Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials

Physiologically based pharmacokinetic (PBPK) approaches that incorporate the developmental physiology and ontogeny of cytochrome P450 (CYP) enzymes may have value in the design of pediatric trials. Four recent submissions to the US Food and Drug Administration (FDA) incorporated different PBPK appli...

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Bibliographic Details
Published inClinical pharmacology and therapeutics Vol. 91; no. 5; p. 926
Main Authors Leong, R, Vieira, M L T, Zhao, P, Mulugeta, Y, Lee, C S, Huang, S-M, Burckart, G J
Format Journal Article
LanguageEnglish
Published United States 01.05.2012
Subjects
Drug and Narcotic Control
Drug Discovery
Humans
Models, Biological
Off-Label Use
Pediatrics
Pharmacokinetics
United States
United States Food and Drug Administration
United States
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Summary:Physiologically based pharmacokinetic (PBPK) approaches that incorporate the developmental physiology and ontogeny of cytochrome P450 (CYP) enzymes may have value in the design of pediatric trials. Four recent submissions to the US Food and Drug Administration (FDA) incorporated different PBPK applications to pediatric drug development.Further testing of PBPK models for three drugs showed that these models generally under predicted drug clearance. PBPK modeling may have potential for improving pediatric trials through the learn-and-confirm approaches utilized in current regulatory submissions.
ISSN:1532-6535
DOI:10.1038/clpt.2012.19