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Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials
Author(s) -
Leong R,
Vieira M L T,
Zhao P,
Mulugeta Y,
Lee C S,
Huang SM,
Burckart G J
Publication year - 2012
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2012.19
Subject(s) - physiologically based pharmacokinetic modelling , clinical pharmacology , pharmacokinetics , food and drug administration , pharmacology , drug , drug development , clinical trial , medicine
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 underpredicted drug clearance. PBPK modeling may have potential for improving pediatric trials through the learn‐and‐confirm approaches utilized in current regulatory submissions. Clinical Pharmacology & Therapeutics (2012); 91 5, 926–931. doi: 10.1038/clpt.2012.19