A regulatory perspective on issues and approaches in characterizing human metabolites

被引：50

作者：

Davis-Bruno, Karen L. ^{[1
]}

Atrakchi, Aisar ^{[1
]}

机构：

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

来源：

CHEMICAL RESEARCH IN TOXICOLOGY | 2006年 / 19卷 / 12期

关键词：

D O I：

10.1021/tx060203m

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

This document captures the current thinking within FDA/CDER on the non-clinical safety assessment of human drug metabolites in new drug products. Examples are provided, which define a scientific based approach to the safety evaluation of human metabolites in new drug candidates. A discussion of the need for, and the adequacy of, the assessment of human drug metabolites with specific regard to their potential as mediators of toxicity is presented from a regulatory perspective.

引用

页码：1561 / 1563

页数：3

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