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Sample records for bioequivalence study comparing

  1. A Pharmacokinetic Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Volunteers.

    Science.gov (United States)

    Pan, Lin; Belloni, Paula; Ding, Han Ting; Wang, Jianshuang; Rubino, Christopher M; Putnam, Wendy S

    2017-09-01

    Pirfenidone film-coated tablets were developed to offer an alternative to the marketed capsule formulation. This study assessed the bioequivalence of the tablet and capsule formulations under fed and fasted states. A Phase I, open-label, randomized, four-treatment-period, four-sequence, crossover pharmacokinetics study (NCT02525484) was conducted. Each subject received an 801-mg single dose of pirfenidone as three 267-mg capsules or one 801-mg tablet under fasted and fed conditions. Pirfenidone plasma C max , AUC 0-t and AUC 0-∞ were used to assess bioequivalence. Forty-four subjects were randomized to treatment. The 801-mg tablet in the fasted state met bioequivalence criteria [90% confidence intervals (CI) 80.00-125.00%] for the GLSM ratios of natural log-transformed C max , AUC 0-t and AUC 0-∞ . Under fed conditions, the 801-mg tablet met the bioequivalence criteria for AUC 0-t and AUC 0-∞ , but slightly exceeded the bioequivalence criteria for the C max (90% CI of 108.26-125.60%). The tablet C max was approximately 17% higher than that of the capsules. In the fed state, the tablet C max , and both AUC 0-t and AUC 0-∞ were reduced by 39% and 17%, respectively, relative to the fasted state. The tablet and capsules had acceptable tolerability profiles. The pirfenidone 801-mg tablet met bioequivalence criteria when compared with three 267-mg capsules in the fasted state. The tablet C max was slightly higher relative to capsules in the fed state, but this is not expected to have a clinically meaningful impact on the benefit-risk profile of pirfenidone. This work was supported by F. Hoffmann-La Roche Ltd.

  2. Comparative bioequivalence study of rifampicin and isoniazid combinations in healthy volunteers.

    Science.gov (United States)

    Padgaonkar, K A; Revankar, S N; Bhatt, A D; Vaz, J A; Desai, N D; D'Sa, S; Shah, V; Gandewar, K

    1999-07-01

    To assess the bioavailability of rifampicin (RMP) in three brands of combination formulations of anti-tuberculosis drugs. A three-way double-blind, cross-over bioavailability study of RMP and isoniazid (INH), consisting of a comparison of a two-drug combination of tablets of RMP and INH each separately (reference brand R) and a tablet of RMP + INH (brand N), and a capsule of RMP + INH (brand L) was carried out in 12 healthy male volunteers. Coded plasma samples were analysed for levels of RMP as well as INH and acetylisoniazid (ACINH) by two high performance liquid chromatography (HPLC) methods. The mean values of RMP in brand N (Cmax 6.49+/-0.52 microg/mL, Tmax 2.33+/-0.18 h, AUC(0-24h) 39.83+/-3.44 microg/mL.h) were comparable with those obtained with brand R (Cmax 5.22+/-0.59 microg/mL, Tmax 2.50+/-0.12 h, AUC(0-24h) 33.33+/-3.47 microg/mL.h). The mean values of RMP in brand L (Cmax 3.05+/-0.52 microg/ mL, Tmax 3.79+/-0.57 h and AUC(0-24h) 21.78+/-3.67 microg/ mL.h) were significantly different from those in brand R. Nevertheless, all of the pharmacokinetic parameters obtained for INH and ACINH in all three brands were comparable. Using brand R as a comparison, brand N was bioequivalent and brand L was not bioequivalent.

  3. [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.

  4. 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 ...

  5. 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.

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

    Directory of Open Access Journals (Sweden)

    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

  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

    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

  8. Pharmacokinetic and bioequivalence study of itopride HCl in healthy volunteers.

    Science.gov (United States)

    Cho, Kyung-Jin; Cho, Wonkyung; Cha, Kwang-Ho; Park, Junsung; Kim, Min-Soo; Kim, Jeong-Soo; Hwang, Sung-Joo

    2010-01-01

    In the present study two different formulations containing 50 mg itopride HCl (N-[4-12-(dimethylamino)ethoxylbenzyl]-3,4-dimethoxybenzamide HCl, CAS 122898-67-3) were compared in 28 healthy male volunteers in order to compare the bioavailability and prove the bioequivalence. The study was performed in an open, single dose randomized, 2-sequence, crossover design in 28 healthy male volunteers with a one-week washout period. Blood samples for pharmacokinetic profiling were drawn at selected times during 24 h. The serum concentrations of itopride HCl were determined using a specific and sensitive HPLC method with fluorescence detection. The detection limit of itopride HCl was 5 ng/ml and no endogenous compounds were found to interfere with analysis. The mean AUC(0-4h), AUC(0 --> infinity), C(max), T(max) and T1/2 were 865.28 ng x h/ml, 873.04 ng x h/ml, 303.72 ng/ml, 0.75 h, and 2.95 h, respectively, for the test formulations, and 833.00 ng x h/ml, 830.97 ng x h/ml, 268.01 ng/ml, 0.78 h, and 2.83 h, respectively, for the reference formulation. Both primary target parameters AUC(0 --> infinity) and C(max) were log-transformed and tested parametrically by analysis of variance (ANOVA). 90% confidence intervals of AUC(0 --> infinity) and C(max) were 100.57%-109.56% and 105.46%-121.18%, respectively, and were in the range of acceptable limits of bioequivalence (80-125%). Based on these results, the two formulations of itopride HCl are considered to be bioequivalent.

  9. Effect of Different Sampling Schedules on Results of Bioavailability and Bioequivalence Studies: Evaluation by Means of Monte Carlo Simulations.

    Science.gov (United States)

    Kano, Eunice Kazue; Chiann, Chang; Fukuda, Kazuo; Porta, Valentina

    2017-08-01

    Bioavailability and bioequivalence study is one of the most frequently performed investigations in clinical trials. Bioequivalence testing is based on the assumption that 2 drug products will be therapeutically equivalent when they are equivalent in the rate and extent to which the active drug ingredient or therapeutic moiety is absorbed and becomes available at the site of drug action. In recent years there has been a significant growth in published papers that use in silico studies based on mathematical simulations to analyze pharmacokinetic and pharmacodynamic properties of drugs, including bioavailability and bioequivalence aspects. The goal of this study is to evaluate the usefulness of in silico studies as a tool in the planning of bioequivalence, bioavailability and other pharmacokinetic assays, e.g., to determine an appropriate sampling schedule. Monte Carlo simulations were used to define adequate blood sampling schedules for a bioequivalence assay comparing 2 different formulations of cefadroxil oral suspensions. In silico bioequivalence studies comparing different formulation of cefadroxil oral suspensions using various sampling schedules were performed using models. An in vivo study was conducted to confirm in silico results. The results of in silico and in vivo bioequivalence studies demonstrated that schedules with fewer sampling times are as efficient as schedules with larger numbers of sampling times in the assessment of bioequivalence, but only if T max is included as a sampling time. It was also concluded that in silico studies are useful tools in the planning of bioequivalence, bioavailability and other pharmacokinetic in vivo assays. © Georg Thieme Verlag KG Stuttgart · New York.

  10. 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

  11. Bioequivalence of a new liquid formulation of benazepril compared with the reference tablet product.

    Science.gov (United States)

    Kelers, K; Devi, J L; Anderson, G A; Zahra, P; Vine, J H; Whittem, T

    2013-08-01

    To compare the bioequivalence and 'switchability' of two formulations of benazepril (tablet and liquid) after oral administration. Randomised cross-over design, followed by parallel comparison. Twelve mixed-breed dogs were administered either a tablet (Group A) or liquid formulation (Group B) of benazepril orally at 0.45 mg/kg daily for 4 days. With no washout period, the dogs then received the alternative treatment at the same dose for a further 4 days. Blood samples taken prior to treatment and serially after treatment were analysed for plasma concentrations of benazepril and benazeprilat and the activity and concentration of angiotensin-converting enzyme (ACE). The calculated percentage inhibition of ACE was defined as the primary outcome variable. No statistically significant differences were found between groups A and B for any variable evaluated. The mean (± SD) percentage of ACE inhibition was 85.5 ± 7.04% for the liquid formulation and 85.9 ± 6.66% for the tablet formulation. The mean of the ratios was 1.00 (80% confidence interval 0.96-1.04). No evaluated effect term (sequence, formulation or period) had any statistical effect on any outcome variable. This study supports a conclusion that, based on pharmacodynamic response, the liquid formulation of benazepril is bioequivalent to the reference tablet formulation. Further, the lack of a sequence effect supports the switchability of these two formulations. © 2013 Australian Veterinary Association.

  12. Bioequivalence and Safety of Twice-Daily Sustained-Release Paracetamol (Acetaminophen) Compared With 3- and 4-Times-Daily Paracetamol: A Repeat-Dose, Crossover Pharmacokinetic Study in Healthy Volunteers.

    Science.gov (United States)

    Liu, Dongzhou J; Collaku, Agron

    2018-01-01

    Twice-daily sustained-release (SR) paracetamol (acetaminophen) offers convenient administration to chronic users. This study investigated at steady state (during the last 24 hours of a 3-day dosing period) the pharmacokinetics, bioequivalence, and safety of twice-daily SR paracetamol compared with extended-release (ER) and immediate-release (IR) paracetamol. In this open-label, randomized, multidose, 3-way crossover study, 28 healthy subjects received paracetamol SR (2 × 1000 mg twice daily), ER (2 × 665 mg 3 times daily), and IR (2 × 500 mg 4 times daily). At steady state, twice-daily SR paracetamol was bioequivalent to ER and IR paracetamol. The 90% confidence intervals for the ratios of geometric means were within the acceptance interval for SR/ER paracetamol (AUC 0-t , 0.973-1.033; AUC 0-24 , 0.974-1.034; AUC 0-∞ , 0.948-1.011; C max , 1.082-1.212; C av , 1.011-1.106) and SR/IR paracetamol (AUC 0-t , 0.969-1.029; AUC 0-24 , 0.968-1.027; AUC 0-∞ , 0.963-1.026; C max , 0.902-1.010; C av , 1.004-1.098). Given twice daily, the SR formulation demonstrated SR properties as expected. Mean time at or above a 4 μg/mL plasma concentration of paracetamol from 2 daily doses of the SR formulation was significantly longer than that from 4 daily doses of IR paracetamol. SR formulation also had a greater T max , a longer half-life, and lower C min compared with ER and IR paracetamol. All formulations were well tolerated. © 2017, The American College of Clinical Pharmacology.

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

    Science.gov (United States)

    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

  14. Bioequivalence study on two brands of 10% enrofloxacin oral ...

    African Journals Online (AJOL)

    A bioequivalence of two brands of 10% enrofloxacin was tested in broiler chickens using a parallel design at 20 mg/kg bodyweight orally. Blood was sampled before and after drug administration for 24 hours. Plasma enrofloxacin concentrations were analyzed using microbiological assay. Peak plasma concentrations ...

  15. Bioequivalence study of two losartan tablet formulations with special emphasis on cardiac safety.

    Science.gov (United States)

    Khandave, Suhas S; Sawant, Satish V; Sahane, Rakhi V; Murthi, Vivekanand; Dhanure, Shivanand S; Surve, Pradeep G

    2012-05-01

    To study the bioequivalence of Losartan Potassium Tablets 50 mg manufactured by Micro Labs Ltd. India to Cozaar® Tablets 50 mg, manufactured by Merck Sharp and Dohme Ltd., UK in normal healthy adult subjects under fasting condition along with the comparative safety evaluation of both treatments. The in vitro dissolution studies were carried out on 12 units each of test and reference products using the paddle method and dissolution media like water, 0.1 N hydrochloric acid with pH 1.2, pH 4.5 acetate buffer and pH 6.8 phosphate buffer. An open label, randomized, two-treatment, two-period, two-sequence, crossover bioequivalence study with a washout period of 7 days was conducted in 60 healthy Indian male subjects. Serial blood samples were collected after drug administration in each study period. Plasma concentrations of losartan and losartan acid were determined using a validated LC-MS-MS method. The pharmacokinetic parameters of losartan and losartan acid were determined using a non compartmental model. Occurrence of adverse events, change in systolic blood pressure, diastolic blood pressure, heart rate and QT interval from the baseline to 3.50 h post dose were studied and compared between the two treatments as safety parameters. The in vitro study proved the essential similarity of both the formulations as evident from the similarity factor of > 50% in all the dissolution media. The ratios for geometric least square means and 90% confidence intervals were within the acceptance criteria of 80% to 125% for log transformed C(max), AUC(0-t) and AUC(0-∞) for losartan. No statistically significant difference between the two treatments was observed for either of the safety parameters. The test product Losartan Potassium tablets 50 mg manufactured by Micro Labs Limited, India was bioequivalent to Cozaar® tablets 50 mg, manufactured by Merck Sharp and Dohme Ltd., UK in terms of rate and extent of absorption. Both treatments were well tolerated and had similar non

  16. Effect of the Wetting Agent Sodium Lauryl Sulfate on the Pharmacokinetics of Alectinib: Results From a Bioequivalence Study in Healthy Subjects.

    Science.gov (United States)

    Morcos, Peter N; Parrott, Neil; Banken, Ludger; Timpe, Carsten; Lindenberg, Marc; Guerini, Elena; Dall, Georgina; Bogman, Katrijn; Sturm, Carolina; Zeaiter, Ali; Martin-Facklam, Meret; Phipps, Alex

    2017-05-01

    The anaplastic lymphoma kinase (ALK) inhibitor alectinib is an effective treatment for ALK-positive non-small-cell lung cancer. This bioequivalence study evaluated the in vivo performance of test 3 formulations with the reduced wetting agent sodium lauryl sulfate (SLS) content. This randomized, 4-period, 4-sequence, crossover study compared alectinib (600 mg) as 25%, 12.5%, and 3% SLS hard capsule formulations with the reference 50% SLS clinical formulation in healthy subjects under fasted conditions (n = 49), and following a high-fat meal (n = 48). Geometric mean ratios and 90% confidence intervals (CIs) for C max , AUC 0-last , and AUC 0-∞ of alectinib, its major active metabolite, M4, and alectinib plus M4 were determined for the test formulations versus the reference formulation. Bioequivalence was concluded if the 90%CIs were within the 80% to 125% boundaries. The 25% SLS formulation demonstrated bioequivalence to the reference 50% SLS formulation for C max , AUC 0-last , and AUC 0-∞ of alectinib, M4, and alectinib plus M4 under both fasted and fed conditions. Further reductions in SLS content (12.5% and 3% SLS) did not meet the bioequivalence criteria. Cross-group comparisons showed an approximately 3-fold positive food effect. Reducing SLS to 25% resulted in a formulation that is bioequivalent to the current 50% SLS formulation used in alectinib pivotal trials. © 2016, The American College of Clinical Pharmacology.

  17. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Science.gov (United States)

    2013-12-05

    ... exposure measures is suitable for documenting BE (e.g., transdermal delivery systems and certain rectal and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1464] Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted...

  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. 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.
.

  20. 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.

  1. 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.

  2. 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.

  3. Significance of metabolites in bioequivalence: losartan potassium as a case study.

    Science.gov (United States)

    Charoo, Naseem Ahmad; Cristofoletti, Rodrigo; Khatri, Aamer Roshanali; Ali, Areeg Anwer

    2014-06-01

    Estimation of metabolite data as a supportive evidence of comparable therapeutic outcome is recommended by various guidance documents. However, a consensus on using it solely to establish bioequivalence (BE) is lacking as parent drug is believed to detect pharmacokinetic differences between test and reference formulations better. Four BE studies of losartan potassium reported in the literature are reviewed. In all the four studies, 90% confidence intervals (CIs) of geometric mean ratios of the test and reference formulations for maximum blood drug concentration (Cmax ) of losartan potassium were outside the acceptable range of 80%-125%, whereas, 90% CIs for its active metabolite, losartan carboxylic acid (LCA), were within the acceptance criteria. Although BE with respect to area under the plasma concentration versus time profile curve was demonstrated in all the cases, BE with respect to Cmax could not be established. However, marketing authorization in all the four cases was granted based on scientific evidence that LCA is 10-40 times more potent than losartan, LCA exhibited higher plasma concentration levels than losartan, pharmacodynamic effects correlate with LCA, and losartan shows wide therapeutic index. Further, widened CI limits for losartan were accepted. Losartan presents an opportunity in the diligence of the principles of quality risk management for selecting moiety on which BE decision must be based. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  4. 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.

  5. Pharmacokinetic and bioequivalence study of two brands of valsartan tablets in healthy male volunteers.

    Science.gov (United States)

    Zakeri-Milani, Parvin; Valizadeh, Hadi; Islambulchilar, Ziba; Nemati, Mahboob

    2010-01-01

    Valsartan (CAS 137862-53-4) is an antihypertensive drug belonging to the family of angiotensin II receptor antagonists acting at the AT1 receptor, which mediates all known effects of angiotensin II on the cardiovascular system. In the present study, the pharmacokinetic parameters of two oral formulations of valsartan tablets were compared in a randomized, single oral dose, two-treatment crossover design in 24 healthy male volunteers under fasting conditions. After an overnight fast, the volunteers received 80 mg valsartan. Blood samples were collected up to 48 h and drug concentrations were determined by a reverse-phase HPLC method with fluorescence detection. Various pharmacokinetic parameters were determined from the plasma concentration-time curves of both formulations. The obtained values for test and reference products were 3067.7 +/- 1,281.7 and 3,304.3 +/- 1,196.4 ng/ml for Cmax; 17,834.4 +/- 7,083.8 and 18,319.1 +/- 7,800.7 ng x h/ml for AUC0-48; 18,825.7 +/- 7,553.2 and 19,172.2 +/- 8,307.2 ng x h/ml for AUC0-infinity, respectively. The 90% confidence intervals obtained by analysis of variance were 86.84-100.87% for Cmax and 93.43-115.54% for AUC0-t, which are within the acceptance range of 80-125%. Therefore it can be concluded that both products are bioequivalent in terms of rate and extent of drug absorption and therefore interchangeable.

  6. 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.

  7. bioequivalence study on two 10% enrofloxacin oral formulations

    African Journals Online (AJOL)

    AONDOVER

    sampled before and after drug administration for 24 hours. Plasma enrofloxacin ... Pharmacokinetic studies have indicated ... variation of the inhibitory effect of antibiotics on .... These factors determine .... dependent, the in vivo performance of.

  8. Pharmacokinetics and bioequivalence study of a fixed dose combination of rabeprazole and itopride in healthy Indian volunteers.

    Science.gov (United States)

    Sahoo, Bijay Kumar; Das, Ayan; Agarwal, Sangita; Bhaumik, Uttam; Bose, Anirbandeep; Ghosh, Debotri; Roy, Bikash; Pal, Tapan Kumar

    2009-01-01

    The aim of the present study was to compare the pharmacokinetics of rabeprazole (CAS 117976-89-3) and itopride (CAS 122898-67-3) after oral administration of a rabeprazole (20 mg)-itopride (150 mg) fixed dose combination (FDC) in healthy human volunteers. The bioequivalence of two formulations (test and reference) was determined in 12 healthy Indian male volunteers (age: 25.25 +/- 4.69 years; weight: 60.50 +/- 5.04 kg) in a randomized, single-dose, two-period, two-treatment crossover study. Both formulations were administered orally as a single dose, with the treatments separated by a washout period of 1 week. Rabeprazole and itopride plasma levels were determined by a validated HPLC method using UV detection. The formulations were compared using the pharmacokinetic parameters area under the plasma concentration-time curve (AUC(0-t)), area under the plasma concentration-time curve from zero to infinity (AUC(0-infinity)) and peak plasma concentration (Cmax). General linear model (GLM) procedures were used in which sources of variation were subject, treatment and period. The results indicated that there were no statistically significant differences (P > 0.05) between the logarithmically transformed AUC(0-infinity) and Cmax values between test and reference formulation. The 90% confidence interval for the ratio of the logarithmically transformed AUC(0-t), AUC(0-infinity) and Cmax were within the bioequivalence limits of 0.8-1.25 and the relative bioavailability of rabeprazole and itopride test and reference formulations was 98.24 and 93.65%, respectively.

  9. 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

  10. 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.

  11. 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

  12. Dissolution efficiency and bioequivalence study using urine data from healthy volunteers: a comparison between two tablet formulations of cephalexin

    Directory of Open Access Journals (Sweden)

    Cristina Helena dos Reis Serra

    2015-06-01

    Full Text Available The aim of the present study was to assess the bioequivalence of two cephalexin tablet formulations available in the Brazilian market (product A as reference formulation and product B as test formulation. Dissolution efficiency (DE% was calculated for both formulations to evaluate their in vitrobiopharmaceutical features. The oral bioequivalence study was performed in twenty-four healthy volunteers in a crossover design. Single oral dose (tablet containing 500 mg of cephalexin of each product was administered with two weeks of washout period. Urinary concentrations of cephalexin were measured by high-performance liquid chromatography (HPLC method and pharmacokinetics parameters were estimated by urinary excretion data. The bioequivalence was determined by the following parameters: the cumulative amount of cephalexin excreted in the urine, the total amount of cephalexin excreted in the urine and the maximum urinary excretion rate of cephalexin. DE values of immediate-release cephalexin tablets (500 mg were 68.69±4.18% for product A and 71.03±6.63% for product B. Regarding the dissolution test of the two brands (A and B analysed, both were in compliance with the official pharmacopeial specifications, since the dissolution of both formulations was superior to 80% of the amount declared in the label after 45 minutes of test (A=92.09%±1.84; B=92.84%±1.08. The results obtained indicated that the products A and B are pharmaceutical equivalents. Confidence intervals for the pharmacokinetic parameters were in compliance with the international standards, indicating that products A and B can be considered bioequivalents and, therefore, interchangeable.

  13. 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.

  14. Pharmaceutical Product Lead Optimization for Better In vivo Bioequivalence Performance: A case study of Diclofenac Sodium Extended Release Matrix Tablets.

    Science.gov (United States)

    Shahiwala, Aliasgar; Zarar, Aisha

    2018-01-01

    In order to prove the validity of a new formulation, a considerable amount of effort is required to study bioequivalence, which not only increases the burden of carrying out a number of bioequivalence studies but also eventually increases the cost of the optimization process. The aim of the present study was to develop sustained release matrix tablets containing diclofenac sodium using natural polymers and to demonstrate step by step process of product development till the prediction of in vivo marketed product equivalence of the developed product. Different batches of tablets were prepared by direct compression. In vitro drug release studies were performed as per USP. The drug release data were assessed using model-dependent, modelindependent and convolution approaches. Drug release profiles showed that extended release action were in the following order: Gum Tragacanth > Sodium Alginate > Gum Acacia. Amongst the different batches prepared, only F1 and F8 passed the USP criteria of drug release. Developed formulas were found to fit Higuchi kinetics model with Fickian (case I) diffusion-mediated release mechanism. Model- independent kinetics confirmed that total of four batches were passed depending on the similarity factors based on the comparison with the marketed Diclofenac. The results of in vivo predictive convolution model indicated that predicted AUC, Cmax and Tmax values for batch F8 were similar to that of marketed product. This study provides simple yet effective outline of pharmaceutical product development process that will minimize the formulation development trials and maximize the product success in bioequivalence studies. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  15. 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

  16. 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.

  17. Bioequivalence of generic lamotrigine 100-mg tablets in healthy Thai male volunteers: a randomized, single-dose, two-period, two-sequence crossover study.

    Science.gov (United States)

    Srichaiya, Arunee; Longchoopol, Chaowanee; Oo-Puthinan, Sarawut; Sayasathid, Jarun; Sripalakit, Pattana; Viyoch, Jarupa

    2008-10-01

    Lamotrigine is an antiepileptic drug which has been used in the treatment of epilepsy and bipolar disorder. A search of the literature did not find previously published bioequivalence and pharmacokinetic evaluations of lamotrigine in healthy Thai male volunteers. The aim of this study was to compare the pharmacokinetic parameters between 2 brands of lamotrigine in healthy Thai male volunteers. A randomized, single-dose, 2-period, 2-sequence, crossover study design with a 2-week washout period was conducted in healthy Thai males. Subjects were randomized to receive either the test or reference formulation in the first period. All subjects were required to be nonsmokers and without a history of alcohol or drug abuse. Plasma samples were collected over a 120-hour period after 100-mg lamotrigine administration in each period. A validated high-performance liquid chromatography ultraviolet method was used to analyze lamotrigine concentration in plasma. Pharmacokinetic parameters were determined using a noncompartmental method. Bioequivalence between the test and reference products, as defined by the US Food and Drug Administration (FDA), is determined when the ratio for the 90% CIs of the difference in the means of the log-transformed AUC(0-t), AUC(0-infinity), and C(max) of the 2 products are within 0.80 and 1.25. Adverse events were determined by measuring vital signs after dosing. Subjects were also asked if they suffered from undesirable effects such as nausea, vomiting, dizziness, and headache. This bioequivalence study was performed in 24 healthy Thai males (mean [SD] age, 20.5 [1.3] years; range, 19-24 years; weight, 62.5 [7.4] kg; height, 172.8 [6.9] cm; body mass index, 20.9 [2.0] kg/m(2)). The mean (SD) C(max) and T(max) of the test formulation of lamotrigine were 1.7 (0.3) microg/mL and 1.2 (0.9) hours, respectively. The mean (SD) C(max) and T(max) of the reference formulation of lamotrigine were 1.7 (0.3) microg/mL and 1.4 (1.0) hours, respectively. The mean

  18. Acceptability and characteristics of 124 human bioequivalence studies with active substances classified according to the Biopharmaceutic Classification System

    Science.gov (United States)

    Ramirez, Elena; Laosa, Olga; Guerra, Pedro; Duque, Blanca; Mosquera, Beatriz; Borobia, Alberto M; Lei, Suhua H; Carcas, Antonio J; Frias, Jesus

    2010-01-01

    AIM The aim of this study was to evaluate the acceptability of 124 bioequivalence (BE) studies with 80 active substances categorized according to the Biopharmaceutics Classification System (BCS) in order to establish if there were different probabilities of proving BE between the different BCS classes. METHODS We evaluated the differences between pharmaceutical products with active substances from different BCS classes in terms of acceptability, number of subjects in the study (n), the point estimates, and intra- and inter-subject coefficients of variation data from BE studies with generic products. RESULTS Out of 124 BE studies 89 (71.77%) were performed with pharmaceutical products containing active substances classified by the BCS. In all BCS classes there were non-bioequivalent pharmaceutical products: 4 out of 26 (15.38%) in class 1, 14 out of 28 (50%) in class 2, 3 out of 22 (13.63%) in class 3 and 1 out of 13 (7.69%) in class 4. When we removed those pharmaceutical products in which intra-subject variability was higher than predicted (2 in class 1 active substances, 9 in class 2 and 2 in class 3) there were still non-BE pharmaceutical products in classes 1, 2 and 3. CONCLUSIONS Comparisons between pharmaceutical products with active substances from the four BCS classes have not allowed us to define differential characteristics of each class in terms of n, inter and intra-subject variability for Cmax or AUC. Despite the usually employed test dissolution methodology proposed as quality control, pharmaceutical products with active substances from the four classes of BCS showed non-BE studies. PMID:21039763

  19. 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.
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  20. 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....

  1. 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

  2. 21 CFR 320.26 - Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE... test product and the reference material should be administered to subjects in the fasting state, unless...

  3. Use of partial AUC (PAUC) to evaluate bioequivalence--a case study with complex absorption: methylphenidate.

    Science.gov (United States)

    Fourie Zirkelbach, Jeanne; Jackson, Andre J; Wang, Yaning; Schuirmann, Donald J

    2013-01-01

    Methylphenidate modified-release products produce early and late peak concentrations critical for treatment of morning and afternoon symptoms of attention deficit hyperactivity disorder (ADHD). Standard bioequivalence (BE) criteria cannot be applied to these products. The performance of partial area under the drug concentration-time curve (PAUC), Cmax and AUCINF to assess BE were independently evaluated for two products. A two-stage analysis was performed on plasma data for two methylphenidate modified-release products (Product 1 and 2). Simulations using the fitted parameters determined how changes in fast absorption rate constant (K0Fast) and fraction available (F1) affected curve shape and BE determination using Cmax, AUCINF and PAUC. The sensitivity of the mean PAUC(test)/PAUC(reference) ratios to changes in K0Fast(test) are product dependent. Product 1 mean PAUC(test)/PAUC(reference) ratios for PAUC0-4h are more responsive to both decreases and increases in K0Fast(test) than Product 2. Product 2 showed a greater response in the mean PAUC(test)/PAUC(reference) ratio for PAUC0-4h when the K0Fast(test) is decreased and less response as the value is increased. PAUC estimated curve shape is sensitive to changes in absorption and are product specific, and may require a new PAUC metric for each drug. A non-product specific metric to assess curve shape is warranted.

  4. 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.

  5. Bioequivalence of azathioprine products.

    Science.gov (United States)

    Baker, Daniel E

    2003-01-01

    All azathioprine oral tablets are considered bioequivalent by the Food and Drug Administration based on traditional testing. However, since these tests were conducted, it has been determined that some patients have a deficiency of the enzyme most responsible for the metabolism of 6-mercaptopurine-thiopurine methyltransferase (TPMT). Azathioprine is rapidly converted to 6-mercaptopurine, its active metabolite. So it is possible that differences in TPMT activity may influence the bioequivalence of azathioprine products among individuals, especially those patients deficient in TPMT enzyme activity. However, this possibility has not been evaluated.

  6. 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.

  7. Determination of itopride in human plasma by liquid chromatography coupled to tandem mass spectrometric detection: application to a bioequivalence study.

    Science.gov (United States)

    Lee, Heon-Woo; Seo, Ji-Hyung; Choi, Seung-Ki; Lee, Kyung-Tae

    2007-01-30

    A simple method using a one-step liquid-liquid extraction (LLE) with butyl acetate followed by high-performance liquid chromatography (HPLC) with positive ion electrospray ionization tandem mass spectrometric (ESI-MS/MS) detection was developed for the determination of itopride in human plasma, using sulpiride as an internal standard (IS). Acquisition was performed in multiple reaction monitoring (MRM) mode, by monitoring the transitions: m/z 359.5>166.1 for itopride and m/z 342.3>111.6 for IS, respectively. Analytes were chromatographed on an YMC C18 reverse-phase chromatographic column by isocratic elution with 1 mM ammonium acetate buffer-methanol (20: 80, v/v; pH 4.0 adjusted with acetic acid). Results were linear (r2=0.9999) over the studied range (0.5-1000 ng mL(-1)) with a total analysis time per run of 2 min for LC-MS/MS. The developed method was validated and successfully applied to bioequivalence studies of itopride hydrochloride in healthy male volunteers.

  8. Determination of itopride hydrochloride in human plasma by RP-HPLC with fluorescence detection and its use in bioequivalence study.

    Science.gov (United States)

    Ma, Jing; Yuan, Li-Hua; Ding, Mei-Juan; Zhang, Jun; Zhang, Qing; Xu, Qun-Wei; Zhou, Xue-Min

    2009-03-01

    A sensitive, selective and simple method using a precipitation of protein with 10% perchloric acid, followed by high-performance liquid chromatography (HPLC) with fluorescence detection was developed for the determination of itopride hydrochloride in human plasma, using levofloxacin as the internal standard (IS). Chromatographic separation was obtained within 7.0 min using a reverse phase Hypersil BDS C(18) (250 mm x 4.6 mm, 5 microm) column and an isocratic mobile phase, constituting of a mixture of 0.1 mol/l ammonium acetate-methanol (30:70, v/v) flowing at 1.1 ml/min. The excitation and emission wavelengths were set at 304 and 344 nm, respectively. The method was validated over the concentration range of 5 ng/ml to 1000.0 ng/ml. The lower limit of quantitation (LLOQ) was 5 ng/ml. The extractive recovery of itopride hydrochloride from the biological matrix was more than 80.77%. The intra-day accuracy of the drug containing serum samples was more than 82.94% with a precision of 2.81-4.37%. The inter-day accuracy was 82.91% or more, with a precision of 6.89-9.54%. The limit we have used (70-143%) is based on the local regulatory authority (SFDA). The developed method was validated and successfully applied to bioequivalence studies of itopride hydrochloride in healthy male volunteers.

  9. 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%.

  10. Advantages of automation in plasma sample preparation prior to HPLC/MS/MS quantification: application to the determination of cilazapril and cilazaprilat in a bioequivalence study.

    Science.gov (United States)

    Kolocouri, Filomila; Dotsikas, Yannis; Apostolou, Constantinos; Kousoulos, Constantinos; Soumelas, Georgios-Stefanos; Loukas, Yannis L

    2011-01-01

    An HPLC/MS/MS method characterized by complete automation and high throughput was developed for the determination of cilazapril and its active metabolite cilazaprilat in human plasma. All sample preparation and analysis steps were performed by using 2.2 mL 96 deep-well plates, while robotic liquid handling workstations were utilized for all liquid transfer steps, including liquid-liquid extraction. The whole procedure was very fast compared to a manual procedure with vials and no automation. The method also had a very short chromatographic run time of 1.5 min. Sample analysis was performed by RP-HPLC/MS/MS with positive electrospray ionization using multiple reaction monitoring. The calibration curve was linear in the range of 0.500-300 and 0.250-150 ng/mL for cilazapril and cilazaprilat, respectively. The proposed method was fully validated and proved to be selective, accurate, precise, reproducible, and suitable for the determination of cilazapril and cilazaprilat in human plasma. Therefore, it was applied to a bioequivalence study after per os administration of 2.5 mg tablet formulations of cilazapril.

  11. 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.

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

    KAUST Repository

    Al-Talla, Zeyad; Akrawi, Sabah H.; Emwas, Abdul-Hamid M.

    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

  13. 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.

  14. Relative bioequivalence evaluation of two oral atomoxetine hydrochloride capsules: a single dose, randomized, open-label, 2-period crossover study in healthy Chinese volunteers under fasting conditions.

    Science.gov (United States)

    Shang, D-W; Guo, W; Zhou, F-C; Wang, X-P; Li, A-N; Zhang, L; Li, W-B; Lu, W; Wang, C-Y

    2013-11-01

    To evaluate the bioequivalence of a new formulation of atomoxetine hydrochloride (CAS 82248-59-7) capsules (test) and an available branded capsules (reference) after administration of a single 40 mg dose, randomized, open-label, 2-period crossover study was conducted in 22 healthy male Chinese subjects with a 1-week wash-out period. This study was designed for/the Honglin Pharmaceutical Co. Ltd and contracted to be done by the Beijing Anding Hospital in order to satisfy Chinese regulatory requirements to allow marketing of this generic product and performed according to the criteria of SFDA. Blood samples were collected before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16 and 24 h after drug administration. Plasma concentrations were determined by high-performance liquid chromatography (HPLC) with UV detection. A non-compartmental method was used to calculate the pharmacokinetic parameters and evaluate bioequivalence of the 2 formulations. The 90% confidence interval (CI) of the ratios (test/reference) of atomoxetine for AUC0-24, AUC0-∞ and Cmax were 100.9% (93.6-108.8%), 103.1% (95.1-111.7%) and 105.2% (92.8-119.4%), respectively, which fell within the interval of 80-125% and 75-133%. No clinically significant changes or abnormalities were noted in laboratory data and vital signs. From these results it can be concluded that the test formulation of atomoxetine capsules met the regulatory criterion for bioequivalence to the reference formulation. © Georg Thieme Verlag KG Stuttgart · New York.

  15. 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.

  16. 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.

  17. Bioequivalence studies of two brands of meloxicam tablets in healthy Pakistani volunteers.

    Science.gov (United States)

    Hasan, Syed Muhammad Farid; Shoaib, Muhammad Harris; Hassan, Fouzia; Rehman, Inam-Ur

    2009-04-01

    The pharmacokinetic parameters of two oral formulations of meloxicam tablets were compared in a randomized, single oral dose; two treatments cross over design in 12 healthy male volunteers belonging to Pakistan under fasting conditions. After an overnight fast, the volunteers received 30 mg meloxicam and the blood samples were collected up to 96 hours and drug concentrations were determined by a validated HPLC method. Various pharmacokinetic parameters were determined from the plasma concentration-time curves of both formulations. The 90% confidence intervals obtained by analysis of variance were 87-94% for C(max) and 88-97% for AUC(0-t), that fell well within the acceptance range of 80-125%. Also, no significant difference (a=0.05, Wilcoxon Signed rank test) were detected between T(max) of both formulations. The two formulations were well tolerated and no adverse effect was reported during the study.

  18. Analysis of Intra- and Intersubject Variability in Oral Drug Absorption in Human Bioequivalence Studies of 113 Generic Products.

    Science.gov (United States)

    Sugihara, Masahisa; Takeuchi, Susumu; Sugita, Masaru; Higaki, Kazutaka; Kataoka, Makoto; Yamashita, Shinji

    2015-12-07

    In this study, the data of 113 human bioequivalence (BE) studies of immediate release (IR) formulations of 74 active pharmaceutical ingredients (APIs) conducted at Sawai Pharmaceutical Co., Ltd., was analyzed to understand the factors affecting intra- and intersubject variabilities in oral drug absorption. The ANOVA CV (%) calculated from area under the time-concentration curve (AUC) in each BE study was used as an index of intrasubject variability (Vintra), and the relative standard deviation (%) in AUC was used as that of intersubject variability (Vinter). Although no significant correlation was observed between Vintra and Vinter of all drugs, Vintra of class 3 drugs was found to increase in association with a decrease in drug permeability (P(eff)). Since the absorption of class 3 drugs was rate-limited by the permeability, it was suggested that, for such drugs, the low P(eff) might be a risk factor to cause a large intrasubject variability. To consider the impact of poor water solubility on the variability in BE study, a parameter of P(eff)/Do (Do; dose number) was defined to discriminate the solubility-limited and dissolution-rate-limited absorption of class 2 drugs. It was found that the class 2 drugs with a solubility-limited absorption (P(eff)/Do high intrasubject variability. Furthermore, as a reason for high intra- or intersubject variability in AUC for class 1 drugs, effects of drug metabolizing enzymes were investigated. It was demonstrated that intrasubject variability was high for drugs metabolized by CYP3A4 while intersubject variability was high for drugs metabolized by CYP2D6. For CYP3A4 substrate drugs, the Km value showed the significant relation with Vintra, indicating that the affinity to the enzyme can be a parameter to predict the risk of high intrasubject variability. In conclusion, by analyzing the in house data of human BE study, low permeability, solubility-limited absorption, and high affinity to CYP3A4 are identified as risk factors for

  19. 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

    as emulsifying excipient. Cremophor(®) EL is known to cause hypersensitivity reactions in some patients, ranging from skin reactions to potentially fatal anaphylactic shock. OBJECTIVES: The primary objective was to assess if CicloMulsion(®), a Cremophor(®) EL-free lipid emulsion of ciclosporin for intravenous...... 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...... adverse events were recorded after treatment with CicloMulsion(®). CONCLUSION: We have assessed the pharmacokinetics and tolerability of a new Cremophor(®) EL-free lipid emulsion of ciclosporin, CicloMulsion(®), compared to Sandimmune(®). The proportion of adverse events was significantly higher...

  20. 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.

  1. Bioequivalence of a new cyclosporine a formulation to Neoral.

    Science.gov (United States)

    David-Neto, Elias; Kakehashi, Erica; Alves, Cristiane Feres; Pereira, Lilian M; de Castro, Maria Cristina R; de Mattos, Renata Maciel; Sumita, Nairo Massakazu; Romano, Paschoalina; Mendes, Maria Elizabete; Nahas, William Carlos; Ianhez, Luiz Estevam

    2004-02-01

    New cyclosporine A (CsA) formulations must prove their bioequivalence to Neoral, the reference CsA formulation, to allow free prescription for the patients. The aim of this study was to compare the pharmacokinetics (PK) of a new CsA formulation (Zinograf-ME), produced by Strides-Arcolab, to Neoral and to demonstrate their interchangeability in stable renal transplant recipients. Twelve-hour PK studies were obtained from 18 (13 M/5 F) adult patients (mean age 44.7 +/- 12 years). They received their renal allografts from 13 cadaver and 5 living donors. Before enrollment, all patients were receiving a third generic CsA for a mean of 48 months. Nine patients were also under azathioprine and 9 under mycophenolate mofetil; 17 received prednisone. A single oral dose of either Zinograf or Neoral was administered. The first PK study was performed with one formulation, and 1 week later, a second PK was done with the other formulation. During the washout period, patients continued taking the third CsA formulation. The drug substitution was done milligram-for-milligram. The CsA whole-blood level was measured by TDx immunoassay. Mean +/- SD of area under the curve (AUC), maximum concentration (C(max)), and concentration at the second hour (C2) of Zinograf were not statistically different from those with Neoral (4019 +/- 1466 vs 3971 +/- 1325 ng x h/mL, 998 +/- 376 vs 1021 +/- 356 ng/mL, and 707 +/- 254 vs 734 +/- 229 ng/mL, respectively). In the same way, the Zinograf 90% confidence interval for either C(max) (-123, +77 ng/mL) or AUC (-214, +311 ng.mL/h) were within the Neoral bioequivalence interval for the same parameters (+/-204 ng/mL and +/-794 ng x mL/h, respectively). These data demonstrate that the ZinografME CsA formulation is bioequivalent to Neoral.

  2. 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....

  3. 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.

  4. 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

  5. Random-effects linear modeling and sample size tables for two special crossover designs of average bioequivalence studies: the four-period, two-sequence, two-formulation and six-period, three-sequence, three-formulation designs.

    Science.gov (United States)

    Diaz, Francisco J; Berg, Michel J; Krebill, Ron; Welty, Timothy; Gidal, Barry E; Alloway, Rita; Privitera, Michael

    2013-12-01

    Due to concern and debate in the epilepsy medical community and to the current interest of the US Food and Drug Administration (FDA) in revising approaches to the approval of generic drugs, the FDA is currently supporting ongoing bioequivalence studies of antiepileptic drugs, the EQUIGEN studies. During the design of these crossover studies, the researchers could not find commercial or non-commercial statistical software that quickly allowed computation of sample sizes for their designs, particularly software implementing the FDA requirement of using random-effects linear models for the analyses of bioequivalence studies. This article presents tables for sample-size evaluations of average bioequivalence studies based on the two crossover designs used in the EQUIGEN studies: the four-period, two-sequence, two-formulation design, and the six-period, three-sequence, three-formulation design. Sample-size computations assume that random-effects linear models are used in bioequivalence analyses with crossover designs. Random-effects linear models have been traditionally viewed by many pharmacologists and clinical researchers as just mathematical devices to analyze repeated-measures data. In contrast, a modern view of these models attributes an important mathematical role in theoretical formulations in personalized medicine to them, because these models not only have parameters that represent average patients, but also have parameters that represent individual patients. Moreover, the notation and language of random-effects linear models have evolved over the years. Thus, another goal of this article is to provide a presentation of the statistical modeling of data from bioequivalence studies that highlights the modern view of these models, with special emphasis on power analyses and sample-size computations.

  6. 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

  7. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

    Science.gov (United States)

    2010-09-29

    The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

  8. Development and validation of a liquid chromatography-tandem mass spectrometry method for topotecan determination in beagle dog plasma and its application in a bioequivalence study.

    Science.gov (United States)

    Ye, Ling; Shi, Jian; Wan, Shanhe; Yang, Xiaoshan; Wang, Ying; Zhang, Jiajie; Zheng, Dayong; Liu, Zhongqiu

    2013-11-01

    Topotecan (TPT) is an important anti-cancer drug that inhibits topoisomerase I. A sensitive and robust liquid chromatography-tandem mass spectrometry (LC-MS/MS) method that potentially determines TPT in beagle dog plasma is needed for a bioequivalence study of TPT formulations. We developed and validated LC-MS/MS to evaluate TPT in beagle dog plasma in terms of specificity, linearity, precision, accuracy, stability, extraction recovery and matrix effect. Plasma samples were treated with an Ostro(TM) sorbent plate (a robust and effective tool) to eliminate phospholipids and proteins before analysis. TPT and camptothecin (internal standard) were separated on an Acquity UPLC BEH C18 column (1.7 µm, 2.1 × 50 mm) with 0.1% formic acid and methanol as the mobile phase at a flow rate of 0.25 mL/min. TPT was analyzed using positive ion electrospray ionization in multiple-reaction monitoring mode. The obtained lower limit of quantitation was 1 ng/mL (signal-to-noise ratio > 10). The standard calibration curve for TPT was linear (correlation coefficient > 0.99) at the concentration range of 1-400 ng/mL. The intra-day and inter-day precision, accuracy, stability, extraction recovery and matrix effect of TPT were within the acceptable limits. The validated method was successfully applied in a bioequivalence study of TPT in healthy beagle dogs. Copyright © 2013 John Wiley & Sons, Ltd.

  9. Quantification of sibutramine and its two metabolites in human plasma by LC–ESI-MS/MS and its application in a bioequivalence study

    Directory of Open Access Journals (Sweden)

    Venkata Suresh Ponnuru

    2012-08-01

    Full Text Available Obesity can be considered as a chronic illness of epidemic proportion and its incidents have increased exponentially in recent years. The use of anti-obesity drugs such as sibutramine is somewhat helpful. There is a need to quantify such drugs in biological samples, which is generally quite difficult. In this report, we developed and validated a simple, sensitive and specific liquid chromatography–tandem mass spectrometry (LC–MS/MS method for the quantification of sibutramine (SB and its two metabolites N-des methyl sibutramine (DSB and N-di desmethyl sibutramine (DDSB in human plasma. Zorbax SB-C18 (4.6 mm×75 mm, 3.5 μm, 80 Å analytical column and 5 mM ammonium formate:acetonitrile (10:90, v/v mobile phase were used for chromatographic separation of SB, DSB and DDSB. Multiple reaction monitoring (MRM in the positive mode was used to detect SB, DSB and DDSB at m/z 280.3/124.9, 266.3/125.3 and 252.2/124.9, respectively. Liquid–liquid extraction was used for the extraction of analytes and internal standard from human plasma. This method was validated over a linear concentration range of 10.0–10,000.0 pg/mL for SB, DSB and DDSB with correlation coefficients (r of ≥0.9997. The drug and the two metabolites were stable in plasma samples. The validated method was successfully applied in a bioequivalence and pharmacokinetic study with human volunteers under fasting condition. Keywords: LC–ESI-MS/MS, Sibutramine, Human plasma, Bioequivalence, Pharmacokinetic study

  10. 77 FR 66621 - Draft Guidance for Industry on Bioequivalence Recommendation for Lenalidomide Capsules; Availability

    Science.gov (United States)

    2012-11-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0433; (formerly Docket No. 2007D-0169)] Draft Guidance for Industry on Bioequivalence Recommendation for...) Acceptable fasting and fed bioequivalence studies on the 25 mg strength, (2) proportional similarity of the...

  11. 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

  12. 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)

    OpenAIRE

    Stavchansky, Salomon

    2008-01-01

    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 ...

  13. 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

  14. 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.

  15. 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

  16. 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

  17. Liquid chromatography-tandem mass spectrometry for the quantification of flurbiprofen in human plasma and its application in a study of bioequivalence.

    Science.gov (United States)

    Mei, Chenghan; Li, Bin; Yin, Qiangfeng; Jin, Jing; Xiong, Ting; He, Wenjuan; Gao, Xiujuan; Xu, Rong; Zhou, Piqi; Zheng, Heng; Chen, Hui

    2015-07-01

    A simple, quick and accurate LC-MS/MS method for the quantification of flurbiprofen in human plasma with indomethacin as internal standard (IS) was developed and validated. Samples were treated with methanol to precipitate proteins, then separated on a Ultimate C18 column (5μm, 2.1×50mm) with a gradient elusion process. Mobile phase A was comprised of water and formic acid, mobile phase B was comprised of acetonitrile and formic acid. Multi reaction monitoring (MRM) signals were saved on a negative ionization electrospray mass spectrometer. The calibration curve showed good linearity in the range of 40.00-10000.00μg/L (r(2)=0.998). Intra-day RE was 0.2-2.2%. Inter-day RE was 0.5-3.4%. The samples showed good stability under the study conditions. No significant matrix effect was observed. The established method was then applied to a bioequivalence study of a flurbiprofen axetil formulation. Copyright © 2015 Elsevier B.V. All rights reserved.

  18. Quantification of amlodipine and atorvastatin in human plasma by UPLC-MS/MS method and its application to a bioequivalence study.

    Science.gov (United States)

    Rezk, Mamdouh R; Badr, Kamal A

    2018-07-01

    A robust, rapid and sensitive UPLC-MS/MS method has been developed, optimized and validated for the determination of amlodipine (AML) and atorvastatin (ATO) in human plasma using eplerenone as an internal standard (IS). Multiple-reaction monitoring in positive electrospray ionization mode was utilized in Xevo TQD LC-MS/MS. Double extraction was used in sample preparation using diethyl ether and ethyl acetate. The prepared samples were analyzed using an Acquity UPLC BEH C 18 (50 × 2.1 mm, 1.7 μm) column. Ammonium formate and acetonitrile, pumped isocraticaly at a flow rate of 0.25 mL/min, were used as a mobile phase. Method validation was done as per the US Food and Drug Administration guidelines. Linearity was achieved in the range of 0.1-10 ng/mL for AML and 0.05-50 ng/mL for ATO. Intra-day and inter-day accuracy and precision were calculated and found to be within the acceptable range. A short run time, of <1.5 min, permits analysis of a large number of plasma samples per batch. The developed and validated method was applied to estimate AML and ATO in a bioequivalence study in healthy human volunteers. Copyright © 2018 John Wiley & Sons, Ltd.

  19. 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.

  20. Simultaneous determination of codeine, ephedrine, guaiphenesin and chlorpheniramine in beagle dog plasma using high performance liquid chromatography coupled with tandem mass spectrometric detection: application to a bioequivalence study.

    Science.gov (United States)

    Hu, Ziyan; Zou, Qiaogen; Tian, Jixin; Sun, Lili; Zhang, Zunjian

    2011-12-15

    A rapid and sensitive method based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the simultaneous determination of codeine, ephedrine, guaiphenesin and chlorpheniramine in beagle dog plasma has been developed and validated. Following liquid-liquid extraction, the analytes were separated on a reversed-phase C(18) column (150 mm × 2.0 mm, 3 μm) using formic acid:10 mM ammonium acetate:methanol (0.2:62:38, v/v/v) as mobile phase at a flow rate of 0.2 mL/min and analyzed by a triple-quadrupole mass spectrometer in the selected reaction monitoring (SRM) mode. The method was linear for all analytes over the following concentration (ng/mL) ranges: codeine 0.08-16; ephedrine 0.8-160; guaiphenesin 80-16,000; chlorpheniramine 0.2-40. Acceptable precision and accuracy were obtained for concentrations over the standard curve range. It is the first time that the validated HPLC-MS/MS method was successfully applied to a bioequivalence study in 6 healthy beagle dogs. Copyright © 2011 Elsevier B.V. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    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.

  2. Three-way, three-period, crossover bioequivalence study of single oral dose of three brands of 300 mg phenytoin sodium tablets marketed in India, on healthy Indian human volunteers.

    Science.gov (United States)

    Doshi, Maulik S; Naik, Anuja A; Mehta, Mohit R; Gogtay, Nithya J; Thatte, Urmila M; Menon, Mala D

    2013-10-01

    To compare the bioavailability of two brands of phenytoin sodium tablets available in the Indian market using Eptoin™ as the reference. A randomized, assessor-blind, three-way crossover design study was carried out over a period of 6 months after approval from the Institutional Review Board (IRB). Twenty-two healthy male participants received a single oral 300 mg oral tablet of either of the formulations with a 2-week washout. Blood samples were collected predose and at regular intervals postdose. Plasma phenytoin levels were estimated by high-performance liquid chromatography. Calculation of Cmax, AUC0-t, and AUC0-∞ was done by the linear trapezoidal rule and 90-110% margin (90% confidence interval (CI)) was used to assess bioequivalence. Twenty volunteers completed the study. It was seen that the log-transformed values of Cmax, AUC0-t, and AUC0-∞ of the test formulations were not within the specified limits. Bioinequivalence of available phenytoin brands indicates that switching brands could lead to variations in blood concentrations and thus impact safety and efficacy. If a brand switch is done for any reason, stringent drug-level monitoring is advised.

  3. Using a single tablet daily to treat latent tuberculosis infection in Brazil: bioequivalence of two different isoniazid formulations (300 mg and 100 mg) demonstrated by a sensitive and rapid high-performance liquid chromatography-tandem mass spectrometry method in a randomised, crossover study.

    Science.gov (United States)

    Daher, André; Pitta, Luciana; Santos, Tereza; Barreira, Draurio; Pinto, Douglas

    2015-06-01

    The recommended treatment for latent tuberculosis (TB) infection in adults is a daily dose of isoniazid (INH) 300 mg for six months. In Brazil, INH was formulated as 100 mg tablets. The treatment duration and the high pill burden compromised patient adherence to the treatment. The Brazilian National Programme for Tuberculosis requested a new 300 mg INH formulation. The aim of our study was to compare the bioavailability of the new INH 300 mg formulation and three 100 mg tablets of the reference formulation. We conducted a randomised, single dose, open label, two-phase crossover bioequivalence study in 28 healthy human volunteers. The 90% confidence interval for the INH maximum concentration of drug observed in plasma and area under the plasma concentration vs. time curve from time zero to the last measurable concentration "time t" was 89.61-115.92 and 94.82-119.44, respectively. The main limitation of our study was that neither adherence nor the safety profile of multiple doses was evaluated. To determine the level of INH in human plasma, we developed and validated a sensitive, simple and rapid high-performance liquid chromatography-tandem mass spectrometry method. Our results showed that the new formulation was bioequivalent to the 100 mg reference product. This finding supports the use of a single 300 mg tablet daily strategy to treat latent TB. This new formulation may increase patients' adherence to the treatment and quality of life.

  4. Using a single tablet daily to treat latent tuberculosis infection in Brazil: bioequivalence of two different isoniazid formulations (300 mg and 100 mg demonstrated by a sensitive and rapid high-performance liquid chromatography-tandem mass spectrometry method in a randomised, crossover study

    Directory of Open Access Journals (Sweden)

    André Daher

    2015-06-01

    Full Text Available The recommended treatment for latent tuberculosis (TB infection in adults is a daily dose of isoniazid (INH 300 mg for six months. In Brazil, INH was formulated as 100 mg tablets. The treatment duration and the high pill burden compromised patient adherence to the treatment. The Brazilian National Programme for Tuberculosis requested a new 300 mg INH formulation. The aim of our study was to compare the bioavailability of the new INH 300 mg formulation and three 100 mg tablets of the reference formulation. We conducted a randomised, single dose, open label, two-phase crossover bioequivalence study in 28 healthy human volunteers. The 90% confidence interval for the INH maximum concentration of drug observed in plasma and area under the plasma concentration vs. time curve from time zero to the last measurable concentration “time t” was 89.61-115.92 and 94.82-119.44, respectively. The main limitation of our study was that neither adherence nor the safety profile of multiple doses was evaluated. To determine the level of INH in human plasma, we developed and validated a sensitive, simple and rapid high-performance liquid chromatography-tandem mass spectrometry method. Our results showed that the new formulation was bioequivalent to the 100 mg reference product. This finding supports the use of a single 300 mg tablet daily strategy to treat latent TB. This new formulation may increase patients’ adherence to the treatment and quality of life.

  5. Validated LC-MS/MS method for the determination of 3-hydroxflavone and its glucuronide in blood and bioequivalent buffers: application to pharmacokinetic, absorption, and metabolism studies.

    Science.gov (United States)

    Xu, Beibei; Yang, Guanyi; Ge, Shufan; Yin, Taijun; Hu, Ming; Gao, Song

    2013-11-01

    The purpose of this study is to develop an UPLC-MS/MS method to quantify 3-hydroxyflavone (3-HF) and its metabolite, 3-hydroxyflavone-glucuronide (3-HFG) from biological samples. A Waters BEH C8 column was used with acetonitrile/0.1% formic acid in water as mobile phases. The mass analysis was performed in an API 5500 Qtrap mass spectrometer via multiple reaction monitoring (MRM) with positive scan mood. The one-step protein precipitation by acetonitrile was used to extract the analytes from blood. The results showed that the linear response range was 0.61-2500.00 nM for 3-HF and 0.31-2500.00 nM for 3-HFG. The intra-day variance is less than 16.5% and accuracy is in 77.7-90.6% for 3-HF and variance less than 15.9%, accuracy in 85.1-114.7% for 3-HFG. The inter-day variance is less than 20.2%, accuracy is in 110.6-114.2% for 3-HF and variance less than 15.6%, accuracy in 83.0-89.4% for 3-HFG. The analysis was done within 4.0 min. Only 10 μl of blood is needed due to the high sensitivity of this method. The validated method was successfully used to pharmacokinetic study in A/J mouse, transport study in the Caco-2 cell culture model, and glucuronidation study using mice liver and intestine microsomes. The applications revealed that this method can be used for 3-HF and 3-HFG analysis in blood as well as in bioequivalent buffers such HBSS and KPI. Copyright © 2013 Elsevier B.V. All rights reserved.

  6. 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.

  7. 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.

  8. Bioequivalence of isoniazid in a two drug fixed dose combination and in a single drug dosage form.

    Science.gov (United States)

    Agrawal, S; Kaul, C L; Panchagnula, R

    2001-08-01

    To increase the patient compliance and reduce the risk of drug resistant strains, WHO and IUATLD recommend the use of Fixed Dose Combination (FDC) tablets as a routine therapeutic regimen in Directly Observed Treatment Shortcourse (DOTS). But the main issue in the use of FDC is the quality of the formulation. At present WHO and IUATLD suggest the bioequivalence assessment of only rifampicin from FDC compared to separate formulations. For the therapeutic effectiveness all the components of the FDCs should be bioavailable at tissue site. Also, the primary and acquired resistance rate of isoniazid is much higher compared to other anti-tubercular drugs. Hence, a comparative bioavailability study of isoniazid from a two drugs FDC compared to a separate formulation was carried out on a group of 12 healthy volunteers. When evaluated by normal or log transformed confidence interval, Two Way ANOVA and Hauschke analysis, the bioequivalence limits for AUC0-8 and AUC0-24 were within 0.8-1.25. For Cmax and Tmax, these limits were within 0.7-1.43. Hence, isoniazid from a FDC formulation was found to be bioequivalent to a separate formulation at same dose levels.

  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. Determination of ergocalciferol in human plasma after Diels-Alder derivatization by LC–MS/MS and its application to a bioequivalence study

    Directory of Open Access Journals (Sweden)

    Pritesh Contractor

    2017-12-01

    Full Text Available An accurate, sensitive and selective method is developed for determination of ergocalciferol (vitamin D2 in human plasma using LC–MS/MS. After liquid-liquid extraction with n-hexane, ergocalciferol was derivatized by reacting with 4-phenyl-1,2,4-triazoline-3,5-dione (PTAD, a strong dienophile based on Diels-Alder reaction. Ergocalciferol and its deuterated internal standard, ergocalciferol-d6, were analyzed on X Select CSH C18 (100 mm×4.6 mm, 2.5 µm column using acetonitrile and 0.1% (v/v formic acid in water containing 0.14% methylamine within 6.0 min under gradient elution mode. Tandem mass spectrometry in positive ionization mode was used to quantify ergocalciferol by multiple reaction monitoring (MRM. Entire data processing was done using Watson LIMS™ software which provided excellent data integrity and high throughput with improved operational efficiency. The major advantage of this method includes higher sensitivity (0.10 ng/mL, superior extraction efficiency (≥83% and small sample volume (100 µL for processing. The method was linear in the concentration range of 0.10–100 ng/mL for ergocalciferol. The intra-batch and inter-batch accuracy and precision (% CV values varied from 97.3% to 109.0% and 1.01% to 5.16%, respectively. The method was successfully applied to support a bioequivalence study of 1.25 mg ergocalciferol capsules in 12 healthy subjects. Keywords: Ergocalciferol, Diels-Alder reaction, 4-phenyl-1,2,4-triazoline-3,5-dione, LC–MS/MS, Human plasma

  11. Quantitation of itopride in human serum by high-performance liquid chromatography with fluorescence detection and its application to a bioequivalence study.

    Science.gov (United States)

    Singh, Sonu Sundd; Jain, Manish; Sharma, Kuldeep; Shah, Bhavin; Vyas, Meghna; Thakkar, Purav; Shah, Ruchy; Singh, Shriprakash; Lohray, Brajbhushan

    2005-04-25

    A new method was developed for determination of itopride in human serum by reversed phase high-performance liquid chromatography (HPLC) with fluorescence detection (excitation at 291 nm and emission at 342 nm). The method employed one-step extraction of itopride from serum matrix with a mixture of tert-butyl methyl ether and dichloromethane (70:30, v/v) using etoricoxib as an internal standard. Chromatographic separation was obtained within 12.0 min using a reverse phase YMC-Pack AM ODS column (250 mm x 4.6 mm, 5 microm) and an isocratic mobile phase constituting of a mixture of 0.05% tri-fluoro acetic acid in water and acetonitrile (75:25, v/v) flowing at a flow rate of 1.0 ml/min. The method was linear in the range of 14.0 ng/ml to 1000.0 ng/ml. The lower limit of quantitation (LLOQ) was 14.0 ng/ml. Average recovery of itopride and the internal standard from the biological matrix was more than 66.04 and 64.57%, respectively. The inter-day accuracy of the drug containing serum samples was more than 97.81% with a precision of 2.31-3.68%. The intra-day accuracy was 96.91% or more with a precision of 5.17-9.50%. Serum samples containing itopride were stable for 180.0 days at -70+/-5 degrees C and for 24.0 h at ambient temperature (25+/-5 degrees C). The method was successfully applied to the bioequivalence study of itopride in healthy, male human subjects.

  12. 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.

  13. Effect of Truncating AUC at 12, 24 and 48 hr When Evaluating the Bioequivalence of Drugs with a Long Half-Life.

    Science.gov (United States)

    Moreno, Isabel; Ochoa, Dolores; Román, Manuel; Cabaleiro, Teresa; Abad-Santos, Francisco

    2016-01-01

    Bioequivalence studies of drugs with a long half-life require long periods of time for pharmacokinetic sampling. The latest update of the European guideline allows the area under the curve (AUC) truncated at 72 hr to be used as an alternative to AUC0-t as the primary parameter. The objective of this study was to evaluate the effect of truncating the AUC at 48, 24 and 12 hr on the acceptance of the bioequivalence criterion as compared with truncation at 72 hr in bioequivalence trials. The effect of truncated AUC on the within-individual coefficient of variation (CVw) and on the ratio of the formulations was also analysed. Twenty-eight drugs were selected from bioequivalence trials. Pharmacokinetic data were analysed using WinNonLin 2.0 based on the trapezoidal method. Analysis of variance (ANOVA) was performed to obtain the ratios and 90% confidence intervals for AUC at different time-points. The degree of agreement of AUC0-72 in relation to AUC0-48 and AUC0-24, according to the Landis and Koch classification, was 'almost perfect'. Statistically significant differences were observed when the CVw of AUC truncated at 72, 48 and 24 hr was compared with the CVw of AUC0-12. There were no statistically significant differences in the AUC ratio at any time-point. Compared to AUC0-72, Pearson's correlation coefficient for mean AUC, AUC ratio and AUC CVw was worse for AUC0-12 than AUC0-24 or AUC0-48. These preliminary results could suggest that AUC truncation at 24 or 48 hr is adequate to determine whether two formulations are bioequivalent. © 2015 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

  14. 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

  15. Bioequivalence assessment of two formulations of ibuprofen

    Directory of Open Access Journals (Sweden)

    Al-Talla ZA

    2011-10-01

    , therefore, Doloraz was considered bioequivalent to Brufen. Keywords: ibuprofen, bioequivalence study, pharmacokinetics

  16. 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.

  17. 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.

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

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    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

  20. Estudio de bioequivalencia: formulaciones genéricas y comerciales de estaduvine, lamiduvine, zidovudine e indinavir en pacientes cubanos infectados con VIH Bioequivalence study: generic and trade formulations of stavudine, lamivudine, zidovudine and indinavir in Cuban HIV-infected subjects

    Directory of Open Access Journals (Sweden)

    Alicia Tarinas Reyes

    2006-08-01

    Full Text Available Objetivo: El presente estudio describe los estudios de bioequivalencia de los genéricos cubanos antirretrovirales estavudina, lamivudina, zidovudina e indinavir con respecto a sus productos innovadores. Diseño: Los estudios de bioequivalencia de cada antirretroviral estudiado (formulación de prueba, P y referencia, R, se realizaron en 13 ó 14 sujetos, según el caso con la utilización de las medias en un estudio aleatorio, cruzado y a dosis única con un período de lavado de 10 días. Métodos: Las concentración de los antirretrovirales en plasma se monitorearon durante un período de 12 h después de la administración de estos, mediante el uso de métodos validados de cromatografía líquida de alta resolución (HPLC. Los parámetros farmacocinéticos se determinaron con el uso el software profesional WinNolin, versión 2.1. La comparación de los parámetros farmacocinéticos se realizó con un intervalo de confianza del 95 % con la utilización del software NCSS 2000 PASS 2000 (hipótesis nula. Para el estudio de bioequivalencia se usó el software Equiv Test de soluciones estadísticas, empleando ANOVA con el 90 % de intervalo de confianza. Resultados: El presente estudio mostró que no se observaron diferencias significativas en las medias de AUC0-12, AUC0-¥, Cmax y Tmax de ambas formulaciones de estavudina, lamivudina, zidovudina e indinavir. Se concluye que los parámetros farmacocinéticos estudiados se encuentran dentro de los rangos establecidos siendo 80-125 % para Cmax, AUC0-12, y AUC0-¥. En el caso de Cmax de la zidovudina el rango fue 70-143 %. Conclusión: Estos resultados avalan que los genéricos antirretrovirales cubanos son bioequivalentes con sus respectivos productos innovadores en términos de velocidad y magnitud de la absorciónObjective: The present study describes the determination of the bioequivalence of the Cuban generic and trade formulations of stavudine, lamivudine, zidovudine, and indinavir. Design: The

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 78 FR 66743 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability

    Science.gov (United States)

    2013-11-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability AGENCY... guidance, FDA recommended an in vivo fasting BE study with pharmacokinetic endpoints and in vitro studies...

  6. 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.

  7. 75 FR 33311 - Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability

    Science.gov (United States)

    2010-06-11

    ... available recommendations on how to design product-specific BE studies to support ANDAs. Under this process... thinking on a new process for making available to sponsors FDA guidance on how to design product-specific... ``Bioequivalence Recommendations for Specific Products.'' This guidance describes a new process for making...

  8. 77 FR 10535 - Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations...

    Science.gov (United States)

    2012-02-22

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

  9. A Comparative Pharmacokinetics Study of the Anti-Parkinsonian Drug Pramipexole

    Directory of Open Access Journals (Sweden)

    Ratih S. I. Putri

    2016-11-01

    Full Text Available The present study aimed to compare pharmacokinetic parameters of two pramipexole 0.25 mg formulations in order to show bioequivalence. The study was conducted in a randomized, open-label, two-period, two-sequence, and crossover design, involving 23 healthy volunteers. One of the 0.25 mg formulations of pramipexole evaluated in the study was manufactured by PT Dexa Medica, Palembang, Indonesia, the other, used as the reference, by Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany. All eligible subjects were required to fast before each drug administration period, which was separated by a one-week washout period. Pramipexole concentrations in plasma were assayed using a validated ultra performance liquid chromatography with mass spectrometry (UPLC-MS/MS detector. The evaluated pharmacokinetic parameters included the area under the plasma concentration curve from time zero to the last observed measurable concentration (AUC0-t, the area under the plasma concentration curve extrapolated to infinite time (AUC0-∞, the maximum plasma concentration (Cmax, the time to reach Cmax (tmax, and the plasma concentration half-life (t1/2. To evaluate the bioequivalence of those two pramipexole formulations, 90% confidence intervals (CIs for geometric mean ratios of both formulations were calculated for AUC and Cmax parameters, while tmax and t1/2 differences were analyzed on the non-transformed data using Wilcoxon matched-pairs and a Student’s paired t-test, respectively. The 90% CIs for the geometric mean ratios of the two pramipexole formulations were 95.89% (90.73%–101.34%, 95.53% (89.75%–101.68%, and 92.11% (84.35%–100.58% for AUC0-t, AUC0-∞, and Cmax, respectively. There were no statistically significant differences for tmax and t1/2 between the two pramipexole formulations. It is concluded that two pramipexole formulations in this study were bioequivalent.

  10. A Comparative Pharmacokinetics Study of the Anti-Parkinsonian Drug Pramipexole.

    Science.gov (United States)

    Putri, Ratih S I; Setiawati, Effi; Aziswan, Syifa A; Ong, Fenny; Tjandrawinata, Raymond R; Susanto, Liana W

    2016-11-18

    The present study aimed to compare pharmacokinetic parameters of two pramipexole 0.25 mg formulations in order to show bioequivalence. The study was conducted in a randomized, open-label, two-period, two-sequence, and crossover design, involving 23 healthy volunteers. One of the 0.25 mg formulations of pramipexole evaluated in the study was manufactured by PT Dexa Medica, Palembang, Indonesia, the other, used as the reference, by Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany. All eligible subjects were required to fast before each drug administration period, which was separated by a one-week washout period. Pramipexole concentrations in plasma were assayed using a validated ultra performance liquid chromatography with mass spectrometry (UPLC-MS/MS) detector. The evaluated pharmacokinetic parameters included the area under the plasma concentration curve from time zero to the last observed measurable concentration (AUC 0-t ), the area under the plasma concentration curve extrapolated to infinite time (AUC 0-∞ ), the maximum plasma concentration (C max ), the time to reach C max (t max ), and the plasma concentration half-life (t 1/2 ). To evaluate the bioequivalence of those two pramipexole formulations, 90% confidence intervals (CIs) for geometric mean ratios of both formulations were calculated for AUC and C max parameters, while t max and t 1/2 differences were analyzed on the non-transformed data using Wilcoxon matched-pairs and a Student's paired t -test, respectively. The 90% CIs for the geometric mean ratios of the two pramipexole formulations were 95.89% (90.73%-101.34%), 95.53% (89.75%-101.68%), and 92.11% (84.35%-100.58%) for AUC 0-t , AUC 0-∞ , and C max , respectively. There were no statistically significant differences for t max and t 1/2 between the two pramipexole formulations. It is concluded that two pramipexole formulations in this study were bioequivalent.

  11. 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

  12. Proposing the Use of Partial AUC as an Adjunctive Measure in Establishing Bioequivalence Between Deltoid and Gluteal Administration of Long-Acting Injectable Antipsychotics.

    Science.gov (United States)

    Lee, Lik Hang N; Choi, Charles; Gershkovich, Pavel; Barr, Alasdair M; Honer, William G; Procyshyn, Ric M

    2016-12-01

    The maximum plasma concentration (C max ) and the area under the plasma concentration-time curve (AUC) are commonly used to establish bioequivalence between two formulations of the same oral medication. Similarly, these pharmacokinetic parameters have also been used to establish bioequivalence between two sites of administration for the same injectable formulation. However, these conventional methods of establishing bioequivalence are of limited use when comparing modified-release formulations of a drug, particularly those with rates of absorption that are amenable to change with the site of injection. Inherent differences in the rate of absorption can result in clinically significant differences in early exposure and drug response. Here, we propose the use of the partial AUC (pAUC) as a measure of early exposure to aid in the assessment of bioequivalence between the gluteal and the deltoid site of administration for long-acting injectable antipsychotics.

  13. 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.

  14. Sodium ferric gluconate (SFG) in complex with sucrose for IV infusion: bioequivalence of a new generic product with the branded product in healthy volunteers.

    Science.gov (United States)

    Baribeault, David

    2011-08-01

    Parenteral sodium ferric gluconate in complex (Ferrlecit [branded SFG]) is used to treat patients with iron deficiency anemia undergoing chronic hemodialysis and receiving supplemental epoetin. This comparative pharmacokinetic study (GeneraMedix, Inc., Study 17909) evaluates whether the recently approved generic product Nulecit (generic SFG) and the branded product Ferrlecit (branded SFG) are bioequivalent. In this open-label study, 240 healthy volunteers in a fasting state were assigned randomly to a single 10-min intravenous (IV) infusion of 125 mg of generic or branded SFG. Total and transferrin-bound iron concentrations were determined for the 36-h period after infusion and corrected for pretreatment levels. Maximum concentration (Cmax) and area under the concentration-time curve of 0 to 36 h (AUC[0-36]) were compared between the two products. Demonstration of bioequivalence required that the 90% confidence intervals of each parameter evaluated for generic SFG were within 80% to 125% of the corresponding values for branded SFG. Uncorrected and baseline-corrected mean serum concentrations of total serum iron during the 36-h assessment period were similar for generic and branded SFG. For total serum iron, the geometric mean ratios of corrected Cmax and AUC[0-36] were 100%. For transferrin-bound iron, the geometric mean ratios were 87% for corrected Cmax and 92% for corrected AUC[0-36]. All associated 90% confidence intervals were within the range of 80% to 125%. A new generic SFG in complex for IV infusion is bioequivalent to the branded SFG in complex for IV infusion. The generic SFG is AB rated by the FDA and considered therapeutically equivalent to the branded product.

  15. 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.

  16. Validation of a Liquid Chromatography-Electrospray Ionization-Tandem Mass Spectrometry Method for Determination of All-Trans Retinoic Acid in Human Plasma and Its Application to a Bioequivalence Study

    Directory of Open Access Journals (Sweden)

    Jing-Bo Peng

    2014-01-01

    Full Text Available A sensitive, reliable and specific LC-MS-MS method was developed and validated for the identification and quantitation of all-trans retinoic acid (ATRA in human plasma. Acitretin was used as the internal standard (IS. After liquid-liquid extraction of 500 μL plasma with methyl tert-butyl ether (MTBE, ATRA and the IS were chromatographed on a HyPURITY C18 column (150 mm × 2.1 mm, 5 μm with the column temperature set at 40 °C. The mobile phase was consisted of 40% phase A (MTBE–methanol–acetic acid, 50:50:0.5, v/v and 60% phase B (water–methanol–acetic acid, 50:50:0.5, v/v with a flow rate of 0.3 mL/min. The API 4000 triple quadrupole mass spectrometer was operated in multiple reaction monitoring (MRM mode via the positive electrospray ionization interface using the transition m/z 301.4 → 123.1 for ATRA and m/z 326.9 → 177.1 for IS, respectively. The calibration curve was linear over the range of 0.45–217.00 ng/mL (r ≥ 0.999 with a lower limit of quantitation (LLOQ of 0.45 ng/mL. The intra- and inter-day precisions values were below 8% relative standard deviation and the accuracy was from 98.98% to 106.19% in terms of relative error. The validated method was successfully applied in a bioequivalence study of ATRA in Chinese healthy volunteers.

  17. 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.

  18. Large-volume injection of sample diluents not miscible with the mobile phase as an alternative approach in sample preparation for bioanalysis: an application for fenspiride bioequivalence.

    Science.gov (United States)

    Medvedovici, Andrei; Udrescu, Stefan; Albu, Florin; Tache, Florentin; David, Victor

    2011-09-01

    Liquid-liquid extraction of target compounds from biological matrices followed by the injection of a large volume from the organic layer into the chromatographic column operated under reversed-phase (RP) conditions would successfully combine the selectivity and the straightforward character of the procedure in order to enhance sensitivity, compared with the usual approach of involving solvent evaporation and residue re-dissolution. Large-volume injection of samples in diluents that are not miscible with the mobile phase was recently introduced in chromatographic practice. The risk of random errors produced during the manipulation of samples is also substantially reduced. A bioanalytical method designed for the bioequivalence of fenspiride containing pharmaceutical formulations was based on a sample preparation procedure involving extraction of the target analyte and the internal standard (trimetazidine) from alkalinized plasma samples in 1-octanol. A volume of 75 µl from the octanol layer was directly injected on a Zorbax SB C18 Rapid Resolution, 50 mm length × 4.6 mm internal diameter × 1.8 µm particle size column, with the RP separation being carried out under gradient elution conditions. Detection was made through positive ESI and MS/MS. Aspects related to method development and validation are discussed. The bioanalytical method was successfully applied to assess bioequivalence of a modified release pharmaceutical formulation containing 80 mg fenspiride hydrochloride during two different studies carried out as single-dose administration under fasting and fed conditions (four arms), and multiple doses administration, respectively. The quality attributes assigned to the bioanalytical method, as resulting from its application to the bioequivalence studies, are highlighted and fully demonstrate that sample preparation based on large-volume injection of immiscible diluents has an increased potential for application in bioanalysis.

  19. 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

  20. 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.

  1. Use of partial AUC to demonstrate bioequivalence of Zolpidem Tartrate Extended Release formulations.

    Science.gov (United States)

    Lionberger, Robert A; Raw, Andre S; Kim, Stephanie H; Zhang, Xinyuan; Yu, Lawrence X

    2012-04-01

    FDA's bioequivalence recommendation for Zolpidem Tartrate Extended Release Tablets is the first to use partial AUC (pAUC) metrics for determining bioequivalence of modified-release dosage forms. Modeling and simulation studies were performed to aid in understanding the need for pAUC measures and also the proper pAUC truncation times. Deconvolution techniques, In Vitro/In Vivo Correlations, and the CAT (Compartmental Absorption and Transit) model were used to predict the PK profiles for zolpidem. Models were validated using in-house data submitted to the FDA. Using dissolution profiles expressed by the Weibull model as input for the CAT model, dissolution spaces were derived for simulated test formulations. The AUC(0-1.5) parameter was indicative of IR characteristics of early exposure and effectively distinguished among formulations that produced different pharmacodynamic effects. The AUC(1.5-t) parameter ensured equivalence with respect to the sustained release phase of Ambien CR. The variability of AUC(0-1.5) is higher than other PK parameters, but is reasonable for use in an equivalence test. In addition to the traditional PK parameters of AUCinf and Cmax, AUC(0-1.5) and AUC(1.5-t) are recommended to provide bioequivalence measures with respect to label indications for Ambien CR: onset of sleep and sleep maintenance.

  2. 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.

  3. 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

  4. Comparison of parametric and bootstrap method in bioequivalence test.

    Science.gov (United States)

    Ahn, Byung-Jin; Yim, Dong-Seok

    2009-10-01

    The estimation of 90% parametric confidence intervals (CIs) of mean AUC and Cmax ratios in bioequivalence (BE) tests are based upon the assumption that formulation effects in log-transformed data are normally distributed. To compare the parametric CIs with those obtained from nonparametric methods we performed repeated estimation of bootstrap-resampled datasets. The AUC and Cmax values from 3 archived datasets were used. BE tests on 1,000 resampled datasets from each archived dataset were performed using SAS (Enterprise Guide Ver.3). Bootstrap nonparametric 90% CIs of formulation effects were then compared with the parametric 90% CIs of the original datasets. The 90% CIs of formulation effects estimated from the 3 archived datasets were slightly different from nonparametric 90% CIs obtained from BE tests on resampled datasets. Histograms and density curves of formulation effects obtained from resampled datasets were similar to those of normal distribution. However, in 2 of 3 resampled log (AUC) datasets, the estimates of formulation effects did not follow the Gaussian distribution. Bias-corrected and accelerated (BCa) CIs, one of the nonparametric CIs of formulation effects, shifted outside the parametric 90% CIs of the archived datasets in these 2 non-normally distributed resampled log (AUC) datasets. Currently, the 80~125% rule based upon the parametric 90% CIs is widely accepted under the assumption of normally distributed formulation effects in log-transformed data. However, nonparametric CIs may be a better choice when data do not follow this assumption.

  5. [Bioequivalence of dermatological topical medicines:the Brazilian scenario and the challenges for health surveillance].

    Science.gov (United States)

    Soares, Kelen Carine Costa; Moraes, Marcelo Vogler; Gelfuso, Guilherme Martins; Gratieri, Taís

    2015-11-01

    The comparative evaluation required for the registration of generic topical medicines in Brazil is conducted by means of a pharmaceutical equivalence study, which merely assesses the physical/chemical and microbiological parameters of the formulations. At the international level, clinical or pharmacodynamic studies are now being required to prove the efficacy and safety of semisolid topical generic formulations. This work presents a comparison of the different requirements for the registration of topical formulations, taking into consideration the various regulatory authorities, and presents a survey of topical medicines registered in Brazil prior to 2013. The survey revealed that in comparison with the USA there were many more copies of these formulations registered in Brazil. This fact, together with the large number of studies in the literature showing the lack of bioequivalence of topical medication, is clear proof of the major importance of the need to realign Brazilian legislation with respect to the technical requirements for the registration of generic and similar medication for dermatological topical application in Brazil.

  6. 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

  7. Method development and validation for naratriptan determination in human plasma by HPLC with tandem mass spectrometry detection, and its application to bioequivalence study

    Directory of Open Access Journals (Sweden)

    Balasekhara Reddy Challa

    2011-03-01

    Full Text Available The authors developed a simple, sensitive and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS method for the quantification of naratriptan (NP in human plasma using naratriptan-d3 (NPD3 as an internal standard (IS. Chromatographic separation was performed on a Zorbax SB-C18, 75 x 4.6 mm, 3.5 µm column with an isocratic mobile phase composed of 0.1% formic acid : acetonitrile (50:50 v/v, at a flow-rate of 0.6 mL/min. NP and NPD3 were detected with proton adducts at m/z 336.5→98.0 and 339.4→101.0 in selected reaction monitoring (SRM positive mode, respectively. The liquid-liquid extraction method was used to extract the NP and NPD3. This method was validated over a linear concentration range of 0.1-25.0 ng/mL with a correlation coefficient of (r2 > 0.9998. The Intra-day and Interday precision was found to be 1.8 to 3.6%, and 2.3 to 2.6%, and accuracy to be 101.7- 104.2% and 101.8 to 102.9%, respectively. NP was found to be stable throughout freeze-thaw (three cycles, bench top and auto sampler stability studies. This method was successfully applied for the analysis of plasma samples following oral administration of NP (2.5 mg in 31 healthy Indian male human volunteers under fasting conditions.Os autores desenvolveram um método simples, sensível e específico de cromatografia líquida-espectrometria de massa-tandem (LC-MS/MS para a quantificação de naratriptan (NP em plasma humano empregando naratriptan-d3 (NPD3 como padrão interno de referência (IS. A separação cromatográfica foi realizada em coluna Zorbax SB-C18, 75 x 4,6 mm, 3,5 μm com fase móvel isocrática composta por 0,1% ácido fórmico : acetronitrila (50:50 v/v e taxa de fluxo de 0,6 mL/min. NP e NPD3 foram detectados com adutos de prótons a m/z 336.5→98.0 e 339.4→101.0 in em modo positivo do tipo monitoramento de reação selecionada (SRM, respectivamente. Extração líquido-líquido foi empregada para extrair NP e NPD3, sendo o método validado

  8. Bioequivalence and in vitro antimicrobial activity between generic and brand-name levofloxacin.

    Science.gov (United States)

    Sun, Hsin-Yun; Liao, Hsiao-Wei; Sheng, Meng-Huei; Tai, Hui-Min; Kuo, Ching-Hua; Sheng, Wang-Huei

    2016-07-01

    Generic agents play a crucial role in reducing the cost of medical care in many countries. However, the therapeutic equivalence remains a great concern. Our study aims to assess the in vitro antimicrobial activity and bioequivalence between generic and brand-name levofloxacin. Enantiomeric purity test, dissolution test, and in vitro antimicrobial susceptibility against seven clinically important pathogens by the agar dilution method were employed to assess the similarity between four generic products and brand-name levofloxacin (Daiichi Sankyo). All the generic and brand-name levofloxacin passed enantiomeric purity test. The results of dissolution tests were not similar among the generic products and the brand-name levofloxacin. Compared with the generic products, the brand-name levofloxacin had the smallest mean variations (-25% to 13%) with reference standard (United States Pharmacopeia levofloxacin Reference Standards). Variations were observed particularly in dissolution profiles and in vitro activity between generic products and brand-name levofloxacin. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Mobile OS Comparative Study

    OpenAIRE

    Joseph, Jyothy; K, Shinto Kurian

    2013-01-01

    In the fast growing mobile revolutionary era, many operating systems are playing vital role in present market. This study is intending to identify the apt and secure mobile based on mobile operating systems capability and user requirements.

  10. 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.

  11. 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.

  12. 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.

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

    Directory of Open Access Journals (Sweden)

    Mona Zarifpour

    2017-05-01

    Full Text Available 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 T2-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.

  14. The impact of new partial AUC parameters for evaluating the bioequivalence of prolonged-release formulations.

    Science.gov (United States)

    Boily, Michaël; Dussault, Catherine; Massicotte, Julie; Guibord, Pascal; Lefebvre, Marc

    2015-01-23

    To demonstrate bioequivalence (BE) between two prolonged-release (PR) drug formulations, single dose studies under fasting and fed state as well as at least one steady-state study are currently required by the European Medicines Agency (EMA). Recently, however, there have been debates regarding the relevance of steady-state studies. New requirements in single-dose investigations have also been suggested by the EMA to address the absence of a parameter that can adequately assess the equivalence of the shape of the curves. In the draft guideline issued in 2013, new partial area under the curve (pAUC) pharmacokinetic (PK) parameters were introduced to that effect. In light of these potential changes, there is a need of supportive clinical evidence to evaluate the impact of pAUCs on the evaluation of BE between PR formulations. In this retrospective analysis, it was investigated whether the newly defined parameters were associated with an increase in discriminatory ability or a change in variability compared to the conventional PK parameters. Among the single dose studies that met the requirements already in place, 20% were found unable to meet the EMA's new requirements in regards to the pAUC PK parameters. When pairing fasting and fed studies for a same formulation, the failure rate increased to 40%. In some cases, due to the high variability of these parameters, an increase of the sample size would be required to prove BE. In other cases however, the pAUC parameters demonstrated a robust ability to detect differences between the shapes of the curves of PR formulations. The present analysis should help to better understand the impact of the upcoming changes in European regulations on PR formulations and in the design of future BE studies. Copyright © 2014 Elsevier B.V. All rights reserved.

  15. Bioequivalence of fixed-dose combination Myrin®-P Forte and reference drugs in loose combination.

    Science.gov (United States)

    Wang, H F; Wang, R; O'Gorman, M; Crownover, P; Naqvi, A; Jafri, I

    2013-12-01

    Myrin®-P Forte is a fixed-dose combination (FDC) tablet containing rifampicin (RMP, 150 mg), isoniazid (INH, 75 mg), ethambutol (EMB) hydrochloride (275 mg) and pyrazinamide (PZA, 400 mg) developed for the treatment of tuberculosis (TB). This study was conducted at a single centre--the Pfizer Clinical Research Unit in Singapore. To demonstrate the bioequivalence of each drug component of the Myrin-P Forte FDC and the individual product in loose combination. In a randomized, open-label, single-dose, two-way, crossover study, subjects received single doses of Myrin-P Forte or four individual products under fasting conditions in a crossover fashion with at least 7 days washout between doses. The primary measures for comparison were peak plasma concentration (C(max)) and the area under plasma concentration-time curve (AUC). Of 36 subjects enrolled, 35 completed the study. The adjusted geometric mean ratios and 90% confidence intervals for C(max) and AUC values were completely contained within bioequivalence limits (80%, 125%) for all four drugs in both formulations. Both treatments were generally well tolerated in the study. The Myrin-P Forte FDC tablet formulation is bioequivalent to the four single-drug references for RMP, INH, EMB hydrochloride and PZA at equivalent doses.

  16. Bioequivalence of fixed-dose combination RIN®-150 to each reference drug in loose combination.

    Science.gov (United States)

    Wang, H F; Wang, R; O'Gorman, M; Crownover, P; Damle, B

    2015-03-01

    RIN(®)-150 is a fixed-dose combination (FDC) tablet containing rifampicin (RMP, 150 mg) and isoniazid (INH, 75 mg) developed for the treatment of tuberculosis. This study was conducted at a single center: the Pfizer Clinical Research Unit in Singapore. To demonstrate bioequivalence of each drug component between RIN-150 and individual products in a loose combination. This was a randomized, open-label, single-dose, two-way crossover study. Subjects received single doses of RIN-150 or two individual reference products under fasting conditions in a crossover fashion, with at least 7 days washout between doses. The primary measures for comparison were peak plasma concentration (Cmax) and the area under plasma concentration-time curve (AUC). Of 28 subjects enrolled, 26 completed the study. The adjusted geometric mean ratios of Cmax and AUClast between the FDC and single-drug references and 90% confidence intervals were respectively 91.63% (90%CI 83.13-101.01) and 95.45% (90%CI 92.07-98.94) for RMP, and 107.58% (90%CI 96.07-120.47) and 103.45% (90%CI 99.33-107.75) for INH. Both formulations were generally well tolerated in this study. The RIN-150 FDC tablet formulation is bioequivalent to the two single-drug references for RMP and INH at equivalent doses.

  17. Comparative bioavailability and pharmacokinetics of two oral formulations of flurbiprofen: a single-dose, randomized, open-label, two-period, crossover study in Pakistani subjects.

    Science.gov (United States)

    Qayyum, Aisha; Najmi, Muzammil Hasan; Abbas, Mateen

    2013-11-01

    Comparative bioavailability studies are conducted to establish the bioequivalence of generic formulation with that of branded reference formulation, providing confidence to clinicians to use these products interchangeably. This study was carried out to compare a locally manufactured formulation of flurbiprofen with that of a branded product. Twenty two healthy male adults received a single dose of flurbiprofen (100mg) either generic or branded product according to randomization scheme on each of 2 periods. Blood samples were collected and plasma flurbiprofen concentration was determined by a validated HPLC method. Pharmacokinetic parameters like AUC(0-t), AUC(0-oo), Cmax, Tmax, t½, Vd and clearance were determined. The 90% CI for the ratio of geometric means of test to reference product's pharmacokinetic variables was calculated. Pharmacokinetic parameters for two formulations were comparable. Ratio of means of AUC(0-24), AUC(0-oo) and Cmax for test to reference products and 90% CI for these ratios were within the acceptable range. The p-values calculated by TOST were much less than the specified value (p-0.05). ANOVA gave p-values which were more than the specified value (p-0.05) for sequence, subject, period and formulation. Test formulation of flurbiprofen (tablet Flurso) was found to meet the criteria for bioequivalence to branded product (tablet Ansaid) based on pharmacokinetic parameters.

  18. Regulatory and clinical aspects of psychotropic medicinal products bioequivalence.

    Science.gov (United States)

    Bałkowiec-Iskra, Ewa; Cessak, Grzegorz; Kuzawińska, Olga; Sejbuk-Rozbicka, Katarzyna; Rokita, Konrad; Mirowska-Guzel, Dagmara

    2015-07-01

    Introduction of generic medicinal products to the market has increased access to modern therapies but also enabled significant reduction in their cost, leading to containment of public expenditures on medicinal products reimbursement. The critical assessment of bioequivalence of any reference medicinal product and its counterpart is based on comparison of their rate and extent of absorption. It is assumed that two medicinal products are bioequivalent when their rate and extent of absorption do not show significant differences when administered at the same dose under similar experimental conditions. Bioequivalent medicinal products are declared to be also therapeutically equivalent and can be used interchangeably. However, despite regulatory declaration, switching from reference to generic drugs is often associated with concerns of healthcare providers about decreased treatment effectiveness or occurrence of adverse drug reactions. The aim of this article is to provide a description of rules that guide registration of generic medicinal products in the European Union and to analyze specific examples from the scientific literature concerning therapeutic equivalence of reference and generic antidepressant and antipsychotic medicinal products. Copyright © 2015 Elsevier B.V. and ECNP. All rights reserved.

  19. Development of a new benazepril hydrochloride chewable tablet and evaluation of its bioequivalence for treatment of heart failure in dogs.

    Science.gov (United States)

    Qian, M; Chen, T; Zhou, D; Zhang, Z; Zhang, Q; Tang, S; Xiao, X

    2016-02-01

    The aim of the study was to develop a new chewable benazepril hydrochloride(BH) tablet, investigate its physical properties, and evaluate its bioequivalence with the branded formulation (Fortekor). A corrective agent was included in the formula to improve its palatability and convenience for administration to dogs. The tablet remained stable in light, heat, and humidity tests, and its physical properties such as hardness, uniformity of content, and dissolution rate were highly consistent with the technical standards. After single and repeated administrations to eight beagles and single dose to 14 mongrel dogs (0.5 mg/kg p.o.), plasma BH and its active metabolite, benazeprilat (BZ), were detected. There was no significant difference in the major pharmacokinetic parameters (Cmax , Tmax, and AUC₀₋₂₄) between the two formulations. The 90% confidence intervals calculated for the ratios of area under the time-concentration curve (AUC₀₋₂₄) were 92.4-116.3% for BH and 89.9-102.3% for BZ, within the accepted range for bioequivalence of 80-125%. The results showed our new chewable tablet is bioequivalent to the commercial product and suitable for addition to the benazepril product family for the treatment of heart failure in dogs. © 2015 John Wiley & Sons Ltd.

  20. 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

  1. 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.

  2. [Comparative studies of face recognition].

    Science.gov (United States)

    Kawai, Nobuyuki

    2012-07-01

    Every human being is proficient in face recognition. However, the reason for and the manner in which humans have attained such an ability remain unknown. These questions can be best answered-through comparative studies of face recognition in non-human animals. Studies in both primates and non-primates show that not only primates, but also non-primates possess the ability to extract information from their conspecifics and from human experimenters. Neural specialization for face recognition is shared with mammals in distant taxa, suggesting that face recognition evolved earlier than the emergence of mammals. A recent study indicated that a social insect, the golden paper wasp, can distinguish their conspecific faces, whereas a closely related species, which has a less complex social lifestyle with just one queen ruling a nest of underlings, did not show strong face recognition for their conspecifics. Social complexity and the need to differentiate between one another likely led humans to evolve their face recognition abilities.

  3. Comparative bioavailability and tolerability of a single 20-mg dose of two fluoxetine hydrochloride dispersible tablet formulations in fasting, healthy Chinese male volunteers: an open-label, randomized-sequence, two-period crossover study.

    Science.gov (United States)

    Shi, Shaojun; Liu, Yani; Wu, Jianhong; Li, Zhongfang; Zhao, Yan; Zhong, Dafang; Zeng, Fandian

    2010-10-01

    The proprietary formulation of fluoxetine hydrochloride is an antidepressant of the selective serotonin reuptake inhibitor class. Pharmacokinetic studies investigating the bioequivalence of generic and branded formulations are needed to market generic fluoxetine in China. The aim of this study was to compare the bioavailability and tolerability of the proposed generic formulation with the established reference formulation of fluoxetine hydrochloride 20 mg in a fasting, healthy Chinese male population. This 10-week, open-label, randomized-sequence, single-dose, 2-period crossover study was conducted in healthy native Han Chinese male volunteers. Eligible subjects were randomly assigned in a 1:1 ratio to receive a single 20-mg dose of the test or reference formulation, followed by a 35-day washout period and administration of the alternate formulation. Doses were administered after a 12-hour overnight fast. For analysis of pharmacokinetic properties (including C(max), T(max), AUC(0-t), AUC(0-∞), and t(½)), blood samples were obtained over a 672-hour period after dosing. Plasma concentrations of fluoxetine and its active metabolite, norfluoxetine, were analyzed using a validated LC-MS/MS method. The formulations were to be considered bioequivalent if the ln-transformed ratios (test/ reference) of C(max) and AUC were within the predetermined bioequivalence range of 80% to 125%, as established by the US Food and Drug Administration, and if the P values were fasting, healthy Chinese male volunteers. Both formulations appeared to be well tolerated. Copyright © 2010 Excerpta Medica Inc. All rights reserved.

  4. Bioequivalence assessment of two formulations of ibuprofen

    KAUST Repository

    Al-Talla, Zeyad; Akrawi, Sabah H; Tolley, Luke T; Sioud, Salim H; Zaater, Mohammed F; Emwas, Abdul-Hamid M

    2011-01-01

    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

  5. 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

    2018-06-01

    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.
.

  6. Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products

    DEFF Research Database (Denmark)

    Yacobi, Avraham; Shah, Vinod P; Bashaw, Edward D

    2014-01-01

    This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry and regulatory agencies to discuss current regulatory issues and industry practices for establishing therapeutic bioequivalence (BE) of dermatologic...

  7. Comparative study of dihydroartemisinin and artesunate safety in healthy Thai volunteers.

    Science.gov (United States)

    Kongpatanakul, S; Chatsiricharoenkul, S; Khuhapinant, A; Atipas, S; Kaewkungwal, J

    2009-09-01

    As part of new drug development initiatives in Thailand, a new tablet formulation of dihydroartemisinin (DHA, an antimalarial drug) has been developed. Our previous bioequivalence study indicated that the new and reference DHA formulations were well tolerated; however, a significant decrease in hemoglobin was detected after a single 200-mg oral dose. To explore further, a clinical study with an emphasis on hematological parameters was conducted. A single-center, randomized, single-blind, cross-over clinical study was conducted in 18 healthy volunteers with a dosage of 300 mg daily for 2 days. Artesunate was used as a comparator. Adverse events were monitored and laboratory parameters on study Days 0, 2, 5, and 7 post drug administrations were analyzed. Eighteen volunteers completed both rounds of the study. Both drugs were well tolerated. All adverse events were mild. Significant decrease in hemoglobin compared to baseline was detected for both drugs 7 days after administration (DHA: 0.48 g/dl, p = 0.007; artesunate 0.38 g/dl, p = 0.001). Transient bone marrow suppression was evidenced by reduction of reticulocytes with a lowest number on study Day 5 (artesunate 75% reduction in reticulocyte count; DHA 47%, p < 0.001 for both drugs compared to baseline). The present study confirmed our previous finding on significant decrease in hemoglobin. Artesunate appeared to have more negative effects on the numbers of reticulocytes and white blood cells than DHA. Systemic laboratory and toxicity profiles presented in this study may be used as a framework for future clinical studies of artemisinin and its derivatives.

  8. Sex work: a comparative study.

    Science.gov (United States)

    McCarthy, Bill; Benoit, Cecilia; Jansson, Mikael

    2014-10-01

    Explanations of adult involvement in sex work typically adopt one of two approaches. One perspective highlights a variety of negative experiences in childhood and adolescence, including physical and sexual abuse, family instability, poverty, associations with "pimps" and other exploiters, homelessness, and drug use. An alternative account recognizes that some of these factors may be involved, but underscores the contribution of more immediate circumstances, such as current economic needs, human capital, and employment opportunities. Prior research offers a limited assessment of these contrasting claims: most studies have focused exclusively on people working in the sex industry and they have not assessed the independent effects of life course variables central to these two perspectives. We add to this literature with an analysis that drew on insights from life course and life-span development theories and considered the contributions of factors from childhood, adolescence, and adulthood. Our comparative approach examined predictors of employment in sex work relative to two other low-income service or care work occupations: food and beverage serving and barbering and hairstyling. Using data from a study of almost 600 workers from two cities, one in Canada and the other in the United States, we found that both immediate circumstances and negative experiences from early life are related to current sex work involvement: childhood poverty, abuse, and family instability were independently associated with adult sex work, as were limited education and employment experience, adult drug use, and marital status.

  9. 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.

  10. Comparative bioavailability of rifampicin, isoniazid and pyrazinamide from a four drug fixed dose combination with separate formulations at the same dose levels.

    Science.gov (United States)

    Agrawal, Shrutidevi; Singh, Inderjit; Kaur, Kanwal Jit; Bhade, Shantaram R; Kaul, Chaman Lal; Panchagnula, Ramesh

    2004-05-19

    Fixed dose combination (FDC) formulations became popular in the treatment of tuberculosis (TB) because of the better patient compliance, reduced risk of monotherapy and emergence of drug resistance in contrast to treatment with separate formulations of two to four first-line drugs. However, its successful implementation in national programs is limited by probable bioinequivalency of rifampicin if present in FDC form. In this regard, World Health Organization (WHO) and International Union Against Tuberculosis and Lung Disease (IUATLD) recommend FDCs only of proven bioavailability. Hence, bioequivalence study of four drug FDC tablet was conducted using 22 healthy male volunteers according to WHO recommended protocol to determine bioavailability of rifampicin, isoniazid and pyrazinamide compared to standard separate combination at the same dose level. The study was designed as two period, two treatment crossover experiment with a washout period of 1 week. Bioequivalence of rifampicin was estimated by plasma and urinary method for both rifampicin and its active metabolite, des-acetyl rifampicin whereas isoniazid and pyrazinamide were estimated from plasma. Mean concentration time profiles and all the pharmacokinetic parameters of rifampicin, isoniazid and pyrazinamide from FDC tablet were comparable to individual formulations and passed the bioequivalence test with power of the test above 95%. Further, bioequivalence of both rifampicin and isoniazid shows that in vitro interaction of rifampicin and isoniazid is clinically insignificant. Thus, it was concluded that FDC formulation is bioequivalent for rifampicin, isoniazid and pyrazinamide and ensures the successful treatment of TB without compromising therapeutic efficacy of any of these components of anti-TB therapy.

  11. Use of an in vitro human skin permeation assay to assess bioequivalence of two topical cream formulations containing butenafine hydrochloride (1%, w/w).

    Science.gov (United States)

    Mitra, Amitava; Kim, Nanhye; Spark, Darren; Toner, Frank; Craig, Susan; Roper, Clive; Meyer, Thomas A

    2016-12-01

    The primary objective of this work was to investigate, using an in vitro human skin permeation study, whether changes in the excipients of butenafine hydrochloride cream would have any effect on bioperformance of the formulation. Such in vitro data would be a surrogate for any requirement of a bioequivalence (BE) study to demonstrate formulation similarity. A LC-MS/MS method for quantitation of butenafine in various matrices was developed and validated. A pilot study was performed to validate the in vitro skin permeation methodology using three cream formulations containing butenafine hydrochloride at concentrations of 0.5, 1.0 and 1.5% (w/w). Finally, a definitive in vitro human skin permeation study was conducted, comparing the extent of butenafine hydrochloride permeation from the new formulation to that from the current formulation. The results of the study comparing the two formulations showed that there was no statistically significant difference in the extent of butenafine permeation into human skin. In conclusion, these in vitro data demonstrated that the formulation change is likely to have no significant impact on the bioperformance of 1% (w/w) butenafine hydrochloride cream. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Comparative study Beamnrc VS Pinnacle

    International Nuclear Information System (INIS)

    Moreno Reyes, J. C.; Macias Jaen, J.; Jimenez Ortega, E.

    2013-01-01

    Has been developed in JAVA a software application called JJGAMMA, capable of manipulating the environment BEAMNRC and Pinnacle output formats 3 , comfortable, fast and accurately. As particular application you can use to compare dose distributions (plans for treatments, checking fields for modeling and clinical accelerators Commissioner) using, as objective criteria, function or Gamma index. (Author)

  13. 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

  14. 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.

  15. Comparative in vitro and in vivo evaluation of three tablet formulations of amiodarone in healthy subjects

    Directory of Open Access Journals (Sweden)

    J Emami

    2010-09-01

    Full Text Available "nBackground and the purpose of the study:The relative in vivo bioavailability and in vitro dissolution studies of three chemically equivalent amiodarone generic products in healthy volunteers was evaluated in three separate occasions. The possibility of a correlation between in vitro and in vivo performances of these tablet formulations was also evaluated. "nMethods: The bioequivalence studies were conducted based on a single dose, two-sequence, cross over randomized design. The bioavailability was compared using AUC0-72, AUC0-∞, Cmax and Tmax. Similarity factor, dissolution efficiency (DE, and mean dissolution time (MDT was used to compare the dissolution profiles. Polynomial linear correlation models were tested using either MDT vs mean residence time (MRT or fraction of the drug dissolved (FRD vs fraction of the drug absorbed (FRA. "nResults: Significant differences were found in the dissolution performances of the tested formulations and therefore they were included in the development of the correlation. The 90% confidence intervals of the log-transformed AUC0-72, AUC0-∞, and Cmax of each two formulations in each bioequivalence studies were within the acceptable range of 80-125%. Differences were not observed between the untransformed Tmax values. Poor correlation was found between MRT and MDT of the products. A point-to-point correlation which is essential for a reliable correlation was not obtained between pooled FRD and FRA. The dissolution condition which was used for amiodarone tablets failed for formulations which were bioequivalent in vivo and significant difference between the dissolution characteristics of products (f2<50 did not reflect their in vivo properties. Major conclusions: Bioequivalence studies should be considered as the only acceptable way to ensure the interchangeability and in vivo equivalence of amiodarone generic drug products. The dissolution conditions used of the present study could be used for routine and in

  16. Benchmarked Library Websites Comparative Study

    KAUST Repository

    Ramli, Rindra M.; Tyhurst, Janis

    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.

  17. 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.

  18. Comparative study of Butterfly valves

    International Nuclear Information System (INIS)

    Galmes Belmonte, F.B.

    1998-01-01

    This work tries to justify the hydrodynamic butterfly valves performance, using the EPRI tests, results carried out in laboratory and in situ. This justification will be possible if: - The valves to study are similar - Their performance is calculated using EPRI's methodology Looking for this objective, the elements of the present work are: 1. Brief EPRI butterfly valve description it wild provide the factors which are necessary to define the butterfly valves similarity. 2. EPRI tests description and range of validation against test data definition. 3. Description of the spanish butterfly analyzed valves, and comparison with the EPRI performance results, to prove that this valves are similar to the EPRI test valves. In this way, it will not be necessary to carry out particular dynamic tests on the spanish valves to describe their hydrodynamic performance. (Author)

  19. 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

  20. Investigation of Bioequivalence Between Brand-name and Generic Irinotecan Products.

    Science.gov (United States)

    Saito, Ken-Ichi; Inoue, Yutaka; Ikegami, Yoji; Nanbo, Izumi; Onozuka, Mari; Sano, Kazumi; Yoshida, Hisahiro; Sakamoto, Toshihiro; Tatebayashi, Emi; Fujita, Ken-Ichi; Sasaki, Yasutsuna; Kitazawa, Takaki

    2016-11-01

    To investigate bioequivalence among generic and brand-name irinotecan products. Products of Yakult and Daiichi-Sankyo (brand-name products), Sandoz, Nippon Kayaku, Taiho, and Sawai were compared with respect to their composition and antitumor activity. High-performance liquid chromatography demonstrated that related substances were within the acceptable range. The 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay revealed significant differences in cytotoxicity for four cancer cell lines among the products. The concentration of the active compound SN-38 was highest in Yakult's product (23.82 ng/ml) and lowest in Daiichi-Sankyo's product (8.96 ng/ml). MTT assay data were correlated with the SN-38 concentration, suggesting that it influenced differences in cytocidal activity among products. However, the SN-38 concentration was far lower than that of irinotecan (20 mg/ml), suggesting a negligible clinical effect. Metabolism of irinotecan to SN-38 or open-ring forms did not differ significantly among the products. The generic products showed equivalent efficacy and safety to the brand-name products. Copyright© 2016 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

  1. 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

  2. Semi-physiologic model validation and bioequivalence trials simulation to select the best analyte for acetylsalicylic acid.

    Science.gov (United States)

    Cuesta-Gragera, Ana; Navarro-Fontestad, Carmen; Mangas-Sanjuan, Victor; González-Álvarez, Isabel; García-Arieta, Alfredo; Trocóniz, Iñaki F; Casabó, Vicente G; Bermejo, Marival

    2015-07-10

    The objective of this paper is to apply a previously developed semi-physiologic pharmacokinetic model implemented in NONMEM to simulate bioequivalence trials (BE) of acetyl salicylic acid (ASA) in order to validate the model performance against ASA human experimental data. ASA is a drug with first-pass hepatic and intestinal metabolism following Michaelis-Menten kinetics that leads to the formation of two main metabolites in two generations (first and second generation metabolites). The first aim was to adapt the semi-physiological model for ASA in NOMMEN using ASA pharmacokinetic parameters from literature, showing its sequential metabolism. The second aim was to validate this model by comparing the results obtained in NONMEM simulations with published experimental data at a dose of 1000 mg. The validated model was used to simulate bioequivalence trials at 3 dose schemes (100, 1000 and 3000 mg) and with 6 test formulations with decreasing in vivo dissolution rate constants versus the reference formulation (kD 8-0.25 h (-1)). Finally, the third aim was to determine which analyte (parent drug, first generation or second generation metabolite) was more sensitive to changes in formulation performance. The validation results showed that the concentration-time curves obtained with the simulations reproduced closely the published experimental data, confirming model performance. The parent drug (ASA) was the analyte that showed to be more sensitive to the decrease in pharmaceutical quality, with the highest decrease in Cmax and AUC ratio between test and reference formulations. Copyright © 2015 Elsevier B.V. All rights reserved.

  3. 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...

  4. The free fractions of circulating docosahexaenoic acid and eicosapentenoic acid as optimal end-point of measure in bioavailability studies on n-3 fatty acids.

    Science.gov (United States)

    Scarsi, Claudia; Levesque, Ann; Lisi, Lucia; Navarra, Pierluigi

    2015-05-01

    The high complexity of n-3 fatty acids absorption process, along with the huge amount of endogenous fraction, makes bioavailability studies with these agents very challenging and deserving special consideration. In this paper we report the results of a bioequivalence study between a new formulation of EPA+DHA ethyl esters developed by IBSA Institut Biochimique and reference medicinal product present on the Italian market. Bioequivalence was demonstrated according to the criteria established by the EMA Guideline on the Investigation of Bioequivalence. We found that the free fractions represent a better and more sensitive end-point for bioequivalence investigations on n-3 fatty acids, since: (i) the overall and intra-subject variability of PK parameters was markedly lower compared to the same variability calculated on the total DHA and EPA fractions; (ii) the absorption process was completed within 4h, and the whole PK profile could be drawn within 12-15 h from drug administration. Copyright © 2014 Elsevier Ltd. All rights reserved.

  5. Bioequivalence and food effect assessment for vildagliptin/metformin fixed-dose combination tablets relative to free combination of vildagliptin and metformin in Japanese healthy subjects.

    Science.gov (United States)

    Mita, Sachiko; Chitnis, Shripad D; Kulmatycki, Kenneth; Salunke, Atish; He, Yan-Ling; Zhou, Wei; Suzuki, Hikoe

    2016-04-01

    To assess the bioequivalence of vildagliptin/metformin fixeddose combination (FDC) tablets (50/250 mg and 50/500 mg) to free combinations of vildagliptin and metformin and the effect of food on the pharmacokinetics (PK) of vildagliptin and metformin following administration of 50/500 mg FDC tablets. Two openlabel, randomized, single-center, singledose, 2-period crossover studies were conducted in Japanese healthy male volunteers. Participants were administered vildagliptin/ metformin FDC tablets (study I: 50/250 mg, study II: 50/500 mg) or their free combinations under fasted condition. Food effect (standard Japanese breakfast: fat, 20 - 30% with ~ 600 kcal in total) was assessed during an additional period in study II (50/500 mg). PK parameters (AUC, C(max), t(max), t(1/2)) were calculated for vildagliptin and metformin. In both studies, vildagliptin/metformin FDC tablets were bioequivalent to their respective free combinations. Administration of FDC tablets after meals had no effect on vildagliptin PK parameters. The rate of absorption of metformin decreased when administered under fed condition, as reflected by a prolonged t(max) (3 hours in fasted state vs. 4 hours in fed state) and decrease in C(max) by 26%, however, the extent of absorption (AUC(last)) was similar to that in the fasted state. Vildagliptin/metformin FDC tablets were bioequivalent to their free combinations. Food decreased the C(max) of metformin by 26%, while AUC(last) was unchanged, consistent with previous reports. No food effect was observed on the C(max) or AUC(last) of vildagliptin. Thus, food had no clinically relevant effects on the PK of metformin or vildagliptin.

  6. 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.

  7. 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.

  8. A randomized two-way crossover comparative pharmacokinetic study of two different tablet formulations containing ilaprazole in healthy human Indian volunteers

    Directory of Open Access Journals (Sweden)

    Shubhasis Dan

    2014-01-01

    Full Text Available Background: Proton Pump Inhibitors (PPI are observed to be great healer in gastroesophageal reflux disorder (GERD and duodenal ulcer. Quantification of the drugs in human plasma by validated bioanalytical method are very important to determine pharmacokinetic parameters for undergoing comparative study with standard available formulations to make the newer one commercially available. Objective: The objective of this study was to determine the relative bioavailability of Ilaprazole, a novel PPI comparing the test formulation to the reference one according to standard regulatory guidelines. Materials and Methods: The bioequivalence of two tablet formulations, one as reference and other as test containing 10 mg of ilaprazole [CAS No. 172152-36-2] was studied in 12 healthy Indian volunteers. This was a single dose, twoperiod and randomized crossover study separated with a washout period of one week. Plasma samples for pharmacokinetic analysis were collected before dosing and at pre-specified time points after dosing. The concentration of ilaprazole in plasma was determined by a validated HPLC-UV method using theophylline as internal standard. The formulations were compared using the parameters Area under the plasma concentration-time curve (AUC 0-t , Area under the plasma concentration-time curve from zero to infinity (AUC 0-͵, Peak plasma concentration (C max , and time to reach peak plasma concentration (t max . Results: Mean AUC 0-t of test and reference product were calculated to be 2627.793 ± 154.989 ng h ml−1 and 2555.905 ± 225.916 ng h ml−1 , with a C max of 347.459 ± 48.175 ng h ml−1 . While mean AUC 0-͵ of test and reference product were calculated to be 2733.334 ± 242.438 ng h ml−1 and 2728.716 ± 284.408 ng h ml−1 . Conclusion: The results of this investigation indicated no statistically significant differences between the logarithmic transformed AUC 0-͵ and C max values of the two preparations. The 90% confidence

  9. 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 ...

  10. Bioequivalence of 250 mg lysine clonixinate tablets after a single oral dose in a healthy female Mexican population under fasting conditions.

    Science.gov (United States)

    Marcelín-Jiménez, G; Angeles, A C P; García, A; Morales, M; Rivera, L; Martín-Del-Campo, A

    2010-05-01

    To evaluate the bioequivalence between two 250 mg-tablets of lysine clonixinate, Dorixina Forte (Siegfried Rhein, México) as reference product, and Prestodol (Farmaceúticos Rayere, S.A., México) as test formulation. 26 healthy adult female Mexican volunteers received a single oral dose of 250-mg lysine clonixinate under fasting conditions. The drug was administered following a randomized, two-period, two-sequence, cross-over design. Twelve serial blood samples were collected up to 8 h after dosing, and clonixin (CLX) was measured by ultra-performance liquid chromatography (UPLC) coupled with tandem mass spectrometry. Decimal logarithm values of Cmax and area under the curve (AUC) were used to construct a classic confidence interval at 90% (90% CI). Bioequivalence was established if 90% CI of mean ratios (test/reference) fall within the 0.8-1.25 range. Volunteers formed a homogeneous population in terms of age (27.2 +/- 6.3 years), weight (55.9 +/- 6.5 kg), height (1.6 +/- 0.04 m), and body mass index (BMI) (22.91 +/- 2.03 kg/m(2)). Reference formulation exhibited the following pharmacokinetics: C(max) (32.39 +/- 8.32 microg/ml); t(max) (0.64 +/- 0.2 h); AUC0-8h (48.92 +/- 16.51 microg x h/ml); t1/2 (1.3 +/- 0.24 h); CLapp (5.64 +/- 1.99 l/h), and Vdapp (10.22 +/- 2.9 l). Concerning bioequivalence, 90% CI were: C(max) (82.32 - 98.79), AUC0-t (94.59-106.29), and AUC(0-inf) (94.61-106.42), with a statistical power of > 0.90 at every tested interval. This single-dose study found that both 250-mg immediate-release tablets of lysine clonixinate met the Mexican regulatory criteria for bioequivalence in these volunteers.

  11. Investigation of bioequivalence of a new fixed-dose combination of nifedipine and candesartan with the corresponding loose combination as well as the drug-drug interaction potential between both drugs under fasting conditions.

    Science.gov (United States)

    Brendel, Erich; Weimann, Boris; Dietrich, Hartmut; Froede, Christoph; Thomas, Dirk

    2013-09-01

    To determine the bioequivalence of a nifedipine and candesartan fixed-dose combination (FDC) with the corresponding loose combination, and to investigate the pharmacokinetic drug-drug interaction potential between both drugs. 49 healthy, white, male subjects received: 60 mg nifedipine and 32 mg candesartan FDC, the loose combination of 60 mg nifedipine GITS and 32 mg candesartan, 60 mg nifedipine GITS alone, or 32 mg candesartan alone in a randomized, non-blinded, 4-period, 4-way crossover design with each dosing following overnight fasting. Treatment periods were separated by washout periods of ≥ 5 days. Plasma samples were collected for 48 hours after dosing and assayed using a validated LC-MS/MS method. Bioequivalence between the FDC and the loose combination as well as the impact of combined treatment with both drugs on candesartan pharmacokinetics was evaluated in 47 subjects, while the corresponding impact of treatment with both drugs on nifedipine pharmacokinetics was assessed in 46 patients. For AUC(0-tlast) and Cmax the 90% confidence intervals (CIs) for the ratios of the FDC vs. the corresponding loose combination were within the acceptance range for bioequivalence of 80 - 125%. When comparing AUC(0-tlast) and Cmax of nifedipine and candesartan after dosing with the loose combination vs. each drug alone, the 90% CIs remained within the range of 80 - 125% indicating the absence of a clinically relevant pharmacokinetic drug-drug interaction. Nifedipine and candesartan as well as the combinations were well tolerated. The FDC containing 60 mg nifedipine and 32 mg candesartan was bioequivalent to the corresponding loose combination following single oral doses under fasting conditions. No clinically relevant pharmacokinetic drug-drug interaction between nifedipine and candesartan was observed.

  12. 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.

  13. 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 ...

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

    Indian Academy of Sciences (India)

    Unknown

    Page 1. 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.

  15. Comparative Studies: historical, epistemological and methodological notes

    Directory of Open Access Journals (Sweden)

    Juan Ignacio Piovani

    2017-09-01

    Full Text Available In this article some historical, epistemological and methodological issues related to comparative studies in the social sciences are addressed, with specific reference to the field of education. The starting point is a discussion of the meaning of comparison, its logical structure and its presence in science and in everyday life. It follows the presentation and critical appraisal of the perspectives regarding comparison as a scientific method. It is argued that, even rejecting this restrictive meaning of comparison as a method, there is some consensus on the specificity of comparative studies within the social sciences. And in relation to them, the article address in more detail those studies that can be defined as trans-contextual (cross-national and cross-cultural, with emphasis on the main methodological and technical challenges they face. The socio-historical comparative perspective, which has gained importance in recent years in the field of education, is also discussed.

  16. 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...... 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...... 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...

  17. 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...

  18. 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.

  19. Comparative study of quantum anharmonic potentials

    International Nuclear Information System (INIS)

    Amore, Paolo; Aranda, Alfredo; De Pace, Arturo; Lopez, Jorge A.

    2004-01-01

    We perform a study of various anharmonic potentials using a recently developed method. We calculate both the wave functions and the energy eigenvalues for the ground and first excited states of the quartic, sextic and octic potentials with high precision, comparing the results with other techniques available in the literature

  20. Comparative study of potato cultivation through micropropagation ...

    African Journals Online (AJOL)

    sonu

    Comparative study of potato cultivation through micropropagation and conventional farming methods .... and Murate potash were used as fertilizer source of nitrogen, phosphorus and potassium, respectively (Table 1) ..... through Tissue culture- Application and Feasibility. U.S.D.A.,. Beltsville. Agric. Res. Sci. Educ. Admin.

  1. AMERICAN EDUCATION SYSTEM: A COMPARATIVE STUDY

    OpenAIRE

    BAS, Gökhan

    2016-01-01

    The purpose of this study was to introduce the Education System of the United States of America (USA) and to compare it with the Turkish Education System. The Education System of the United States of America was held from different factors (e.g., education structure, curriculum and instruction, principal selection, educational supervision, special education ,teacher education, finance for education, international examinations, vs.) and these factors were explained under headlines in the study...

  2. A comparative study of various advanced fusions

    International Nuclear Information System (INIS)

    Momota, H.; Tomita, Y.; Nomura, Y.

    1983-01-01

    For the purpose of comparing the merits and demerits of various advanced fuel cycles, parametric studies of operation conditions are examined. The effects of nuclear elastic collisions and synchrotron radiation are taken into account. It is found that the high-#betta# Catalyzed DD fuel cycle with the transmutation of fusion-produced tritium into helium-3 is most feasible from the point of view of neutron production and tritium handling. The D-D fuel cycles seem to be less attractive compared to the Catalyzed DD. The p- 11 B and p- 6 Li fusion plasmas hardly attain the plasma Q value relevant to reactors. (author)

  3. 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.

  4. Environmental Comparative Risk Assessment: A Case Study

    International Nuclear Information System (INIS)

    Ali, M.M.

    2007-01-01

    Health and environmental impacts associated with energy production and industrial activities as well as food production and agricultural activities have had great concern in the last decades. Early activities emerged in late 80s of the last century through an Inter- Agency project (lAEA, UNDY, WHO, ... ) on the comparative risk assessment from energy systems and industrial complexes. A work-shop on Risk Assessment and Management in large industrial areas was held in Alexandria Egypt on 20-33 Det 1993, sponsored by IAEA. Several conferences, experts work groups and workshops were held there of Recent trends in determining risks are: 1. Use of probabilistic risk assessment approach to identify hazardous activities and accident scenario. 2. development of data base on failure probabilities and appropriate physical models. 3. Development of related directives and regulations and criteria Comparative risk assessment case study as a tool for comparing risk is emphasized Criteria of exposure to human and ecological risks are addressed

  5. Comparative fasting bioavailability of 2 bepotastine formulations in healthy male Chinese volunteers: an open-label, randomized, single-dose, 2-way crossover study.

    Science.gov (United States)

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

    2014-04-01

    Bepotastine is a second-generation histamine1 receptor antagonist that is used in the treatment of allergic rhinitis, urticaria, and pruritus associated with skin disease. A new generic formulation of bepotastine has been developed in China, and information concerning bioavailability and pharmacokinetic properties in the Chinese population has not been reported. The aim of the present study was to compare the bioavailability and pharmacokinetic properties of 2 tablet formulations of bepotastine, the 10-mg generic formulation (test) and a branded formulation (reference), in healthy male Chinese volunteers to obtain registration approval of the test formulation. A single-center, open-label, randomized, 2-way crossover study with a 1-week washout period was conducted in 24 healthy male volunteers. Blood samples were collected for 16 hours after a single dose of the 10-mg bepotastine test formulation or the reference formulation. Plasma bepotastine concentrations were determined using a validated LC-MS/MS method. Cmax, Tmax, AUC₀-t, AUC₀-∞, and t½ were determined using noncompartmental analysis. The formulations were considered bioequivalent if the 90% CIs for the log-transformed Cmax and AUC values were within the predetermined interval of 75% to 133% and 80% to 125%, respectively, according to the guidelines of the China Food and Drug Administration. No significant differences were found in mean (SD) pharmacokinetic parameters between the test and reference drugs, including Cmax (74.81 [9.91] ng/mL vs 78.60 [29.58] ng/mL), AUC₀-t (295.55[115.29] ng·h/mL vs 299.17[109.29] ng·h/mL), and AUC0-∞ (305.28 [118.50] ng·h/mL vs 310.90 [112.20] ng·h/mL). The mean (SD) t½ values of the test and reference formulations were 2.53 (0.50) hours and 2.62 (0.41) hours, respectively. The 90% CIs of the treatment ratios for the logarithmic transformed values of Cmax, AUC₀-t, and AUC₀-∞ were 86.96% to 101.80%, 93.22% to 104.13%, and 92.66% to 103.30%, respectively

  6. 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%

  7. Robust canonical correlations: A comparative study

    OpenAIRE

    Branco, JA; Croux, Christophe; Filzmoser, P; Oliveira, MR

    2005-01-01

    Several approaches for robust canonical correlation analysis will be presented and discussed. A first method is based on the definition of canonical correlation analysis as looking for linear combinations of two sets of variables having maximal (robust) correlation. A second method is based on alternating robust regressions. These methods axe discussed in detail and compared with the more traditional approach to robust canonical correlation via covariance matrix estimates. A simulation study ...

  8. Comparative Study on Water Impact Problem

    OpenAIRE

    Yang, Liang; Yang, Hao; Yan, Shiqiang; Ma, Qingwei; Bihnam, Maria

    2016-01-01

    This paper presents a comparative numerical study for the water impact problems due to dropping of triangular wedges or ship sections. In the numerical investigation, both the dynamic mesh technique and immersed boundary method adopting fixed Cartesian grids have been adopted in order to conform to the motion of the structure. For the former, a multiple-phase solver with the volume of fluid for identifying the free surface is implemented. In the simulation using this method, both the compress...

  9. 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.

  10. A comparative study of two shovel designs.

    Science.gov (United States)

    Degani, A; Asfour, S S; Waly, S M; Koshy, J G

    1993-10-01

    In the present study a modified shovel design with two perpendicular shafts is presented. This modified, two-shaft shovel was compared with a regular shovel. The modified shovel was evaluated and tested in a controlled laboratory environment using surface electromyography recorded from the lumbar paraspinal muscles. The new shovel design was also tested in a field study using ratings of perceived exertion. The results indicate that there was a significant reduction in EMG values of the lumbar paraspinal muscles and a consistent reduction in perceived exertion ratings while the modified shovel was being used for removing dirt in digging trenches up to 90 cm in depth.

  11. [Nonprocess autism in children: comparative etiopathogenetic study].

    Science.gov (United States)

    Kagan, V E

    1979-01-01

    Etiopathogenesis of the childhood autism syndrome of a non-process nature is discussed on the basis of a comparative study of 156 children aged from 3 to 16 years. In the etiological complex there is a prevalence of early exogenous-organic noxious factors, which is reflected in disturbances of mental divelopment, maturation of the system of hemispheric pair work. The data of follow-up studies and treatment confirm a conclusion about a residual-organic basis in the syndrome of childhood autism.

  12. Comparative Study of Daylighting Calculation Methods

    Directory of Open Access Journals (Sweden)

    Mandala Ariani

    2018-01-01

    Full Text Available The aim of this study is to assess five daylighting calculation method commonly used in architectural study. The methods used include hand calculation methods (SNI/DPMB method and BRE Daylighting Protractors, scale models studied in an artificial sky simulator and computer programs using Dialux and Velux lighting software. The test room is conditioned by the uniform sky conditions, simple room geometry with variations of the room reflectance (black, grey, and white color. The analyses compared the result (including daylight factor, illumination, and coefficient of uniformity value and examines the similarity and contrast the result different. The color variations trial is used to analyses the internally reflection factor contribution to the result.

  13. Risk indices in comparative risk assessment studies

    International Nuclear Information System (INIS)

    Hubert, P.

    1984-01-01

    More than a decade ago the development of comparative risk assessment studies aroused overwhelming interest. There was no doubt that data on the health and safety aspects of energy systems would greatly benefit, or even end, the debate on nuclear energy. Although such attempts are still strongly supported, the rose-coloured expectations of the early days have faded. The high uncertainties, and the contradictory aspect, of the first results might explain this evolution. The loose connection between the range of computed risk indices and the questions on which the debate was focused is another reason for this decline in interest. Important research work is being carried out aiming at reducing the different kinds of uncertainties. Rather than the uncertainties, the paper considers the meaning of available risk indices and proposes more significant indices with respect to the goals of risk assessment. First, the indices which are of frequent use in comparative studies are listed. The stress is put on a French comparative study from which most examples are drawn. Secondly, the increase in magnitude of the indices and the decrease in the attributability of the risk to a given system is shown to be a consequence of the trend towards more comprehensive analyses. Thirdly, the ambiguity of such indices as the collective occupational risk is underlined, and a possible solution is suggested. Whenever risk assessments are related to pragmatic decision making problems it is possible to find satisfactory risk indices. The development of cost-effectiveness analyses and the proposals for quantitative safety goals clearly demonstrate this point. In the field of comparison of social impacts some proposals are made, but there remain some gaps still to be filled. (author)

  14. 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

  15. 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.

  16. 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

  17. Scatterometry or imaging overlay: a comparative study

    Science.gov (United States)

    Hsu, Simon C. C.; Pai, Yuan Chi; Chen, Charlie; Yu, Chun Chi; Hsing, Henry; Wu, Hsing-Chien; Kuo, Kelly T. L.; Amir, Nuriel

    2015-03-01

    Most fabrication facilities today use imaging overlay measurement methods, as it has been the industry's reliable workhorse for decades. In the last few years, third-generation Scatterometry Overlay (SCOL™) or Diffraction Based Overlay (DBO-1) technology was developed, along another DBO technology (DBO-2). This development led to the question of where the DBO technology should be implemented for overlay measurements. Scatterometry has been adopted for high volume production in only few cases, always with imaging as a backup, but scatterometry overlay is considered by many as the technology of the future. In this paper we compare imaging overlay and DBO technologies by means of measurements and simulations. We outline issues and sensitivities for both technologies, providing guidelines for the best implementation of each. For several of the presented cases, data from two different DBO technologies are compared as well, the first with Pupil data access (DBO-1) and the other without pupil data access (DBO-2). Key indicators of overlay measurement quality include: layer coverage, accuracy, TMU, process robustness and robustness to process changes. Measurement data from real cases across the industry are compared and the conclusions are also backed by simulations. Accuracy is benchmarked with reference OVL, and self-consistency, showing good results for Imaging and DBO-1 technology. Process sensitivity and metrology robustness are mostly simulated with MTD (Metrology Target Designer) comparing the same process variations for both technologies. The experimental data presented in this study was done on ten advanced node layers and three production node layers, for all phases of the IC fabrication process (FEOL, MEOL and BEOL). The metrology tool used for most of the study is KLA-Tencor's Archer 500LCM system (scatterometry-based and imaging-based measurement technologies on the same tool) another type of tool is used for DBO-2 measurements. Finally, we conclude that

  18. 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.

  19. 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 cases, falls (42.6%) and collisions with other vehicles (39.3%) were the most common causes of injury. Although the severity of injuries was slightly lower in bicycle lane cases, it was not significantly lower than non-bicycle lane cases. Although people are increasingly using bicycle lanes for safety, this study shows that they are not definitively safer. Therefore, improvements in the policies related to implementing bicycle lane safety are needed, for example, by enforcing the use of protective gear or preventing the use of bicycle lanes by pedestrians. More safety education programs are also needed. III.

  20. Laproscopic versus open appendectomy: A comparative study

    International Nuclear Information System (INIS)

    Shirazi, B.; Naureen Ali, N.; Shamim, M.S.

    2010-01-01

    Objective: To compare the results of open with laparoscopic appendectomy in terms of postoperative pain, rate of wound infection and hospital stay. Methods: This quasi-experimental study was conducted in Department of Surgery, Ziauddin University Hospital, Karachi, over a period of six months. Patients undergoing surgery for acute appendicitis were randomly assigned into one of the two groups (A or B) after obtaining written and informed consent. In Group-A patients underwent open appendectomy and in Group B laparoscopic appendectomy was performed. Post operatively pain chart and wound infection was recorded and, at the time of discharge, number of days in hospital was calculated. Result: Sixty patients (38 male, 22 female), with clinical diagnosis of acute appendicitis based on Alvarado score of six and above, were included in the study. They were randomized into 2 groups of A and B with 30 patients in each group. Group-A comprised open appendectomy procedure and Group-B comprised laparoscopic appendectomy. Mean comparison of postoperative pain by visual analogue scale, was significantly low in Group B, compared with Group A, on day 0, 1 and 2. Number of days in Hospital was 4.1 +- 0.8 days in Group A and 1.5 +- 0.06 days in Group B. None of the patients in Group B, while 8 (26.67%) patients in-Group A, developed postoperative wound infection at 1 week follow up. Conclusion: Laparoscopic appendectomy is safe and effective. Wound infection and postoperative pain is significantly lower after this mode of surgery. (author)

  1. 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.

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

    International Nuclear Information System (INIS)

    Szebeni, Janos; Storm, Gert

    2015-01-01

    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.

  3. 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.

  4. Comparative economic analysis: Anaerobic digester case study

    International Nuclear Information System (INIS)

    Lusk, P.D.

    1991-01-01

    An economic guide is developed to assess the value of anaerobic digesters used on dairy farms. Two varieties of anaerobic digesters, a conventional mixed-tank mesophilic and an innovative earthen psychrophilic, are comparatively evaluated using a cost-effectiveness index. The two case study examples are also evaluated using three other investment merit statistics: simple payback period, net present value, and internal rate of return. Life-cycle savings are estimated for both varieties, with sensitivities considered for investment risk. The conclusion is that an earthen psychrophilic digester can have a significant economic advantage over a mixed-tank mesophilic digester because of lower capital cost and reduced operation and maintenance expenses. Because of this economic advantage, additional projects are being conducted in North Carolina to increase the rate of biogas utilization. The initial step includes using biogas for milk cooling at the dairy farm where the existing psychrophilic digester is located. Further, a new project is being initiated for electricity production with thermal reclaim at a swine operation

  5. Comparative studies of stellarator and tokamak transport

    Energy Technology Data Exchange (ETDEWEB)

    Stroth, U; Burhenn, R; Geiger, J; Giannone, L.; Hartfuss, H J; Kuehner, G; Ledl, L; Simmet, E E; Walter, H [Max-Planck-Inst. fuer Plasmaphysik, IPP-Euratom Association, Garching (Germany); ECRH Team; W7-AS Team

    1997-09-01

    Transport properties in the W7-AS stellarator and in tokamaks are compared. The parameter dependences and the absolute values of the energy confinement time are similar. Indications are found that the density dependence, which is usually observed in stellarator confinement, can vanish above a critical density. The density dependence in stellarators seems to be similar to that in the linear ohmic confinement regime, which, in small tokamaks, extends to high density values, too. Because of the similarity in the gross confinement properties, transport in stellarators and tokamaks should not be dominated by the parameters which are very different in the two concepts, i.e. magnetic shear, major rational values of the rotational transform and plasma current. A difference in confinement is that there exists evidence for pinches in the particle and, possibly, energy transport channels in tokamaks whereas in stellarators no pinches have been observed, so far. In order to study the effect of plasma current and toroidal electric fields, stellarator discharges were carried out with an increasing amount of plasma current. From these experiments, no clear evidence of a connection of pinches with these parameters is found. The transient response in W7-AS plasmas can be described in terms of a non-local model. As in tokamaks, also cold pulse experiments in W7-AS indicate the importance of non-local transport. (author). 8 refs, 5 figs.

  6. 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.

  7. 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.

  8. A Comparative Study of Human Saposins

    Directory of Open Access Journals (Sweden)

    María Garrido-Arandia

    2018-02-01

    Full Text Available Saposins are small proteins implicated in trafficking and loading of lipids onto Cluster of Differentiation 1 (CD1 receptor proteins that in turn present lipid antigens to T cells and a variety of T-cell receptors, thus playing a crucial role in innate and adaptive immune responses in humans. Despite their low sequence identity, the four types of human saposins share a similar folding pattern consisting of four helices linked by three conserved disulfide bridges. However, their lipid-binding abilities as well as their activities in extracting, transporting and loading onto CD1 molecules a variety of sphingo- and phospholipids in biological membranes display two striking characteristics: a strong pH-dependence and a structural change between a compact, closed conformation and an open conformation. In this work, we present a comparative computational study of structural, electrostatic, and dynamic features of human saposins based upon their available experimental structures. By means of structural alignments, surface analyses, calculation of pH-dependent protonation states, Poisson-Boltzmann electrostatic potentials, and molecular dynamics simulations at three pH values representative of biological media where saposins fulfill their function, our results shed light into their intrinsic features. The similarities and differences in this class of proteins depend on tiny variations of local structural details that allow saposins to be key players in triggering responses in the human immune system.

  9. Assays for mammalian tyrosinase: a comparative study

    International Nuclear Information System (INIS)

    Jara, J.R.; Solano, F.; Lozano, J.A.

    1988-01-01

    This work describes a comparative study of the tyrosinase activity determined using three methods which are the most extensively employed; two radiometric assays using L-tyrosine as substrate (tyrosine hydroxylase and melanin formation activities) and one spectrophotometric assay using L-dopa (dopa oxidase activity). The three methods were simultaneously employed to measure the activities of the soluble, melanosomal, and microsomal tyrosinase isozymes from Harding-Passey mouse melanoma through their purification processes. The aim of this study was to find any correlation among the tyrosinase activities measured by the three different assays and to determine whether that correlation varied with the isozyme and its degree of purification. The results show that mammalian tyrosinase has a greater turnover number for L-dopa than for L-tyrosine. Thus, enzyme activity, expressed as mumol of substrate transformed per min, is higher in assays using L-dopa as substrate than those using L-tyrosine. Moreover, the percentage of hydroxylated L-tyrosine that is converted into melanin is low and is affected by several factors, apparently decreasing the tyrosinase activity measured by the melanin formation assay. Bearing these considerations in mind, average interassay factors are proposed. Their values are 10 to transform melanin formation into tyrosine hydroxylase activity, 100 to transform tyrosine hydroxylase into dopa oxidase activity, and 1,000 to transform melanin formation into dopa oxidase activity. Variations in these values due to the presence in the tyrosinase preparations of either inhibitors or regulatory factors in melanogenesis independent of tyrosinase are also discussed

  10. 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...

  11. 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 m...

  12. 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

  13. 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 ...

  14. A comparative study of fingerprint thinning algorithms

    CSIR Research Space (South Africa)

    Khanyile, NP

    2011-08-01

    Full Text Available are compared in terms of the quality of the skeletons they produce (i.e. connectivity and spurious branches) as well as the time complexity associated with each algorithm. Results show that faster algorithms have difficulty preserving connectivity. Zhang...

  15. 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…

  16. Calcaneal fracture classification: a comparative study

    NARCIS (Netherlands)

    Schepers, Tim; van Lieshout, Esther M. M.; Ginai, Abida Z.; Mulder, Paul G. H.; Heetveld, Martin J.; Patka, Peter

    2009-01-01

    Comparing different types of calcaneal fractures, associated treatment options, and outcome data is currently hampered by the lack of consensus regarding fracture classification. A systematic search for articles dealing with calcaneal fracture was performed, and the prevalence of use of each

  17. The Teaching of Anthropology: A Comparative Study.

    Science.gov (United States)

    Lombard, Jacques

    1984-01-01

    College-level anthropology teaching in various countries, including Belgium, France, Germany, the Netherlands, Portugal, South Africa, the United Kingdom, and Yugoslavia, is compared. Terminology is examined and historical background is provided. Also discussed are educational crises, the organization of teaching, and teaching methods. (RM)

  18. Hans Strahl's pioneering studies in comparative placentation

    DEFF Research Database (Denmark)

    Carter, Anthony Michael; Mess, A

    2010-01-01

    Hans Strahl, a contemporary of Duval and Hubrecht, made many important contributions to comparative placentation. Despite this he is not well known and some of his original observations tend to be attributed to later authors. Strahl published a classification of placental types based on their shape...... of the most important findings made by Strahl including work on placentation in carnivores and higher primates that remains unsurpassed....

  19. 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

  20. 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

  1. 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…

  2. 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.

  3. A Comparative Comment on the Case Studies

    DEFF Research Database (Denmark)

    Kjeldsen, Christian Christrup; Ley, Thomas; Jensen, Niels Rosendal

    2012-01-01

    Denne konklusion sammenfatter hovedtrækkene af de gennemførte case studies i WorkAble-projektet. Vigtige pointer er, at unge på tværs af de forskellige case studies har vanskeligt ved at blive hørt og taget alvorligt. I stedet spises de af med "realistisk vejledning" eller dårlige uddannelses- og...

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

    African Journals Online (AJOL)

    This study aims to introduce and systematically investigate the environmental issues during important decision-making stages. Meanwhile, impacts of development on the environmental components will be also analyzed. This research studies various methods of predicting the environmental changes and determining the ...

  5. Comparative bioavailability of two formulations of sibutramine.

    Science.gov (United States)

    Franco Spínola, A C; Almeida, S; Filipe, A; Neves, R; Abolfathi, Z; Yritia, M; Anctil, D

    2009-10-01

    This study was conducted in order to compare the bioavailability of two capsule formulations containing 15 mg of sibutramine, N-{1-[1-(4-chlorophenyl)cyclobutyl]-3-methylbutyl}-N,N-dimethylamine hydrochloride monohydrate, 84485-00-7 CAS registry number. 62 healthy subjects were enrolled in a single-center, randomized, single-dose, open-label, 2-way crossover study, with a minimum washout period of 14 days. Plasma samples were collected up to 72.0 hours post-dosing. R-sibutramine, S-sibutramine, N-mono-desmethyl-sibutramine (M1) and N-di-desmethyl-sibutramine (M2) levels were determined by reverse liquid chromatography and detected by tandem mass spectrometry detection, LC/MS/MS method. Pharmacokinetic parameters used for bioequivalence assessment were the area under the concentration-time curve from time zero to time of last non-zero concentration (AUC0-t) and the maximum observed concentration (Cmax). These parameters were determined from sibutramine enantiomers as well from M1 and M2 concentration data using non-compartmental analysis. The 90% confidence intervals obtained by analysis of variance were 89.25 - 122.88% for Cmax, 90.37 - 123.18% for AUC0-t and 91.20 - 122.38% for AUCinf for R-sibutramine and 88.27 - 124.08% for Cmax, 86.15 - 121.78% for AUC0-t and 88.02 - 120.96% for AUCinf for S-sibutramine. These results were all within the range of 80.00 - 125.00% established by regulatory requirements. Bioequivalence between formulations was concluded both in terms of rate and extent of absorption.

  6. Nonlinear analysis of RED - a comparative study

    International Nuclear Information System (INIS)

    Jiang Kai; Wang Xiaofan; Xi Yugeng

    2004-01-01

    Random Early Detection (RED) is an active queue management (AQM) mechanism for routers on the Internet. In this paper, performance of RED and Adaptive RED are compared from the viewpoint of nonlinear dynamics. In particular, we reveal the relationship between the performance of the network and its nonlinear dynamical behavior. We measure the maximal Lyapunov exponent and Hurst parameter of the average queue length of RED and Adaptive RED, as well as the throughput and packet loss rate of the aggregate traffic on the bottleneck link. Our simulation scenarios include FTP flows and Web flows, one-way and two-way traffic. In most situations, Adaptive RED has smaller maximal Lyapunov exponents, lower Hurst parameters, higher throughput and lower packet loss rate than that of RED. This confirms that Adaptive RED has better performance than RED

  7. 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

  8. Nonlinear analysis of RED - a comparative study

    Energy Technology Data Exchange (ETDEWEB)

    Jiang Kai; Wang Xiaofan E-mail: xfwang@sjtu.edu.cn; Xi Yugeng

    2004-09-01

    Random Early Detection (RED) is an active queue management (AQM) mechanism for routers on the Internet. In this paper, performance of RED and Adaptive RED are compared from the viewpoint of nonlinear dynamics. In particular, we reveal the relationship between the performance of the network and its nonlinear dynamical behavior. We measure the maximal Lyapunov exponent and Hurst parameter of the average queue length of RED and Adaptive RED, as well as the throughput and packet loss rate of the aggregate traffic on the bottleneck link. Our simulation scenarios include FTP flows and Web flows, one-way and two-way traffic. In most situations, Adaptive RED has smaller maximal Lyapunov exponents, lower Hurst parameters, higher throughput and lower packet loss rate than that of RED. This confirms that Adaptive RED has better performance than RED.

  9. War And Reconstruction: Four Comparative Case Studies

    African Journals Online (AJOL)

    The four case studies are taken from four different continents, four different wars under .... and revolutionary changes in the structures and power relations in society and ..... general public accept nowadays that although states' rights were the ...

  10. Phytochemical screening and study of comparative antibacterial ...

    African Journals Online (AJOL)

    SARAH

    2013-06-30

    Jun 30, 2013 ... Objectives: In this study, methanol, ethanol and aqueous extracts of ... of resistance in bacteria previously susceptible to ... increase in antibiotic resistance in hospitals and ..... extraction process (Masoko et al., 2008). Use of ...

  11. COMPARATIVE STUDY OF HONEY COLLECTED FROM ...

    African Journals Online (AJOL)

    lanez

    2014-06-30

    Jun 30, 2014 ... content, electrical conductivity, total dissolved solids, color intensity ... used in this study on the basis of date of harvest, geographical origin. ... The determination of physical and chemical parameters such as content of water, ...

  12. 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.

  13. 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.

  14. 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...

  15. 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...

  16. 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.

  17. 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.

  18. Toucan and hornbill beaks: a comparative study.

    Science.gov (United States)

    Seki, Yasuaki; Bodde, Sara G; Meyers, Marc A

    2010-02-01

    The structure and mechanical behavior of Toco Toucan (Ramphastos toco) and Wreathed Hornbill (Rhyticeros undulatus) beaks were compared. The beak of both species is a sandwich-structured composite, having an exterior, or rhamphotheca, consisting of multiple layers of keratin scales and a core composed of a fibrous network of bony closed-cell foam. The rhamphotheca is an arrangement of approximately 50microm diameter, overlapping, keratin tiles. The hornbill rhamphotheca exhibits a surface morphology on the ridged casque that is distinguishable from that observed on the bill proper. Intermediate filaments in the keratin matrix were observed by transmission electron microscopy. The Young's modulus measurements of toucan rhamphotheca indicate isotropy in longitudinal and transverse directions, whereas those of hornbill rhamphotheca may suggest anisotropy. The compressive response of beak foam is governed by brittle crushing behavior. The crushing strength of hornbill foam is six times higher than that of toucan foam. Micro- and nanoindentation hardness values were measured for rhamphotheca and foam trabeculae of toucan and hornbill specimens. The sandwich design of beaks was analyzed using the Karam-Gibson and Dawson-Gibson models. The presence of a cellular core increases the bending resistance (Brazier moment) by a factor of 3-6 while decreasing the compressive strength by only 50%.

  19. 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)

  20. COMPARATIVE STUDY OF CONSERVATIVE RESECTION AND ...

    African Journals Online (AJOL)

    1999-05-05

    May 5, 1999 ... Depmment of Surgery, University Teaching Hospital, PMB 2076. Jos, Nigeria ... Design: A retrospective study of patients with thyroid cancers that were managed during an ... This logical basis for either cure or palliation of a .... palliative purposes. A mixed ... Pulmonary metastasis are usually of the classical.

  1. Metacognition and Group Differences: A Comparative Study

    Science.gov (United States)

    Al-Hilawani, Yasser A.

    2014-01-01

    In this study, metacognition refers to performing visual analysis and discrimination of real life events and situations in naïve psychology, naïve physics, and naïve biology domains. It is used, along with measuring reaction time, to examine differences in the ability of four groups of students to select appropriate pictures that correspond with…

  2. 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.…

  3. Comparative study of fixation density maps

    NARCIS (Netherlands)

    Engelke, U.; Liu, H.; Wang, Junle; Callet, Le P.; Heynderickx, I.E.J.; Zepernick, H.-J.; Maeder, A.

    2013-01-01

    Fixation density maps (FDM) created from eye tracking experiments are widely used in image processing applications. The FDM are assumed to be reliable ground truths of human visual attention and as such, one expects a high similarity between FDM created in different laboratories. So far, no studies

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

    Science.gov (United States)

    Yoon, Seonghae; Lee, Howard; Kim, Tae-Eun; Lee, SeungHwan; Chee, Dong-Hyun; Cho, Joo-Youn; Yu, Kyung-Sang; Jang, In-Jin

    2014-01-01

    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. 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 (AUC(0-24h)), were determined by noncompartmental analysis. The geometric mean ratio of the pharmacokinetic parameters was derived using an analysis of variance model. 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 AUC(0-24h) 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 AUC(0-24h) was not affected. There were no serious adverse events and both formulations were generally well tolerated. At steady state, once-daily itopride ER at 150 mg has a bioavailability comparable with that of itopride IR at 50 mg given three times a day under fasting conditions. Food delayed the absorption of itopride ER, with no marked change in its oral bioavailability.

  5. Earthquake correlations and networks: A comparative study

    Science.gov (United States)

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

    2011-04-01

    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 EULEEJ1539-375510.1103/PhysRevE.69.06610669, 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.

  6. 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.

  7. 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.

  8. 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)

  9. 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.

  10. 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.

  11. Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs.

    Science.gov (United States)

    van Gelder, Teun; Gabardi, Steven

    2013-08-01

    Within the field of solid organ transplantation, the patents for a number of immunosuppressive drugs have expired in the last few years. Tacrolimus, cyclosporine, and mycophenolate mofetil are now available as generic drugs. In some countries, the market penetration of these generic formulations is as high as 70%, whereas in some other countries, this figure is below 10%. Several professional societies have published position papers on the risks and benefits of generic substitution of immunosuppressive drugs. It often appears that transplant professionals are not fully aware of the requirements for registration of generic drugs. This article describes the registration requirements with a focus on bioequivalence testing, the strengths and weaknesses in this process, and the differences between Europe and the US. © 2013 The Authors Transplant International © 2013 European Society for Organ Transplantation. Published by Blackwell Publishing Ltd.

  12. 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.

  13. Comparative study of the pharmacopeial quality and dissolution profiles of generic and other drug forms of sodium metamizole (dipyrone sold in Brazil

    Directory of Open Access Journals (Sweden)

    Morenna Alana Giordani

    2012-08-01

    Full Text Available In Brazil, in order for a pharmaceutical company to register a drug form as generic or ‘similar’ with the Brazilian food and drug agency (Anvisa, it must be proved bioequivalent to its innovatory branded form (reference drug. This requires comparative trials, carried out in conformity with official compendia (Brazilian Pharmacopeia or another officially recognized code. Additionally, according to the Anvisa resolution RDC 31/2010, the dissolution profile of the drug must be tested and compared with that of the branded reference, as a benchmark of quality. The aim of this study was to assess the quality of 500 mg sodium metamizole (dipyrone tablets produced by seven different laboratories in Brazil: three generic drugs (G1, G2, G3, three (branded similar drugs (S1, S2,S3 and their reference branded product (Novalgina®, Sanofi-Aventis, drug R. All tests were carried out by methods specified in the Brazilian Pharmacopeia 4th edition (Farmacopeia Brasileira IV. The following tests were performed: uniformity of mass, friability, disintegration time, hardness, assay, uniformity of dosage units, salicylic acid limit assay, dissolution and identification. The dissolution profile was also recorded, as recommended in RDC 31/2010. Whereas every sample was approved in all the Farmacopeia Brasileira IV tests, the results in the dissolution profile test showed that four of the test drugs (G1, G2, S1 and S2 were notpharmaceutically equivalent to drug R. Thus, only drugs G3 and S3 showed dissolution profiles similar to that of drug R and the other four drugs could not be considered equivalent to it and were not approved.

  14. What Do We Compare When We Compare Religions? Philosophical Remarks on the Psychology of Studying Comparative Religion Abroad

    Science.gov (United States)

    Irvine, Andrew

    2015-01-01

    The issue of comparison is a vexing one in religious and theological studies, not least for teachers of comparative religion in study abroad settings. We try to make familiar ideas fresh and strange, in settings where students may find it hard not to take "fresh" and "strange" as signs of existential threat. The author explores…

  15. 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

  16. 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 ...

  17. 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

  18. Comparative study on current trading system and online trading: the ...

    African Journals Online (AJOL)

    Comparative study on current trading system and online trading: the case of ... of online trading and factors affecting its feasibility of implementation in ECX. ... The study found that there is significant capacity problem with major skills gap with ...

  19. Genetic diversity, classification and comparative study on the larval ...

    African Journals Online (AJOL)

    Genetic diversity, classification and comparative study on the larval phenotypic ... B. mori showed different performance based on larval phenotypic data. The analysis of variance regarding the studied traits showed that different strains have ...

  20. Bioequivalence assessment of rifampicin, isoniazid and pyrazinamide in a fixed dose combination of rifampicin, isoniazid, pyrazinamide and ethambutol vs. separate formulations.

    Science.gov (United States)

    Agrawal, S; Singh, I; Kaur, K J; Bhade, S R; Kaul, C L; Panchagnula, R

    2002-10-01

    Depending on the patient category, tuberculosis requires treatment with 3 to 5 drugs which means that patient's compliance to therapy may not be optimal. To increase patient's adherence to treatment schedules, these drugs can be given as single drug preparations or fixed dose combinations (FDCs) of 2 or more drugs in a single formulation. However, an important issue associated with a rifampicin-containing FDC is its quality. Hence, to avoid spurious formulations entering the market, the World Health Organization and the International Union Against Tuberculosis and Lung Disease have recommended FDCs only of proven bioavailability. In this study, the relative bioavailability of rifampicin, isoniazid and pyrazinamide was assessed in a group of 14 healthy male subjects using the FDC tablet containing 4 drugs versus separate formulations at the same dose levels. The study was designed as an open, crossover trial. A total of 9 blood samples were collected over a period of 24 h. The concentration of rifampicin, its main metabolite desacetyl rifampicin, isoniazid and pyrazinamide in plasma were assessed using HPLC analysis. The pharmacokinetic parameters AUC(0-24) and Cmax were subjected to parametric and non-parametric statistical tests at 90% confidence interval. In addition, time to reach peak concentration (tmax), elimination rate constant (Kel) and terminal elimination half-life (t1/2) for each drug were also calculated. It was concluded that the FDC tablet containing 4 drugs is bioequivalent to separate rifampicin, isoniazid and pyrazinamide formulations at the same dose levels.

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

    Science.gov (United States)

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

    2017-08-01

    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." 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. © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  2. The BEST study - a prospective study to compare business class ...

    African Journals Online (AJOL)

    Background. As many as 10% of airline passengers travelling without prophylaxis for long distances may develop a venous thrombosis. There is, however, no evidence that economy class travellers are at increased risk of thrombosis. Objectives. A suitably powered prospective study, based on the incidence of deep-vein ...

  3. Comparative bioavailability of two oral formulations of clopidogrel: Determination of clopidogrel and its carboxylic acid metabolite (SR26334 under fasting and fed conditions in healthy subjects

    Directory of Open Access Journals (Sweden)

    Brvar Nina

    2014-03-01

    Full Text Available Two randomized, single dose, 2-period, 2-sequence crossover studies were conducted to evaluate the comparative bioavailability of two clopidogrel formulations under fasting and fed conditions. Assessment of bioequivalence was based upon measurement of plasma concentrations of the parent drug, clopidogrel, and its major (inactive metabolite, clopidogrel carboxylic acid, using improved methanol-free extraction. Bioequivalence of Krka’s formulation to the innovator’s formulation was demonstrated under both fasting and fed conditions on 205 volunteers. Confidence intervals for AUC0-t, AUC0-inf and Cmax of clopidogrel and its main metabolite were well within the acceptance range of 80.00 to 125.00 %. Food substantially increased the bioavailability of clopidogrel from both formulations, while no effect of food on the extent and rate of exposure to the metabolite was observed. The effect of food was comparable between the two formulations, as indicated by the same direction and rank of food impact on the bioavailability of both formulations.

  4. 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.

  5. Assessment of bioequivalence of rifampicin, isoniazid and pyrazinamide in a four drug fixed dose combination with separate formulations at the same dose levels.

    Science.gov (United States)

    Agrawal, Shrutidevi; Kaur, Kanwal Jit; Singh, Inderjit; Bhade, Shantaram R; Kaul, Chaman Lal; Panchagnula, Ramesh

    2002-02-21

    Tuberculosis (TB) needs treatment with three to five different drugs simultaneously, depending on the patient category. These drugs can be given as single drug preparations or fixed dose combinations (FDCs) of two more drugs in a single formulation. World Health Organization and International Union against Tuberculosis and Lung Disease (IUATLD) recommend FDCs only of proven bioavailability. The relative bioavailability of rifampicin (RIF), isoniazid (INH) and pyrazinamide (PYZ) was assessed on a group of 13 healthy male subjects from a four drug FDC versus separate formulations at the same dose levels. The study was designed to be an open, crossover experiment. A total of nine blood samples each of 3 ml volume were collected over a period of 24-h. The concentrations of RIF, its main metabolite desacetyl RIF (DRIF), INH and PYZ in plasma were assessed by HPLC analysis. Pharmacokinetic parameters namely AUC(0-24), AUC(0-inf), C(max), T(max), were calculated and subjected to different statistical tests (Hauschke analysis, two way ANOVA, normal and log transformed confidence interval) at 90% confidence interval. In addition, elimination rate constant (K(el)) and absorption efficiencies for each drug were also calculated. It was concluded that four drugs FDC tablet is bioequivalent for RIF, INH and PYZ to separate formulation at the same dose levels.

  6. 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.

  7. 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…

  8. Important Questions of Comparative Studies in Asian Countries

    Science.gov (United States)

    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,…

  9. 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 ...

  10. Mobile Learning vs. Traditional Classroom Lessons: A Comparative Study

    Science.gov (United States)

    Furió, D.; Juan, M.-C.; Seguí, I.; Vivó, R.

    2015-01-01

    Different methods can be used for learning, and they can be compared in several aspects, especially those related to learning outcomes. In this paper, we present a study in order to compare the learning effectiveness and satisfaction of children using an iPhone game for learning the water cycle vs. the traditional classroom lesson. The iPhone game…

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

    African Journals Online (AJOL)

    The return to competitive level of sport dates were also documented and compared. A single blind randomised control study comparing the JSFB rehabilitation programme with conventional ankle rehabilitation programmes was used. Ultrasound examinations were done on all first time lateral ankle ligament injuries 72 ...

  12. 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

  13. A comparative study of child marriage and parenthood in Ethiopia ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    A comparative study of child marriage and parenthood in Ethiopia, India, Peru and Zambia ... By taking an approach that emphasizes life course poverty and gender ... Goal #5, Achieve gender equality and empower all women and girls.

  14. Comparative Studies on the Cardiovascular System in the Wistar ...

    African Journals Online (AJOL)

    PROF HORSFALL

    http://ww.bioline.org.br/ja. Comparative Studies on the Cardiovascular System in the Wistar Rat (Rattus .... norvegicus) were gotten from the animal house of the. Department of Anatomy .... Locomotion and Respiration in. Marine Air – Breathing ...

  15. Comparative Study on the Proximate Analysis and Nutritional ...

    African Journals Online (AJOL)

    ADOWIE PERE

    2018-01-19

    Jan 19, 2018 ... especially when compared with synthetic drugs. Moreso, due to their ... 1992), antihypertensive (Kamanyi et al., 1991) and antiglycaemic agents ..... extensive toxicity study on both plants needs to be done to ascertain their ...

  16. 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 ...

  17. 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 ...

  18. 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

  19. 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

  20. Information Technology Diffusion: A Comparative Case Study of Intranet Adoption

    OpenAIRE

    Zolla, George A., Jr.

    1999-01-01

    This exploratory study identifies factors that influence the adoption and diffusion of intranet technology. A comparative case study of bipolar organizations is used to identify crucial implementation factors and create an innovation adoption model. A strategic approach for the adoption and diffusion of intranet technology is then presented.

  1. New Image Qualities in Education: A Comparative Study

    Science.gov (United States)

    Çankaya, Ibrahim

    2018-01-01

    The aim of this study is to compare Turkish and European Union Countries Educations in terms of the new image qualities such as data like access to online education, digital access, foreign languages learnt per pupil, research & development investments, human resources employed in science and technology, the study opportunities offered to…

  2. 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 ...

  3. 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

  4. 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…

  5. 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 ...

  6. 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.

  7. 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 ...

  8. Political Ideology: A Comparative Study of Three Chicano Youth Organizations.

    Science.gov (United States)

    Garcia, Richard A.

    The study investigated the political ideology of three Chicano youth groups in El Paso, Texas: Mexican American Youth Association (MAYA), Mexican American Political Association (MAPA), and the Alianza. Purpose of the study was to identify and compare the political ideas and attitudes of the three organizations. Questionnaires were administered to…

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

    African Journals Online (AJOL)

    ... a comparative study of the obstetric performance of primiparous teenagers and ... 2006-31st December, 2007) in Lagos State University Teaching Hospital,Ikeja. ... The incidence of teenage pregnancy in the study population was 1.01% with ...

  10. 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…

  11. 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.

  12. CHALLENGES IN THE STUDIES OF COMPARATIVE CONSTRUCTIONS OF GENDER EQUALITY

    OpenAIRE

    Rönnblom, Malin

    2016-01-01

    Why are comparisons interesting, or what are comparisons all about? In this article, the comparative ambition in the social constructivist tradition is scrutinized, and the other articles of the issue are used as examples of what is seen as principle problems of comparative studies. The first part of the article deals with the need of reflexivity in order for the researcher to avoid implicit notions of «good gender equality» or «real feminism». In the second part, the problems of comparative ...

  13. 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

  14. 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.

  15. Comparative study of oxihydrogen injection in turbocharged compression ignition engines

    Science.gov (United States)

    Barna, L.; Lelea, D.

    2018-01-01

    This document proposes for analysis, comparative study of the turbocharged, compression-ignition engine, equipped with EGR valve, operation in case the injection in intake manifold thereof a maximum flow rate of 1l/min oxyhydrogen resulted of water electrolysis, at two different injection pressures, namely 100 Pa and 3000 Pa, from the point of view of flue gas opacity. We found a substantial reduction of flue gas opacity in both cases compared to conventional diesel operation, but in different proportions.

  16. 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

  17. 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

  18. Interchangeability and comparative effectiveness between generic and brand montelukast immediate release tablets after a single oral administration in healthy volunteers.

    Science.gov (United States)

    Zaid, Abdel Naser; Mousa, Ayman; Ghazal, Nadia; Bustami, Rana

    2015-01-01

    Montelukast is a leukotriene receptor antagonist. The release of leukotrienes causes narrowing and constricting in the respiratory airways. Blocking the action of these leukotrienes, montelukast can be used for the prophylaxis and treatment of chronic asthma. The aim of this study was to evaluate the interchangeability and comparative effectiveness between a generic and a brand montelukast 10 mg immediate release tablets (Broncast(®) and Singulair(®), respectively) after a single oral dose among Arab Mediterranean volunteers. An open-label, randomized two-period crossover bioequivalence design was conducted in 31 healthy male volunteers with a 1 week washout between each study period and under fasting conditions. The plasma drug concentration was assessed by using a previously validated LC MS/MS method. The ratio between the generic and brand of geometric least squares means was reported for both generic and brand products. Moreover, an in vitro dissolution study was conducted on generic and brand tablets using three different pH media, and similarity and non-similarity factors (f2 and f1) were calculated. The used bioanalytical method was found to be linear within the range 6.098-365.855 ng/mL. The correlation coefficient was close to 0.999 during the course of the study validation. Statistical comparison of the main pharmacokinetic parameters showed the inexistence of any significant difference between generic and the brand. The point estimates (ratios of geometric means) were 111.939, 111.711, and 112.169 % for AUC0-24, AUC0-∞, and Cmax, respectively. The 90 % confidence intervals (CIs) were within the pre-defined limits of 80.00-125.00 % as specified by the FDA and EMA for bioequivalence studies. F2 and f1 were higher than 50 and lower than 15, respectively in all selected pH media. Broncast(®) immediate release film coated tablets (10 mg/tablet) are bioequivalent to Singulair(®) immediate release film coated tablets (10 mg/tablet), with a

  19. 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.

  20. 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

  1. 78 FR 46965 - Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories...

    Science.gov (United States)

    2013-08-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369... mesalamine rectal suppositories: A BE study with clinical endpoints and a fasting BE study with... suppositories: A fasting BE study with pharmacokinetic endpoints and comparative in vitro studies (melting point...

  2. 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.

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

    African Journals Online (AJOL)

    The study was conducted in goats to compare the pathogenic effects of .... membrane was examined, the rectal temperature of the goats was recorded ... the plasma layer, the content was expressed on the slide and covered with slip. ... measure analysis of variance in SPSS version 15.0 (2000). ..... Canadanian Journal of.

  4. 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.

  5. 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 ...

  6. 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 ...

  7. Comparative study on corpus development for Malay investment ...

    African Journals Online (AJOL)

    Comparative study on corpus development for Malay investment fraud detection in website. ... Journal of Fundamental and Applied Sciences ... The aim of this research is to develop a corpus for Malay investment fraud so that it can be used in ...

  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 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 ...

  10. 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 ...

  11. 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,…

  12. A Comparative Study on the Influence of Formal (School) Career ...

    African Journals Online (AJOL)

    A Comparative Study on the Influence of Formal (School) Career Guidance and Non-Formal (Parents) Career Guidance on Secondary School Students' ... These participants were purposively selected from a population of four research sites in Harare; (Ministry of education, Ministry of health, Business office and industry).

  13. 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 ...

  14. 65 Comparative Studies of Some Polypores Using High ...

    African Journals Online (AJOL)

    Administrator

    Comparative Studies of Some Polypores Using High Performance Liquid. Chromatography. Ofodile L. N., Attah L. E. Agbaje Williams and Simmonds, M. S. J ... Chromatography characteristics of their secondary metabolites. ..... Roja, G. and Rao, P. S. (1998) Biotechnology investigation in medicinal plants for the product.

  15. 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).

  16. 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 ...

  17. 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, ...

  18. Comparative study of electron conduction in azulene and naphthalene

    Indian Academy of Sciences (India)

    Wintec

    tional or electronic devices. Recent advances in experi- mental techniques have allowed ... stimulates us to study the electronic conduction in azulene molecule and to compare that with its isomer, naphthalene. ..... ernment of India, for funding and (SD) acknowledges CSIR,. Government of India, for a research fellowship.

  19. Comparative study of oven and traditionally roasted suya : an ...

    African Journals Online (AJOL)

    Comparative study of oven and traditionally roasted suya: an indigenous Nigerian meat. M C Okafor, H U Nwanjo, G O Oze. Abstract. No Abstract. Animal Production Research Avancees Vol. 3 (2) 2007: pp. 131-136. Full Text: EMAIL FULL TEXT EMAIL FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL TEXT.

  20. Comparative studies of chemically synthesized and RF plasma ...

    Indian Academy of Sciences (India)

    journal of. April 2015 physics pp. 653–665. Comparative studies of ... MS received 16 April 2013; revised 5 February 2014; accepted 28 May 2014 ... RF plasma polymerization; poly(o-toluidine); Fourier transform infrared; UV–visible ... tial applications, e.g., as electrodes and membranes for electrochemical energy ...

  1. 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 ... Log in or Register to get access to full text downloads. ... I adopted particpant observation as an instrument of ethnographic design of fact finding, ... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's ...

  2. 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 ...

  3. Comparative study of thermal insulation boards from leaf and bark ...

    African Journals Online (AJOL)

    Thus, several researches have succeeded in using these plants and agro waste fibres in developing renewable and 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 Pilios tigma thonningii L.in terms of density, ...

  4. a comparative study on different bmi category and physical fitness ...

    African Journals Online (AJOL)

    2017-08-08

    Aug 8, 2017 ... International License. Libraries Resour. A COMPARATIVE STUDY ON DIFF. FITNESS HEALTH RELATED COMP. V. Eswaramoorthi. 2,3. , M. R. Abdullah. Kosni. 2. , N. Alias. 1. East Coast Environmental Research Ins. Badak Campus, Kuala Teren. 2. Faculty of Applied Social Science,. Kuala Terengganu 2.

  5. 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 ...

  6. Research Governance and the Role of Evaluation: A Comparative Study

    Science.gov (United States)

    Molas-Gallart, Jordi

    2012-01-01

    Through a comparative study of the United Kingdom and Spain, this article addresses the effect of different research governance structures on the functioning and uses of research evaluation. It distinguishes three main evaluation uses: distributive, improvement, and controlling. Research evaluation in the United Kingdom plays important…

  7. 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 ...

  8. 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 ...

  9. 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…

  10. 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 ...

  11. The Comparative Rowhouse Study: An Introduction to Architectural Design.

    Science.gov (United States)

    Hirshorn, Paul

    1982-01-01

    A course is described that involves a comparative study of Philadelphia rowhouses. Students each visit a house and complete its architectural drawing according to established guidelines. The drawings are later reduced and offset printed for sale. A series of exercises focuses on a number of design elements. (MSE)

  12. 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 ...

  13. 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, ...

  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. 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 ...

  16. 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 ...

  17. Pedestrian Path Prediction with Recursive Bayesian Filters: A Comparative Study

    NARCIS (Netherlands)

    Schneider, N.; Gavrila, D.M.

    2013-01-01

    In the context of intelligent vehicles, we perform a comparative study on recursive Bayesian filters for pedestrian path prediction at short time horizons (< 2s). We consider Extended Kalman Filters (EKF) based on single dynamical models and Interacting Multiple Models (IMM) combining several such

  18. 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).

  19. Comparative study of magnetization in conventional and high Tc superconductors

    International Nuclear Information System (INIS)

    Sarkissian, B.V.B.; Grover, A.K.; Balakrishnan, G.; Paulose, P.L.; Vijayaraghavan, R.

    1989-01-01

    Results of a comparative study of thermomagnetic history effects and anomalous variations in isothermal magnetization hysteresis curves in a High T compound (YBa 2 Cu 3 O 7 ) with two specimens of Nb are presented. They show that the former behaves like any hard type c II superconductor

  20. Comparative study of contrast dacryocystogram and nuclear dacryocystogram

    International Nuclear Information System (INIS)

    Chaudhuri, T.K.; Saparoff, G.R.; Dolan, K.D.; Chaudhuri, T.K.

    1975-01-01

    A comparative study was run between conventional radiographic contrast dacryocystogram and radioisotope scan of the lacrimal drainage apparatus (henceforth called ''nuclear dacryocystogram''). A total of 20 contrast dacryocystograms (DCG), 22 irrigations, and 42 nuclear dacryocystograms (DCG) were performed in 21 patients having symptoms of obstruction in the lacrimal drainage system. The study revealed that there was a good correlation between these two diagnostic techniques and nuclear DCG was, perhaps, superior to contrast DCG. (U.S.)

  1. British and Italian electric power systems: Comparative study

    International Nuclear Information System (INIS)

    Lolli, A.

    1992-01-01

    This study compares the new electricity system in England, Wales and Scotland, after the 1989 Electricity Act, and the Italian electricity system (as modified by the January, 9, 1991, Law No. 9 and by the December 5, 1991, Decree No. 386 made law (No. 35) on January, 29, 1992). The study focuses on legal aspects and socio-economic factors influencing planning and organizing by the national electric power industries in their efforts to maintain supply and demand equilibrium

  2. COMPARATIVE STUDY OF TERTIARY WASTEWATER TREATMENT BY COMPUTER SIMULATION

    OpenAIRE

    Stefania Iordache; Nicolae Petrescu; Cornel Ianache

    2010-01-01

    The aim of this work is to asses conditions for implementation of a Biological Nutrient Removal (BNR) process in theWastewater Treatment Plant (WWTP) of Moreni city (Romania). In order to meet the more increased environmentalregulations, the wastewater treatment plant that was studied, must update the actual treatment process and have tomodernize it. A comparative study was undertaken of the quality of effluents that could be obtained by implementationof biological nutrient removal process li...

  3. 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.

  4. Comparative Study of Inference Methods for Bayesian Nonnegative Matrix Factorisation

    DEFF Research Database (Denmark)

    Brouwer, Thomas; Frellsen, Jes; Liò, Pietro

    2017-01-01

    In this paper, we study the trade-offs of different inference approaches for Bayesian matrix factorisation methods, which are commonly used for predicting missing values, and for finding patterns in the data. In particular, we consider Bayesian nonnegative variants of matrix factorisation and tri......-factorisation, and compare non-probabilistic inference, Gibbs sampling, variational Bayesian inference, and a maximum-a-posteriori approach. The variational approach is new for the Bayesian nonnegative models. We compare their convergence, and robustness to noise and sparsity of the data, on both synthetic and real...

  5. Standards, criteria, comparative study. Final report 1993-1994

    International Nuclear Information System (INIS)

    David, M.

    1995-01-01

    The goal of this report is to compare standards and criteria used for the design of seismic resistant Nuclear Power plants in former USSR and Eastern Europe to the actual practice in Western Europe and USA. A review of USSR and Czech-Slovak standards for design of WWER-1000 NPPs is included. Comparative study deals involves a general comparison of standards and the comparison of seismic loads according to Eastern standards with the to-day practices. According to these comparisons it can be theoretically concluded that despite some differences the structural seismic forces calculated according to Soviet-Russian standards are in good agreement with the ones resulting from Western Standards

  6. Linguistic Features of English and Russian Dictionaries (A Comparative Study

    Directory of Open Access Journals (Sweden)

    Robert Leščinskij

    2013-06-01

    Full Text Available The purpose of this study is to establish differences and similarities between linguistic characteristics of English and Russian dictionaries. Two dictionaries were selected for the study – electronic version of the 8th edition of Oxford Advanced Learner’s Dictionary (OALD and the online version of Ozhegov’s explanatory dictionary. The methods chosen for the study were descriptive, comparative and contrastive analysis. Linguistic characteristics of the dictionaries were analysed and compared. The research showed that both reference books provided different linguistic information on the headwords. OALD provided exhaustive phonetic information, which Ozhegov’s dictionary lacked. The two dictionaries provided different orthographic information. OALD disclosed semantic information via various tools available in the electronic version; these were unavailable in Ozhegov’s dictionary. Both dictionaries used similar stylistic labels.

  7. A comparative study of ICU patient diaries vs. hospital charts

    DEFF Research Database (Denmark)

    Egerod, Ingrid; Christensen, Doris

    2010-01-01

    Intensive care survivors often suffer from memory disorders, and some go on to develop anxiety, depression, and posttraumatic stress. Since the 1980s nurses have written diaries for intensive care patients to help them understand their illness and come to terms with their experiences after...... discharge. The central question we posed in this study was: Why do nurses write diaries in addition to conventional charting in the medical record? To answer this question, we compared intensive care diaries and hospital charts using textual analysis and narrative theory. The aims of our study were...... to compare patient diaries and hospital charts to explore (a) what each documentation instrument has to offer patients in their quest to make sense of their illness, and (b) why it is worthwhile for nurses to sustain the practice of writing diaries. The study findings show that the diary is coherent...

  8. A Comparative Study Of Stock Price Forecasting Using Nonlinear Models

    Directory of Open Access Journals (Sweden)

    Diteboho Xaba

    2017-03-01

    Full Text Available This study compared the in-sample forecasting accuracy of three forecasting nonlinear models namely: the Smooth Transition Regression (STR model, the Threshold Autoregressive (TAR model and the Markov-switching Autoregressive (MS-AR model. Nonlinearity tests were used to confirm the validity of the assumptions of the study. The study used model selection criteria, SBC to select the optimal lag order and for the selection of appropriate models. The Mean Square Error (MSE, Mean Absolute Error (MAE and Root Mean Square Error (RMSE served as the error measures in evaluating the forecasting ability of the models. The MS-AR models proved to perform well with lower error measures as compared to LSTR and TAR models in most cases.

  9. 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.

  10. A comparative study of flurbiprofen and piroxicam in osteoarthritis.

    Directory of Open Access Journals (Sweden)

    Misra N

    1992-10-01

    Full Text Available In this single-blind, multiple-dose study the efficacy and tolerability of flurbiprofen was compared with that of piroxicam in 60 adult patients suffering from osteoarthritis of the knee. The patients were randomly allocated to receive either flurbiprofen 100 mg twice daily or piroxicam 20 mg once daily for a period of four weeks. Clinical assessments w.r.t. pain, tenderness, stiffness, swelling and general activity of patient were carried out prior to initiation of trial therapy and thereafter at weekly intervals for four weeks. The findings were graded. Though significant improvements as compared to baseline data occurred in both the treatment groups, flurbiprofen was found to be superior to piroxicam in improving pain on movement and at rest (p < 0.05. The incidence of side effects was less in the group receiving flurbiprofen (6% compared to 47% observed with piroxicam.

  11. 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)

  12. Comparative metallurgical study of thick hard coatings without cobalt

    International Nuclear Information System (INIS)

    Clemendot, F.; Van Duysen, J.C.; Champredonde, J.

    1992-07-01

    Wear and corrosion of stellite type hard coatings for valves of the PWR primary system raise important problems of contamination. Substitution of these alloys by cobalt-free hard coatings (Colmonoy 4 and 4.26, Cenium 36) should allow to reduce this contamination. A comparative study (chemical, mechanical, thermal, metallurgical), as well as a corrosion study of these coatings were carried out. The results of this characterization show that none of the studied products has globally characteristics as good as those of grade 6 Stellite currently in service

  13. Different truncation methods of AUC between Japan and the EU for bioequivalence assessment: influence on the regulatory judgment.

    Science.gov (United States)

    Oishi, Masayo; Chiba, Koji; Fukushima, Takashi; Tomono, Yoshiro; Suwa, Toshio

    2012-01-01

    In regulatory guidelines for bioequivalence (BE) assessment, the definitions of AUC for primary assessment are different in ICH countries, i.e., AUC from zero to the last sampling point (AUCall) in Japan, AUC from zero to infinity (AUCinf) or AUC from zero to the last measurable point (AUClast) in the US, and AUClast in the EU. To assure sufficient accuracy of truncated AUC for BE assessment, the ratio of truncated AUC (AUCall or AUClast) to AUCinf should be more than 80% both in Japanese and EU guidelines. We investigated how the difference in the definition of truncated AUC affects BE assessment of sustained release (SR) formulation. Our simulation result demonstrated that AUCall/AUCinf could be ≥80% despite AUClast/AUCinf being AUC affected the judgment of validity of truncated AUC for BE assessment, and AUCall could fail to detect the substantially different in vivo dissolution profile of generic drugs with SR formulation from the original drug.

  14. 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.

  15. 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.

  16. Tensile strength of biological fibrin sealants: a comparative study.

    Science.gov (United States)

    Lacaze, Laurence; Le Dem, Nicolas; Bubenheim, Michael; Tsilividis, Basile; Mezghani, Julien; Schwartz, Lilian; Francois, Arnaud; Ertaud, Jean Yves; Bagot d'Arc, Maurice; Scotté, Michel

    2012-08-01

    Fibrin sealants are commonly used in liver surgery, although their effectiveness in routine clinical practice remains controversial. Individual sealant characteristics are based on hemostatic effects and adhesion properties that can be experimentally measured using the 'rat skin test' or the 'pig skin test'. This study used a more relevant and realistic experimental canine model to compare the differences in the adhesive properties of four fibrin sealants in hepatectomy: Tisseel/Tissucol, Tachosil, Quixil, and Beriplast. A partial hepatectomy was performed in beagle dogs under general anesthesia to obtain liver cross-sections. Fibrin sealants were allocated to dog livers using a Youden square design. The tensile strength measurement was performed using a traction system to measure the rupture stress point of a small wooden cylinder bonded to the liver cross-section. Significantly greater adhesion properties were observed with Tisseel/Tissucol compared with Quixil or Beriplast (P = 0.002 and 0.001, respectively). Similarly, Tachosil demonstrated significantly greater adhesive properties compared with Beriplast (P = 0.009) or Quixil (P = 0.014). No significant differences were observed between Tisseel/Tissucol and Tachosil or between Beriplast and Quixil. The results of this comparative study demonstrate that different fibrin sealants exhibit different adhesive properties. Tisseel/Tissucol and Tachosil provided greatest adhesion to liver cross-section in our canine model of hepatectomy. These results may enable the optimal choice of fibrin sealants for this procedure in clinical practice. Copyright © 2012 Elsevier Inc. All rights reserved.

  17. 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.

  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

    , dialysis-related complications, dialysis-related expenses. RESULTS: The quality-of-life studies showed that significantly more time for work, family, and social activities was available to patients on APD compared to those on CAPD (p ...) 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. Comparative study of approaches to estimate pipe break frequencies

    Energy Technology Data Exchange (ETDEWEB)

    Simola, K.; Pulkkinen, U.; Talja, H.; Saarenheimo, A.; Karjalainen-Roikonen, P. [VTT Industrial Systems (Finland)

    2002-12-01

    The report describes the comparative study of two approaches to estimate pipe leak and rupture frequencies for piping. One method is based on a probabilistic fracture mechanistic (PFM) model while the other one is based on statistical estimation of rupture frequencies from a large database. In order to be able to compare the approaches and their results, the rupture frequencies of some selected welds have been estimated using both of these methods. This paper highlights the differences both in methods, input data, need and use of plant specific information and need of expert judgement. The study focuses on one specific degradation mechanism, namely the intergranular stress corrosion cracking (IGSCC). This is the major degradation mechanism in old stainless steel piping in BWR environment, and its growth is influenced by material properties, stresses and water chemistry. (au)

  1. Comparative study of Danish prefab houses made of wood

    DEFF Research Database (Denmark)

    Wraber, Ida Kristina

    2011-01-01

    The use of wood in Danish prefab building projects is increasing, but there is not a strong architectural tradition in Denmark for constructing timber housing. This paper therefore contains a comparative study of various manners of incorporating architectural features in prefab houses made of wood....... In the study four Danish prefab housing concepts based on wood con¬struc¬tion is compared and discussed, in order to investigate and exemplify how it is possible to work with architectural quality in prefab timber housing and maximise the use of the material, the prefab production and the architectural values....... It was concluded that especially two aspects are of great importance for the concrete handling of the architectural quality of prefab houses made of wood; 1) flexibility in relation to user and site, and 2) the interaction between form, logics and material. It is suggested that keeping these two aspects in mind...

  2. COMPARATIVE STUDY OF OLANZAPINE AND QUETIAPINE IN PSYCHOTIC DISORDERS

    Directory of Open Access Journals (Sweden)

    Bithorai Basumatary

    2018-01-01

    Full Text Available BACKGROUND Psychotic disorders are a group of chronic debilitating psychiatric illness characterised by loss in touch with reality and disorders of thought, behaviour, appearance and speech. The second generation atypical antipsychotic olanzapine has been reported to be the commonly prescribed antipsychotic. However, olanzapine can cause adverse effects like weight gain, hyperglycaemia, diabetes, dyslipidaemia and metabolic syndrome. Quetiapine, another second generation antipsychotic has good efficacy and has become well established in the treatment of schizophrenia and manic episodes. There are reports on adverse effects of hyperglycaemia and diabetes with quetiapine, but these are comparatively lesser than olanzapine. The aim of the study is to compare the efficacy of olanzapine and quetiapine in patients with psychotic disorders. MATERIALS AND METHODS It was an unicentric, open label, prospective and comparative clinical study. Subjects (n=80 who were diagnosed with psychotic disorder were randomly assigned to receive olanzapine (group 1 or quetiapine (group 2. The efficacy of the two drugs was assessed on the basis Brief Psychiatric Rating Scale (BPRS scores at baseline, 1 week and 6 weeks. UKU scale (Udvalg Kliniske Undersogelser and laboratory investigations were used to assess the safety profile. RESULTS The two study groups had comparable sociodemographic profile. Both the groups showed significant reduction in psychotic symptoms as compared from baseline to 1 week and 6 weeks (p<0.001. The intergroup comparison of the efficacy of the two groups did not show any statistically significant results. There was statistically insignificant differences in the occurrence of adverse effects in both the groups. Sedation (50% in both the groups was the most common adverse effect in both the groups. The use of concomitant medications was comparable in both the groups. Benzodiazepines (56.3% in the olanzapine group and 51.9% in the quetiapine group

  3. A COMPARATIVE STUDY OF ROLE OF CORTICAL MASTOIDECTOMY IN MYRINGOPLASTY

    Directory of Open Access Journals (Sweden)

    Rahul Kawatra

    2015-01-01

    Full Text Available BACKGROUND : Chronic suppurative otitis media is an inflammatory process of mucoperiosteal lining of middle ear space and mastoid. Effect of mastoidectomy on patients without evidence of active infectious disease remains highly debated and unproven. In this study the role of cortical mastoidectomy in myringoplasty in patients of CSOM in dry as well as wet ears was evaluated. OBJECTIVE : To evaluate the efficacy and role of cortical mastoidectomy in patients with CSOM (safe type in dry as well as wet ears. STUDY DESIGN: Prospective randomized. METHODS : Data was collected from the patients undergoing myringoplasty with or without cortical mastoidectomy. Study was carried out on a total of 80 patients undergoing the surgery. Study period was 18 months with 6 months of follow up. Outcome was evaluated in terms of graft rejection, lateralization and change in AB gap. STATISTICAL ANALYSIS: The statistical analysis was done using SPSS (Statistical Package for Social Sciences Version 15.0 statistical Analysis Software. RESULT S : overall success rate was 77.5%. It was higher in dry ear (87.5% as compared to wet ear (67.5% and this difference was significant statistically. On evaluating odds of failure for wet ear, it was observed that group 1 had higher odds of failure for wet ear as compared to that of group 2. CONCLUSION : In both myringoplasty alone or with cortical mastoidectomy, failure rates were higher in wet as compared to dry ears, however odds of failure in wet cases were much higher in myringoplasty alone group as compared to myringoplasty with cortic al mastoidectomy

  4. Comparing Case Study and Ethnography as Qualitative Research Approaches

    OpenAIRE

    Suryani, Anne

    2008-01-01

    Abstract: This article reviews several differences between case study and ethnography in terms of definitions, characteristics, strengths and limitations. It provides current information by comparing these approaches from various social researchers’ perspectives. Although each method has strong points, they both have differences in conducting observation and interview as data collection techniques; choosing the length of time of data gathering and reporting details of a particular reality....

  5. Comparing Case Study and Ethnography as Qualitative Research Approaches

    Directory of Open Access Journals (Sweden)

    Anne Suryani

    2013-12-01

    Full Text Available Abstract: This article reviews several differences between case study and ethnography in terms of definitions, characteristics, strengths and limitations. It provides current information by comparing these approaches from various social researchers’ perspectives. Although each method has strong points, they both have differences in conducting observation and interview as data collection techniques; choosing the length of time of data gathering and reporting details of a particular reality.

  6. 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...

  7. A comparative study of tranexamic acid and ethamsylate in menorrhagia

    OpenAIRE

    Nita K. Patel; Manish R. Pandya

    2012-01-01

    Background: Menorrhagia interferes with the woman's physical, social, emotional, and/or material quality of life. Antifibrinolytic drugs are effective in decreasing excessive menstrual bleeding. The objective of this study was to compare the effects of tranexamic acid and ethamsylate on quality of life in women with menorrhagia. Methods: The 50 women with menorrhagia were randomised to receive either tranexamic acid or ethamsylate. Twenty five patients were allocated to receive tranexamic aci...

  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...... are some of the major series of human and animal embryos, such as the Boyd and Carnegie collections, as these also house placental material....

  9. 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...

  10. A comparative study of fuel management in PWR reactors

    International Nuclear Information System (INIS)

    Barroso, D.E.G.; Nair, R.P.K.; Vellozo, S.O.

    1981-01-01

    A study about fuel management in PWR reactors, where not only the conventional uranium cycle is considered, but also the thorium cycle as an alternative is presented. The final results are presented in terms of U 3 O 8 demand and SWU and the approximate costs of the principal stages of the fuel cycle, comparing with the stardand cycle without recycling. (E.G.) [pt

  11. Comparative study of radiosensitivity of normal and regenerating tissues

    International Nuclear Information System (INIS)

    Samokhvalova, H.S.; Popova, M.F.

    1983-01-01

    A comparative study of radiosensitivity of cells of normal and regenerating tissues of bone marrow and spleen has demonstrated that single exposure to X-rays produces a lesser damaging effect on regenerating tissues than on normal ones. The data obtained indicate that the increase in radioresistance of the organism during active regeneration of the haemopoietic organs is due not merely to the increase in the dividing cell pool of these organs but also to qualitative changes in their functional state

  12. COMPARATIVE STUDY OF GLASS FIBRE CONCRETE AND NORMAL CONCRETE

    OpenAIRE

    Mr.Yogesh S.Lanjewar*

    2018-01-01

    Concrete is basically the most important material concerning with the construction and infrastructural procedures, for which it should be of good strength and durability. Many researches are being conducted to make concrete more sustainable and of more strength and durability. Therefore keeping this in mind i have chosen to do the comparative study regarding the strength of normal concrete with the glass fibre added concrete using mix design procedure as per IS 10262-2009 for concrete. As w...

  13. Quality of Sibling Relationship and Substance Misuse: A Comparative Study

    OpenAIRE

    Anastasia Tsamparli; Elvisa Frrokaj

    2016-01-01

    The aim of the current study is to examine the quality of sibling relationship in families with a sibling with substance misuse (SSU) and compare the relationship to families with a sibling with no use (SNU). Thirty-six (36) families participated in the study (17 with SSU and 19 with SNU; N = 144). Semi-structured interviews were conducted with 40 siblings (20 SNU and 20 SSU; 18-31 years old) in order to qualitatively investigate the characteristics of the sibling relationship. The siblings w...

  14. 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

  15. 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.

  16. 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)

  17. 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.

  18. Comparative inter-institutional study of stress among dentists.

    Science.gov (United States)

    Pozos-Radillo, Blanca E; Galván-Ramírez, Ma Luz; Pando, Manuel; Carrión, Ma De los Angeles; González, Guillermo J

    2010-01-01

    Dentistry is considered to be a stressful profession due to different factors caused by work, representing a threat to dentists'health. The objectives of this work were to identify and compare chronic stress in dentists among the different health institutions and the association of stress with risk factors. The study in question is observational, transversal and comparative; 256 dentists were included, distributed among five public health institutions in the city of Guadalajara, Jalisco, Mexico, namely: the Mexican Institute of Social Security (IMSS), the Ministry of Health (SS), the Integral Development of the Family (DIF), the Social Security Services Institute for the Workers (ISSSTE) and the University of Guadalajara (U. de G) Data were obtained by means of the census technique. Stress was identified using the Stress Symptoms Inventory and the statistical analysis was performed using the Odds Ratio (O.R.) and the chi-square statistic. From the total population studied, 219 subjects presented high levels of chronic stress and 37, low levels. In the results of comparative analysis, significant differences were found between IMSS and U. de G and likewise between IMSS and SS. However, in the analysis of association, only U. de G was found to be associated with the high level of chronic stress.

  19. 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.

  20. 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)

  1. 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.

  2. Comparative study between computed radiography and conventional radiography

    International Nuclear Information System (INIS)

    Noorhazleena Azaman; Khairul Anuar Mohd Salleh; Sapizah Rahim; Shaharudin Sayuti; Arshad Yassin; Abdul Razak Hamzah

    2010-01-01

    In Industrial Radiography, there are many criteria that need to be considered based on established standards to accept or reject the radiographic film. For conventional radiography, we need to consider the optical density by using the densitometer when viewing the film on the viewer. But in the computed radiography (CR) we need to evaluate and performed the analysis from the quality of the digital image through grey value. There are many factors that affected the digital image quality. One of the factors which are affected to the digital image quality in the image processing is grey value that related to the contrast resolution. In this work, we performed grey value study measurement on digital radiography systems and compared it with exposed films in conventional radiography. The test sample is a steel step wedge. We found out the contrast resolution is higher in Computed Radiography compared with Conventional Radiography. (author)

  3. 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

  4. 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)

  5. Comparative studies of industrial grade carbon black powders

    Energy Technology Data Exchange (ETDEWEB)

    Chawla, Komal, E-mail: komalchawla.rs@gmail.com; Chauhan, Alok P. S., E-mail: chauhan.alok@gmail.com, E-mail: alok.chauhan@alumni.stonybrook.edu [Department of Physics and Material Science and Engineering, Jaypee Institute of Information Technology, A-10, Sector-62, Noida-201307, UP, India. (India)

    2016-05-06

    Comparative studies of two dissimilar industrial grade Carbon Black (CB) powders (N375 and N405) were conducted. The structure, surface area and particle size are the three important characteristics of CB powder that determine their processability and application as filler in preparing rubber compounds. The powders were characterized for their structure using dibutyl phthalate absorption (DBPA), particle size via laser particle size analyzer and surface area by nitrogen adsorption method. The structural characterization showed that N405 had lower DBPA in comparison to N375, confirming low structure of N405 grade CB powder. It was observed from the particle size analysis that N375 was coarser than N405 grade CB. The total surface area values were determined by the BET method based on the cross sectional area of the nitrogen molecule. N375, a coarse grade CB powder with high structure, depicted less surface area as compared to N405.

  6. 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.

  7. 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

  8. 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

  9. Achalasia in the elderly patient: a comparative study

    Directory of Open Access Journals (Sweden)

    Rosana B. Schechter

    2011-03-01

    Full Text Available CONTEXT: Achalasia is a primary esophageal motor disorder secondary to the degeneration of ganglion cells of the inhibitory intramural myenteric plexus. It affects both sexes similarly and has two peaks of incidence, one in the 3rd to 4th decades of life and the other after 60 years of age. The effect of age on esophageal motility of patients with achalasia is not well known. Studies have shown that healthy older people, when compared to the young, have: a a lower number of ganglion cells in the intramural myenteric plexus; b a reduced normal relaxation of the lower esophageal sphincter; and c a reduced esophageal peristalsis. Thus, as both age and achalasia can produce comparable degenerative changes in the intramural myenteric plexus, it is possible that advanced age could be an important factor in enhancing the clinical and manometric abnormalities commonly found in patients with achalasia. OBJECTIVES: To compare the clinical, radiological and manometric findings in young as compared to elderly (>60 years old achalasia patients. METHODS: A retrospective study of a group of patients with untreated achalasia separated into young and elderly patients. Demographic, clinical, serology for Chagas' disease, radiological and manometric data were compared between these groups. The level of significance was P<0.05. RESULTS: The study included 105 patients, 52 young (25 M/27 F, mean age 40 years old and 53 elderly (21 M/32 F, mean age 70 years old. The elderly group had a higher prevalence of Chagas' disease (P = 0.004 and a lower pressure of the lower esophageal sphincter [26.4 mm Hg vs 31.9 mm Hg] P = 0.001, a difference that persisted when analyzed only elderly and young patients with idiopathic achalasia. Younger patients had a higher prevalence of heartburn (P = 0.001 and chest pain (P = 0.012 than the elderly. CONCLUSION: Elderly patients with achalasia had a lower esophageal sphincter pressure than the young, even when we excluded patients with

  10. PLURALISM AND THE STUDY OF RELIGION: A COMPARATIVE PERSPECTIVE

    Directory of Open Access Journals (Sweden)

    A.L. SAMIAN

    2010-11-01

    Full Text Available In the Malaysian government outline of Vision 2020, the importance of the study of religion as an integral component of general education is explicitly stated. This paper examines the present state of comparative religious studies in Malaysian Institutes of Higher Learning. Several philosophical issues are highlighted including the local concept and objective of religious studies, suitability of courses offered, and its relevance to the national development, i.e., industrialization of the country. An attempt is made to suggest how the religious course in a plural society like Malaysia, in the future, can be used to achieve Vision 2020 by integrating science and religion based on the position that science is a problem-solving activity.

  11. 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.

  12. Comparative study of resist stabilization techniques for metal etch processing

    Science.gov (United States)

    Becker, Gerry; Ross, Matthew F.; Wong, Selmer S.; Minter, Jason P.; Marlowe, Trey; Livesay, William R.

    1999-06-01

    This study investigates resist stabilization techniques as they are applied to a metal etch application. The techniques that are compared are conventional deep-UV/thermal stabilization, or UV bake, and electron beam stabilization. The electron beam tool use din this study, an ElectronCure system from AlliedSignal Inc., ELectron Vision Group, utilizes a flood electron source and a non-thermal process. These stabilization techniques are compared with respect to a metal etch process. In this study, two types of resist are considered for stabilization and etch: a g/i-line resist, Shipley SPR-3012, and an advanced i-line, Shipley SPR 955- Cm. For each of these resist the effects of stabilization on resist features are evaluated by post-stabilization SEM analysis. Etch selectivity in all cases is evaluated by using a timed metal etch, and measuring resists remaining relative to total metal thickness etched. Etch selectivity is presented as a function of stabilization condition. Analyses of the effects of the type of stabilization on this method of selectivity measurement are also presented. SEM analysis was also performed on the features after a compete etch process, and is detailed as a function of stabilization condition. Post-etch cleaning is also an important factor impacted by pre-etch resist stabilization. Results of post- etch cleaning are presented for both stabilization methods. SEM inspection is also detailed for the metal features after resist removal processing.

  13. [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.

  14. 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).

  15. 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...

  16. Multiple comparative studies of Green Supply Chain Management

    DEFF Research Database (Denmark)

    Xu, Lihui; Mathiyazhagan, K.; Govindan, Kannan

    2013-01-01

    friendly operation strategies to lower their overall carbon footprint. Currently, there is increased awareness among customers even in developing countries about eco friendly manufacturing solutions. Multi-national firms have identified economies of developed nations as a potential market...... for their products. Such organizations in developing countries like India and China are under pressure to adopt green concepts in supply chain operations to compete in the market and satisfy their customers' increasing needs. This paper offers a comparative study of pressures that impact the adoption of Green Supply...

  17. 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.

  18. 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

  19. Engineering Ethics Education: A Comparative Study of Japan and Malaysia.

    Science.gov (United States)

    Balakrishnan, Balamuralithara; Tochinai, Fumihiko; Kanemitsu, Hidekazu

    2018-03-22

    This paper reports the findings of a comparative study in which students' perceived attainment of the objectives of an engineering ethics education and their attitude towards engineering ethics were investigated and compared. The investigation was carried out in Japan and Malaysia, involving 163 and 108 engineering undergraduates respectively. The research method used was based on a survey in which respondents were sent a questionnaire to elicit relevant data. Both descriptive and inferential statistical analyses were performed on the data. The results of the analyses showed that the attainment of the objectives of engineering ethics education and students' attitude towards socio-ethical issues in engineering were significantly higher and positive among Japanese engineering students compared to Malaysian engineering students. Such findings suggest that a well-structured, integrated, and innovative pedagogy for teaching ethics will have an impact on the students' attainment of ethics education objectives and their attitude towards engineering ethics. As such, the research findings serve as a cornerstone to which the current practice of teaching and learning of engineering ethics education can be examined more critically, such that further improvements can be made to the existing curriculum that can help produce engineers that have strong moral and ethical characters.

  20. 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.

  1. [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.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. COMPARATIVE STUDY OF ROCURONIUM AND SUXAMETHONIUM IN ENDOTRACHEAL INTUBATION

    Directory of Open Access Journals (Sweden)

    Dadichiluka Veeragouri Sankararao

    2017-06-01

    Full Text Available BACKGROUND Tracheal intubation is one of the best methods of securing a patent airway. Good intubating conditions minimise the risk of trauma associated with tracheal intubation. Intubating conditions (muscle tone, vocal cords position, reaction to laryngoscopy and tube positioning depend on depth of anaesthesia and kind of anaesthetic used. Tracheal intubation is commonly facilitated by muscle relaxation. Rocuronium has rapid onset of action, which is comparable to suxamethonium. It has been shown to produce intubating conditions similar to those produced by suxamethonium. This study compares rocuronium and suxamethonium in tracheal intubation. MATERIALS AND METHODS A total of 100 patients of ASA grade 1 and 2 for elective surgeries under general anaesthesia were recruited for this study after obtaining clearance from institutional ethics committee and informed consent from the patients. These 100 patients were divided into 2 groups, group R received rocuronium and group S received suxamethonium. All patients underwent through preanaesthetic checkup on the day before surgery. Thorough airway assesssment was done to rule out difficult intubation. Patients were advised to be nil orally from 10 p.m. onwards, the night before surgery. RESULTS The intubating conditions in the rocuronium group were found to be excellent in 50%, fair in 34% and satisfactory in 16% of the patients compared to excellent in 68%, fair in 32% in suxamethonium group. Clinically, acceptable intubating conditions were seen in 84% and 100% of patients administered rocuronium and suxamethonium, respectively. CONCLUSION Rocuronium in a dose of 0.6 mg/kg is a suitable alternative to suxamethonium in a dose of 1.5 mg/kg in premedicated and anaesthetised patients scheduled for elective surgeries.

  8. 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.

  9. 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)

  10. 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.

  11. 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.

  12. 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

  13. 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.

  14. Comparative studies of energy sources in gynecologic laparoscopy.

    Science.gov (United States)

    Law, Kenneth S K; Lyons, Stephen D

    2013-01-01

    Energy sources incorporating "vessel sealing" capabilities are being increasingly used in gynecologic laparoscopic surgery although conventional monopolar and bipolar electrosurgery remain popular. The preference for one device over another is based on a combination of factors, including the surgeon's subjective experience, availability, and cost. Although comparative clinical studies and meta-analyses of laparoscopic energy sources have reported small but statistically significant differences in volumes of blood loss, the clinical significance of such small volumes is questionable. The overall usefulness of the various energy sources available will depend on a number of factors including vessel burst pressure and seal time, lateral thermal spread, and smoke production. Animal studies and laboratory-based trials are useful in providing a controlled environment to investigate such parameters. At present, there is insufficient evidence to support the use of one energy source over another. Copyright © 2013 AAGL. All rights reserved.

  15. 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

  16. Female Sexual Homicide Offenders: A Descriptive and Comparative Study.

    Science.gov (United States)

    Skott, Sara; Beauregard, Eric; Darjee, Rajan

    2018-04-23

    Research on female sexual homicide has been very scarce. In Europe, it has rarely been examined, and in Scotland, it has never previously been studied. This exploratory study aims to examine the characteristics of sexual homicides involving female offenders between 1990 and 2015 in Scotland. Using data from the Scottish Homicide Database between 1990 and 2015, female sexual homicides (n = 7) were compared to nonsexual homicides committed by females (n = 106) and to sexual homicides committed by men (n = 89) using Fisher's exact tests. The findings show that although female sexual homicide offenders are similar to both female nonsexual homicide offenders and male sexual homicide offenders in certain aspects, there are important differences that distinguish sexual homicides involving female offenders from both groups. Female sexual homicide offenders can arguably be seen as a distinct group of offenders, with specific characteristics and specific needs. © 2018 American Academy of Forensic Sciences.

  17. 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.

  18. A comparative phylogenetic study of genetics and folk music.

    Science.gov (United States)

    Pamjav, Horolma; Juhász, Zoltán; Zalán, Andrea; Németh, Endre; Damdin, Bayarlkhagva

    2012-04-01

    Computer-aided comparison of folk music from different nations is one of the newest research areas. We were intrigued to have identified some important similarities between phylogenetic studies and modern folk music. First of all, both of them use similar concepts and representation tools such as multidimensional scaling for modelling relationship between populations. This gave us the idea to investigate whether these connections are merely accidental or if they mirror population migrations from the past. We raised the question; does the complex structure of musical connections display a clear picture and can this system be interpreted by the genetic analysis? This study is the first to systematically investigate the incidental genetic background of the folk music context between different populations. Paternal (42 populations) and maternal lineages (56 populations) were compared based on Fst genetic distances of the Y chromosomal and mtDNA haplogroup frequencies. To test this hypothesis, the corresponding musical cultures were also compared using an automatic overlap analysis of parallel melody styles for 31 Eurasian nations. We found that close musical relations of populations indicate close genetic distances (music; maternal lineages have a more important role in folk music traditions than paternal lineages. Furthermore, the combination of these disciplines establishing a new interdisciplinary research field of "music-genetics" can be an efficient tool to get a more comprehensive picture on the complex behaviour of populations in prehistoric time.

  19. 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.

  20. 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

  1. Lessons learned from international comparative crosscultural studies on dementia.

    Science.gov (United States)

    Hendrie, Hugh C

    2006-06-01

    International and crosscultural comparative studies of Alzheimer disease (AD) offer significant advantages in elucidating risk factors for the disease by providing a wider diversity of environmental exposures as well as greater genetic diversity than do studies confined to a single ethnic group in a developed country. They also present with major methodological problems. The problems and their possible solutions are discussed in this article by describing three projects involving the Cree and English-speaking residents of Manitoba, blacks from Indianapolis, Indiana, and Yoruba from Ibadan and residents of Chinese villages. In this review, the development and harmonization of a culture fair screening instrument for dementia, the CSID, is described. The advantage of a scientific paradigm that can incorporate genetic and environmental factors as well as their interactions to explore the etiology of AD is presented. The importance of developing strategies for recruitment and retention in international community-based studies is emphasized as is the necessity of establishing academic partnerships between the countries. The unique opportunity provided by geopolitical and sociocultural influences to study environmental exposures is exemplified by the ongoing study of the influence of selenium levels on cognition in Chinese villagers. Results from the Indianapolis, Indiana-Ibadan dementia project are presented suggesting that the incidence of AD is lower in Yoruba than in blacks and that this lower rate may be the result of a combination of genetic and environmental factors.

  2. Mac protocols for wireless sensor network (wsn): a comparative study

    International Nuclear Information System (INIS)

    Arshad, J.; Akram, Q.; Saleem, Y.

    2014-01-01

    Data communication between nodes is carried out under Medium Access Control (MAC) protocol which is defined at data link layer. The MAC protocols are responsible to communicate and coordinate between nodes according to the defined standards in WSN (Wireless Sensor Networks). The design of a MAC protocol should also address the issues of energy efficiency and transmission efficiency. There are number of MAC protocols that exist in the literature proposed for WSN. In this paper, nine MAC protocols which includes S-MAC, T-MAC, Wise-MAC, Mu-MAC, Z-MAC, A-MAC, D-MAC, B-MAC and B-MAC+ for WSN have been explored, studied and analyzed. These nine protocols are classified in contention based and hybrid (combination of contention and schedule based) MAC protocols. The goal of this comparative study is to provide a basis for MAC protocols and to highlight different mechanisms used with respect to parameters for the evaluation of energy and transmission efficiency in WSN. This study also aims to give reader a better understanding of the concepts, processes and flow of information used in these MAC protocols for WSN. A comparison with respect to energy reservation scheme, idle listening avoidance, latency, fairness, data synchronization, and throughput maximization has been presented. It was analyzed that contention based MAC protocols are less energy efficient as compared to hybrid MAC protocols. From the analysis of contention based MAC protocols in term of energy consumption, it was being observed that protocols based on preamble sampling consume lesser energy than protocols based on static or dynamic sleep schedule. (author)

  3. 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)

  4. Epidural analgesia during labor vs no analgesia: A comparative study

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    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.

  5. A Comparative Study between Universal Eclectic Septoplasty Technique and Cottle

    Science.gov (United States)

    Amaral Neto, Odim Ferreira do; Mizoguchi, Flavio Massao; Freitas, Renato da Silva; Maniglia, João Jairney; Maniglia, Fábio Fabrício; Maniglia, Ricardo Fabrício

    2017-01-01

    Introduction  Since the last century surgical correction of nasal septum deviation has been improved. The Universal Eclectic Technique was recently reported and there are still few studies dedicated to address this surgical approach. Objective  The objective of this study is to compare the results of septal deviation correction achieved using the Universal Eclectic Technique (UET) with those obtained through Cottle's Technique. Methods  This is a prospective study with two consecutive case series totaling 90 patients (40 women and 50 men), aged between 18 and 55 years. We divided patients into two groups according to the surgical approach. Fifty-three patients underwent septoplasty through Universal Eclectic Technique (UET) and thirty-seven patients were submitted to classical Cottle's septoplasty technique. All patients have answered the Nasal Obstruction Symptom Evaluation Scale (NOSE) questionnaire to assess pre and postoperative nasal obstruction. Results  Statistical analysis showed a significantly shorter operating time for the UET group. Nasal edema assessment performed seven days after the surgery showed a prevalence of mild edema in UET group and moderate edema in Cottle's technique group. In regard to complication rates, UET presented a single case of septal hematoma while in Cottle's technique group we observed: 02 cases of severe edemas, 01 case of incapacitating headache, and 01 complaint of nasal pain. Conclusion  The Universal Eclectic Technique (UET) has proven to be a safe and effective surgical technique with faster symptomatic improvement, low complication rates, and reduced surgical time when compared with classical Cottle's technique. PMID:28680499

  6. A comparative study of three different kinds of school furniture.

    Science.gov (United States)

    Aagaard, Jens; Storr-Paulsen, Annette

    1995-05-01

    Several studies indicate that the ISO standards for school furniture seem to be inappropriate, and there is increasing evidence that the inclination of the seat should be forward and that it should be possible to adjust the table-top to a certain non-horizontal angle. However, these studies have predominantly used objective measurement methods on adult subjects for short-term experiments in rather artificial surroundings. By means of structured interviews registering the school children's perception of ergonomic comfort, the present study has compared three types of school furniture-the original ISO-standard type, and two different new types characterized by forward slanting seats and tiltable desk-tops, the main difference between the two being approximately 15 cm in the height of the chair as well as the table. The study showed that the highest of the two tilting types was perceived to be significantly better than the two others in terms of table height, chair height, reading position, back-rest, and global assessment. Likewise, the feature of a tiltable table-top was considered overwhelmingly positive independently of the height of the furniture. It is recommended that school authorities, producers of school furniture, and relevant medical personnel consider these results for alternative designs of school furniture. It should be kept in mind, however, that school furniture is only one among many factors in the multifactorial field of the back health of school children.

  7. A comparative study of road traffic accidents in West Malaysia.

    Science.gov (United States)

    Silva, J F

    1978-11-01

    The problem of road traffic accidents in developing countries is now becoming a cause for concern. This is more so as preventive measures have not kept pace with economic progress and development. This paper reviews the present situation in West Malaysia, one of the better developed countries of the East, during the period 1970 to 1975. A comparative study has been made between the United States and Malaysia. To enable the urgency of the problem in developing countries to be appreciated the increases in the country's population and in the number of vehicles in use and their relation to the lesser increase in road mileage over the period of study have been discussed. The study has considered every aspect of the causative factors leading to traffic accidents, such as the effects of weather, seasonal variation, and road and lighting conditions. The common human errors leading to accidents have been discussed. Other factors, such as the ethnic distribution in Malaysia, and their relation to road accidents have shown the effect of the social structure on the problems. The data evaluated in this study make it clear that preventive measures are very necessary in underdeveloped as well as in developed countries.

  8. A comparative study of two-piece ostomy appliances.

    Science.gov (United States)

    Welser, Marion; Riedlinger, Inge; Prause, Ulla

    The quality of life of people with a stoma may be affected by peristomal skin disorders and by frequent unplanned changes of ostomy appliances due to problems with those appliances. The aim of this study was to evaluate two new, two-piece ostomy appliances with mechanical couplings (both from the SenSura range by Coloplast) and their ability to address areas that may be important to the quality of life of people with stomas, including appliance changes, stool seepage and overfilling. The study design featured two comparative, crossover, randomized multi-centre studies that were conducted in Germany. The SenSura appliances were evaluated against established reference appliances. Seventy-three individuals with a colostomy (closed-end appliances) and 75 individuals with an ileostomy (drainable appliances) participated in the studies. The participants tested 4-6 flanges of each type within a maximum period of two weeks. The results demonstrated that there was less seepage of stool observed under the SenSura flange when it was removed (pappliances. The SenSura flanges had better adhesion and flexibility and were easier to remove than the references (pappliances on quality of life indicators - there were fewer unplanned changes and less seepage of stool was observed in patients using the SenSura products.

  9. 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.

  10. A Prospective Study Comparing Ligasure and Open Hemorrhoidectomy

    Directory of Open Access Journals (Sweden)

    Rahimi M

    2011-11-01

    Full Text Available Background: Hemorrhoid is among the most common anorectal diseases and patients with high-grade disease conditions need surgical treatment. Many surgical procedures are available to treat the disease. The aim of this study was to compare the operative time and outcomes, (post-operative pain and complications of LigaSure hemorrhoidectomy with those of the open conventional method.Methods : This randomized single-blind clinical trial included 57 patients (28 in LigaSure and 29 in the open group. The primary variable was the operative time for the excision of a single hemorrhoidal packet. The other variables were post-operative pain measured by morphine doses administered to control pain, scores of visual analogue scale (VAS used to measure pain severity, pain during home stay measured by doses of oral ibuprofen and the mean daily VAS scores, early complications including bleeding and urinary retention, longer-term complications and time to return to work.Results : The demographic data were comparatively the same between the two groups. The average time to excise a single packet of hemorrhoid was significantly shorter in the LigaSure group (8.91 min vs. 17.35 min, P<0.001. Post-operative pain measurements (morphine doses and VAS scores were lower in the LigaSure group, but the differences were not statistically significant (P=0.055 and 0.077, respectively. Complications of the two procedures were also comparable. Neither of the groups returned to work in a shorter time.Conclusion: LigaSure hemorrhoidectomy seems to be a safe method and it can reduce the operative time significantly. It may also have a modest effect on post-operative pain.

  11. COMPARATIVE STUDY OF THE PROFESSIONAL RULES USED BY ACCOUNTANTS

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    ŢOGOE GRETI DANIELA

    2014-08-01

    Full Text Available This paper aims to conduct a comparative study on national, European and international accounting rules in the field of accounting profession’s organization and exertion. The first step of this scientific approach is positioning the general area of research chosen within the scientific theory in accounting regulations. Our scientific approach seeks to explain through a thorough and detailed approach the different aspects (conceptual and practical of accounting regulations while seeking solutions regarding the evolution of their regulatory frame and practices in the field. Throughout the paper are to be found various concepts, regulations and practices in the field, in an interpretative manner, the point of view adopted by us being neutral, but also critical, since we get involved in the research from a private and personal perspective. In terms of methodology and research perspective, the whole scientific approach has combined the qualitative research with the quantitative one and the theoretical (descriptive-conceptual perspective with the practical one by analyzing the most important contributions of various Romanian and foreign authors to scientific knowledge in the field, respecting the coordinates based on which the accounting rules are addressed internationally and nationally. Throughout the paper we used a wide range of research methods among which we highlight: document analysis, comparative method and typological method, non-participatory and participatory observation. Transversal researches aim the comparative analysis of different viewpoints, the theoretical and technical aspects regarding accounting regulations, while longitudinal researches take into account while analyzing the evolution of scientific knowledge in the field of global, European and national relevant accounting regulations.

  12. Comparing the Leadership Styles of Two Heads of Department at Carnelian School: Comparative Case Studies

    Science.gov (United States)

    Parascandalo, Marthese

    2014-01-01

    The purpose of this dissertation was to compare and contrast the Leadership Styles of two Heads of Department who work at Carnelian Secondary School (anonymized). It augments a previous paper (Parascandalo 2011) which examined the role of the middle leader in secondary schools in educational literature. The investigation by means of two…

  13. Communication linguistique: Etude comparative faite sur le terrain (Linguistic Communication: A Comparative Field Study).

    Science.gov (United States)

    Piron, Claude

    2002-01-01

    Compares the four international systems of linguistic communication used in the field (systems used in the United Nations, multinationals, the European Union, and Esperanto organizations) on select criteria (e.g., previous government investment). Discusses research that shows unilingual systems (English used alone, Esperanto) are those that…

  14. Values in nursing students and professionals: An exploratory comparative study.

    Science.gov (United States)

    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.

  15. EARLY ENTERAL FEEDING AND DELAYED ENTERAL FEEDING- A COMPARATIVE STUDY

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    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

  16. A COMPARATIVE STUDY ON THE PROFITABILITY OF TOURISTIC PENSIONS

    Directory of Open Access Journals (Sweden)

    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.

  17. Mode of administration does matter: comparability study using IPAQ

    Directory of Open Access Journals (Sweden)

    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. Manual tracing versus smartphone application (app) tracing: a comparative study.

    Science.gov (United States)

    Sayar, Gülşilay; Kilinc, Delal Dara

    2017-11-01

    This study aimed to compare the results of conventional manual cephalometric tracing with those acquired with smartphone application cephalometric tracing. The cephalometric radiographs of 55 patients (25 females and 30 males) were traced via the manual and app methods and were subsequently examined with Steiner's analysis. Five skeletal measurements, five dental measurements and two soft tissue measurements were managed based on 21 landmarks. The durations of the performances of the two methods were also compared. SNA (Sella, Nasion, A point angle) and SNB (Sella, Nasion, B point angle) values for the manual method were statistically lower (p < .001) than those for the app method. The ANB value for the manual method was statistically lower than that of app method. L1-NB (°) and upper lip protrusion values for the manual method were statistically higher than those for the app method. Go-GN/SN, U1-NA (°) and U1-NA (mm) values for manual method were statistically lower than those for the app method. No differences between the two methods were found in the L1-NB (mm), occlusal plane to SN, interincisal angle or lower lip protrusion values. Although statistically significant differences were found between the two methods, the cephalometric tracing proceeded faster with the app method than with the manual method.

  19. 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.

  20. Heuristic Synthesis of Reversible Logic – A Comparative Study

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    Chua Shin Cheng

    2014-01-01

    Full Text Available Reversible logic circuits have been historically motivated by theoretical research in low-power, and recently attracted interest as components of the quantum algorithm, optical computing and nanotechnology. However due to the intrinsic property of reversible logic, traditional irreversible logic design and synthesis methods cannot be carried out. Thus a new set of algorithms are developed correctly to synthesize reversible logic circuit. This paper presents a comprehensive literature review with comparative study on heuristic based reversible logic synthesis. It reviews a range of heuristic based reversible logic synthesis techniques reported by researchers (BDD-based, cycle-based, search-based, non-search-based, rule-based, transformation-based, and ESOP-based. All techniques are described in detail and summarized in a table based on their features, limitation, library used and their consideration metric. Benchmark comparison of gate count and quantum cost are analysed for each synthesis technique. Comparing the synthesis algorithm outputs over the years, it can be observed that different approach has been used for the synthesis of reversible circuit. However, the improvements are not significant. Quantum cost and gate count has improved over the years, but arguments and debates are still on certain issues such as the issue of garbage outputs that remain the same. This paper provides the information of all heuristic based synthesis of reversible logic method proposed over the years. All techniques are explained in detail and thus informative for new reversible logic researchers and bridging the knowledge gap in this area.

  1. In vitro acellular dissolution of mineral fibres: A comparative study.

    Science.gov (United States)

    Gualtieri, Alessandro F; Pollastri, Simone; Bursi Gandolfi, Nicola; Gualtieri, Magdalena Lassinantti

    2018-05-04

    The study of the mechanisms by which mineral fibres promote adverse effects in both animals and humans is a hot topic of multidisciplinary research with many aspects that still need to be elucidated. Besides length and diameter, a key parameter that determines the toxicity/pathogenicity of a fibre is biopersistence, one component of which is biodurability. In this paper, biodurability of mineral fibres of social and economic importance (chrysotile, amphibole asbestos and fibrous erionite) has been determined for the first time in a systematic comparative way from in vitro acellular dissolution experiments. Dissolution was possible using the Gamble solution as simulated lung fluid (pH = 4 and at body temperature) so to reproduce the macrophage phagolysosome environment. The investigated mineral fibres display very different dissolution rates. For a 0.25 μm thick fibre, the calculated dissolution time of chrysotile is in the range 94-177 days, very short if compared to that of amphibole fibres (49-245 years), and fibrous erionite (181 years). Diffraction and SEM data on the dissolution products evidence that chrysotile rapidly undergoes amorphization with the formation of a nanophasic silica-rich fibrous metastable pseudomorph as first dissolution step whereas amphibole asbestos and fibrous erionite show minor signs of dissolution even after 9-12 months.

  2. Comparative study of dose descriptor in pediatric computed tomography exams

    International Nuclear Information System (INIS)

    Finatto, Jerusa Dalbosco; Silva, Ana Maria Marques da; Froner, Ana Paula Pastre; Pimentel, Juliana

    2014-01-01

    This work aims to investigate the dose descriptor, volumetric Computed Tomography Dose Index (CTDI), a pediatric patients sample undergoing to skull CT, comparing the results with the diagnostic reference levels of the literature. Were collected volumetric CTDI values of all skull CT exams performed retrospectively in children of 0-10 years of age in a period of 12 months in a large hospital size. Patients, in a total of 103, were divided into four groups, where the criterion of separation used was age, trying to use the same division used in international references dose descriptors. In all acquisitions we used the pediatric protocol and the Automatic Exposure Control (AEC) available on the equipment. The CDTI values, with and without the use of AEC for pediatric studies, were compared. There was a reduction of approximately 100% in the absorbed dose value due to the use of the AEC. From the data collected and analyzed in this work, it is concluded that the use of dose reduction systems is relevant, such as the Care Dose, to maintain volumetric CTDI values within the reference levels. Also it is important the observation of range of children age to the appropriate choice of parameters used in the test protocol. The values obtained are according to the diagnostic reference levels from the literature

  3. Comparative study of computational model for pipe whip analysis

    International Nuclear Information System (INIS)

    Koh, Sugoong; Lee, Young-Shin

    1993-01-01

    Many types of pipe whip restraints are installed to protect the structural components from the anticipated pipe whip phenomena of high energy lines in nuclear power plants. It is necessary to investigate these phenomena accurately in order to evaluate the acceptability of the pipe whip restraint design. Various research programs have been conducted in many countries to develop analytical methods and to verify the validity of the methods. In this study, various calculational models in ANSYS code and in ADLPIPE code, the general purpose finite element computer programs, were used to simulate the postulated pipe whips to obtain impact loads and the calculated results were compared with the specific experimental results from the sample pipe whip test for the U-shaped pipe whip restraints. Some calculational models, having the spring element between the pipe whip restraint and the pipe line, give reasonably good transient responses of the restraint forces compared with the experimental results, and could be useful in evaluating the acceptability of the pipe whip restraint design. (author)

  4. 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.

  5. Skin cancer in Puerto Rico: a multiannual incidence comparative study.

    Science.gov (United States)

    De La Torre-Lugo, Eneida M; Figueroa, Luz D; Sánchez, Jorge L; Morales-Burgos, Adisbeth; Conde, Daniel

    2010-09-01

    The incidence of skin cancer continues to increase worldwide. The purpose of this study was to determine the incidence of skin cancer in Puerto Rico in a selected year (2005) and to compare these findings with those previously reported for Puerto Rico in 1974 and 1981 and with other countries. The data was collected from the pathology reports corresponding to the period of January to December 2005 of 21 participating Pathology Laboratories throughout Puerto Rico. The rate and distribution of the main types of skin cancer was calculated based on sex, age, anatomic location and laterality. The incidence of skin cancer in Puerto Rico for 2005 was 6,568 cases, which represent a rate of 167.9 per 100,000 inhabitants. The most common type of skin cancer was basal-cell carcinoma. Skin cancer was more common in males except for melanoma, which was more common in females. The incidence increases with age on all types of skin cancer. The head and neck area was the most frequent location, except for melanoma in women, which was more common on the legs. The incidence rate was 41.5/100,000 in 1974, 52.5/100,000 in 1981 and 167.9/100,000 in 2005, a 305% increase. We found an increasing incidence of skin cancer in Puerto Rico when compared with previous reported data. This analysis provides a comprehensive evaluation of the epidemiology of skin cancer in Puerto Rico.

  6. Comparative study of Danish and foreign wind turbine economics

    International Nuclear Information System (INIS)

    Godtfredsen, F.

    1993-02-01

    This comparative study indicates that Denmark still is the leading nation in wind turbine technology in regard to economics as well as energy output and nacelle weight per swept rotor area. For roughness class 1, the levellized socioeconomic costs of wind power from Danish wind turbines is DKK 0.396 - 0.536 per kWh compared with production costs of DKK 0.525 for the most economic of the foreign wind turbines investigated. Furthermore it is pointed out, that there seems to be no correlation between generator capacity or swept rotor area and costs of windpower for the wind turbines investigated. Nevertheless there are arguments for the statement that large scale wind turbines will be relatively more economic in the future. Danish wind turbine manufacturers only produce tree-bladed, stall- or pitch regulated wind turbines with constant rotational speed. In Holland, Germany and UK two-bladed wind turbines and turbines with variable speed has been introduced. Still the new concepts are less economic, but not without future interest. (au)

  7. COMPARATIVE STUDY OF TWO DYEING METHODS USING REACTIVE DYE

    Directory of Open Access Journals (Sweden)

    HINOJOSA Belén

    2016-05-01

    Full Text Available Environment preservation is a common worry not only for people but for companies as well. Industry is more and more concern about the necessity of developing new and more respectful processes. Dye is one of the most important processes in the textile industry but it is also considered as no too safe regarding environment issues. This process uses large amounts of water and generates big volumes of wastewater. Following this issue, new regulations and laws emerge to control the waste generated. This leads to the companies and increased costs in terms of wastewater treatments and high water consumption. In this research we compare two systems on garment finishing application, the conventional bath process and the new Ecofinish system that is able to save water and product. To compare these processes, we carried out a reactive dyeing using both systems in order to determine the quality differences in the final product. For this purpose, the samples have been tested to washing and rubbing fastness, according to UNE EN ISO 105 C10 and UNE- EN ISO 105 X12 standards, respectively. This study confirms that this system achieves water savings and reduces the wastewater produced, getting a good dyeing. This process can be considered as an alternative to the conventional one.

  8. THE FLAT TAX - A COMPARATIVE STUDY OF THE EXISTING MODELS

    Directory of Open Access Journals (Sweden)

    Schiau (Macavei Laura - Liana

    2011-07-01

    Full Text Available In the two last decades the flat tax systems have spread all around the globe from East and Central Europe to Asia and Central America. Many specialists consider this phenomenon a real fiscal revolution, but others see it as a mistake as long as the new systems are just a feint of the true flat tax designed by the famous Stanford University professors Robert Hall and Alvin Rabushka. In this context this paper tries to determine which of the existing flat tax systems resemble the true flat tax model by comparing and contrasting their main characteristics with the features of the model proposed by Hall and Rabushka. The research also underlines the common features and the differences between the existing models. The idea of this kind of study is not really new, others have done it but the comparison was limited to one country. For example Emil Kalchev from New Bulgarian University has asses the Bulgarian income system, by comparing it with the flat tax and concluding that taxation in Bulgaria is not simple, neutral and non-distortive. Our research is based on several case studies and on compare and contrast qualitative and quantitative methods. The study starts form the fiscal design drawn by the two American professors in the book The Flat Tax. Four main characteristics of the flat tax system were chosen in order to build the comparison: fiscal design, simplicity, avoidance of double taxation and uniformity of the tax rates. The jurisdictions chosen for the case study are countries all around the globe with fiscal systems which are considered flat tax systems. The results obtained show that the fiscal design of Hong Kong is the only flat tax model which is built following an economic logic and not a legal sense, being in the same time a simple and transparent system. Others countries as Slovakia, Albania, Macedonia in Central and Eastern Europe fulfill the requirement regarding the uniformity of taxation. Other jurisdictions avoid the double

  9. Comparative study of SEA experiences between EU and China

    DEFF Research Database (Denmark)

    Gao, Jingjing; Kørnøv, Lone; Christensen, Per

    Strategic Environmental Assessment (SEA) can be a useful tool in the pursuit of achieving sustainable development. It is used to assess the environmental consequences of proposed policies, plans and programmes (PPP) and also ensures that environmental knowledge is integrated at an early stage...... 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...

  10. [Comparative study of two treatment methods for acute periodontal abscess].

    Science.gov (United States)

    Jin, Dong-mei; Wang, Wei-qian

    2012-10-01

    The aim of this short-term study was to compare the clinical efficacy of 2 different methods to treat acute periodontal abscesses. After patient selection, 100 cases of acute periodontal abscess were randomly divided into two groups. The experimental group was treated by supra- and subgingival scaling, while the control group was treated by incision and drainage. A clinical examination was carried out to record the following variables: subjective clinical variables including pain, edema, redness and swelling; objective clinical variables including gingival index(GI), bleeding index(BI), probing depth(PD),suppuration, lymphadenopathy and tooth mobility. The data was analyzed with SPSS 19.0 software package. RESULES: Subjective clinical variables demonstrated statistically significant improvements with both methods from the first day after treatment and lasted for at least 30 days(P0.05), but the experimental group showed more improvement in edema and redness than the control group(Pperiodontal abscesses.

  11. A Comparative Study on Cutting Electrodes for Batteries with Lasers

    Science.gov (United States)

    Luetke, Matthias; Franke, Volker; Techel, Anja; Himmer, Thomas; Klotzbach, Udo; Wetzig, Andreas; Beyer, Eckhard

    E-mobility is still one of the most discussed topics within the automotive industry. Electric powered vehicles can drive emissionfree and present consequently the future propulsion. Nearly all global players in the automotive industry are making great efforts to develop cost-efficient electric drives, which are suitable for series production. The national governments support this evolution progressively. For example the mobility research programme of the Federal Republic of Germany looks at the production of Li- Ion cells in its entirety. Within this programme the cutting of electrodes for Li-Ion cells by lasers is an issue, too. This paper provides a comparative study on cutting materials relevant for Li-Ion cells with beam sources operating in a cw mode and a pulsed mode respectively.

  12. Comparative study of synthesis and reduction methods for graphene oxide

    KAUST Repository

    Alazmi, Amira; Rasul, Shahid; Patole, Shashikant P.; Da Costa, Pedro M. F. J.

    2016-01-01

    Graphene oxide (GO) and reduced graphene oxide (rGO) have congregated much interest as promising active materials for a variety of applications such as electrodes for supercapacitors. Yet, partially given the absence of comparative studies in synthesis methodologies, a lack of understanding persists on how to best tailor these materials. In this work, the effect of using different graphene oxidation-reduction strategies in the structure and chemistry of rGOs is systematically discussed. Two of the most popular oxidation routes in the literature were used to obtain GO. Subsequently, two sets of rGO powders were synthesised employing three different reduction routes, totalling six separate products. It is shown that the extension of the structural rearrangement in rGOs is not just dependent on the reduction step but also on the approach followed for the initial graphite oxidation.

  13. Enculturating Conversational Agents based on a Comparative Corpus Study

    DEFF Research Database (Denmark)

    Lipi, Afia Akhter; Yamaoka, Yuji; Rehm, Matthias

    2008-01-01

    When encountering people who have a different cultural background from our own, many of us feel uncomfortable because gestures and facial expressions may not be familiar to us. Thus, to enhance the believability of conversational agents, culture-specific nonverbal behaviors should be implemented ...... a more detailed analysis about posture shifts, and proposes a chat system with an embodied conversational agent (ECA) that can act as a language trainer....... into the agents. In our previous study, with the goal of building a user interface that incorporates a user’s cultural background, we have collected comparative conversation corpus in Germany and Japan, and investigated the differences in gestures and posture shifts between these two countries. This paper reports...

  14. A comparative study of machine learning models for ethnicity classification

    Science.gov (United States)

    Trivedi, Advait; Bessie Amali, D. Geraldine

    2017-11-01

    This paper endeavours to adopt a machine learning approach to solve the problem of ethnicity recognition. Ethnicity identification is an important vision problem with its use cases being extended to various domains. Despite the multitude of complexity involved, ethnicity identification comes naturally to humans. This meta information can be leveraged to make several decisions, be it in target marketing or security. With the recent development of intelligent systems a sub module to efficiently capture ethnicity would be useful in several use cases. Several attempts to identify an ideal learning model to represent a multi-ethnic dataset have been recorded. A comparative study of classifiers such as support vector machines, logistic regression has been documented. Experimental results indicate that the logical classifier provides a much accurate classification than the support vector machine.

  15. COMPARATIVE STUDY OF STUDENT SUPPORT SERVICES OF AIOU AND UKOU

    Directory of Open Access Journals (Sweden)

    Amtul Hafeez CHOUDHRY

    2008-01-01

    Full Text Available ABSTRACT This paper attempts to compare the availability, quality, similarities and differences of student support services in Allama Iqbal Open University (AIOU and United Kingdom Open University (UKOU and also to identify and enlist the deficiencies that AIOU students are facing in the student support services. The study found out that student support services of AIOU are quantitatively developing rapidly on the lines of UKOU. Though the regional campuses of both the institutions have almost the same status in the provision of student support service yet the UKOU students have better services in the guidance and counseling, modern communication facilities and career guidance. Moreover, there also exists Open University student association in UKOU. The conclusions led to the recommendation that AIOU regional campuses may be made independent like UKOU, counseling and guidance cell might be established at every regional campus, modern communication facilities like toll free, auto answer may be provided at AIOU regional campuses.

  16. Mycobacterial species as case-study of comparative genome analysis

    DEFF Research Database (Denmark)

    Zakham, F.; Belayachi, L.; Ussery, David

    2011-01-01

    . Pasteur 1173P2, M. leprae Br4923, M. marinum M, M. sp. KMS, M. sp. MCS, M. tuberculosis CDC1551, M. tuberculosis F11, M. tuberculosis H37Ra, M. tuberculosis H37Rv, M. tuberculosis KZN 1435 , M. ulcerans Agy99,and M. vanbaalenii PYR—1, For this purpose a comparison has been done based on their length...... defined for twelve Mycobacterial species. We have also introduced the genome atlas of the reference strain M. tuberculosis H37Rv which can give a good overview of this genome. And for examining the phylogenetic relationships among these bacteria, a phylogenic tree has been constructed from 16S rRNA gene...... the evolutionary events of these species and improving drugs, vaccines, and diagnostics tools for controlling Mycobacterial diseases. In this present study we aim to outline a comparative genome analysis of fourteen Mycobacterial genomes: M. avium subsp. paratuberculosis K—10, M. bovis AF2122/97, M. bovis BCG str...

  17. Comparative DEMS study on the electrochemical oxidation of carbon blacks

    DEFF Research Database (Denmark)

    Ashton, Sean James; Arenz, Matthias

    2012-01-01

    Publication year: 2012 Source:Journal of Power Sources, Volume 217 Sean J. Ashton, Matthias Arenz The intention of the study presented here is to compare the electrochemical oxidation tendencies of a pristine Ketjen Black EC300 high surface area (HSA) carbon black, and four graphitised counterparts...... heat-treated between 2100 and 3200 °C, such as those typically used as corrosion resistant carbon (CRC) supports for polymer electrolyte membrane fuel cell (PEMFC) catalysts. A methodology combining cyclic voltammetry (CV) and differential electrochemical mass spectrometry (DEMS) is used, which allows......; however, CRC samples graphitised =2800 °C did not exhibit this same behaviour. Highlights ¿ We quantitatively determine electrooxidation of carbon support materials. ¿ We can distinguish between the total and partial electrooxidation. ¿ Non or mildly heat treated carbon forms passivating layer. ¿ Heat...

  18. A comparative study of two stochastic mode reduction methods

    Energy Technology Data Exchange (ETDEWEB)

    Stinis, Panagiotis

    2005-09-01

    We present a comparative study of two methods for thereduction of the dimensionality of a system of ordinary differentialequations that exhibits time-scale separation. Both methods lead to areduced system of stochastic differential equations. The novel feature ofthese methods is that they allow the use, in the reduced system, ofhigher order terms in the resolved variables. The first method, proposedby Majda, Timofeyev and Vanden-Eijnden, is based on an asymptoticstrategy developed by Kurtz. The second method is a short-memoryapproximation of the Mori-Zwanzig projection formalism of irreversiblestatistical mechanics, as proposed by Chorin, Hald and Kupferman. Wepresent conditions under which the reduced models arising from the twomethods should have similar predictive ability. We apply the two methodsto test cases that satisfy these conditions. The form of the reducedmodels and the numerical simulations show that the two methods havesimilar predictive ability as expected.

  19. Comparative study of ozonized olive oil and ozonized sunflower oil

    Directory of Open Access Journals (Sweden)

    Díaz Maritza F.

    2006-01-01

    Full Text Available 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 observed in both oils but they were higher in ozonized sunflower oil. Iodine value was zero in ozonized olive oil whereas in ozonized sunflower was 8.8 g Iodine per 100 g. The antimicrobial activity was similar for both ozonized oils except for Minimum Bactericidal Concentrations of Pseudomona aeruginosa. Composition of fatty acids in both ozonized oils showed gradual decrease in unsaturated fatty acids (C18:1, C18:2 with gradual increase in ozone doses.

  20. Comparative study of synthesis and reduction methods for graphene oxide

    KAUST Repository

    Alazmi, Amira

    2016-05-14

    Graphene oxide (GO) and reduced graphene oxide (rGO) have congregated much interest as promising active materials for a variety of applications such as electrodes for supercapacitors. Yet, partially given the absence of comparative studies in synthesis methodologies, a lack of understanding persists on how to best tailor these materials. In this work, the effect of using different graphene oxidation-reduction strategies in the structure and chemistry of rGOs is systematically discussed. Two of the most popular oxidation routes in the literature were used to obtain GO. Subsequently, two sets of rGO powders were synthesised employing three different reduction routes, totalling six separate products. It is shown that the extension of the structural rearrangement in rGOs is not just dependent on the reduction step but also on the approach followed for the initial graphite oxidation.

  1. Comparative study of strontium adsorption on dioctahedral and trioctahedral smectites

    International Nuclear Information System (INIS)

    Galambos, M.; Rosskopfova, O.; Krajnak, A.; Rajec, P.; Osacky, M.; Comenius University, Bratislava

    2012-01-01

    Slovak bentonites characterized by good rheological, mineralogical and chemical stability are considered as suitable sealing barriers for construction of Slovak deep geological repository for high-level radioactive waste and spent nuclear fuel. There is several Slovak bentonite deposits, bentonites of which have appropriate adsorption properties meeting the geotechnical requirements for this type of barriers. Study of adsorption properties of bentonites (mainly smectites) is an essential step for developing the migration model long-lived corrosion and activation products, and fission products of uranium. Nuclear wastes contain the most important nuclear fission products, β-emitter 90 Sr with long half-life, biological half-life and high mobility. The present paper investigates and compares the strontium adsorption properties of bentonites of different mineral composition consisted mainly of dioctahedral and trioctahedral smectites. (author)

  2. A comparative study of European nuclear energy programs

    Energy Technology Data Exchange (ETDEWEB)

    Presas i Puig, Albert [ed.

    2011-07-01

    The report includes the following contributions: Comparative study of European Nuclear Energy Programs. From international cooperation to the failure of a national program: the Austrian case. The ''go-and-stop'' of the Italian civil nuclear programs, among improvisations, ambitions and conspiracy. Nuclear energy in Spain - a research agenda for economic historians. The Portuguese nuclear program: a peripheral experience under dictatorship (1945-1973). The nuclear energy programs in Switzerland. The rise and decline of an independent nuclear power industry in Sweden, 1945-1970. The German fast breeder program, a historical review. Fast reactors as future visions - the case of Sweden. Transnational flows of nuclear knowledge between the U.S. and the U.K. and continental Europe in the 1950/60s. The Carter administration and its non-proliferation policies: the road to INFCE.

  3. MRI compatibility of robot actuation techniques--a comparative study.

    Science.gov (United States)

    Fischer, Gregory S; Krieger, Axel; Iordachita, Iulian; Csoma, Csaba; Whitcomb, Louis L; Gabor, Fichtinger

    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 MRJ 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 cylinders function with no loss of SNR with controller both inside and outside of the scanner room. The Nanomotion motor performs with moderate loss of SNR when moving during imaging. The Shinsei is unsuitable for motion during imaging. All may be used when motion is appropriately interleaved with imaging cycles.

  4. PREDICTING THE INTENTION TO USE INTERNET – A COMPARATIVE STUDY

    Directory of Open Access Journals (Sweden)

    Slaven Brumec

    2006-06-01

    Full Text Available This article focuses on an application of the Triandis Model in researching Internet usage and the intention to use Internet. Unlike other TAM-based studies undertaken to date, the Triandis Model offers a sociological account of interaction between the various factors, particularly attitude, intention, and behavior. The technique of Structural Equation Modeling was used to assess the impact those factors have on intention to use the Internet in accordance with the relationships posited by the Triandis Model. The survey was administered to Croatian undergraduate students at and employed individuals. The survey results are compared to the results of a similar survey that was carried out by two universities in Hong Kong.

  5. MRI Compatibility of Robot Actuation Techniques – A Comparative Study

    Science.gov (United States)

    Fischer, Gregory S.; Krieger, Axel; Iordachita, Iulian; Csoma, Csaba; Whitcomb, Louis L.; Fichtinger, Gabor

    2010-01-01

    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 cylinders function with no loss of SNR with controller both inside and outside of the scanner room. The Nanomotion motor performs with moderate loss of SNR when moving during imaging. The Shinsei is unsuitable for motion during imaging. All may be used when motion is appropriately interleaved with imaging cycles. PMID:18982643

  6. Sibling relationships in individuals with Angelman syndrome: a comparative study.

    Science.gov (United States)

    Love, Victoria; Richters, Lotte; Didden, Robert; Korzilius, Hubert; Machalicek, Wendy

    2012-01-01

    Investigating the impact of Angelman syndrome on the sibling relationship. This study explored differences in sibling relationships between children with a typically-developing sibling (n = 55) and children with a sibling with Angelman syndrome (n = 44). Sibling relationships were compared on four factors and 16 sub-scales of the Sibling Relationship Questionnaire-Revised. Results showed significant differences in mean scores on each of the four factors (i.e. Warmth/Closeness, Conflict, Rivalry and Dominance/Nurturance) and most of the sub-scales. ANCOVAs showed that demographic variables (number of siblings, living in a two-parent vs single parent household, gender, participant's age, place of residence) did not influence significant differences in sibling relationships between the two groups. Having a brother or sister with Angelman syndrome may influence the way in which the sibling perceives the sibling relationship. This may have important implications for family-centred intervention for this population.

  7. A comparative study of preservation and storage of Haemophilus influenzae

    Directory of Open Access Journals (Sweden)

    Olga C Aulet de Saab

    2001-05-01

    Full Text Available The aim of this study was to compare the efficacy of conservation by freezing the strains of Haemophilus influenzae at -20ºC and -70ºC. Skim milk supplemented with glucose, yeast extract and glycerol allowed highest viability of H. influenzae both at -20ºC and -70ºC from the media analyzed. Trypticase soy broth and brain heart infusion broth supplemented with glycerol, allowed excellent recovery. Use of cotton swaps as supporting material, with or without addition of cryoprotective agents, did not modify H. influenzae viability after six months of storage. Concentration of the initial inoculum positively affected viability when stored at -20ºC. Initial concentration did not influence survival after storage at -70ºC. Thawing at room temperature should not exceed 3 h as to get highest survival percentage.

  8. A comparative study of two different clear aligner systems.

    Science.gov (United States)

    Ercoli, Federica; Tepedino, Michele; Parziale, Vincenzo; Luzi, Cesare

    2014-05-02

    This study aims to compare the 'Nuvola®' system with 'Fantasmino®' system, examine their material properties, and define the indications for use of the aligners. Two groups of patients were selected and were respectively treated with Nuvola® aligner and Fantasmino® system. The goal of treatment has been achieved with the two systems. The two types of aligners have shown differences during the treatment. Fantasmino® system has elastic properties of high performance, but its size does not encourage compliance throughout the day. Nuvola® system determines good tooth movement and its size facilitates the patient's collaboration. In both aligner systems, difficulties were found in the correction of torque information and rotations.

  9. Response comparative study of Rn-222 alpha particles track monitors

    International Nuclear Information System (INIS)

    Pereira, Osvaldo Luiz dos Santos

    2010-01-01

    This work was a comparative study between the responses of three monitors, the NRPB, an acrylic monitor (in thin film geometry) and the aluminum monitor (also thin film geometry) in controlled and mixed environment. The experiments consisted on placing the monitors in a plastic tube, with a radio-226 source internal. Only internal CR-39 plastic detectors were analyzed in this work. It was found that the monitors in thin film geometry had activities response of approximately 15% less than the NRPB monitors. All monitors responded the same way when in controlled environment. Related to the type of material, conductive plastic or dielectric (insulator) plastic, the NRPB, in environments without ventilation, responded in the same way. (author)

  10. A Comparative Study of Distribution System Parameter Estimation Methods

    Energy Technology Data Exchange (ETDEWEB)

    Sun, Yannan; Williams, Tess L.; Gourisetti, Sri Nikhil Gup

    2016-07-17

    In this paper, we compare two parameter estimation methods for distribution systems: residual sensitivity analysis and state-vector augmentation with a Kalman filter. These two methods were originally proposed for transmission systems, and are still the most commonly used methods for parameter estimation. Distribution systems have much lower measurement redundancy than transmission systems. Therefore, estimating parameters is much more difficult. To increase the robustness of parameter estimation, the two methods are applied with combined measurement snapshots (measurement sets taken at different points in time), so that the redundancy for computing the parameter values is increased. The advantages and disadvantages of both methods are discussed. The results of this paper show that state-vector augmentation is a better approach for parameter estimation in distribution systems. Simulation studies are done on a modified version of IEEE 13-Node Test Feeder with varying levels of measurement noise and non-zero error in the other system model parameters.

  11. Psychological profile of women with infertility: A comparative study.

    Science.gov (United States)

    Poddar, Shuvabrata; Sanyal, Nilanjana; Mukherjee, Urbi

    2014-01-01

    An endeavour to probe into the psychological profile of infertile women in a comparative stance with the fertile women is not very common. This study is an attempt to explore the possible non-apparent personality factors which contribute to the unexplained pain of infertility. The main objectives of the present study were (a) to examine whether infertile women are different from fertile women in terms of selected psychological variables- narcissistic components, dimensions of attachment style and uses of defensive manoeuvres; and (b) whether the primary infertile women (n=18) are different from the secondary infertile women (n=12) with respect to those variables. A total of 60 individuals (30 infertile women and 30 matched fertile women) were assessed through Attachment Style Questionnaire (ASQ), Narcissistic Personality Inventory (NPI) and Defense Style Questionnaire (DSQ-40). General Health Questionnaire (GHQ) was administered on to the fertile women to rule out the psychiatric morbidity. Findings revealed that infertile women group differed from fertile women group with respect to narcissism, dimensions of attachment style and uses of defense mechanism. The primary infertile group also showed marked difference from the secondary infertile group with respect to those variables. This study endeavours to enrich the knowledge regarding the personality dynamics of infertile women to design psychotherapeutic programme to aid their well-being, help them to cherish the flavour of parenthood and improve their quality of life.

  12. Psychological profile of women with infertility: A comparative study

    Directory of Open Access Journals (Sweden)

    Shuvabrata Poddar

    2014-01-01

    Full Text Available Background: An endeavour to probe into the psychological profile of infertile women in a comparative stance with the fertile women is not very common. This study is an attempt to explore the possible non-apparent personality factors which contribute to the unexplained pain of infertility. Methods: The main objectives of the present study were (a to examine whether infertile women are different from fertile women in terms of selected psychological variables- narcissistic components, dimensions of attachment style and uses of defensive manoeuvres; and (b whether the primary infertile women (n=18 are different from the secondary infertile women (n=12 with respect to those variables. A total of 60 individuals (30 infertile women and 30 matched fertile women were assessed through Attachment Style Questionnaire (ASQ, Narcissistic Personality Inventory (NPI and Defense Style Questionnaire (DSQ-40. General Health Questionnaire (GHQ was administered on to the fertile women to rule out the psychiatric morbidity. Results: Findings revealed that infertile women group differed from fertile women group with respect to narcissism, dimensions of attachment style and uses of defense mechanism. The primary infertile group also showed marked difference from the secondary infertile group with respect to those variables. Conclusions: This study endeavours to enrich the knowledge regarding the personality dynamics of infertile women to design psychotherapeutic programme to aid their well-being, help them to cherish the flavour of parenthood and improve their quality of life.

  13. Circulation of cerebrospinal fluid. Comparative study of various tracers

    International Nuclear Information System (INIS)

    Bok, B.; Thebault, B.; Cavailloles, F.; Aboulker, J.

    1977-01-01

    The dynamics of cerebrospinal fluid in the spinal subarachnoid space is studied by gammamyelography. There are still controversies about the ideal properties of the tracer to be used. The influence of the tracer's molecular weight on the kinetic of ascent in the medullar cerebrospinal fluid with a view to rating the criterias for choice of an available radiopharmaceutical was evaluated. Three compounds injected simultaneously through a lombar puncture were compared: indium 111 labelled transferrin, iodine 131 labelled human serum albumin and technetium 99m labelled diethylenetriaminepentaacetic acid. The individual stability of the compounds and a possible interference between them was investigated especially by electrophoretic technics. A spectrometric study showed that it is possible to simultaneously identify and count each of the isotopes included in the mixture on the detector device: an hybrid scanner. The comparison of linear activity profils collected on phantoms and on ten patients showed a similar fate of the three compounds during the first hours of the investigation studying the ascent of tracers into basal cisterns either in normal or pathological patients. It is therefore concluded that molecular weight does not influence in a detectable manner the spinal C.S.F. kinetics of the radiopharmaceuticals. This allows the use of the most convenient and best tolerated tracer from the dosimetric and toxicological stand point [fr

  14. COMPARATIVE STUDY OF TERTIARY WASTEWATER TREATMENT BY COMPUTER SIMULATION

    Directory of Open Access Journals (Sweden)

    Stefania Iordache

    2010-01-01

    Full Text Available The aim of this work is to asses conditions for implementation of a Biological Nutrient Removal (BNR process in theWastewater Treatment Plant (WWTP of Moreni city (Romania. In order to meet the more increased environmentalregulations, the wastewater treatment plant that was studied, must update the actual treatment process and have tomodernize it. A comparative study was undertaken of the quality of effluents that could be obtained by implementationof biological nutrient removal process like A2/O (Anaerobic/Anoxic/Oxic and VIP (Virginia Plant Initiative aswastewater tertiary treatments. In order to asses the efficiency of the proposed treatment schemata based on the datamonitored at the studied WWTP, it were realized computer models of biological nutrient removal configurations basedon A2/O and VIP process. Computer simulation was realized using a well-known simulator, BioWin by EnviroSimAssociates Ltd. The simulation process allowed to obtain some data that can be used in design of a tertiary treatmentstage at Moreni WWTP, in order to increase the efficiency in operation.

  15. A comparative study of quality control in diagnostic radiology

    International Nuclear Information System (INIS)

    Kharita, M. H.; Khedr, M.S.; Wannus, K.M.

    2008-01-01

    The main objective of this comparative study was to evaluate the national quality assurance program for X-ray diagnostic radiology in Syrian governmental hospitals. Two periods were covered in this study, the first period was from 1986 to 1998 (52 hospitals and 149 X-ray machines were considered) and the second period from 1999 to 2005 (41 hospitals and 95 X-ray machines were considered). Most of the X-ray machines studied were within the acceptable performance, but few machines needed recalibration for some parameters. Considerable improvement of about 50% was reported in the second period. This improvement could be attributed to the establishment of an effective National Regulatory Authority in Syria in 1998 that introduced and gradually enforced the quality assurance requirement for X-ray equipment as part of the licensing process and to the relatively newer X-ray machines covered in the second period. The Author 2008. Published by Oxford Univ. Press. All rights reserved. (authors)

  16. Atherosclerotic Plaque Destabilization in Mice: A Comparative Study.

    Directory of Open Access Journals (Sweden)

    Helene Hartwig

    Full Text Available Atherosclerosis-associated diseases are the main cause of mortality and morbidity in western societies. The progression of atherosclerosis is a dynamic process evolving from early to advanced lesions that may become rupture-prone vulnerable plaques. Acute coronary syndromes are the clinical manifestation of life-threatening thrombotic events associated with high-risk vulnerable plaques. Hyperlipidemic mouse models have been extensively used in studying the mechanisms controlling initiation and progression of atherosclerosis. However, the understanding of mechanisms leading to atherosclerotic plaque destabilization has been hampered by the lack of proper animal models mimicking this process. Although various mouse models generate atherosclerotic plaques with histological features of human advanced lesions, a consensus model to study atherosclerotic plaque destabilization is still lacking. Hence, we studied the degree and features of plaque vulnerability in different mouse models of atherosclerotic plaque destabilization and find that the model based on the placement of a shear stress modifier in combination with hypercholesterolemia represent with high incidence the most human like lesions compared to the other models.

  17. Comparative study of the synthesis of layered transition metal molybdates

    Science.gov (United States)

    Mitchell, S.; Gómez-Avilés, A.; Gardner, C.; Jones, W.

    2010-01-01

    Mixed metal oxides (MMOs) prepared by the mild thermal decomposition of layered double hydroxides (LDHs) differ in their reactivity on exposure to aqueous molybdate containing solutions. In this study, we investigate the reactivity of some T-Al containing MMOs ( T=Co, Ni, Cu or Zn) towards the formation of layered transition metal molybdates (LTMs) possessing the general formula AT2(OH)(MoO 4) 2·H 2O, where A=NH 4+, Na + or K +. The phase selectivity of the reaction was studied with respect to the source of molybdate, the ratio of T to Mo and the reaction pH. LTMs were obtained on reaction of Cu-Al and Zn-Al containing MMOs with aqueous solutions of ammonium heptamolybdate. Rehydration of these oxides in the presence of sodium or potassium molybdate yielded a rehydrated LDH phase as the only crystalline product. The LTM products obtained by the rehydration of MMO precursors were compared with LTMs prepared by direct precipitation from the metal salts in order to study the influence of preparative route on their chemical and physical properties. Differences were noted in the composition, morphology and thermal properties of the resulting products.

  18. Dense Descriptors for Optical Flow Estimation: A Comparative Study

    Directory of Open Access Journals (Sweden)

    Ahmadreza Baghaie

    2017-02-01

    Full Text Available Estimating the displacements of intensity patterns between sequential frames is a very well-studied problem, which is usually referred to as optical flow estimation. The first assumption among many of the methods in the field is the brightness constancy during movements of pixels between frames. This assumption is proven to be not true in general, and therefore, the use of photometric invariant constraints has been studied in the past. One other solution can be sought by use of structural descriptors rather than pixels for estimating the optical flow. Unlike sparse feature detection/description techniques and since the problem of optical flow estimation tries to find a dense flow field, a dense structural representation of individual pixels and their neighbors is computed and then used for matching and optical flow estimation. Here, a comparative study is carried out by extending the framework of SIFT-flow to include more dense descriptors, and comprehensive comparisons are given. Overall, the work can be considered as a baseline for stimulating more interest in the use of dense descriptors for optical flow estimation.

  19. Comparative histological study of the mammalian facial nucleus.

    Science.gov (United States)

    Furutani, Rui; Sugita, Shoei

    2008-04-01

    We performed comparative Nissl, Klüver-Barrera and Golgi staining studies of the mammalian facial nucleus to classify the morphologically distinct subdivisions and the neuronal types in the rat, rabbit, ferret, Japanese monkey (Macaca fuscata), pig, horse, Risso's dolphin (Grampus griseus), and bottlenose dolphin (Tursiops truncatus). The medial subnucleus was observed in all examined species; however, that of the Risso's and bottlenose dolphins was a poorly-developed structure comprised of scattered neurons. The medial subnuclei of terrestrial mammals were well-developed cytoarchitectonic structures, usually a rounded column comprised of densely clustered neurons. Intermediate and lateral subnuclei were found in all studied mammals, with differences in columnar shape and neuronal types from species to species. The dorsolateral subnucleus was detected in all mammals but the Japanese monkey, whose facial neurons converged into the intermediate subnucleus. The dorsolateral subnuclei of the two dolphin species studied were expanded subdivisions comprised of densely clustered cells. The ventromedial subnuclei of the ferret, pig, and horse were richly-developed columns comprised of large multipolar neurons. Pig and horse facial nuclei contained another ventral cluster, the ventrolateral subnucleus. The facial nuclei of the Japanese monkey and the bottlenose dolphin were similar in their ventral subnuclear organization. Our findings show species-specific subnuclear organization and distribution patterns of distinct types of neurons within morphological discrete subdivisions, reflecting functional differences.

  20. Comparative study of maximum isometric grip strength in different sports

    Directory of Open Access Journals (Sweden)

    Noé Gomes Borges Junior

    2009-06-01

    Full Text Available The objective of this study was to compare maximum isometric grip strength (Fmaxbetween 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 the subjects was that suggested by the American Society of Hand Therapy. Factorial 2X5 ANOVA with Bonferroni correction, followed by a paired t test and Tukey test, was used for statistical analysis. The highest Fmax values were observed for the JJ group when using the dominant hand,followed by the JU, RO, AI and NA groups. Variation in Fmax could be attributed to handdominance (30.9%, sports modality (39.9% and the interaction between hand dominance andsport (21.3%. The present results demonstrated significant differences in Fmax between the JJ and AI groups and between the JJ and NA groups for both the dominant and non-dominant hand. Significant differences in Fmax between the dominant and non-dominant hand were only observed in the AI and NA groups. The results indicate that Fmax can be used for comparisonbetween different sports modalities, and to identify differences between the dominant and nondominanthand. Studies involving a larger number of subjects will permit the identification of differences between other modalities.

  1. Comparative study of heuristic evaluation and usability testing methods.

    Science.gov (United States)

    Thyvalikakath, Thankam Paul; Monaco, Valerie; Thambuganipalle, Himabindu; Schleyer, Titus

    2009-01-01

    Usability methods, such as heuristic evaluation, cognitive walk-throughs and user testing, are increasingly used to evaluate and improve the design of clinical software applications. There is still some uncertainty, however, as to how those methods can be used to support the development process and evaluation in the most meaningful manner. In this study, we compared the results of a heuristic evaluation with those of formal user tests in order to determine which usability problems were detected by both methods. We conducted heuristic evaluation and usability testing on four major commercial dental computer-based patient records (CPRs), which together cover 80% of the market for chairside computer systems among general dentists. Both methods yielded strong evidence that the dental CPRs have significant usability problems. An average of 50% of empirically-determined usability problems were identified by the preceding heuristic evaluation. Some statements of heuristic violations were specific enough to precisely identify the actual usability problem that study participants encountered. Other violations were less specific, but still manifested themselves in usability problems and poor task outcomes. In this study, heuristic evaluation identified a significant portion of problems found during usability testing. While we make no assumptions about the generalizability of the results to other domains and software systems, heuristic evaluation may, under certain circumstances, be a useful tool to determine design problems early in the development cycle.

  2. Comparative studies of brain activation with MEG and functional MRI

    International Nuclear Information System (INIS)

    George, J.S.; Aine, C.J.; Sanders, J.A.; Lewine, J.D.; Caprihan, A.

    1993-01-01

    The past two years have witnessed the emergence of MRI as a functional imaging methodology. Initial demonstrations involved the injection of a paramagnetic contrast agent and required ultrafast echo planar imaging capability to adequately resolve the passage of the injected bolus. By measuring the local reduction in image intensity due to magnetic susceptibility, it was possible to calculate blood volume, which changes as a function of neural activation. Later developments have exploited endogenous contrast mechanisms to monitor changes in blood volume or in venous blood oxygen content. Recently, we and others have demonstrated that it is possible to make such measurements in a clinical imager, suggesting that the large installed base of such machines might be utilized for functional imaging. Although it is likely that functional MRI (fMRI) will subsume some of the clinical and basic neuroscience applications now touted for MEG, it is also clear that these techniques offer different largely complementary, capabilities. At the very least, it is useful to compare and cross-validate the activation maps produced by these techniques. Such studies will be valuable as a check on results of neuromagnetic distributed current reconstructions and will allow better characterization of the relationship between neurophysiological activation and associated hemodynamic changes. A more exciting prospect is the development of analyses that combine information from the two modalities to produce a better description of underlying neural activity than is possible with either technique in isolation. In this paper we describe some results from initial comparative studies and outline several techniques that can be used to treat MEG and fMRI data within a unified computational framework

  3. Outpatient- and inpatient-based buckling surgery: a comparative study

    Directory of Open Access Journals (Sweden)

    Lee JC

    2014-04-01

    Full Text Available Jin Cheol Lee,* Yu Cheol Kim*Department of Ophthalmology, Keimyung University School of Medicine, Dongsan Medical Center, Daegu, Korea *Both authors contributed equally to this workPurpose: To evaluate the clinical outcomes of ambulatory buckling surgery, comparing outpatient- with inpatient-based surgery.Methods: The authors performed a retrospective study of 80 consecutive cases of rhegmato genous retinal detachment from January 2009 to December 2011 treated by scleral buckling surgery. Two groups of patients were defined according to inpatient (group 1 or outpatient (group 2 surgery, and a comparison of several parameters between these two groups was performed.Results: Of the 80 subjects in this study, the average age of group 1 (50 patients was 49.7 years, and that of group 2 (30 patients was 47.5 years. There were no statistically significant differences in the average logarithm of the minimum angle of resolution-visual acuity, the condition of the lens, or the presence of retinal lattice degeneration prior to the surgery between the groups. There were no statistically significant differences in the patterns of tear or retinal detachment or in surgical procedure between the groups. Comparing the best-corrected visual acuity after 6 months with that prior to the surgery, the changes in group 1 and group 2 were 0.26 and 0.31, respectively. The functional success rates of group 1 and group 2 after 6 months were 90% and 93%, respectively, and the anatomical success rates of group 1 and group 2 after 6 months were 94% and 96%, respectively, but these were also statistically insignificant.Conclusion: Hospitalization is not essential for buckling surgery in uncomplicated rhegmatogenous retinal detachment surgery.Keywords: ambulatory, scleral buckling, rhegmatogenous retinal detachment

  4. Saccharomyces cerevisiae as a model organism: a comparative study.

    Directory of Open Access Journals (Sweden)

    Hiren Karathia

    Full Text Available BACKGROUND: Model organisms are used for research because they provide a framework on which to develop and optimize methods that facilitate and standardize analysis. Such organisms should be representative of the living beings for which they are to serve as proxy. However, in practice, a model organism is often selected ad hoc, and without considering its representativeness, because a systematic and rational method to include this consideration in the selection process is still lacking. METHODOLOGY/PRINCIPAL FINDINGS: In this work we propose such a method and apply it in a pilot study of strengths and limitations of Saccharomyces cerevisiae as a model organism. The method relies on the functional classification of proteins into different biological pathways and processes and on full proteome comparisons between the putative model organism and other organisms for which we would like to extrapolate results. Here we compare S. cerevisiae to 704 other organisms from various phyla. For each organism, our results identify the pathways and processes for which S. cerevisiae is predicted to be a good model to extrapolate from. We find that animals in general and Homo sapiens in particular are some of the non-fungal organisms for which S. cerevisiae is likely to be a good model in which to study a significant fraction of common biological processes. We validate our approach by correctly predicting which organisms are phenotypically more distant from S. cerevisiae with respect to several different biological processes. CONCLUSIONS/SIGNIFICANCE: The method we propose could be used to choose appropriate substitute model organisms for the study of biological processes in other species that are harder to study. For example, one could identify appropriate models to study either pathologies in humans or specific biological processes in species with a long development time, such as plants.

  5. COMPARATIVE STUDY FOR SUBCHRONIC TOXICITY OF VASELINE OIL AND GLYCELAX

    Directory of Open Access Journals (Sweden)

    A. V. Voronkov

    2016-01-01

    Full Text Available Contemporary therapeutic approaches offer a wide range of laxative agents, which are often used without a control, exceeding the regime recommended. Therefore, the comparative study for subchronic toxicity of both drugs from this group (Vaseline oil and Glycelax appears interesting.The aim of the study was the comparison of a toxic influence of 14-days application of the drugs under study.Methods. The drugs were studied in two doses: higher therapeutic, and toxic, which 10 times exceeds therapeutic dose. We used “Polispektr-8/B” electrocardiograph, BC 2800vet (Mindray hematologic veterinary analyzer, BS-380 (Mindray biochemical analyzer, CL-50 urine analyzer. After the animals autopsy we determined organs’ coefficient (heart, lungs, spleen, liver, stomach, kidneys, adrenals.Results. While studying the ECG of female rats, amplitude of R wave increased after they got Glycelax in both doses. Female rats who got Vaseline oil this index decreased at minimum dose and increased at maximum dose. After Glycelax application, male rats had an increased activity of alanine aminotransferase. After Vaseline oil application at maximum dose, female rats had alkaline phosphatase activity lowered. Female rats, which got a maximum dose of Vaseline oil had a total protein lowered. Glycelax at maximum dose increased the content of bilirubin and its fractions in male and female rats, while Vaseline oil application at maximum dose increased the content of bilirubin in female rats. Male rats which got Glycelax had hemoglobin and hematocrit level increased.Conclusion. At long-term application of Vaseline oil, animals of both genders had heart disorders with possible development of arrhythmia, hepatotoxic effect, lipid exchange dysfunction. After excessive use of Glycelax the above mentioned is added with possible hemoglobin and rheological blood properties level decrease.

  6. Comparative study of two commercially pure titanium casting methods

    Directory of Open Access Journals (Sweden)

    Renata Cristina Silveira Rodrigues

    2010-10-01

    Full Text Available The interest in using titanium to fabricate removable partial denture (RPD frameworks has increased, but there are few studies evaluating the effects of casting methods on clasp behavior. OBJECTIVE: This study compared the occurrence of porosities and the retentive force of commercially pure titanium (CP Ti and cobalt-chromium (Co-Cr removable partial denture circumferential clasps cast by induction/centrifugation and plasma/vacuum-pressure. MATERIAL AND METHODS: 72 frameworks were cast from CP Ti (n=36 and Co-Cr alloy (n=36; control group. For each material, 18 frameworks were casted by electromagnetic induction and injected by centrifugation, whereas the other 18 were casted by plasma and injected by vacuum-pressure. For each casting method, three subgroups (n=6 were formed: 0.25 mm, 0.50 mm, and 0.75 mm undercuts. The specimens were radiographed and subjected to an insertion/removal test simulating 5 years of framework use. Data were analyzed by ANOVA and Tukey's to compare materials and cast methods (α=0.05. RESULTS: Three of 18 specimens of the induction/centrifugation group and 9 of 18 specimens of plasma/vacuum-pressure cast presented porosities, but only 1 and 7 specimens, respectively, were rejected for simulation test. For Co-Cr alloy, no defects were found. Comparing the casting methods, statistically significant differences (p<0.05 were observed only for the Co-Cr alloy with 0.25 mm and 0.50 mm undercuts. Significant differences were found for the 0.25 mm and 0.75 mm undercuts dependent on the material used. For the 0.50 mm undercut, significant differences were found when the materials were induction casted. CONCLUSION: Although both casting methods produced satisfactory CP Ti RPD frameworks, the occurrence of porosities was greater in the plasma/vacuum-pressure than in the induction/centrifugation method, the latter resulting in higher clasp rigidity, generating higher retention force values.

  7. A Comparative Growth and Pigments Study of Nine Different ...

    African Journals Online (AJOL)

    Mostafa

    2012-10-18

    Oct 18, 2012 ... Comparative biodiversity and effect of different media on growth and ... of the food chain will accumulate astaxanthin in their ... and are very fast when compared to most other ..... Bad and the Recovery in an Assisted Migration.

  8. A comparative study in disaster planning in selected countries

    Directory of Open Access Journals (Sweden)

    Mahmode M

    2007-11-01

    Full Text Available Background: Assessment of different strategic in disaster planning in selected countries. According to the international report indicating that IRAN is among the seven countries most susceptible to disaster, experiencing 31 known disasters out of 40 in the world, occurrence of 1536 moderate to severe earthquake, during 1370-80 and 712 other disasters at the same period it seems necessary to design a disaster plan."nMethods: This research is a comparative-descriptive and case based study in which the researcher used random sampling process in selecting the statistical society from both developed and developing countries. In this goal oriented research the necessary information are extracted from valid global reports, articles and many questionnaires which were subjected to scientific analysis."nResults: Studying different countries (which includes: Canada, Japan, India, USA, Turkey, Pakistan and Iran shows that there is a direct relationship between the level of countries development and their success in disaster planning and management (including preventive measures and confrontation. In most of the studied countries, decentralized planning caused many professional planners participate in different levels of disaster management which ultimately led to development of efficient and realistic plans which in turn decreased the catastrophic effects of disasters dramatically. The results of the aforementioned countries showed that a balanced approach to disaster plan with investment in prophylactic area is very important."nConclusion: As our country uses a centralized strategy for disaster management which has proven its ineffectiveness, the researcher suggests that we should change our approach in disaster management and let our planners participate from all levels include: provincial, rural and etc. This will led to a reality based planning and using all potential capacities in disaster management. According to this study it will be possible to use

  9. A Comparative Study of Food Idioms Between English and Chinese

    Institute of Scientific and Technical Information of China (English)

    林玲俐

    2017-01-01

    Idioms are the essence of language, the most common language, the strongest expression, the most abundant cultural connotation. In recent years, the study on the contrast between English and Chinese Idioms' has attracted wide attention. But the existing research on comparison of food idioms between English and Chinese involves less. First of all, searching and reading existing related literature about contrastive study on food idioms between English and Chinese by using literature resources in library and summarizing the relevant content. Secondly, selecting the English-Chinese dictionary to look up, collecting the embodiment of food idioms between English and Chinese, and then arranging, analyzing and comparing some examples. The purpose of this thesis is to analyze the similarities and differences on food idioms between English and Chinese, and analyzing the causes of the similarities and differences.Through analyzing some examples, this thesis would like to make sure that English learners can understand and use the related food idioms better, so as to help them understand well about the English and Chinese culture, and to achieve success in language communication.

  10. A comparative study of the constitutive models for silicon carbide

    Science.gov (United States)

    Ding, Jow-Lian; Dwivedi, Sunil; Gupta, Yogendra

    2001-06-01

    Most of the constitutive models for polycrystalline silicon carbide were developed and evaluated using data from either normal plate impact or Hopkinson bar experiments. At ISP, extensive efforts have been made to gain detailed insight into the shocked state of the silicon carbide (SiC) using innovative experimental methods, viz., lateral stress measurements, in-material unloading measurements, and combined compression shear experiments. The data obtained from these experiments provide some unique information for both developing and evaluating material models. In this study, these data for SiC were first used to evaluate some of the existing models to identify their strength and possible deficiencies. Motivated by both the results of this comparative study and the experimental observations, an improved phenomenological model was developed. The model incorporates pressure dependence of strength, rate sensitivity, damage evolution under both tension and compression, pressure confinement effect on damage evolution, stiffness degradation due to damage, and pressure dependence of stiffness. The model developments are able to capture most of the material features observed experimentally, but more work is needed to better match the experimental data quantitatively.

  11. Comparative studies on antisickling properties of thiocyanate, tellurite and hydroxyurea

    International Nuclear Information System (INIS)

    Oyewole, O.I.; Maloma, S.O.; Adebayo, J.O.

    2008-01-01

    Thiocyanate, hydroxyurea and tellurite are among chemical agents being used as antisickling drugs and currently receiving attention for research. The antisickling properties of these drugs was investigated and compared in this study. Human sickle blood was incubated with the drugs in vitro at concentrations related to the dose used by patients in vivo. Haemoglobin function and specific aspects of the sickling process were then measured by employing standard methods used in screening potential antisickling agents. All the drugs significantly inhibited (P<0.05) sickling of deoxygenated sickle blood and formation of irreversibly sickled cell in a dose and time-dependent manner. Thiocyanate, hydroxyurea and tellurite inhibited sickling optimally at 20 mM, 40 mM and 50 microM respectively. Thiocyanate and hydroxyurea prolonged sickle red blood cell life span as indicated in the significant decrease in haemolysis and osmotic fragility while tellurite increased these blood parameters. The three drugs also caused significant prolongation of delay time of haemoglobin S (HbS) polymerization while thiocyanate and hydroxyurea significantly increased (P<0.05) both solubility ratio and oxygen affinity of HbS. Results obtained in this study suggest that the three drugs have remarkable antisickling potential in vitro with thiocyanate being the most efficient followed by tellurite. (author)

  12. Comparative study of conventional and ultrasonically-assisted bone drilling.

    Science.gov (United States)

    Alam, K; Ahmed, Naseer; Silberschmidt, V V

    2014-01-01

    Bone drilling is a well-known surgical procedure in orthopaedics and dentistry for fracture treatment and reconstruction. Advanced understanding of the mechanics of the drill-bone interaction is necessary to overcome challenges associated with the process and related postoperative complications. The aim of this study was to explore the benefits of a novel drilling technique, ultrasonically-assisted drilling (UAD), and its possible utilization in orthopaedic surgeries. The study was performed by conducting experiments to understand the basic mechanics of the drilling process using high speed filming of the drilling zone followed by measurements to quantify thrust force, surface roughness and cracking of the bone near the immediate vicinity of the hole with and without ultrasonic assistance. Compared to the spiral chips produced during conventional drilling (CD), UAD was found to break the chips in small pieces which facilitated their fast evacuation from the cutting region. In UAD, lower drilling force and better surface roughness was measured in drilling in the radial and longitudinal axis of the bone. UAD produced crack-free holes which will enhance postoperative performance of fixative devices anchoring the bone. UAD may be used as a possible substitute for CD in orthopaedic clinics.

  13. Comparative study of biogenic and abiotic iron-containing materials

    Energy Technology Data Exchange (ETDEWEB)

    Cherkezova-Zheleva, Z., E-mail: zzhel@ic.bas.bg; Shopska, M., E-mail: shopska@ic.bas.bg; Paneva, D. [Bulgarian Academy of Sciences, Institute of Catalysis (Bulgaria); Kovacheva, D. [Bulgarian Academy of Sciences, Institute of General and Inorganic Chemistry (Bulgaria); Kadinov, G.; Mitov, I. [Bulgarian Academy of Sciences, Institute of Catalysis (Bulgaria)

    2016-12-15

    Series of iron-based biogenic materials prepared by cultivation of Leptothrix group of bacteria in different feeding media (Sphaerotilus-Leptothrix group of bacteria isolation medium, Adler, Lieske and silicon-iron-glucose-peptone) were studied. Control samples were obtained in the same conditions and procedures but the nutrition media were not infected with bacteria, i.e. they were sterile. Room and low temperature Mössbauer spectroscopy, powder X-ray diffraction (XRD), and infrared spectroscopy (IRS) were used to reveal the composition and physicochemical properties of biomass and respective control samples. Comparative analysis showed differences in their composition and dispersity of present phases. Sample composition included different ratio of nanodimensional iron oxyhydroxide and oxide phases. Relaxation phenomena such as superparamagnetism or collective magnetic excitation behaviour were registered for some of them. The experimental data showed that the biogenic materials were enriched in oxyhydroxides of high dispersion. Catalytic behaviour of a selected biomass and abiotic material were studied in the reaction of CO oxidation. In situ diffuse-reflectance (DR) IRS was used to monitor the phase transformations in the biomass and CO conversion.

  14. Comparative study of seven glasses for solidification of nuclear wastes

    International Nuclear Information System (INIS)

    Nogues, J.L.; Hench, L.L.; Zarzycki, J.

    1982-06-01

    The relative leaching behavior of seven alkali borosilicate glasses considered for immobilization of high level radioactive wastes was compared using a static 90 0 C leach test. Leaching times studied were 1, 3, 7, 14 and 28 days with ratios of glass surface area (SA) to solution volume (V) being SA/V = 1.0 cm -1 and 0.1 cm -1 . With the range of glass compositions studied, it was not possible to determine the effect of each element on leaching behavior, however some conclusions regarding the general influence of the glass network formers can be made: the addition of Al 2 O 3 , results in a large increase in the chemical durability of the glass. The presence of Fe 2 O 3 , is necessary to develop with Al 2 O 3 a second protective layer on top of the silica-rich film that results from rapid dealkalization. The difference between the results obtained at SA/V = 1.0 cm -1 and 0.1 cm -1 shows the importance of understanding both the effects of glass composition and solution concentrations on the behavior of nuclear waste glasses

  15. A Comparative study on sexual dysfunctions before and after menopause

    Science.gov (United States)

    Beigi, Marjan; Fahami, Fariba

    2012-01-01

    Background: Sexual instinct which is the cause of numerous changes in an individual’s life could be influenced by different factors such as menopause and ageing. This study was designed to compare sexual dysfunction before and after menopause. Materials and Methods: This was a cross-sectional study. Participants were 174 menopausal women who referred to medical health centers of Isfahan, Iran. Data were collected through self constructed sexual dysfunctions questionnaire in relation to their sexual activities before and after menopause. The reliability and validity of this questionnaire was determined by content validity and Cronbach’s alpha coefficient. Findings: Findings showed that the relative frequency of sexual dysfunctions was 38% in the productive period and 72.4% in the menopause period. There was a significant association between sexual dysfunctions before and after the menopause period (p vaginismus, respectively. Conclusions: A considerable percentage of women experienced sexual dysfunctions in productive and menopause periods, and menopause could be a factor to maintain or intensify sexual dysfunctions. PMID:23833604

  16. California study compares natural/drilling discharge contaminants offshore

    International Nuclear Information System (INIS)

    Steinhauer, W.G.; Imamura, E.; Barminski, J.R.; Neff, J.M.

    1992-01-01

    An analysis of drilling fluid and this paper reports that cuttings discharges in the southern Santa Maria basin offshore California indicates that the amount of metal and hydrocarbon contaminants from drilling operations is small relative to that from natural sources. The metal and hydrocarbon discharges were calculated for only one of the three platforms discharging between 1986 and 1989 in the Point Arguello field. However, assuming concentrations are similar on each platform, the combined input of metals and hydrocarbons over the 3-year period was still low (except for barium and lead) compared to the average annual flux from natural sources. The MMS is monitoring the Santa Maria basin to understand possible long-term environmental effects of oil and gas development (California Monitoring Program, Phase II; and Effects of OCS Production Platforms on Rocky Reef Fishes and Fisheries). A site-specific study area was established to determine effects of drilling-related discharges at Chevron U.S.S. Inc.'s platform Hidalgo in the Point Arguello field. Part of the study included review of discharge records for platforms Hidalgo, Hermosa (Chevron), and Harvest (Texaco Exploration and Production Inc.)

  17. Comparative Study of Silk-Silk Alloy Materials

    Science.gov (United States)

    Xue, Ye; Jao, Dave; Hu, Wenbing; Wolf, Nathan; Rocks, Eva-Marie; Hu, Xiao

    Silk fibroin materials can be used for various kinds of biomedical applications. We report a comparative study of silk-silk blend materials using thermal analysis and infrared spectroscopy. Four groups of silk-silk blend films: Mori-Tussah, Mori-Muga, Mori-Eri and Mori-Thai, were fabricated from aqueous solutions and blended at different weight ratios, respectively. These silk-silk blend systems exploit the beneficial material properties of both silks. DSC and temperature-modulated DSC were used to measure the transition temperatures and heat capacity of these water-based silk-silk blend films. Fourier transform infrared spectrometer was used to characterize secondary structures of silk-silk blends. This study demonstrates that Mori silk are fully miscible with Tussah, Muga, Eri and Thai silk at different weight ratios without phase separation. Glass transition temperatures, degradation temperatures and the contents of alpha-helix and random coils of those silk-silk blend films can be controlled by changing the contents of different silks in the blend system. The features of Mori silk combined with the attributes of Tussah, Muga, Eri and Thai silk offer a useful suite of materials for a variety of applications in the future.

  18. Comparative study for the design of optimal composite pressure vessels

    International Nuclear Information System (INIS)

    Butt, A.M.; Haq, S.W.U.

    2009-01-01

    Composite pressure vessels require special design attention to the dome region because of the varying wind angles generated using the filament winding process. Geometric variations in the dome region cause the fiber to change angels and thickness and hence offer difficulty to acquire a constant stress profile (isotensoid). Therefore a dome contour which allows an isotensoid behavior is the required structure. Two design methods to generate dome profiles for similar dome openings were investigated namely Netting Analysis and Optimal Design method. Both methods assume that loads are carried by the fiber alone (monotropic) ignoring the complete composite behavior. Former method produced a lower dome internal volume and a higher fiber thickness as compared to the later optimal design method when studied against different normalized dome opening radiuses. The optimal dome contour was studied in ANSYS with a trial design. The dome was considered to have transversely isotropic property with a dome contour based on monotropic model. While investigating the dome with non linear large displacement finite element analysis, the dome still exhibited isotensoid behavior with transverse isotropic material assignment. Elliptic integrals were used to generate the optimal dome contours and hence elliptic dome contours were formed which were isotensoid in nature with complete composite representation. (author)

  19. Laser diagnodent: a comparative study with other diagnostic techniques

    International Nuclear Information System (INIS)

    Godinho, Reugma Rego

    2002-01-01

    An evaluation of the Diagnodent equipment (Kavo Company, Germany) for the occlusal caries detection was dane through the comparison with other conventional diagnostic techniques, such as visual inspection, intra-oral micro camera and digital X-ray. The effectiveness of the equipment in the detection of hidden caries and its viability as a diagnosis method for caries in their initial stage was also studied. Fifty eight permanent molars and premolars teeth from patients with age between 6 and 30 years were studied. The obtained results indicated that the conventional methods employed for the caries diagnosis are unable to detect the carious lesion in its initial stage. The Diagnodent equipment has this capability to detect caries presenting a flawless surface, specially the hidden caries, allowing the dentist to decide between a preventive ar a conservative procedure. The main advantage of the Diagnodent is to be an objective method, compared to the visual and radiographic ones, that are dependent on the professional interpretation. The Diagnodent is, therefore, a promising alternative as an objective and standardized diagnosis method for the final diagnostic. (author)

  20. Comparative histological and immunohistochemical study of ameloblastomas and ameloblastic carcinomas

    Science.gov (United States)

    Mosqueda-Taylor, Adalberto; Carlos-Bregni, Román; Pires, Fabio-Ramoa; Delgado-Azañero, Wilson; Neves-Silva, Rodrigo; Aldape-Barrios, Beatriz; Paes-de Almeida, Oslei

    2017-01-01

    Background This study aimed to compare the histological and immunohistochemical characteristics of ameloblastomas (AM) and ameloblastic carcinomas (AC). Material and Methods Fifteen cases of AM and 9 AC were submitted to hematoxilin and eosin (H&E) and immunohistochemical analysis with the following antibodies: cytokeratins 5,7,8,14 and 19, Ki-67, p53, p63 and the cellular adhesion molecules CD138 (Syndecan-1), E-cadherin and β-catenin. The mean score of the expression of Ki-67 and p53 labelling index (LIs) were compared between the groups using the t test. A value of p<0.05 was considered to be statistically significant. Results All cases were positive for CKs 5, 14 and 19, but negative for CKs 7 and 8. CKs 5 and 19 were positive mainly in the central regions of the ameloblastic islands, while the expression in AC was variable in intensity and localization. CK14 was also variably expressed in both AM and AC. Ki-67 (P=.001) and p53 (P=.004) immunoexpression was higher in AC. All cases were positive for p63, but values were higher in AC. CD138 was mainly expressed in peripheral cells of AM, with a weak positivity in the central areas, while it was positive in most areas of ACs, except in less differentiated regions, where expression was decreased or lost. E-cadherin and β-catenin were weakly positive in both AM and AC. Conclusions These results shows that Ki-67, p53 and p63 expression was higher in AC as compared to AM, suggesting that these markers can be useful when considering diagnosis of malignancy, and perhaps could play a role in malignant transformation of AM. Pattern of expression of CKs 5 and 19 in AC were different to those found in AM, suggesting genetic alterations of these proteins in malignant cells. It was confirmed that CK19 is a good marker for benign odontogenic tumors, such as AM, but it is variably expressed in malignant cases. Key words:Ameloblastoma, ameloblastic carcinoma, immunohistochemistry, odontogenic tumors. PMID:28390135