Regulatory Experience With Physiologically Based Pharmacokinetic Modeling for Pediatric Drug Trials

被引：143

作者：

Leong, R. ^{[1
]}

Vieira, M. L. T. ^{[1
]}

Zhao, P. ^{[1
]}

Mulugeta, Y. ^{[1
]}

Lee, C. S. ^{[2
]}

Huang, S-M ^{[1
]}

Burckart, G. J. ^{[1
]}

机构：

[1] US FDA, Off Clin Pharmacol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[2] US FDA, Off Pediat Therapeut, Commissioners Off, Silver Spring, MD USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2012年 / 91卷 / 05期

关键词：

CHILDREN; THEOPHYLLINE; OMEPRAZOLE; PREDICTION; CLEARANCE; DISPOSITION; MIDAZOLAM; INFANTS;

D O I：

10.1038/clpt.2012.19

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.

引用

页码：926 / 931

页数：6

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