Bioequivalence of Highly Variable Drugs

2014 ◽  
pp. 139-164 ◽  
Author(s):  
Barbara M. Davit ◽  
Devvrat T. Patel
Keyword(s):  
Highly Variable Drugs

scholarly journals Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications

2008 ◽  
Vol 10 (1) ◽  
pp. 148-156 ◽  
Author(s):  
Barbara M. Davit ◽  
Dale P. Conner ◽  
Beth Fabian-Fritsch ◽  
Sam H. Haidar ◽  
Xiaojian Jiang ◽  
...  
Keyword(s):  
Generic Drug ◽  
Highly Variable Drugs

The bioequivalence of highly variable drugs and drug products

2005 ◽  
Vol 43 (10) ◽  
pp. 485-498 ◽  
Author(s):  
K.K. Midha ◽  
M.J. Rawson ◽  
J.W. Hubbard
Keyword(s):  
Highly Variable Drugs ◽  
Drug Products

Individual and Average Bioequivalence of Highly Variable Drugs and Drug Products

1997 ◽  
Vol 86 (11) ◽  
pp. 1193-1197 ◽  
Author(s):  
Kamal K. Midha ◽  
Maureen J. Rawson ◽  
John W. Hubbard
Keyword(s):  
Highly Variable Drugs ◽  
Average Bioequivalence ◽  
Drug Products

scholarly journals Likelihood approach for evaluating bioequivalence of highly variable drugs

2014 ◽  
Vol 14 (2) ◽  
pp. 82-94 ◽  
Author(s):  
Liping Du ◽  
Leena Choi
Keyword(s):  
Highly Variable Drugs ◽  
Likelihood Approach

scholarly journals Bioequivalence Studies of Highly Variable Drugs - An Example of Itraconazole

2017 ◽  
Vol 39 (8) ◽  
pp. e15 ◽  
Author(s):  
V. Dragojevic-Simic ◽  
A. Kovacevic ◽  
N. Rancic ◽  
V. Jacevic ◽  
S. Djordjevic ◽  
...  
Keyword(s):  
Highly Variable Drugs

scholarly journals Pharmacogenetic perspectives in improving pharmacokinetic profiles for efficient bioequivalence trials with highly variable drugs: a review

2020 ◽  
pp. IPK02
Author(s):  
Pai-Jung Huang ◽  
Yunsheng Hsieh ◽  
Yan-Wen Huang ◽  
Li Ding ◽  
Chong Liu ◽  
...  
Keyword(s):  
Generic Drugs ◽  
Pharmacokinetic Studies ◽  
Metabolizing Enzymes ◽  
Highly Variable Drugs ◽  
Drug Products ◽  
Branded Drug ◽  
Coefficient Of Variability ◽  
Acceptance Limits ◽  
Study Designs ◽  
Screening Approaches

Conducting bioequivalence trials under traditional crossover study designs without exposing a large number of healthy volunteers to demonstrate two highly variable (%coefficient of variability greater than 30) test/reference (branded) drug products in different formulations to meet the standard 90% confidence interval criteria of relevant pharmacokinetic metrics between 0.80 and 1.25 and to maintain the consumer risk smaller than 5% has been a challenging task. Genetic polymorphisms encoding key drug-metabolizing enzymes can significantly influence absorption, distribution, metabolism and elimination of many highly variable generic drugs after administration. This article briefly reviews the case studies and examples of utilizing pharmacogenetic screening approaches in the recent literature to alleviate the resources and ethical burden of recruiting larger numbers of subjects in bioequivalence trials needed to perform pharmacokinetic studies for formulations of highly variable drug products without widening the bioequivalence acceptance limits.

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