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

INTRODUCTION: 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 submissio...

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Main Authors: Davit, Barbara M., Conner, Dale P., Fabian-Fritsch, Beth, Haidar, Sam H., Jiang, Xiaojian, Patel, Devvrat T., Seo, Paul R. H., Suh, Keri, Thompson, Christina L., Yu, Lawrence X.
Format: Artigo
Sprog:Inglês
Udgivet: Springer US 2008
Fag:
Research Article
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC2751460/
https://ncbi.nlm.nih.gov/pubmed/18446515
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-008-9015-x
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