A Regulatory Perspective on Issues and Approaches in Characterizing Human Metabolites
- 8 November 2006
- journal article
- review article
- Published by American Chemical Society (ACS) in Chemical Research in Toxicology
- Vol. 19 (12) , 1561-1563
- https://doi.org/10.1021/tx060203m
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.Keywords
This publication has 1 reference indexed in Scilit:
- Letter to the EditorToxicology and Applied Pharmacology, 2003