Issue Date: November 22, 2016
Issued by: Center for Drug Evaluation and Research
Topic(s): Device & Drug Safety, Pharmacology/Toxicology
Status: Final
Safety Testing of Drug Metabolites
This guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. Drug metabolites may need to be determined in nonclinical studies when they are disproportionate drug metabolites, that is, metabolites identified only in humans or present at higher plasma concentrations in humans than in any of the animal species used during standard nonclinical toxicology testing.
Download the Guidance Document
