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