and acidity values was observ...

  3. Environmental liability in Germany: a comparative study with Brazilian Law

    OpenAIRE

    Gonçalves, Daniela Oliveira; Escola Superior Dom Helder Câmara; Rezende, Élcio Nacur; Escola Superior Dom Helder Câmara

    2015-01-01

    Seek compare the environmental liability institutes from Germany with those of Brazil, this study intends to conduct an analysis of civil liability for environmental damage in Germany. The concepts of liability and its species, subjective and objective initially are analyzed. Then the concept of civil liability for environmental damage under Brazilian law is analyzed, also discussing the concept of environmental damage. Finally it is carried out the assessment of some of the German Civil Code...

  4. Technology Approach: DoD Versus Boeing (A Comparative Study)

    Science.gov (United States)

    2016-01-01

    BOEING (A Comparative Study) A. Lee Battershell This is an analysis of different approaches in the use of technology by Boeing and DoD to determine how...they may have affected development time for the C-17 and the Boeing 777. Boeing’s focus on cost, schedule, performance, and market competition is...military cargo plane, Boeing 777 passenger plane, Air Force tactical plane, strategic airlift capability, management structure 29Defense ARJ, January

  5. An interspecies comparative study of invasive electrophysiological functional connectivity.

    Science.gov (United States)

    Casimo, Kaitlyn; Levinson, Lila H; Zanos, Stavros; Gkogkidis, C Alexis; Ball, Tonio; Fetz, Eberhard; Weaver, Kurt E; Ojemann, Jeffrey G

    2017-12-01

    Resting-state connectivity patterns have been observed in humans and other mammal species, and can be recorded using a variety of different technologies. Functional connectivity has been previously compared between species using resting-state fMRI, but not in electrophysiological studies. We compared connectivity with implanted electrodes in humans (electrocorticography) to macaques and sheep (microelectrocorticography), which are capable of recording neural data at high frequencies with spatial precision. We specifically examined synchrony, implicated in functional integration between regions. We found that connectivity strength was overwhelmingly similar in humans and monkeys for pairs of two different brain regions (prefrontal, motor, premotor, parietal), but differed more often within single brain regions. The two connectivity measures, correlation and phase locking value, were similar in most comparisons. Connectivity strength agreed more often between the species at higher frequencies. Where the species differed, monkey synchrony was stronger than human in all but one case. In contrast, human and sheep connectivity within somatosensory cortex diverged in almost all frequencies, with human connectivity stronger than sheep. Our findings imply greater heterogeneity within regions in humans than in monkeys, but comparable functional interactions between regions in the two species. This suggests that monkeys may be effectively used to probe resting-state connectivity in humans, and that such findings can then be validated in humans. Although the discrepancy between humans and sheep is larger, we suggest that findings from sheep in highly invasive studies may be used to provide guidance for studies in other species.

  6. Image based 3D city modeling : Comparative study

    Directory of Open Access Journals (Sweden)

    S. P. Singh

    2014-06-01

    Full Text Available 3D city model is a digital representation of the Earth’s surface and it’s related objects such as building, tree, vegetation, and some manmade feature belonging to urban area. The demand of 3D city modeling is increasing rapidly for various engineering and non-engineering applications. Generally four main image based approaches were used for virtual 3D city models generation. In first approach, researchers were used Sketch based modeling, second method is Procedural grammar based modeling, third approach is Close range photogrammetry based modeling and fourth approach is mainly based on Computer Vision techniques. SketchUp, CityEngine, Photomodeler and Agisoft Photoscan are the main softwares to represent these approaches respectively. These softwares have different approaches & methods suitable for image based 3D city modeling. Literature study shows that till date, there is no complete such type of comparative study available to create complete 3D city model by using images. This paper gives a comparative assessment of these four image based 3D modeling approaches. This comparative study is mainly based on data acquisition methods, data processing techniques and output 3D model products. For this research work, study area is the campus of civil engineering department, Indian Institute of Technology, Roorkee (India. This 3D campus acts as a prototype for city. This study also explains various governing parameters, factors and work experiences. This research work also gives a brief introduction, strengths and weakness of these four image based techniques. Some personal comment is also given as what can do or what can’t do from these softwares. At the last, this study shows; it concluded that, each and every software has some advantages and limitations. Choice of software depends on user requirements of 3D project. For normal visualization project, SketchUp software is a good option. For 3D documentation record, Photomodeler gives good

  7. Comparative study of maximum isometric grip strength in different sports

    OpenAIRE

    Noé Gomes Borges Junior; Susana Cristina Domenech; Jonathan Ache Dias; Affonso Celso Kulevicz da Silva; Yoshimasa Sagawa Junior

    2009-01-01

    http://dx.doi.org/10.5007/1980-0037.2009v11n3p292   The objective of this study was to compare maximum isometric grip strength (Fmax)between different sports and between the dominant (FmaxD) and non-dominant (FmaxND) hand. Twenty-nine male aikido (AI), jiujitsu (JJ), judo (JU) and rowing (RO) athletes and 21non-athletes (NA) participated in the study. The hand strength test consisted of maintainingmaximum isometric grip strength for 10 seconds using a hand dynamometer. The position of...

  8. Comparative study of durability test methods for pellets and briquettes

    Energy Technology Data Exchange (ETDEWEB)

    Temmerman, Michaeel; Rabier, Fabienne [Centre wallon de Recherches agronomiques (CRA-W), 146, chaussee de Namur, B-5030, Gembloux (Belgium); Jensen, Peter Daugbjerg [Forest and Landscape, The Royal Veterinary and Agricultural University, Rolighedsvej 23, DK-1958 Frederiksberg C (Denmark); Hartmann, Hans; Boehm, Thorsten [Technologie- und Foerderzentrum fuer Nachwachsende Rohstoffe-TFZ, Schulgasse 18, D-94315 Straubing (Germany)

    2006-11-15

    Different methods for the determination of the mechanical durability (DU) of pellets and briquettes were compared by international round robin tests including different laboratories. The DUs of five briquette and 26 pellet types were determined. For briquettes, different rotation numbers of a prototype tumbler and a calculated DU index are compared. For pellets testing, the study compares two standard methods, a tumbling device according to ASAE S 269.4, the Lignotester according to ONORM M 7135 and a second tumbling method with a prototype tumbler. For the tested methods, the repeatability, the reproducibility and the required minimum number of replications to achieve given accuracy levels were calculated. Additionally, this study evaluates the relation between DU and particle density. The results show for both pellets and briquettes, that the measured DU values and their variability are influenced by the applied method. Moreover, the variability of the results depend on the biofuel itself. For briquettes of DU above 90%, five replications lead to an accuracy of 2%, while 39 replications are needed to achieve an accuracy of 10%, when briquettes of DU below 90% are tested. For pellets, the tumbling device described by the ASAE standard allows to reach acceptable accuracy levels (1%) with a limited number of replications. Finally, for the tested pellets and briquettes no relation between DU and particle density was found. (author)

  9. COMPARATIVE STUDY ON THE TREATMENT OF DISC HERNIATIONS

    Directory of Open Access Journals (Sweden)

    María Luz Suárez-Huerta

    Full Text Available ABSTRACT Objective: To compare the results of treatment of patients with low back pain and radiculalgia resulting from disc herniation associated with disc degeneration through instrumentation with pedicle screws and dynamic rod, with root release and without diskectomy compared with other non-instrumented techniques (microdiskectomy with or without foraminotomy. Methods: This is a retrospective descriptive study of interventions for patients with herniated discs in the Traumatology and Neurosurgery that used the following variables: age, sex, type of technique, surgical time, time of evolution, degree of satisfaction, and complications. Two groups were formed: instrumentation with dynamic rods and non-instrumented techniques, comparing the results of each group. The software used was the SPSS v20.0. Results: We presented 142 interventions carried out between 2009 and 2012, 86 with dynamic instrumentation and 56 by other decompression techniques without instrumentation. No statistically significant differences were observed between age and sex groups and time elapsed until intervention. We found statistically significant differences (p=0.001 in surgical time, which was lower in the instrumented technique. No significant differences were found in complications between the techniques in both re-operations and in infections. Conclusions: In this study, we found no significant differences between the use of instrumentation with dynamic rods with respect to other non-instrumented surgical techniques in the treatment of herniated discs over 6 months of evolution or the complications and the degree of the patients' satisfaction.

  10. Comparing protein VEGF inhibitors: In vitro biological studies

    Energy Technology Data Exchange (ETDEWEB)

    Yu, Lanlan; Liang, Xiao Huan [Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080 (United States); Ferrara, Napoleone, E-mail: nf@gene.com [Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080 (United States)

    2011-05-06

    Highlights: {yields} VEGF is a mediator of angiogenesis. {yields} VEGF inhibitors have clinical applications in cancer and eye disorders. {yields} Five protein VEGF inhibitors were compared for their ability to inhibit. {yields} VEGF-induced activities in cultured endothelial cells. -- Abstract: VEGF inhibitors are widely used as a therapy for tumors and intravascular neovascular disorders, but limited and conflicting data regarding their relative biological potencies are available. The purpose of the study is to compare different protein VEGF inhibitors for their ability to inhibit VEGF-stimulated activities. We tested ranibizumab, the full-length variant of ranibizumab (Mab Y0317), bevacizumab, the VEGF-TrapR1R2 and Flt(1-3)-IgG in bioassays measuring VEGF-stimulated proliferation of bovine retinal microvascular endothelial cells or chemotaxis of human umbilical vein endothelial cells (HUVEC). The inhibitors were also compared for their ability to inhibit MAP kinase activation in HUVECs following VEGF addition. Ranibizumab, VEGF-TrapR1R2 and Flt(1-3)-IgG had very similar potencies in the bioassays tested. Bevacizumab was over 10-fold less potent than these molecules. Mab Y0317 was over 30-fold more potent than bevacizumab. The findings reported in this manuscript describe important intrinsic characteristics of several VEGF inhibitors that may be useful to design and interpret preclinical or clinical studies.

  11. A comparative study of three different gene expression analysis methods.

    Science.gov (United States)

    Choe, Jae Young; Han, Hyung Soo; Lee, Seon Duk; Lee, Hanna; Lee, Dong Eun; Ahn, Jae Yun; Ryoo, Hyun Wook; Seo, Kang Suk; Kim, Jong Kun

    2017-12-04

    TNF-α regulates immune cells and acts as an endogenous pyrogen. Reverse transcription polymerase chain reaction (RT-PCR) is one of the most commonly used methods for gene expression analysis. Among the alternatives to PCR, loop-mediated isothermal amplification (LAMP) shows good potential in terms of specificity and sensitivity. However, few studies have compared RT-PCR and LAMP for human gene expression analysis. Therefore, in the present study, we compared one-step RT-PCR, two-step RT-LAMP and one-step RT-LAMP for human gene expression analysis. We compared three gene expression analysis methods using the human TNF-α gene as a biomarker from peripheral blood cells. Total RNA from the three selected febrile patients were subjected to the three different methods of gene expression analysis. In the comparison of three gene expression analysis methods, the detection limit of both one-step RT-PCR and one-step RT-LAMP were the same, while that of two-step RT-LAMP was inferior. One-step RT-LAMP takes less time, and the experimental result is easy to determine. One-step RT-LAMP is a potentially useful and complementary tool that is fast and reasonably sensitive. In addition, one-step RT-LAMP could be useful in environments lacking specialized equipment or expertise.

  12. Comparative study of codes for the seismic design of structures

    Directory of Open Access Journals (Sweden)

    S. H. C. Santos

    Full Text Available A general evaluation of some points of the South American seismic codes is presented herein, comparing them among themselves and with the American Standard ASCE/SEI 7/10 and with the European Standard Eurocode 8. The study is focused in design criteria for buildings. The Western border of South America is one of the most seismically active regions of the World. It corresponds to the confluence of the South American and Nazca plates. This region corresponds roughly to the vicinity of the Andes Mountains. This seismicity diminishes in the direction of the comparatively seismically quieter Eastern South American areas. The South American countries located in its Western Border possess standards for seismic design since some decades ago, being the Brazilian Standard for seismic design only recently published. This study is focused in some critical topics: definition of the recurrence periods for establishing the seismic input; definition of the seismic zonation and design ground motion values; definition of the shape of the design response spectra; consideration of soil amplification, soil liquefaction and soil-structure interaction; classification of the structures in different importance levels; definition of the seismic force-resisting systems and respective response modification coefficients; consideration of structural irregularities and definition of the allowable procedures for the seismic analyses. A simple building structure is analyzed considering the criteria of the several standards and obtained results are compared.

  13. EMPLOYEE PERCEPTIONS OF JOB SATISFACTION: COMPARATIVE STUDY ON INDIAN BANKS

    Directory of Open Access Journals (Sweden)

    Arunima Shrivastava

    2009-01-01

    Full Text Available The present study examined the job satisfaction level of a public sector and private sector bank employees in India. The sample consisted of 340 bank employees from both sectors. Job Diagnostic Survey by Hackman and Oldham (1975 was used to ascertain the level of job satisfaction. This study used independent samples t-test and qualitative analysis to study the differences in employee attitudes. Results indicated that the means of the public and private banks were significantly different from each other. It was found that private sector bank employees perceive greater satisfaction with pay, social, and growth aspects of job as compared to public sector bank employees. On the other hand, public sector bank employees have expressed greater satisfaction with job security as compared to private sector bank employees. The findings of the study highlight important satisfiers and dissatisfiers present in the job and suggest both the banks to take performance initiatives in the areas where employees have reported reduced satisfaction.

  14. Comparative study of Si diodes for gamma radiation dosimetry

    International Nuclear Information System (INIS)

    Pascoalino, Kelly Cristina da Silva

    2010-01-01

    In this work it is presented the comparative study of Si diodes response for gamma radiation dosimetry. The diodes investigated, grown by float zone (Fz) and magnetic Czochralski (MCz) techniques, were processed at the Physics Institute of Helsinki University in the framework of the research and development of rad-hard silicon devices. To study the dosimetric response of these diodes they were connected in the photovoltaic mode to the input of a digital electrometer to measure the photocurrent signal due to the incidence of gamma-rays from a 60 Co source (Gammacell 220). The dosimetric parameter utilized to study the response of these devices was the charge, obtained trough the integration of the current signals, as a function of the absorbed dose. Studies of the influence of the pre-irradiation procedures on both sensitivity and stability of these diodes showed that the sensitivity decreased with the total absorbed dose but after a preirradiation of about 873 kGy they became more stable. Radiation damage effects eventually produced in the devices were monitored trough dynamic current and capacitance measurements after each irradiation step. Both samples also exhibited good response reproducibility, 2,21% (Fz) and 2,94% (MCz), obtained with 13 consecutive measurements of 15 kGy compared with the equivalent 195 kGy absorbed dose in one step of irradiation. It is important to note that these results are better than those obtained with routine polymethylmethacrylate (PMMA) dosimeters used in radiation processing dosimetry. (author)

  15. Bronchography in dogs. Comparative study with two barium sulphate solutions

    International Nuclear Information System (INIS)

    Thibaut, J.; Gallardo, P.; Vargas, L.; Deppe, R.; Born, R.

    1998-01-01

    Two solutions of barium sulphate, 60 and 30% w/v, were compared with the ''overflow'' Bronchographic method. Two groups of eight healthy adult does of both sexes, weighing 7 to 18 kg were used for the study. The dogs were anaesthetised with thiopentone sodium 2% (20 mg/kg iv). After intubation, each dog received contrast medium by a catheter connected to a syringe, in a 9 mi dose. Two series of two x-rays plates were taken in left lateral recumbent, 3 and 6 min after administering the contrast medium and in ventrodorsal projection, 30 sec. later. The x-ray plates obtained were analysed and compared intra and inter group considering the advance speed of the contrast medium, the radiographic density and outlines. Adverse reactions were controlled

  16. Comparative study of methods for potential and actual evapotranspiration determination

    International Nuclear Information System (INIS)

    Kolev, B.

    2004-01-01

    Two types of methods for potential and actual evapotranspiration determining were compared. The first type includes neutron gauge, tensiometers, gypsum blocks and lysimeters. The actual and potential evapotranspiration were calculated by water balance equation. The second type of methods used a simulation model for all calculation. The aim of this study was not only to compare and estimate the methods using. It was mainly pointed on calculations of water use efficiency and transpiration coefficient in potential production situation. This makes possible to choose the best way for water consumption optimization for a given crop. The final results find with the best of the methods could be used for applying the principles of sustainable agriculture in random region of Bulgarian territory. (author)

  17. A comparative study of seven human cochlear filter models.

    Science.gov (United States)

    Saremi, Amin; Beutelmann, Rainer; Dietz, Mathias; Ashida, Go; Kretzberg, Jutta; Verhulst, Sarah

    2016-09-01

    Auditory models have been developed for decades to simulate characteristics of the human auditory system, but it is often unknown how well auditory models compare to each other or perform in tasks they were not primarily designed for. This study systematically analyzes predictions of seven publicly-available cochlear filter models in response to a fixed set of stimuli to assess their capabilities of reproducing key aspects of human cochlear mechanics. The following features were assessed at frequencies of 0.5, 1, 2, 4, and 8 kHz: cochlear excitation patterns, nonlinear response growth, frequency selectivity, group delays, signal-in-noise processing, and amplitude modulation representation. For each task, the simulations were compared to available physiological data recorded in guinea pigs and gerbils as well as to human psychoacoustics data. The presented results provide application-oriented users with comprehensive information on the advantages, limitations and computation costs of these seven mainstream cochlear filter models.

  18. Comparative Study of Smeared Cracking Models for Concrete Structures

    Directory of Open Access Journals (Sweden)

    Samuel Silva Penna

    2014-02-01

    Full Text Available The article shows how the constitutive modeling of concrete has evolved since the initial attempts to characterize the medium cracked as continuous, moving from smeared cracking, damage and microplane models, until the current tendency to design different models according to a single theoretical framework. A generic formulation for smeared cracking models, including fixed and rotational models, as well as degradation in tension and in compression, is provided. Using this formulation, three models are generated by specifying the laws of degradation. A comparative study of models, based on computer simulations of a beam subjected to shear at four points, is presented. The results are compared, between themselves and with experimental results, providing a critical analysis of the models.

  19. Replacement fluids in plasmapheresis: cross-over comparative study.

    Science.gov (United States)

    Le Conte, P; Nicolas, F; Adjou, C; N'Guyen, J M; Billaud, E; Moreau, P

    1997-03-01

    To compare the tolerance and the cost of three replacement fluids in plasmapheresis: albumin 4% alone, albumin 4% + dextran 40, or albumin 4% + hydroxyethylstarch 6%. A one center randomized, cross-over, comparative study designed to explore the tolerance and the colloid oncotic pressure in patients undergoing plasmapheresis. 225 plasmapheresis procedures were performed in 27 patients. Hemodynamic tolerance was good in the three treatment groups. Serum protein concentration after plasmapheresis was significantly lower in the albumin + hydroxyethylstarch group, followed by albumin + dextran 40, versus albumin alone. Colloid oncotic pressure before and after exchange was similar in the three groups. The clinical use of 25-30% of hydroxyethylstarch 6% or dextran 40 with albumin 4% was clinically well tolerated and associated with a 12% decrease of the cost of substitution solutions.

  20. COMPARATIVE STUDY OF NALBUPHINE VS. PENTAZOCINE FOR POSTOPERATIVE ANALGESIA

    Directory of Open Access Journals (Sweden)

    Naresh Ganpatrao Tirpude

    2016-10-01

    Full Text Available BACKGROUND To provide postoperative pain relief is a prime duty of health care providers. Failure to relieve pain is morally and ethically unacceptable. Post-operative pain may results in adverse effects such as: a Physiological Changes: Reduced pulmonary functions, e.g. vital capacity, tidal volume, functional residual capacity; sympathetic stimulation; reduced the physical activity of patients; thereby increasing the risk of venous thrombosis. b Psychological disturbances: Anger, Resentment, Depression, Adversarial Relationship with Doctors, Insomnia. Aim of this study was 1. To investigate whether “Postoperative analgesia with Nalbuphine is longer than Pentazocine”. 2. To investigate whether “Side effects/complications are less with Nalbuphine as compared to Pentazocine”. MATERIALS AND METHODS It was a prospective randomized double blind observational study. Eighty patients of hydrocoele & inguinal hernia were operated under spinal anaesthesia of age group 20-70 years, ASA grade I & II & patients with controlled co-morbid conditions. In postoperative period, Group N- Inj. Nalbuphine (0.3 mg/kg IM or Group P- Inj. Pentazocine (0.5 mg/kg IM was administered to provide postoperative pain relief & to know the duration of pain relief & its side effects. RESULTS On statistical analysis, demographic data i.e. age, sex had no influence on outcome of study. Mean VAS score in group N was highly significant (p-value in Inj. Pentazocine group. 2. Side Effects - Incidence of sedation was more in Nalbuphine group as compared to Pentazocine group. Nausea & Vomiting were more so in Pentazocine group as compared to Nalbuphine group. Limitation of the present study was that sample size was very small.

  1. EFFECTIVELY SELECTING A TARGET POPULATION FOR A FUTURE COMPARATIVE STUDY.

    Science.gov (United States)

    Zhao, Lihui; Tian, Lu; Cai, Tianxi; Claggett, Brian; Wei, L J

    2013-01-01

    When comparing a new treatment with a control in a randomized clinical study, the treatment effect is generally assessed by evaluating a summary measure over a specific study population. The success of the trial heavily depends on the choice of such a population. In this paper, we show a systematic, effective way to identify a promising population, for which the new treatment is expected to have a desired benefit, utilizing the data from a current study involving similar comparator treatments. Specifically, using the existing data, we first create a parametric scoring system as a function of multiple multiple baseline covariates to estimate subject-specific treatment differences. Based on this scoring system, we specify a desired level of treatment difference and obtain a subgroup of patients, defined as those whose estimated scores exceed this threshold. An empirically calibrated threshold-specific treatment difference curve across a range of score values is constructed. The subpopulation of patients satisfying any given level of treatment benefit can then be identified accordingly. To avoid bias due to overoptimism, we utilize a cross-training-evaluation method for implementing the above two-step procedure. We then show how to select the best scoring system among all competing models. Furthermore, for cases in which only a single pre-specified working model is involved, inference procedures are proposed for the average treatment difference over a range of score values using the entire data set, and are justified theoretically and numerically. Lastly, the proposals are illustrated with the data from two clinical trials in treating HIV and cardiovascular diseases. Note that if we are not interested in designing a new study for comparing similar treatments, the new procedure can also be quite useful for the management of future patients, so that treatment may be targeted towards those who would receive nontrivial benefits to compensate for the risk or cost of the

  2. Bilateral Breast Reduction Without Opioid Analgesics: A Comparative Study.

    Science.gov (United States)

    Parsa, Fereydoun Don; Cheng, Justin; Stephan, Brad; Castel, Nikki; Kim, Leslie; Murariu, Daniel; Parsa, Alan A

    2017-09-01

    Breast reduction has traditionally been performed under general anesthesia with adjunct opioid use. However, opioids are associated with a wide variety of adverse effects, including nausea, vomiting, constipation, postoperative sedation, dizziness, and addiction. This study compares bilateral breast reduction using a multimodal opioid-free pain management regimen vs traditional general anesthesia with adjunct opioids. A total of 83 female patients were enrolled in this study. Group 1 includes a retrospective series of 39 patients that underwent breast reduction via general anesthesia with adjunct opioid use. This series was compared to 2 prospective groups of patients who did not receive opioids either preoperatively or intraoperatively. In group 2, twenty-six patients underwent surgery under intravenous sedation and local anesthesia. In group 3, eighteen patients underwent surgery with general anesthesia. All patients in groups 2 and 3 received preoperative gabapentin and celecoxib along with infiltration of local anesthetics during the operation and prior to discharge to the Post-Anesthesia Care Unit (PACU). Primary outcome measures included the duration of surgery, time from end of operation to discharge home, postoperative opioid and antiemetic use, and unplanned postoperative hospitalizations. When compared to group 1, groups 2 and 3 experienced a shorter time from end of operation to discharge home (P opioid use (P opioid-free bilateral breast reduction either under local or general anesthesia as an outpatient. This method resulted in significantly less morbidity, use of opioids postoperatively, as well as unplanned hospital admissions compared to "traditional" breast reduction under general anesthesia with the use of opioids. 3. © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com

  3. A Comparative Study on Emerging Electric Vehicle Technology Assessments

    Energy Technology Data Exchange (ETDEWEB)

    Ford, Jonathan [Sentech, Inc.; Khowailed, Gannate [Sentech, Inc.; Blackburn, Julia [Sentech, Inc.; Sikes, Karen [Sentech, Inc.

    2011-03-01

    Numerous organizations have published reports in recent years that investigate the ever changing world of electric vehicle (EV) technologies and their potential effects on society. Specifically, projections have been made on greenhouse gas (GHG) emissions associated with these vehicles and how they compare to conventional vehicles or hybrid electric vehicles (HEVs). Similar projections have been made on the volumes of oil that these vehicles can displace by consuming large amounts of grid electricity instead of petroleum-based fuels. Finally, the projected rate that these new vehicle fleets will enter the market varies significantly among organizations. New ideas, technologies, and possibilities are introduced often, and projected values are likely to be refined as industry announcements continue to be made. As a result, over time, a multitude of projections for GHG emissions, oil displacement, and market penetration associated with various EV technologies has resulted in a wide range of possible future outcomes. This leaves the reader with two key questions: (1) Why does such a collective range in projected values exist in these reports? (2) What assumptions have the greatest impact on the outcomes presented in these reports? Since it is impractical for an average reader to review and interpret all the various vehicle technology reports published to date, Sentech Inc. and the Oak Ridge National Laboratory have conducted a comparative study to make these interpretations. The primary objective of this comparative study is to present a snapshot of all major projections made on GHG emissions, oil displacement, or market penetration rates of EV technologies. From the extensive data found in relevant publications, the key assumptions that drive each report's analysis are identified and 'apples-to-apples' comparisons between all major report conclusions are attempted. The general approach that was taken in this comparative study is comprised of six primary

  4. COMPARATIVE STUDY TO EVALUATE LIPID-LOWERING EFFECT OF

    Directory of Open Access Journals (Sweden)

    Niteesh Shanbag

    2017-03-01

    Full Text Available BACKGROUND Dyslipidaemia is a widely established risk factor for coronary artery disease. As Asians differ in pattern of various lipid abnormalities than non-Asians, this study was undertaken to compare efficacy of commonly administrated drugs, atorvastatin and fenofibrate. MATERIALS AND METHODS The present study was carried out in 100 diagnosed cases of hypertriglyceridaemia divided into two groups, A and B. The mean, standard deviation, standard error of mean and t value were calculated following 12 weeks of therapy of atorvastatin 10 mg in group A and micronized fenofibrate in group B. RESULTS Our study showed that fenofibrate is more efficacious in reducing the levels of triglycerides and rising level of HDL cholesterol, while atorvastatin is more efficacious in reducing LDL cholesterol. CONCLUSION Micronized fenofibrate has more efficiency in reducing triglycerides and raising HDL. Atorvastatin is more efficacious in reducing LDL levels.

  5. In vitro dissolution of generic immediate-release solid oral dosage forms containing BCS class I drugs: comparative assessment of metronidazole, zidovudine, and amoxicillin versus relevant comparator pharmaceutical products in South Africa and India.

    Science.gov (United States)

    Reddy, Nallagundla H S; Patnala, Srinivas; Löbenberg, Raimar; Kanfer, Isadore

    2014-10-01

    Biowaivers are recommended for immediate-release solid oral dosage forms using dissolution testing as a surrogate for in vivo bioequivalence studies. Several guidance are currently available (the World Health Organization (WHO), the US FDA, and the EMEA) where the conditions are described. In this study, definitions, criteria, and methodologies according to the WHO have been applied. The dissolution performances of immediate-release metronidazole, zidovudine, and amoxicillin products purchased in South African and Indian markets were compared to the relevant comparator pharmaceutical product (CPP)/reference product. The dissolution performances were studied using US Pharmacopeia (USP) apparatus 2 (paddle) set at 75 rpm in each of three dissolution media (pH1.2, 4.5, and 6.8). Concentrations of metronidazole, zidovudine, and amoxicillin in each dissolution media were determined by HPLC. Of the 11 metronidazole products tested, only 8 could be considered as very rapidly dissolving products as defined by the WHO, whereas 2 of those products could be considered as rapidly dissolving products but did not comply with the f 2 acceptance criteria in pH 6.8. All 11 zidovudine products were very rapidly dissolving, whereas in the case of the 14 amoxicillin products tested, none of those products met any of the WHO criteria. This study indicates that not all generic products containing the same biopharmaceutics classification system (BCS) I drug and in similar strength and dosage form are necessarily in vitro equivalent. Hence, there is a need for ongoing market surveillance to determine whether marketed generic products containing BCS I drugs meet the release requirements to confirm their in vitro bioequivalence to the respective reference product.

  6. A comparative study of "Idiopathic catatonia" with catatonia in schizophrenia.

    Science.gov (United States)

    Krishna, K R; Maniar, R C; Harbishettar, V S

    2011-06-01

    Catatonia has been defined as a cluster of signs and occurs secondary to or as a subgroup of schizophrenia, mood disorders or organic syndrome. This study specifically examined the distinct variety of catatonia that did not meet any standard psychiatric diagnostic criteria on globally recognised psychiatric rating tools and compared the clinical features with the catatonia that occurred in association with a diagnosis of schizophrenia. The inpatients in a tertiary psychiatric ward in Ahmedabad, India, between 2002 and 2005 who presented with two or more catatonic signs present for more than 24h period were assessed on Structured Clinical Interview for DSM IV tool. Those with catatonic signs that met diagnostic criteria for schizophrenia (n=21) were compared, with those without any disorder called Idiopathic catatonia (n=13), on measures of Bush Francis Catatonia Rating Scale (BFRCS), Brief Psychiatric Rating Scale (BPRS) and Scale for Assessment of Negative Symptoms (SANS). The scores on duration of illness (U=14.00; pschizophrenia group. The Idiopathic group had significantly higher scores on mean total BFCRS (t=-3.50; df=32; p=0.001) and also on subscores of negativism (p=0.02), waxy flexibility (p=0.02), mitgehen (pcatatonic signs. The study also supports the current concept that there does exists, a distinct variety of catatonia that probably has its own course and prognosis, which need further consideration and more studies to explore this. Copyright © 2011. Published by Elsevier B.V.

  7. Comparative study of PCA in classification of multichannel EMG signals.

    Science.gov (United States)

    Geethanjali, P

    2015-06-01

    Electromyographic (EMG) signals are abundantly used in the field of rehabilitation engineering in controlling the prosthetic device and significantly essential to find fast and accurate EMG pattern recognition system, to avoid intrusive delay. The main objective of this paper is to study the influence of Principal component analysis (PCA), a transformation technique, in pattern recognition of six hand movements using four channel surface EMG signals from ten healthy subjects. For this reason, time domain (TD) statistical as well as auto regression (AR) coefficients are extracted from the four channel EMG signals. The extracted statistical features as well as AR coefficients are transformed using PCA to 25, 50 and 75 % of corresponding original feature vector space. The classification accuracy of PCA transformed and non-PCA transformed TD statistical features as well as AR coefficients are studied with simple logistic regression (SLR), decision tree (DT) with J48 algorithm, logistic model tree (LMT), k nearest neighbor (kNN) and neural network (NN) classifiers in the identification of six different movements. The Kruskal-Wallis (KW) statistical test shows that there is a significant reduction (P PCA transformed features compared to non-PCA transformed features. SLR with non-PCA transformed time domain (TD) statistical features performs better in accuracy and computational power compared to other features considered in this study. In addition, the motion control of three drives for six movements of the hand is implemented with SLR using TD statistical features in off-line with TMSLF2407 digital signal controller (DSC).

  8. [Laparoscopic versus open surgery for colorectal cancer. A comparative study].

    Science.gov (United States)

    Arribas-Martin, Antonio; Díaz-Pizarro-Graf, José Ignacio; Muñoz-Hinojosa, Jorge Demetrio; Valdés-Castañeda, Alberto; Cruz-Ramírez, Omar; Bertrand, Martin Marie

    2014-01-01

    Laparoscopic surgery for colorectal cancer is currently accepted and widespread worldwide. However, according tol the surgical experience on this approach, surgical and short-term oncologic results may vary. Studies comparing laparoscopic vs. open surgery in our population are scarce. To determine the superiority of the laparoscopic vs. open technique for colorectal cancer surgery. This retrospective and comparative study collected data from patients operated on for colorectal cancer between 1999 and 2011 at the Angeles Lomas Hospital, Mexico. A total of 82 patients were included in this study; 47 were operated through an open approach and 35 laparoscopically. Mean operative time was significantly lower in the open approach group (p= 0.008). There were no significant difference between both techniques for intraoperative bleeding (p= 0.3980), number of lymph nodes (p= 0.27), time to initiate oral feeding (p= 0.31), hospital stay (p= 0.12), and postoperative pain (p= 0.19). Procedure-related complications rate and type were not significantly different in both groups (p= 0.44). Patients operated laparoscopically required significantly less analgesic drugs (p= 0.04) and less need for epidural postoperative analgesia (p= 0.01). Laparoscopic approach is as safe as the traditional open approach for colorectal cancer. Early oncological and surgical results confirm its suitability according to this indication.

  9. Comparative and evaluating analysis of selected energy studies

    International Nuclear Information System (INIS)

    Majer, H.; Ruehle, G.; Thoene, E.

    1978-02-01

    Energy problems are long-term problems. Consequently the decisive authorities of energy policy shall have to provide measures which are able to contribute to solving the energy problem. These measures require prognoses on the presumable development of energetic, economic, and social factors. There is no want of such prognoses. As, however, the results frequently do not agree with each otheer, it seems necessary to find out the starting positions, assumptions, and results of several studies, to compare and to critically assess them. This is the target of the present expert's report which is to contribute to the transparency of the energy policy debate. (orig.) [de

  10. Comparative studies of the secretome of fungus-growing ants

    DEFF Research Database (Denmark)

    Linde, Tore; Grell, Morten Nedergaard; Schiøtt, Morten

    2009-01-01

    Leafcutter ants of the species Acromyrmex echinatior live in symbiosis with the fungus Leucoagaricus gongylophorus. The ants harvest fragments of leaves and carry them to the nest where they place the material on the fungal colony. The fungus secretes a wide array of proteins to degrade the leaves...... into nutrients that the ants can feed on. The focus of this study is to discover, characterize and compare the secreted proteins. In order to do so cDNA libraries are constructed from mRNA extracted from the fungus material. The most efficient technology to screen cDNA libraries selectively for secreted...

  11. Comparative study of SEA experiences between EU and China

    DEFF Research Database (Denmark)

    Gao, Jingjing; Kørnøv, Lone; Christensen, Per

    making, such as: How inclusive will the system be in relation to environmental, economic and social indicators? And how can the appropriate aggregation level for indicators be found? This paper makes a comparative study of the experiences of using indicators in SEA in two European countries and China......, in order to investigate the following questions: Are indicators used when performing an assessment? How are they used? Do indicators lead to opportunities or limitations in an evaluation process? And, are they positive or negative in providing information for decision making? Through a review of national...

  12. Environmental liability in Germany: a comparative study with Brazilian Law

    Directory of Open Access Journals (Sweden)

    Daniela Oliveira Gonçalves

    2015-09-01

    Full Text Available Seek compare the environmental liability institutes from Germany with those of Brazil, this study intends to conduct an analysis of civil liability for environmental damage in Germany. The concepts of liability and its species, subjective and objective initially are analyzed. Then the concept of civil liability for environmental damage under Brazilian law is analyzed, also discussing the concept of environmental damage. Finally it is carried out the assessment of some of the German Civil Code provisions as well as the Environmental Liability Act of Germany.

  13. A Comparative Study of Actuator Configurations for Satellite Attitude Control

    Directory of Open Access Journals (Sweden)

    Raymond Kristiansen

    2005-10-01

    Full Text Available In this paper a controllability study of different actuator configurations consisting of magnetic torquers, reaction wheels and a gravity boom is presented. The theoretical analysis is performed with use of controllability gramians, and simulation results with the different configurations are presented and compared regarding settling time and power consumption to substantiate the theoretical analysis. A reference model is also introduced to show how the power consumption can he lowered to the same magnitude as when magnetic torquers are used, without degrading the satellite response significantly.

  14. Risk-based Comparative Study of Fluid Power Pitch Concepts

    DEFF Research Database (Denmark)

    Liniger, Jesper; Pedersen, Henrik Clemmensen; N. Soltani, Mohsen

    2017-01-01

    Fault Tree Analysis and Failure Mode and Effect Criticality Analysis in a systematic framework that lowers the bias issues normally encountered for qualitative studies. Under the assumption of similar components, the results indicate an equal risk of the two concepts. A decreased reliability is seen...... for the bootstrap concept due to additional components in the supply circuit compared to the conventional system. It is noted that careful selection of high reliable pumps and relief valves may significantly reduce risk and increase reliability of the bootstrap concept....

  15. Bioequivalence of two metformin formulations: 850 mg tablets in healthy colombian volunteers Bioequivalencia de dos formulaciones de metformina, tabletas de 850 mg, en voluntarios sanos colombianos

    Directory of Open Access Journals (Sweden)

    Ómar de Jesús Correa Cano

    2005-03-01

    Full Text Available Introduction: Metformin is an orally active antidiabetic agent used to treat type II diabetes; it is found in the Colombian market in both the innovator brand and the generic formulations. The latter have to prove some biopharmaceutical quality outcomes to guarantee interchangeable proprieties. Objective: To determine whether the drug Dimefor®/Metformina MK is bioequivalent to the reference product Glucophage®, when the products are administrated, at the same dose, to a group of healthy volunteers. Method: The study was made with 24 healthy volunteers who met the inclusion criteria and spontaneously decided to participate after being thoroughly informed. We used a two-sequence threeperiod randomized, crossed and double-blind study. The volunteers took an 850 mg dose of each medicine; then, blood samples were taken throughout 24 hours and the metformin quantification in plasma was determined by High Performance Liquid Chromatography with UV detection (HPLC/UV. For statistical analysis, Schuirmann’s test was used. Results: The study showed that both preparations are bioequivalent; confidence intervals for ln AUC0-∞, ln Cmax, ln AUC0-Tmax and Tmax were [84.6-100.0%], [89.1-109.0%], [83.4–01.4%] and [85.1-109.8% ], respectively. Introducción: la metformina es un antihiperglicemiante útil en el manejo de la diabetes mellitus tipo II, del que se encuentran en el mercado colombiano tanto el producto innovador como diferentes formulaciones genéricas. Para garantizar la seguridad y eficacia de estas últimas, es necesario demostrar su bioequivalencia con respecto al producto innovador. Objetivo: determinar si el producto Dimefor®/Metformina MK es bioequivalente con el producto Glucophage® (referencia cuando se administran en dosis iguales a un grupo de voluntarios sanos. Método: el estudio se realizó sobre veinticuatro voluntarios que cumplieron con los requisitos de inclusión y decidieron participar espontáneamente después de ser

  16. Comparative studies of atomic independent-particle potentials

    International Nuclear Information System (INIS)

    Talman, J.D.; Ganas, P.S.; Green, A.E.S.

    1979-01-01

    A number of atomic properties are compared in various independent-particle models for atoms. The models studied are the Hartree-Fock method, a variationally optimized potential model, a parametrized analytic form of the same model, parametrized analytic models constructed to fit atomic energy levels, the so-called Hartree-Fock-Slater model, and the Xα model. The physical properties compared are single-particle energy levels, total energies, and dipole polarizabilities. The extent to which the virial theorem is satisfied in the different models is also considered. The atoms Be, Ne, Ar, Kr, and Xe and ions O v and Al iv hav been compared. The results show that the experimental properties can be well represented by several of the independent-particle models. Since it has been shown that the optimized potential models yield wavefunctions that are almost the same as Hartree-Fock wavefunctions, they provide a natural solution to the problem of extending the Hartree-Fock method to excited states

  17. Comparative study of bedside and laboratory measurements of hemoglobin.

    Science.gov (United States)

    Krenzischek, D A; Tanseco, F V

    1996-11-01

    The purpose of this study was to examine the effects of variations in technique on measurements of hemoglobin level done at the bedside and to compare these results with laboratory measurements of hemoglobin. In accordance with hospital policy, procedure, and protocol, various techniques were used to obtain samples of capillary and venous blood and of blood from arterial and central venous catheters. Levels of hemoglobin were measured at the bedside and in the laboratory, and the results were compared. The Johns Hopkins Hospital adult postanesthesia care unit. A total of 187 blood samples were obtained from 62 adults who had undergone general surgery. Group I comprised 20 subjects with capillary and venous blood samples. Group II comprised 21 subjects with arterial blood samples. Group III comprised 21 subjects with central venous blood samples. The results showed that the amount of blood to be discarded before obtaining samples of arterial and central venous blood need not be any larger than double the dead space of the catheter, and that shaking the blood sample for 10 seconds was sufficient to mix the sample before measurement of hemoglobin levels. Results of bedside and laboratory measurements of hemoglobin level were comparable. Bedside measurement of hemoglobin increases efficiency in patient care, decreases risk of blood-transmitted infection for staff, and decreases cost to the patient. However, the persons who perform the assay must be responsible in adhering to the standard of practice to minimize errors in the measurements.

  18. A Comparative Study Of Psychiatric Morbidity In Dermatological Patients

    Directory of Open Access Journals (Sweden)

    Sharma Neelu

    2003-01-01

    Full Text Available The psychiatric morbidity in five chronic and disfiguring diseases, namely psoriasis, chronic urticaria, leprosy, vitiligo and lichen simplex chronicus (LSC was assessed and compared using the standardized Hindi (Vernacular languages version of General Health Questionnaire (GHQ-H. Thirty new untreated patients of each of the above skin diseases between the age group of 18-60 years were included in the study. The overall prevalence of the psychiatric morbidity was found to be 39%, depression and anxiety were present in 13% and 10.66% of the patients and suicidal ideations and somatisation in 16% and 13% of the patients respectively. Prevalence of interpersonal conflict and suicidal attempt were 10% and 2.6% respectively. On comparative analysis of psychiatric morbidity, significant difference was observed between vitiligo and other disorders (p=0.0028, i.e., chronic urticaria (p=0.0242 and psoriasis and other disorders (p=0.0028, however no significant difference could be elicited between psoriasis and leprosy or leprosy and vitiligo. Comparative analysis of anxiety revealed statistically significant difference between the patients of LSC and vitiligo (p=0.02 or vitiligo and chronic urticaria (p=0.04 but no significant difference was observed for vitiligo and leprosy of psoriasis and leprosy. The prevalence of somatic complaints showed significant difference between the patients of LSC and Leprosy.

  19. A Comparative Study on Decision Making Methods with Interval Data

    Directory of Open Access Journals (Sweden)

    Aditya Chauhan

    2014-01-01

    Full Text Available Multiple Criteria Decision Making (MCDM models are used to solve a number of decision making problems universally. Most of these methods require the use of integers as input data. However, there are problems which have indeterminate values or data intervals which need to be analysed. In order to solve problems with interval data, many methods have been reported. Through this study an attempt has been made to compare and analyse the popular decision making tools for interval data problems. Namely, I-TOPSIS (Technique for Order Preference by Similarity to Ideal Solution, DI-TOPSIS, cross entropy, and interval VIKOR (VlseKriterijumska Optimiza-cija I Kompromisno Resenje have been compared and a novel algorithm has been proposed. The new algorithm makes use of basic TOPSIS technique to overcome the limitations of known methods. To compare the effectiveness of the various methods, an example problem has been used where selection of best material family for the capacitor application has to be made. It was observed that the proposed algorithm is able to overcome the known limitations of the previous techniques. Thus, it can be easily and efficiently applied to various decision making problems with interval data.

  20. [Comparing audiological evaluation and screening: a study on presbycusis].

    Science.gov (United States)

    Samelli, Alessandra Giannella; Negretti, Camila Aparecida; Ueda, Kerli Saori; Moreira, Renata Rodrigues; Schochat, Eliane

    2011-01-01

    Given the high prevalence of presbycusis and the damage it brings about, a screening test can be useful in the identification of hearing loss in primary care. To estimate the prevalence of hearing loss in a representative sample of elderly people living at Butantan using an audiological screening method (questionnaire) and a basic audiological evaluation; to compare the results of the two kinds of evaluations, checking the validity of this tool for hearing loss screening. Cross sectional descriptive study. 200 individuals (above 60 years old, both genders) were randomly selected to undergo audiological screening (questionnaire). Another randomly selected group encompassed 100 individuals who were submitted to a set of audiological tests. Then, we compared the results from the two methods. There were no statistically significant associations between the questionnaire and the degree of hearing loss of the patients. The prevalence of hearing loss in our sample was of 56% in the screening and of 95% when checked by the audiological evaluation. Therefore, screening was not proven valid to assess hearing when compared to audiological evaluation.

  1. Bioequivalence and tolerability assessment of a novel intravenous ciclosporin lipid emulsion compared to branded ciclosporin in Cremophor ® EL

    DEFF Research Database (Denmark)

    Ehinger, Karl Henrik Johannes; Hansson, Magnus Joakim; Sjövall, Fredrik

    2013-01-01

    to current guidelines were performed. RESULTS: The geometric mean ratios for CicloMulsion(®)/Sandimmune(®) (90 % confidence interval [CI]) were 0.90 (0.88, 0.92) for AUC(0-last) (area under the blood concentration-time curve from time zero to time of last measurable concentration) and 0.95 (0.92, 0.97) for C...

  2. Innovation Policies: A comparative study Between Brazil and France

    Directory of Open Access Journals (Sweden)

    Graciela Dias Coelho Jones

    2017-03-01

    Full Text Available The aim of this study is to present a comparison between the main actions promoted to encourage innovation by France, as well as the current stage of research and development initiatives (R&D, in relation to Brazil. Is a qualitative study that the procedures for its development ranks as literature and documents. The data collection technique was documentary and had as a data source primary and secondary documents, coming from public archives and statistical sources. For the survey of brazilian data for the development of this study, it was used as informational basis the fifth edition of the Innovation Research (PINTEC 2011. The data from France raised through the use of OECD year Report 2014 " Reviews of Innovation Policy France in 2014."  For the presentation of the study results comparative charts and tables were used. As the present study results can be highlighted, among others: France is a country with a long scientific tradition and technique, and plays a significant role in the world in this area. On the other hand, Brazil has one of the lowest proportions of R&D and export of high technology to GDP. The completion of this study brought an important diagnosis: there is a wide and interesting research topic that is still little explored by Brazilian researchers.

  3. Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies

    Science.gov (United States)

    2018-02-28

    Hematological Neoplasms; Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Lymphoma; Multiple Myeloma; Acute Myeloid Leukemia; Leukemia; Myelodysplastic Syndromes; Neoplasms; Melanoma; Breast Cancer; Metastatic Breast Cancer; Non-Small Cell Lung Cancer; Small Cell Lung Cancer; Renal Cell Carcinoma; Glioblastoma Multiforme; Osteosarcoma; Sarcoma; Thyroid Cancer; Genitourinary

  4. Radioactivity of natural and artificial building materials - a comparative study.

    Science.gov (United States)

    Szabó, Zs; Völgyesi, P; Nagy, H É; Szabó, Cs; Kis, Z; Csorba, O

    2013-04-01

    Building materials and their additives contain radioactive isotopes, which can increase both external and internal radioactive exposures of humans. In this study Hungarian natural (adobe) and artificial (brick, concrete, coal slag, coal slag concrete and gas silicate) building materials were examined. We qualified 40 samples based on their radium equivalent, activity concentration, external hazard and internal hazard indices and the determined threshold values of these parameters. Absorbed dose rate and annual effective dose for inhabitants living in buildings made of these building materials were also evaluated. The calculations are based on (226)Ra, (232)Th and (40)K activity concentrations determined by gamma-ray spectrometry. Measured radionuclide concentrations and hence, calculated indices and doses of artificial building materials show a rather disparate distribution compared to adobes. The studied coal slag samples among the artificial building materials have elevated (226)Ra content. Natural, i.e. adobe and also brick samples contain higher amount of (40)K compared to other artificial building materials. Correlation coefficients among radionuclide concentrations are consistent with the values in the literature and connected to the natural geochemical behavior of U, Th and K elements. Seven samples (coal slag and coal slag concrete) exceed any of the threshold values of the calculated hazard indices, however only three of them are considered to be risky to use according to the fact that the building material was used in bulk amount or in restricted usage. It is shown, that using different indices can lead to different conclusions; hence we recommend considering more of the indices at the same time when building materials are studied. Additionally, adding two times their statistical uncertainties to their values before comparing to thresholds should be considered for providing a more conservative qualification. We have defined radon hazard portion to point

  5. Mathematical modelling of human growth: A comparative study.

    Science.gov (United States)

    Guo, Shumei; Siervogel, Roger M; Roche, Alex F; Chumlea, Wm Cameron

    1992-01-01

    Kernel regression is a nonparametric procedure that provides good approximations to individual serial data. The method is useful and flexible when a parametric method is inappropriate due to restricted assumptions on the shape of the curve. In the present study, we compared kernel regression in fitting human stature growth with two models, one of which incorporates the possible existence of the midgrowth spurt while the other does not. Two families of mathematical functions and a nonparametric kernel regression were fitted to serial measures of stature on 227 participants enrolled in the Fels Longitudinal Study. The growth parameters that describe the timing, magnitude, and duration of the growth spurt, such as midgrowth spurt and pubertal spurts, were derived from the fitted models and kernel regression for each participant. The two parametric models and kernel regression were compared in regard to their overall goodness of fit and their capabilities to quantify the timing, rate of increase, and duration of the growth events. The Preece-Baines model does not describe the midgrowth spurt. The dervied growth parameters from the Preece-Baines model show an earlier onset and a longer duration of the pubertal spurt, and a slower increase in velocity. The kernel regression with bandwidth 2 years and a second-order polynomial kernel function yields relatively good fits compared with the triple logistic model. The derived biological parameters for the pubertal spurt are similar between the kernel regression and the triple logistic model. Kernel regression estimates an earlier onset and a more rapid increase of velocity for the midgrowth spurt. Copyright © 1992 Wiley-Liss, Inc., A Wiley Company.

  6. A comparative study of image low level feature extraction algorithms

    Directory of Open Access Journals (Sweden)

    M.M. El-gayar

    2013-07-01

    Full Text Available Feature extraction and matching is at the base of many computer vision problems, such as object recognition or structure from motion. Current methods for assessing the performance of popular image matching algorithms are presented and rely on costly descriptors for detection and matching. Specifically, the method assesses the type of images under which each of the algorithms reviewed herein perform to its maximum or highest efficiency. The efficiency is measured in terms of the number of matches founds by the algorithm and the number of type I and type II errors encountered when the algorithm is tested against a specific pair of images. Current comparative studies asses the performance of the algorithms based on the results obtained in different criteria such as speed, sensitivity, occlusion, and others. This study addresses the limitations of the existing comparative tools and delivers a generalized criterion to determine beforehand the level of efficiency expected from a matching algorithm given the type of images evaluated. The algorithms and the respective images used within this work are divided into two groups: feature-based and texture-based. And from this broad classification only three of the most widely used algorithms are assessed: color histogram, FAST (Features from Accelerated Segment Test, SIFT (Scale Invariant Feature Transform, PCA-SIFT (Principal Component Analysis-SIFT, F-SIFT (fast-SIFT and SURF (speeded up robust features. The performance of the Fast-SIFT (F-SIFT feature detection methods are compared for scale changes, rotation, blur, illumination changes and affine transformations. All the experiments use repeatability measurement and the number of correct matches for the evaluation measurements. SIFT presents its stability in most situations although its slow. F-SIFT is the fastest one with good performance as the same as SURF, SIFT, PCA-SIFT show its advantages in rotation and illumination changes.

  7. Comparative activity of carbapenem testing (the COMPACT study in Turkey

    Directory of Open Access Journals (Sweden)

    Leblebicioglu Hakan

    2012-02-01

    Full Text Available Abstract Background Recent evidence indicates that Gram-negative bacterial pathogens, the most common of which are Pseudomonas spp., Enterobacteriaceae, and Acinetobacter baumannii, are frequent causes of hospital-acquired infections. This study aims to evaluate the in vitro activity of doripenem and comparator carbapenem antibiotics against Gram-negative clinical isolates collected from COMParative Activity of Carbapenem Testing (COMPACT study centres in Turkey. Methods Ten centres in Turkey were invited to submit Pseudomonas aeruginosa, Enterobacteriaceae, and other Gram-negative isolates from intensive care unit (ICU/non-ICU patients with complicated intra-abdominal infections, bloodstream infections, or nosocomial pneumonia, including ventilator-associated pneumonia, between May and October 2008. Susceptibility was determined by each centre using E-test. A central laboratory performed species confirmation as well as limited susceptibility and quality-control testing. Results Five hundred and ninety six isolates were collected. MIC90 values for doripenem, meropenem, and imipenem, respectively, were 32, ≥ 64, and ≥ 64 mg/L against Pseudomonas spp.; 0.12, 0.12, and 0.5 mg/L against Enterobacteriaceae; and ≥ 64 mg/L for each against other Gram-negative isolates. In determining the susceptibility of hospital isolates of selected Gram-negative pathogens to doripenem, imipenem, and meropenem, we found that against all pathogens combined, the MIC90 for ICU compared with non-ICU isolates was higher. Conclusions Doripenem showed similar or slightly better activity than meropenem and better activity than imipenem against the Gram-negative pathogens collected in Turkey.

  8. Comparative activity of carbapenem testing (the COMPACT study) in Turkey

    Science.gov (United States)

    2012-01-01

    Background Recent evidence indicates that Gram-negative bacterial pathogens, the most common of which are Pseudomonas spp., Enterobacteriaceae, and Acinetobacter baumannii, are frequent causes of hospital-acquired infections. This study aims to evaluate the in vitro activity of doripenem and comparator carbapenem antibiotics against Gram-negative clinical isolates collected from COMParative Activity of Carbapenem Testing (COMPACT) study centres in Turkey. Methods Ten centres in Turkey were invited to submit Pseudomonas aeruginosa, Enterobacteriaceae, and other Gram-negative isolates from intensive care unit (ICU)/non-ICU patients with complicated intra-abdominal infections, bloodstream infections, or nosocomial pneumonia, including ventilator-associated pneumonia, between May and October 2008. Susceptibility was determined by each centre using E-test. A central laboratory performed species confirmation as well as limited susceptibility and quality-control testing. Results Five hundred and ninety six isolates were collected. MIC90 values for doripenem, meropenem, and imipenem, respectively, were 32, ≥ 64, and ≥ 64 mg/L against Pseudomonas spp.; 0.12, 0.12, and 0.5 mg/L against Enterobacteriaceae; and ≥ 64 mg/L for each against other Gram-negative isolates. In determining the susceptibility of hospital isolates of selected Gram-negative pathogens to doripenem, imipenem, and meropenem, we found that against all pathogens combined, the MIC90 for ICU compared with non-ICU isolates was higher. Conclusions Doripenem showed similar or slightly better activity than meropenem and better activity than imipenem against the Gram-negative pathogens collected in Turkey. PMID:22340940

  9. Politeness in Brazil and Spain: a comparative case study

    Directory of Open Access Journals (Sweden)

    Enrique Huelva Unterbäumen

    2011-12-01

    Full Text Available The aim of this paper is to present some results of a comparative study between the politeness strategies that two Spanish and two Brazilian professors would use, both in Portuguese and Spanish, in twelve hypothetical situations presented on a social behavior questionnaire. This work is based on a previous study published by Piatti (2003 in Argentina, where the author observed some pragmatic differences between a group of students of Spanish as a foreign language and a group of native speakers of the language. With her hypotheses as a starting point, the scope was moved to a small group of people with high communicative competence in both languages, in order to give a different insight on of the pragmatic differences that exist between Brazilians and the Spanish. Based on the findings, we have tried to establish some intercultural differences among the politeness strategies used in Brazil and in Spain.

  10. Comparative study of Waste Isolation Pilot Plant (WIPP) transportation alternatives

    International Nuclear Information System (INIS)

    1994-02-01

    WIPP transportation studies in the Final Supplement Environmental Impact Statement for WIPP are the baseline for this report. In an attempt to present the most current analysis, this study incorporates the most relevant data available. The following three transportation options are evaluated for the Disposal Phase, which is assumed to be 20 years: Truck shipments, consisting of a tractor and trailer, with three TRUPACT-IIs or one RH-72B; Regular commercial train shipments consisting of up to three railcars carrying up to 18 TRUPACT-IIs or up to six RH-72Bs; Dedicated train shipments consisting of a locomotive, an idle car, railcars carrying 18 TRUPACT-IIs or six RH-72Bs, another idle car, and a caboose or passenger car with an emergency response specialist. No other cargo is carried. This report includes: A consideration of occupational and public risks and exposures, and other environmental impacts; A consideration of emergency response capabilities; and An extimation of comparative costs

  11. Comparative study of aqueous and solvent methods for cleaning metals

    International Nuclear Information System (INIS)

    Briggs, J.L.; Goad, H.A.

    1976-01-01

    Studies were performed to determine the comparative effectiveness of solvent and aqueous detergent methods for cleaning various metals. The metals investigated included 304L stainless steel, beryllium, uranium-6.5 wt percent niobium alloy, and unalloyed uranium ( 238 U). The studies were initiated in response to governmental regulations restricting the use of some chlorinated solvents. Results showed that aqueous detergent cleaning was more effective than solvents, i.e. trichloroethylene and methyl chloroform, for the removal of light industrial soils. The subsequent adoption of aqueous cleaning at this plant has facilitated waste disposal, which contributed to recorded economic savings. The controlled use of aqueous detergents is environmentally acceptable and has decreased the hazards of fire and toxicity that are generally associated with solvents. 8 tables, 15 figures

  12. Comparative international studies of osteoporosis using isotope techniques

    International Nuclear Information System (INIS)

    Krishnan, S.

    1998-01-01

    Over 200 volunteers were recruited through Newspaper advertisements and other means to measure the BMD of the Lumbar Spine, Femoral Neck and Whole Body of normal healthy Canadians from the Toronto Area. All these people were carefully interviewed by trained scientists or medical personnel with respect to their medical history, life style and habits. Persons with histories that will affect bone mineral status were excluded from the study. The resulting study population consisted of 137 persons. The data was used to examine, using statistical methods, the parameters which determine bone mineral status of normal persons. The DEXA and In-vivo Neutron Activation Analysis (IVNAA) data on the same persons were compared. Further, the data was used to determine the age at which peak BMD is attained in this normal population. The Measurements were made using a DEXA instrument made by Hologic Inc., Model 1000 W. (author)

  13. Comparative study of Waste Isolation Pilot Plant (WIPP) transportation alternatives

    Energy Technology Data Exchange (ETDEWEB)

    1994-02-01

    WIPP transportation studies in the Final Supplement Environmental Impact Statement for WIPP are the baseline for this report. In an attempt to present the most current analysis, this study incorporates the most relevant data available. The following three transportation options are evaluated for the Disposal Phase, which is assumed to be 20 years: Truck shipments, consisting of a tractor and trailer, with three TRUPACT-IIs or one RH-72B; Regular commercial train shipments consisting of up to three railcars carrying up to 18 TRUPACT-IIs or up to six RH-72Bs; Dedicated train shipments consisting of a locomotive, an idle car, railcars carrying 18 TRUPACT-IIs or six RH-72Bs, another idle car, and a caboose or passenger car with an emergency response specialist. No other cargo is carried. This report includes: A consideration of occupational and public risks and exposures, and other environmental impacts; A consideration of emergency response capabilities; and An extimation of comparative costs.

  14. Internal Structure Quality Control of Solid Pharmaceuticals. A Comparative Study

    Directory of Open Access Journals (Sweden)

    Imre Silvia

    2016-03-01

    Full Text Available Objective: The aim of the study was a comparative investigation by spectral and thermal analysis in order to asses a number of characteristics of different varieties ofrawmaterials of ursodeoxycholic acid and ibuprofen. The different dissolution behavior of two ursodeoxycholic acid pharmaceutical product by crystallinity pattern was investigated. Methods: Raw materials of ursodeoxycholic acid and ibuprofen were used. IR spectroscopy, differential scanning calorimetry and X-Ray Diffraction Analysis were applied. Results: The results show no crystallinitydifferences for different batches of the tested drugs. No solid solid transition was proved during sample preparation for transmission IR analysis. Conclusions: A combination of two more affordabletests by IR spectrometry and differential scanning calorimetry lead to the same results as X-Ray diffraction analysis for crystallinity similarity assessment of the studied substances. The dissolution differences of test drugs were not related to the polymorphism of the raw materials.

  15. Comparing interventions for selective mutism: a pilot study.

    Science.gov (United States)

    Manassis, Katharina; Tannock, Rosemary

    2008-10-01

    To examine the outcome within 6 to 8 months of medical and nonmedical intervention for children with severe selective mutism (SM). Children with SM (n = 17) and their mothers, seen in a previous study, attended follow-up appointments with a clinician. Obtained by maternal report were: treatment received, current diagnosis (based on semi-structured interview), speech in various environments, and global improvement. An independent clinician also rated global functioning. The diagnosis of SM persisted in 16 children, but significant symptomatic improvement was evident in the sample. All children had received school consultations. Children who had been treated with selective serotonin reuptake inhibitors (SSRI) (n = 10) showed greater global improvement, improvement in functioning, and improvement in speech outside the family than children who were unmedicated (n = 7). No differences were evident for children receiving and not receiving additional nonmedical intervention. The findings suggest the potential benefit of SSRI treatment in severe SM, but randomized comparative treatment studies are indicated.

  16. SMEs’ Organizational Performance: Comparative Study between Cooperated and Uncooperated Companies

    Directory of Open Access Journals (Sweden)

    Ana Karla de Lucena Justino Gomes

    2017-12-01

    Full Text Available Faced with the need for survival and competitiveness, here called micro and small enterprises (MPE, they seek to develop competitive differentials, such as the insertion of the company into a cooperation network. Several researches seek to identify the benefits of cooperative strategies, but few studies seek to compare the organizational performance of cooperating companies with that of uncooperated companies. Thus, the present study has as general objective to verify if the MPE, when inserted in cooperation networks, present organizational performance superior to those that are not inserted in that context. The present research is of the survey type and involves 67 companies inserted in cooperation networks and 154 companies that do not participate in cooperation networks. To achieve the objective, the organizational performance was analyzed based on the managers' perception regarding aspects associated to the following performance measures: customer satisfaction, employee satisfaction, company growth, company profitability and overall performance. The results indicate that the companies included in cooperation networks presented superior performance when compared to the companies not included in cooperation networks

  17. Comparative study of chemotherapeutic protocols for advanced breast cancer

    International Nuclear Information System (INIS)

    Perveen, S.; Ilyas, N.; Shahid, M.A.; Asgar, S.

    2002-01-01

    Objective: To compare the efficacy and toxicity of epirubicin the two-dose levels with combination of standard chemotherapy drugs. Design: A single center trial conducted under the sponsorship of Pakistan oncology co-operative group (POCG). Place and Duration of Study: The trial was conducted at the Institute of Nuclear Medicine and Oncology Lahore (INMOL). The study started in October 1995 and patient accrual was completed in June 1997. Patients and Methods: Breast cancer patients presenting with distant metastases were randomized to receive either single agent epirubicin, 120 mg/ m/sup 2/ weekly (arm A), epirubicin 40 mg/m/sup 2/, (Arm B), standard CMF regimen (Arm C) or standard FEC regimen (Arm D). Efficacy of each regimen, its toxicity and the quality of life of the patients were the factors compared. Results: FEC showed a response rate of 68% with median duration of 14 months, CMF showed 57% response rate with median duration of 8 months. High dose epirubicin 120 mg/m/sup 2/ showed a response rate of 31% with response duration of 2.5 months, while epirubicin 40 mg/m/sup 2/ showed partial response (pr) in 17% of patients with response duration of 1.7 months. Both FEC and CMF arms were found to be more effective (p<0.05) than the epirubicin regimens. Conclusion: FEC regimen was most effective in producing long lasting palliation. Single agent regimens produced low response rare and intolerable toxicity amongst metastatic breast cancer patients. (author)

  18. Comparative photoluminescence study of crystalline and nanostructured scintillators

    Science.gov (United States)

    McKinney, George; McDonald, Warren; Tzolov, Marian

    2014-03-01

    Scintillators are widely used for conversion of high energy radiation/particles to visible light which can be either directly observed or further converted to electrical signal in photomultipliers or solid state detectors. We compare the light emission properties of traditional crystalline scintillators with nanostructured films created in our laboratory with the potential for use as scintillators. We have studied zinc oxide (ZnO) nanowires, zinc tungstate (ZnWO4) thin films, commercially available crystals of ZnO, ZnWO4 and commercial scintillators of yttrium aluminum garnet (YAG) and yttrium aluminum perovskite (YAP). We will present the photoluminescence emission spectra, the intensity dependence of the emission, and the photoluminescence excitation spectra. We have found that the emission spectrum of zinc oxide nanowires becomes very intense at high excitation intensities and becomes comparable with the emission from the commercial scintillators. The excitation spectra indicate the presence of subgap electronic states in the nanostructured samples and in the commercial scintillators. This study contributes to our effort of creating electron detectors for scanning electron microscopy using nanostructured scintillators.

  19. Comparative planning study for proton radiotherapy of benign brain tumors

    Energy Technology Data Exchange (ETDEWEB)

    Cozzi, L.; Nicolini, G.; Fogliata, A. [Medical Physics, Oncology Inst. of Southern Switzerland, Bellinzona (Switzerland); Clivio, A.; Vanetti, E. [Medical Physics, Oncology Inst. of Southern Switzerland, Bellinzona (Switzerland); Medical Physics Specialization School, Univ. of Milan (Italy)

    2006-07-15

    Purpose: a comparative study of different systems for proton-based radiotherapy was conducted. Material and methods: the Paul Scherrer Institute method for spot scanning was compared with the systems for passive scattering from the helax-TMS and the varian eclipse. Twelve cases of ''benign'' brain tumors were considered (meningiomas, neurinomas, and hypophyseal adenomas). Organs at risk included chiasm, brainstem, eyes and optic nerves as well as the not otherwise specified healthy brain tissue in view of long-term toxicity. Results: the results showed that high target coverage was achievable (V{sub 90} > 98% for all systems). Plans designed with the spot-scanning technique presented the minimum involvement of healthy tissue (e.g., the lowest maximum significant dose to healthy brain [25.6 Gy] or the lowest conformity index [CI{sub 95} = 1.3], between 38% and 46% lower than for the other techniques). Conclusion: in this study, no definitive indication of superiority of any technique can be drawn but spot scanning can better conform dose distributions and minimize the irradiation of healthy volumes at medium to low dose levels, a factor of interest when long life expectancy is considered. (orig.)

  20. A comparative study of physical performance measures in Parkinson's disease.

    Science.gov (United States)

    Tanji, Haruko; Gruber-Baldini, Ann L; Anderson, Karen E; Pretzer-Aboff, Ingrid; Reich, Stephen G; Fishman, Paul S; Weiner, William J; Shulman, Lisa M

    2008-10-15

    The objective of this study is to compare physical performance measures for their ability to discriminate between levels of disability and disease severity in Parkinson's disease (PD). Disability in PD is commonly assessed by patient self-report, which may be limited by patient insight. Seventy-nine patients with PD were tested with seven performance measures: Physical Performance Test (PPT), modified Physical Performance Test (mPPT), Short Physical Performance Battery (SPPB), Performance Test of Activities of Daily Living (PADL), Berg Balance Scale (BBS), Timed Up and Go (TUG), and Functional Reach (FR). These measures were compared with patient-reported disability on the Older Americans Resource and Services Disability subscale (OARS) and disease severity on the Unified Parkinson's Disease Rating Scale (UPDRS). The performance measures were more sensitive to levels of disease severity than disability. Four measures discriminated across quartiles of disability (PPT, mPPT, BBS, TUG: P mPPT, BBS, TUG, FR: P < 0.01; SPPB, PADL: P < 0.05). However, no measure consistently discriminated between subgroups with a range of early and advanced disease severity. The seven physical performance measures showed different profiles of strengths and weaknesses in assessing disability and disease severity. The results of this study will facilitate choosing performance measures for clinical care and clinical trials in PD. (c) 2008 Movement Disorder Society.

  1. Comparative study of gabapentin and isoflavone in menopausal vasomotor symptoms.

    Science.gov (United States)

    Singhal, Savita Rani; Shullai, Wansalan Kuru

    2016-01-01

    This study was planned to compare the effects of gabapentin and isoflavones in menopausal vasomotor symptoms. This prospective comparative study was conducted on 100 patients with complaints of hot flashes, divided into two groups of 50 each. Group I received 900 mg of gabapentin and Group II received 60 mg of isoflavones daily for 3 months. The patients were interviewed to calculate hot flash, global and depression scores and were rescored after 2, 4, 8, and 12 weeks. The primary outcome measure was a change in the hot flash score from baseline. The secondary outcome was an improvement in sleep, depression, and lipid profile. Data were analyzed using Chi-square test and Student's t -test. Both groups showed significant improvement in hot flash score at the end of 12 weeks (82% Group I, 74% Group II; P = 0.076). Statistically significant difference was seen at 12 weeks in sleep quality in favor of gabapentin ( P = 0.011) and in depression in favor of isoflavones (0.026). Isoflavone had significant improvement in cholesterol, high-density lipoprotein, low-density lipoprotein, and triglycerides profiles after 12 weeks ( P sleep disturbance.

  2. Femoral anteversion measured by ultrasound and CT: a comparative study

    International Nuclear Information System (INIS)

    Aamodt, A.; Terjesen, T.; Eine, J.; Kvistad, K.A.

    1995-01-01

    Both computed tomography (CT) and ultrasonography have been used successfully to estimate the femoral anteversion (AV) angle. In this study, AV angles in 20 human adult femurs were determined by ultrasonography and CT and the measurements compared. On CT the real AV angle was measured as the angle between the head-neck centreline and the posterior condylar plane. In addition, the angle between the anterior head-trochanter (HT) tangent and the posterior condylar plane was determined. The latter angle was also measured by ultrasonography using the tilted transducer technique. The mean interobserver variation in the ultrasound measurements was 1.9 . We found ultrasonography to correlate very well with CT, both when comparing with the HT angle (r=0.95) and with the AV angle (r=0.93). The HT angle was on average 4 greater than the AV angle. In this study the accuracy of ultrasonography was ±5 and the method is recommended for screening in patients with rotational disorders of the femur. (orig.)

  3. Programming PHREEQC calculations with C++ and Python a comparative study

    Science.gov (United States)

    Charlton, Scott R.; Parkhurst, David L.; Muller, Mike

    2011-01-01

    The new IPhreeqc module provides an application programming interface (API) to facilitate coupling of other codes with the U.S. Geological Survey geochemical model PHREEQC. Traditionally, loose coupling of PHREEQC with other applications required methods to create PHREEQC input files, start external PHREEQC processes, and process PHREEQC output files. IPhreeqc eliminates most of this effort by providing direct access to PHREEQC capabilities through a component object model (COM), a library, or a dynamically linked library (DLL). Input and calculations can be specified through internally programmed strings, and all data exchange between an application and the module can occur in computer memory. This study compares simulations programmed in C++ and Python that are tightly coupled with IPhreeqc modules to the traditional simulations that are loosely coupled to PHREEQC. The study compares performance, quantifies effort, and evaluates lines of code and the complexity of the design. The comparisons show that IPhreeqc offers a more powerful and simpler approach for incorporating PHREEQC calculations into transport models and other applications that need to perform PHREEQC calculations. The IPhreeqc module facilitates the design of coupled applications and significantly reduces run times. Even a moderate knowledge of one of the supported programming languages allows more efficient use of PHREEQC than the traditional loosely coupled approach.

  4. Prevalence of Lebanese stroke survivors: A comparative pilot study

    Directory of Open Access Journals (Sweden)

    Nathalie Lahoud

    2016-09-01

    Full Text Available Stroke is a leading cause of morbidity and mortality worldwide and its late burden has mainly been attributable to developing countries. Lebanon is one of these countries where epidemiological studies on stroke burden are scarce but necessary. Thus, the present study was conducted to assess the prevalence of stroke survivors among Lebanese inhabitants. A cross-sectional survey was carried out using randomly selected landline phone numbers on all governorates to retrieve data on stroke survivors and their sociodemographic characteristics. Results were then standardized over the Lebanese and the World Health Organization (WHO world populations. A total of 6963 Lebanese inhabitants were included in the study; among these were 56 stroke survivors. This led to an adjusted stroke prevalence of 0.50% [95% confidence interval (CI = 0.33–0.66%] and a world-standardized prevalence of 0.60% (95% CI = 0.42–0.78%. A significantly higher stroke prevalence was found among older age groups and more socioeconomically privileged areas. Overall, the study showed a relatively higher prevalence of stroke in this sample of Lebanese inhabitants when compared to other developing countries. However, larger community-based studies with a clinical assessment of stroke cases are needed to confirm our findings.

  5. Comparative professional plaque removal study using 8 branded toothbrushes.

    Science.gov (United States)

    Claydon, N; Addy, M; Scratcher, C; Ley, F; Newcombe, R

    2002-04-01

    Considerable interest has been shown in the plaque removal properties of modern toothbrush designs. The primary aim of the study was to compare the plaque removal properties of 8 relatively recent designs of manual toothbrush using a professional tooth brusher and within a commonly used time frame. A secondary aim was established to utilise the data to observationally appraise plaque accumulation together with the patterns of removal as a consequence of using the timed professional tooth brusher. The method was an 8-period, single-examiner, randomized, blind cross-over study involving 24 healthy volunteers, balanced for residual effects. Subjects accumulated plaque over a 4 day no oral hygiene period. On day 4, the accumulated plaque was scored by plaque index at the mesial, mid and distal sites of each of the buccal and lingual surfaces of the assessed teeth. Subjects were then removed from the assessment area where they received a professional brushing timed to last 48 s. Brushing was completed according to pre-study training without toothpaste and was followed by a re-scoring of the remaining plaque. A washout period of 3 days was then allowed prior to the next period during which normal oral hygiene was resumed. Similar quantities of plaque accumulated in each arch, although the difference between the buccal and lingual surfaces was of the order of 30%. The professional toothbrusher removed approximately 40% of the accumulated plaque in the 48 s allocated. The buccal surfaces were most effectively cleaned (approximately 45%) compared with the lingual (approximately 25%), with the plaque removal in the mesial and mid sections approaching 40% and 60% respectively. The difference in performance between the test brushes corresponded to 5% of the residual plaque values with none being significantly more efficient overall. Pair wise site comparisons did produce differences of the order of 10% (p=0.004) at the mesio-buccal, and 8% (p=0.030) at the mid-buccal sites

  6. Comparative divertor-transport study for helical devices

    International Nuclear Information System (INIS)

    Feng, Y.; Sardei, F.; Kobayashi, M.

    2008-10-01

    Using the island divertors (ID) of W7-AS and W7-X and the helical divertor (HD) of LHD as examples, the paper presents a comparative divertor transport study for three typical helical devices of different machine-size following two distinct divertor concepts, aiming at identifying common physics issues/effects for mutual validation and combined studies. Based on EMC3/EIRENE simulations supported by experimental results, the paper first reviews and compares the essential transport features of the W7-AS ID and the LHD HD in order to build a base and framework for a predictive study of W7-X. Revealed is the fundamental role of the low-order magnetic islands in both divertor concepts. Preliminary EMC3/EIRENE simulation results for W7-X are presented and discussed with respect to W7-AS and LHD in order to show how the individual field and divertor topologies affect the divertor transport and performance. For instance, a high recycling regime which is absent from W7-AS and LHD is expected for W7-X. Topics addressed are restricted to the basic function elements of a divertor such as particle flux enhancement and impurity retention. In particular, the divertor function on reducing the influx of intrinsic impurities is examined for all the three devices under different divertor plasma conditions. Special attention is paid to examining the island screening potential of intrinsic impurities which has been predicted for all the three devices under high divertor collisionality conditions. The results are discussed in conjunction with the experimental observations for high density divertor plasmas in W7-AS and LHD. (author)

  7. Epidural analgesia during labor vs no analgesia: A comparative study

    Directory of Open Access Journals (Sweden)

    Wesam Farid Mousa

    2012-01-01

    Full Text Available Background: Epidural analgesia is claimed to result in prolonged labor. Previous studies have assessed epidural analgesia vs systemic opioids rather than to parturients receiving no analgesia. This study aimed to evaluate the effect of epidural analgesia on labor duration compared with parturients devoid of analgesia. Methods: One hundred sixty nulliparous women in spontaneous labor at full term with a singleton vertex presentation were assigned to the study. Parturients who request epidural analgesia were allocated in the epidural group, whereas those not enthusiastic to labor analgesia were allocated in the control group. Epidural analgesia was provided with 20 mL bolus 0.5% epidural lidocaine plus fentanyl and maintained at 10 mL for 1 h. Duration of the first and second stages of labor, number of parturients receiving oxytocin, maximal oxytocin dose required for each parturient, numbers of instrumental vaginal, vacuum-assisted, and cesarean deliveries and neonatal Apgar score were recorded. Results: There was no statistical difference in the duration of the active-first and the second stages of labor, instrumental delivery, vacuum-assisted or cesarean delivery rates, the number of newborns with 1-min and 5-min Apgar scores less than 7 between both groups and number of parturients receiving oxytocin, however, the maximal oxytocin dose was significantly higher in the epidural group. Conclusion: Epidural analgesia by lidocaine (0.5% and fentanyl does not prolong labor compared with parturients without analgesia; however, significant oxytocin augmentation is required during the epidural analgesia to keep up the aforementioned average labor duration.

  8. Epidural analgesia during labor vs no analgesia: A comparative study

    Science.gov (United States)

    Mousa, Wesam Farid; Al-Metwalli, Roshdi; Mostafa, Manal

    2012-01-01

    Background: Epidural analgesia is claimed to result in prolonged labor. Previous studies have assessed epidural analgesia vs systemic opioids rather than to parturients receiving no analgesia. This study aimed to evaluate the effect of epidural analgesia on labor duration compared with parturients devoid of analgesia. Methods: One hundred sixty nulliparous women in spontaneous labor at full term with a singleton vertex presentation were assigned to the study. Parturients who request epidural analgesia were allocated in the epidural group, whereas those not enthusiastic to labor analgesia were allocated in the control group. Epidural analgesia was provided with 20 mL bolus 0.5% epidural lidocaine plus fentanyl and maintained at 10 mL for 1 h. Duration of the first and second stages of labor, number of parturients receiving oxytocin, maximal oxytocin dose required for each parturient, numbers of instrumental vaginal, vacuum-assisted, and cesarean deliveries and neonatal Apgar score were recorded. Results: There was no statistical difference in the duration of the active-first and the second stages of labor, instrumental delivery, vacuum-assisted or cesarean delivery rates, the number of newborns with 1-min and 5-min Apgar scores less than 7 between both groups and number of parturients receiving oxytocin, however, the maximal oxytocin dose was significantly higher in the epidural group. Conclusion: Epidural analgesia by lidocaine (0.5%) and fentanyl does not prolong labor compared with parturients without analgesia; however, significant oxytocin augmentation is required during the epidural analgesia to keep up the aforementioned average labor duration. PMID:22412775

  9. Evaluation systems for clinical governance development: a comparative study.

    Science.gov (United States)

    Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

    2014-01-01

    Lack of scientific and confirmed researches and expert knowledge about evaluation systems for clinical governance development in Iran have made studies on different evaluation systems for clinical governance development a necessity. These studies must provide applied strategies to design criteria of implementing clinical governance for hospital's accreditation. This is a descriptive and comparative study on development of clinical governance models all over the world. Data have been gathered by reviewing related articles. Models have been studied in comprehensive review method. The evaluated models of clinical governance development were Australian, NHS, SPOCK and OPTIGOV. The final aspects extracted from these models were Responsiveness, Policies and Strategies, Organizational Structure, Allocating Resources, Education and Occupational Development, Performance Evaluation, External Evaluation, Patient Oriented Approach, Risk Management, Personnel's Participation, Information Technology, Human Resources, Research and Development, Evidence Based Medicine, Clinical Audit, Health Technology Assessment and Quality. These results are applicable for completing the present criteria which evaluating clinical governance application and provide practical framework to evaluate country's hospital on the basis of clinical governance elements.

  10. Translation Evaluation: A Comparative Study of an Oblique Translation

    Directory of Open Access Journals (Sweden)

    / Esmail Zare Behtash

    2017-06-01

    Full Text Available Translation is of an absolute necessity in today’s world. Robinson (1997 states that the study of translation is an integral part of intercultural relations and of conveying scientific and technological knowledge. He further mentions that “translators need to be able to process linguistic materials quickly and efficiently; but they also need to be able to recognize problem areas and to slow down to solve them in complex analytical ways” (p. 2. This study is an attempt to explore and evaluate an oblique translation of a text from English into Persian to find the most frequent translation strategy. To reach the goal of the study, the researchers selected one hundred and ten sentences of an original English text which had been translated freely at random and compared them with their Persian counterparts. The findings of the study indicated that Persian translator used equivalent strategy with the highest percentage (45% in the translated corpus. After that, modulation, and transposition had the highest percentages respectively.

  11. Biopharmaceutics classification system-based biowaivers for generic oncology drug products: case studies.

    Science.gov (United States)

    Tampal, Nilufer; Mandula, Haritha; Zhang, Hongling; Li, Bing V; Nguyen, Hoainhon; Conner, Dale P

    2015-02-01

    Establishing bioequivalence (BE) of drugs indicated to treat cancer poses special challenges. For ethical reasons, often, the studies need to be conducted in cancer patients rather than in healthy volunteers, especially when the drug is cytotoxic. The Biopharmaceutics Classification System (BCS) introduced by Amidon (1) and adopted by the FDA, presents opportunities to avoid conducting the bioequivalence studies in humans. This paper analyzes the application of the BCS approach by the generic pharmaceutical industry and the FDA to oncology drug products. To date, the FDA has granted BCS-based biowaivers for several drug products involving at least four different drug substances, used to treat cancer. Compared to in vivo BE studies, development of data to justify BCS waivers is considered somewhat easier, faster, and more cost effective. However, the FDA experience shows that the approval times for applications containing in vitro studies to support the BCS-based biowaivers are often as long as the applications containing in vivo BE studies, primarily because of inadequate information in the submissions. This paper deliberates some common causes for the delays in the approval of applications requesting BCS-based biowaivers for oncology drug products. Scientific considerations of conducting a non-BCS-based in vivo BE study for generic oncology drug products are also discussed. It is hoped that the information provided in our study would help the applicants to improve the quality of ANDA submissions in the future.

  12. Comparative study on diagonal equivalent methods of masonry infill panel

    Science.gov (United States)

    Amalia, Aniendhita Rizki; Iranata, Data

    2017-06-01

    ratio of height to width of 1 to 1.5. Load used in the experiment was based on Uniform Building Code (UBC) 1991. Every method compared was calculated first to get equivalent diagonal strut width. The second step was modelling method using structure analysis software as a frame with a diagonal in a linear mode. The linear mode was chosen based on structure analysis commonly used by structure designers. The frame was loaded and for every model, its load and deformation values were identified. The values of load - deformation of every method were compared to those of experimental test specimen by Mehrabi and open frame. From comparative study performed, Holmes' and Bazan-Meli's equations gave results the closest to the experimental test specimen by Mehrabi. Other equations that gave close values within the limit (by comparing it to the open frame) are Saneinejad-Hobbs, Stafford-Smith, Bazan-Meli, Liauw Kwan, Paulay and Priestley, FEMA 356, Durani Luo, Hendry, Papia and Chen-Iranata.

  13. Antiamoebic Chemoprophylaxis Using Quinfamide in Children: A Comparative Study

    Directory of Open Access Journals (Sweden)

    Nicolas Padilla

    2002-01-01

    Full Text Available This study sought to examine whether the administration of quinfamide at 3- or 6-month intervals diminished the frequency of Entamoeba histolytica cysts in stool samples compared to controls. The prospective, longitudinal, randomized, single-blind study examined children from six primary schools in Celaya and Neutla, Guanajuato. Of the 1,524 students in these schools, we selected participants for the study as follows: Children were included in the study if their parents agreed in writing to the study and if the children demonstrated evidence of E. histolytica cysts after a parasitoscopic analysis by concentration (PSC in three samples over consecutive days using Faust’s method. Those included in the study received a single 4.3-g/kg dose of quinfamide, and we performed PSC on days 5, 6, and 7 following dose administration to examine whether quinfamide had affected the presence of the cysts. The study participants who tested negative for cysts were divided into three groups: Group 1 had 102 patients who underwent quinfamide treatment and three CPS analyses after the 12 months of the study; Group 2 had 98 subjects who underwent the quinfamide treatment and three CPS analyses at months 3, 6, 9, and 12 after their entrance into the study; and Group 3 had 102 patients, who underwent the quinfamide treatment and series of three CPS analyses at months 6 and 12 of the study. All participants received the dose of quinfamide after providing stool samples and after a clinical gastrointestinal history was obtained. Further clinical gastrointestinal data were collected 5 days after the quintamide dose was administered. We used EpiInfo 6.0 for statistical analysis, calculating X2 and p values for the clinical data and the CPS data after the 12 months concluded. Of the initial samples of 1,524 subjects, 308 (20.2% had Entamoebic cysts. Of these, six were further eliminated because they did not meet the inclusion requirements. At the conclusion of the study

  14. A comparative contrast-detail study of five medical displays

    International Nuclear Information System (INIS)

    Samei, Ehsan; Ranger, Nicole T.; Delong, David M.

    2008-01-01

    The objective of this study was to compare the contrast-detail performance of five different commercial liquid crystal displays (LCDs) to other LCD and cathode-ray tube (CRT) displays for medical applications. A contrast-detail phantom, supplemented with 5 in. of acrylic, was imaged on a commercial digital radiographic system using techniques comparable to chest radiography. The phantom design enabled observer evaluation by a four-alternative forced choice paradigm. The acquired images were independently scored by five observers on five medical display devices: a 5 megapixel monochrome LCD, a 3 megapixel monochrome LCD, a 9 megapixel color LCD, a 5 megapixel monochrome CRT, and a mammographic-grade monochrome CRT. The data were analyzed using the method suggested by the manufacturer based on a nearest neighbor correction technique. They were further analyzed using a logistic regression response model with a natural threshold using an overall chi-square test for display type followed by pairwise comparisons for individual display performance. The differences between the display devices were small. The standard analysis of the results based on the manufacturer-recommended method did not yield any statistically discernible trend among displays. The logistic regression analysis, however, indicated that the 5 megapixel monochrome LCD was statistically significantly (p<0.0001) superior to the others, followed by the 3 megapixel monochrome LCD (p<0.0001). The three other displays exhibited lower but generally similar performance characteristics. The findings suggest that 5 and 3 megapixel monochrome LCDs provide comparable but subtly superior contrast detectability than other tested displays, with the former performing slightly better in the detection of subtle and fine details

  15. Values in nursing students and professionals: An exploratory comparative study.

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    Jiménez-López, F Rosa; Roales-Nieto, Jesus Gil; Seco, Guillermo Vallejo; Preciado, Juan

    2016-02-01

    Many studies have explored personal values in nursing, but none has assessed whether the predictions made by the theory of intergenerational value change are true for the different generations of nursing professionals and students. This theory predicts a shift in those personal values held by younger generations towards ones focussed on self-expression. The purpose of the study was to identify intergenerational differences in personal values among nursing professionals and nursing students and to determine whether generational value profiles fit the predictions made by the theory. An exploratory comparative design with a cross-sectional survey method was used. Participants were recruited from four public hospitals and 10 Primary Care Centres in medium-size cities in Spain. A sample of 589 nurses and 2295 nursing students participated in the study. An open survey method was used to collect data that were classified grouping reported values into categories following a method of value lexicon construction and analysed by contingency tables with Pearson's χ (2) and standardized residuals. Approval to conduct the study was obtained from the Deans of the nursing schools and the Directors of Nursing of the institutions. Anonymity was guaranteed, participation was voluntary and participants were informed of the purpose of the study. The results can be synthesized in two age-related trends in the reporting of values among three groups of participants. First, among younger nurses and students, some nursing core values (e.g. ethical and professional) decreased in importance, while other values centred on social relationships and personal well-being increased. This study shows intergenerational change in personal values among both nursing students and young nursing professionals. Findings suggest the need to pay more attention to value training and professional socialization during the schooling period. © The Author(s) 2014.

  16. EARLY ENTERAL FEEDING AND DELAYED ENTERAL FEEDING- A COMPARATIVE STUDY

    Directory of Open Access Journals (Sweden)

    Alli Muthiah

    2017-03-01

    Full Text Available BACKGROUND Nutrients form the fuel for the body, which comes in the form of carbohydrates, proteins and lipids. The body is intended to burn fuels in order to perform work. Starvation with malnutrition affects the postoperative patients and patients with acute pancreatitis. There is an increased risk of nosocomial infections and a delay in the wound healing may be noted. They are more prone for respiratory tract infections. Enteral Nutrition (EN delivers nutrition to the body through gastrointestinal tract. This also includes the oral feeding. This study will review the administration, rationale and assess the pros and cons associated with the early initiation of enteral feeding. The aim of this study is to evaluate if early commencement of enteral nutrition compared to traditional management (delayed enteral feeding is associated with fewer complications and improved outcome-  In patients undergoing elective/emergency gastrointestinal surgery.  In patients with acute pancreatitis. It is also used to determine whether a period of starvation (nil by mouth after gastrointestinal surgery or in the early days of acute pancreatitis is beneficial in terms of specific outcomes. MATERIALS AND METHODS A prospective cohort interventional study was conducted using 100 patients from July 2012 to November 2012. Patients satisfying the inclusion and exclusion criteria were included in the study. Patients admitted in my unit for GIT surgeries or acute pancreatitis constituted the test group, while patients admitted in other units for similar disease processes constituted the control group. RESULTS Our study concluded that early enteral feeding resulted in reduced incidence of surgical site infections. When the decreased length of stay, shorter convalescent period and the lesser post-interventional fatigue were taken into account, early enteral feeding has a definite cost benefit.CONCLUSION Early enteral feeding was beneficial associated with fewer

  17. Mode of administration does matter: comparability study using IPAQ

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    Felipe de Magalhães Bandeira

    2015-12-01

    Full Text Available Abstract This study compared all-domains and domain-specific physical activity scores assessed through four variations of the IPAQ long version: (a typical week, administered by an interviewer; (b typical week, self-administered; (c past seven days, interviewer-administered; (d past seven days, self-administered. The sample included 38 physical education college students. Self-reported scores were in general twice higher than interview-administered scores, regardless the recall period used. In terms of domain-specific scores, occupational physical activity scores generated by self-report were 6-7 times greater than those originated from interviews. The same trend was observed for household physical activity. Transport physical activity scores did not change according to the mode of administration. In terms of leisure-time physical activity, scores were similar except for the interviewer-administered past seven days, whose scores were lower than the other three versions of IPAQ. In conclusion, the mode of administration of IPAQ does matter; higher scores are obtained through self-report as compared to interviews, probably by misinterpretation of the instrument in self-report mode. The recall period had little effect on physical activity estimates.

  18. Comparative Study between Standard and Totally Tubeless Percutaneous Nephrolithotomy.

    Science.gov (United States)

    Yun, Sung Il; Lee, Yoon Hyung; Kim, Jae Soo; Cho, Sung Ryong; Kim, Bum Soo; Kwon, Joon Beom

    2012-11-01

    Several recent studies have reported the benefits of tubeless percutaneous nephrolithotomy (PNL). Postoperatively, tubeless PNL patients have an indwelling ureteral stent placed, which is often associated with stent-related morbidity. We have performed totally tubeless (tubeless and stentless) PNL in which no nephrostomy tube or ureteral stent is placed postoperatively. We evaluated the safety, effectiveness, and feasibility of totally tubeless PNL. From March 2008 to February 2012, 57 selected patients underwent standard or totally tubeless PNL. Neither a nephrostomy tube nor a ureteral stent was placed in the totally tubeless PNL group. We compared patient and stone characteristics, operation time, length of hospitalization, analgesia requirements, stone-free rate, blood loss, change in creatinine, and perioperative complications between the standard and totally tubeless PNL groups. There were no significant differences in preoperative patient characteristics, postoperative complications, or the stone-free rate between the two groups, but the totally tubeless PNL group showed a shorter hospitalization and a lesser analgesic requirement compared with the standard PNL group. Blood loss and change in creatinine were not significantly different between the two groups. Totally tubeless PNL appears to be a safe and effective alternative for the management of renal stone patients and is associated with a decrease in length of hospital stay.

  19. Early parenting styles and sexual offending behavior: A comparative study.

    Science.gov (United States)

    Sigre-Leirós, Vera; Carvalho, Joana; Nobre, Pedro J

    2016-01-01

    Sexual offenders, in general, report problematic rearing practices from their parents, lacking however more empirical research on this topic regarding particular subtypes of offenders. The current study examined the relationship between early parenting styles and different types of sexual offending. A total of 113 sexual offenders (rapists, pedophilic and nonpedophilic child molesters), and 51 nonsexual offenders completed the EMBU (My Memories of Upbringing), the Brief Symptom Inventory, and the Socially Desirable Response Set Measure. Results showed that rapists were less likely to remember their fathers as being emotionally warm compared with nonsexual offenders and pedophilic child molesters. In addition, compared with rapists, pedophilic offenders perceived their mothers as having been less emotionally warm to them. Overall, results showed that certain developmental experiences with parents were able to distinguish between subtypes of offenders supporting an association between distal interpersonal factors and sexual offending. These findings may have important implications for early intervention and prevention of sexual crimes. Further research using larger samples of pedophilic child molesters is recommended. Copyright © 2016 Elsevier Ltd. All rights reserved.

  20. A COMPARATIVE STUDY ON THE PROFITABILITY OF TOURISTIC PENSIONS

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    Cristiana TINDECHE

    2013-01-01

    Full Text Available The expansion that rural tourism has witnessed in the late XIXth century was determined by the existence of two reasons: on the one side the revival and development of the rural area, and the other side the alternative tourism form compared to traditional, classic or table tourism. It is known that regardless of the external environment in which tourist accommodation units operate, an important role belongs to the quality of the services offered and the satisfaction level of the customers. This study aimed to comparatively analyze the economic efficiency of the Confort Pension located in a rural area and the Danacris Pension from the urban area. The reason for choosing these two units was that the types of tourism they represent are significant areas of operation, namely leisure tourism ("Confort " Pension from Suceava area and business tourism ("Danacris" Pension fromBucharest. Based on the existing methodology in the specialized literature, specific indicators were calculated in order to highlight economic efficiency. Based on the analysis of the main financial standing indicators and the evolution of income and expenditure one may conclude that both companies were profitable.