M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

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 Biologics Evaluation and Research (U.S.), issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018 Language(s): English Format: Text Subject(s): Carcinogenicity Tests -- standards Carcinogens Chemistry, Pharmaceutical DNA Damage -- genetics Drug Contamination -- prevention & control Mutagenicity Tests -- standards Mutagens United States United States. Department of Health and Human Services United States. Food and Drug Administration Genre(s): Guideline Technical Report Copyright: The National Library of Medicine believes this item to be in the public domain. (More information) Extent: 1 online resource (1 PDF file (129 pages)) Edition: Revision 1 Illustrations: Illustrations NLM Unique ID: 101734078 (See catalog record) Permanent Link: http://resource.nlm.nih.gov/101734078