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Chem Res Toxicol. 2006 Dec;19(12):1561-3.

A regulatory perspective on issues and approaches in characterizing human metabolites.

Author information

1
US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, Maryland 20993, USA. karen.davisbruno@fda.hhs.gov

Abstract

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.

PMID:
17173368
DOI:
10.1021/tx060203m
[Indexed for MEDLINE]

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