Safety testing of drug metabolites

Safety testing of drug metabolites

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Language(s):
English
Format:
Text
Subject(s):
Pharmaceutical Preparations -- metabolism
Toxicity Tests
Drug-Related Side Effects and Adverse Reactions
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
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. This guidance applies to small molecule nonbiologic drug products. This guidance does not apply to some cancer therapies. This guidance supersedes the guidance of the same name published in November 2016. The guidance has been revised to align with the ICH guidance for industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (January 2010).
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (11 pages))
Edition:
Revision 2
Illustrations:
Illustrations
NLM Unique ID:
101772629 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101772629