title: A regulatory perspective on issues and approaches in characterizing human metabolites.
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.
authors.affiliation: 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
authors.forename: Karen L
authors.initials: KL
authors.lastname: Davis-Bruno
authors.forename: Aisar
authors.initials: A
authors.lastname: Atrakchi
mesh_terms: D000818:Animals; D004341:Drug Evaluation / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions / Q000378:metabolism*; D033161:Government Regulation; D006801:Humans; D050216:Metabolic Detoxication, Phase I; D004364:Pharmaceutical Preparations / Q000378:metabolism*; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations