Application of Quantitative Systems Pharmacology to Pediatric Drug Safety Assessment

被引：0

作者：

Samuels, Sherbet ^{[1
]}

Bai, Jane P. F. ^{[1
]}

Green, Dionna J. ^{[2
]}

Abulwerdi, Gelareh ^{[1
]}

Burckart, Gilbert J. ^{[1
]}

机构：

[1] US FDA, Ctr Drug Evaluat & Res, Off Clin Pharmacol, Silver Spring, MD 20993 USA

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

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2023年 / 114卷 / 04期

关键词：

D O I：

10.1002/cpt.2990

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The challenges with identifying and addressing drug safety concerns in the pediatric population are compounded by physiological and maturational factors. With their mechanistic and multiscale capabilities, quantitative systems pharmacology (QSP) models are well-poised to support critical pediatric drug safety assessments and decision making. However, we must be mindful of the opportunities and limitations of use of QSP models in this space. Herein, we discuss considerations for QSP models to support pediatric drug safety assessments.

引用

页码：748 / 750

页数：3

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