Lack of Bioequivalence between Two Aciclovir Tablets in Healthy Subjects (original ) (raw )Evaluation of Performance of the Truncated Area Under Curve (AUC) as a Primary Pharmacokinetic Parameter in Bioequivalence Studies
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Journal of Bioequivalence & Bioavailability, 2010
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Multiple-Dose Studies can be a More Sensitive Assessment for Bioequivalence than Single-Dose Studies
abraham danon
Clinical Drug Investigation, 2002
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Average parameters as a trend to reduce the residual variability in bioequivalence trials
Pietro Fagiolino
European Journal of Drug Metabolism and Pharmacokinetics, 1998
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Comparative bioavailability of two tablet formulations of acyclovir in healthy volunteers
Saleh Bawazir
PubMed, 1998
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Concepts of Bioequivalence and it’s Impact on Truncated Area Under Curve (AUC) of Drugs with Long Half Life in point estimate and intra-subject variability
Francis Micheal
2011
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Evaluation of Bioequivalence for Highly Variable Drugs with Scaled Average Bioequivalence
Lászlo Tóthfalusi
Clinical Pharmacokinetics, 2009
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A post hoc analysis of intra-subject coefficients of variation in pharmacokinetic measures to calculate optimal sample sizes for bioequivalence studies
Inbum Chung
Translational and Clinical Pharmacology
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Guidelines for bioavailability and bioequivalence studies: A review
brahmaiah bonthagarala
The Pharma Innovation Journal, 2018
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Randomized, open-label, two-way crossover bioequivalence study of Novirax (Drug International Ltd, Bangladesh) compared with Zovirax (Glaxo Wellcome, UK) – two brands of Acyclovir – in healthy male volunteers
Mir Misbahuddin
Asian Journal of Pharmaceutical Research and Development
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Bioequivalence and Bioavailability Clinical Trials: A Status Report from the National Institutes of Health ClinicalTrials.gov Registry
Catherine M T Sherwin
Journal of bioequivalence & bioavailability, 2013
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Investigation on the need of multiple dose bioequivalence studies for prolonged-release generic products
COVADONGA ALVAREZ ALVAREZ
International Journal of Pharmaceutics, 2012
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Drug ; Interchangeability of Generic and Brand Products of Fixed Dose Combination Tablets of Sofosbuvir and Ledipasvir (400/90 mg): Employment of Reference Scaled Average Bioequivalence Study on Healthy Egyptian Volunteers
kamal badr
Drug ; Interchangeability of Generic and Brand Products of Fixed Dose Combination Tablets of Sofosbuvir and Ledipasvir (400/90 mg): Employment of Reference Scaled Average Bioequivalence Study on Healthy Egyptian Volunteers, 2018
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Evaluating average bioequivalence using methods for high variability drugs: A case study
CARLOS VON PLESSING
Int. Journal of Clinical Pharmacology and Therapeutics, 2008
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Yesim Ozarda , Kiyoshi Ichihara* , Julian H. Barth and George Klee and on behalf of the Committee on Reference Intervals and Decision Limits (C-RIDL), International Federation for Clinical Chemistry and Laboratory Medicine Protocol and standard operating procedures for common use in a worldwide m...
julian barth
2013
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On the leveling-off properties of the new bioequivalence limits for highly variable drugs of the EMA guideline
Vangelis D . Karalis
European Journal of Pharmaceutical Sciences, 2011
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Demonstrating bioequivalence using clinical endpoint studies
Jerome del Castillo
Journal of veterinary pharmacology and therapeutics, 2012
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Determination of Bioequivalence for Drugs with Narrow Therapeutic Index: Reduction of the Regulatory Burden
Lászlo Tóthfalusi
Journal of Pharmacy & Pharmaceutical Sciences, 2013
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Acceptability and characteristics of 124 human bioequivalence studies with active substances classified according to the Biopharmaceutic Classification System
Alberto Borobia
British Journal of Clinical Pharmacology, 2010
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Bioequivalence and interchangeability of narrow therapeutic range drugs. Canadian Society for Pharmaceutical Sciences discussion
Yun K. Tam
Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Société canadienne des sciences pharmaceutiques
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Bioequivalence evaluation of three different oral formulations of ciprofloxacin in healthy volunteers
Nuno Silva
European Journal of Drug Metabolism and Pharmacokinetics, 2003
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Lászlo Tóthfalusi
Journal of Pharmacy & Pharmaceutical Sciences, 2009
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Bioequivalence & Bioavailability
nguyen minh y
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The importance of sample size, log-mean ratios, and intrasubject variability in the acceptance criteria of 108 bioequivalence studies
O. Laosa
European Journal of Clinical Pharmacology, 2008
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