Pharmacogenetic Approaches to Optimize Bioequivalence Studies in Generic Drug Development

Given the significant impacts of interindividual genetic variability on drug safety and pharmacokinetics, integrating pharmacogenetic (PGx) considerations into pharmacokinetic (PK) bioequivalence (BE) study design can improve subject safety and data robustness in generic drug development. While PGx...

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Bibliographic Details
Published in:	Journal of clinical pharmacology Vol. 65; no. 11; pp. 1598 - 1608
Main Authors:	Bae, Jihyun, Shon, Jihong, Kim, Myong‐Jin, Li, Karen
Format:	Journal Article
Language:	English
Published:	England Wiley Subscription Services, Inc 01.11.2025
Subjects:	Bioequivalence bioequivalence studies with pharmacokinetic endpoints Cytochrome P450 Drug development Drug Development - methods Drugs, Generic - pharmacokinetics Gene polymorphism generic drug development Generic drugs Genetic variability Humans Information processing Pharmacogenetics - methods pharmacogenetics/pharmacogenomics Pharmacokinetics Pharmacovigilance product‐specific guidances regulatory/scientific affairs Therapeutic Equivalency United States United States Food and Drug Administration United States generic drug development bioequivalence studies with pharmacokinetic endpoints product‐specific guidances pharmacogenetics/pharmacogenomics regulatory/scientific affairs
ISSN:	0091-2700, 1552-4604, 1552-4604
Online Access:	Get full text
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