Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications
Journal Title: The AAPS Journal - Year 2008, Vol 10, Issue 1
Abstract
It is widely believed that acceptable bioequivalence studies of drugs with high within-subject pharmacokinetic variability must enroll higher numbers of subjects than studies of drugs with lower variability. We studied the scope of this issue within US generic drug regulatory submissions.
Authors and Affiliations
Barbara M. Davit, Dale P. Conner, Beth Fabian-Fritsch, Sam H. Haidar, Xiaojian Jiang, Devvrat T. Patel, Paul R. H. Seo, Keri Suh, Christina L. Thompson, Lawrence X. Yu
Keywords
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- EP ID EP681531
- DOI 10.1208/s12248-008-9015-x
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