期刊
CHEMICAL RESEARCH IN TOXICOLOGY
卷 19, 期 12, 页码 1561-1563出版社
AMER CHEMICAL SOC
DOI: 10.1021/tx060203m
关键词
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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.
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