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- Title
Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials.
- Authors
Leong, R; Vieira, M L T; Zhao, P; Mulugeta, Y; Lee, C S; Huang, S-M; Burckart, G J
- Abstract
The article offers information on modeling of physiologically based pharmacokinetic (PBPK) approaches for trials of pediatric drug. It is stated that PBPK incorporate the developmental physiology and ontogeny of cytochrome P450 (CYP) enzymes. It states that the U.S. Food and Drug Administration (FDA) incorporated different PBPK applications to pediatric drug development in 4 recent submissions. It mentions the potential for improving pediatric trials PBPK by modeling.
- Subjects
UNITED States; PHARMACOKINETICS; PEDIATRICS; UNITED States. Food &; Drug Administration; PHARMACODYNAMICS; ONTOGENY; CYTOCHROME P-450; DRUG development
- Publication
Clinical Pharmacology & Therapeutics, 2012, Vol 91, Issue 5, p926
- ISSN
0009-9236
- Publication type
Article
- DOI
10.1038/clpt.2012.19