M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
- Series Title(s):
- Guidance for industry
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.
- Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
- Carcinogenicity Tests -- standards Carcinogens Chemistry, Pharmaceutical DNA Damage -- genetics Drug Contamination -- prevention & control Mutagenicity Tests -- standards Mutagens Acrylonitrile -- toxicity Aniline Compounds -- toxicity Benzyl Compounds -- toxicity Bis(Chloromethyl) Ether -- toxicity Ethyl Chloride -- toxicity Hydrazines -- toxicity Hydrogen Peroxide -- toxicity Methyl Chloride -- toxicity Nitrobenzenes -- toxicity No-Observed-Adverse-Effect Level Quality Control Toxicity Tests -- standards Humans United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Guideline Technical Report
- The National Library of Medicine believes this item to be in the public domain. (More information)
- 1 online resource (1 PDF file (129 pages))
- Revision 1
- NLM Unique ID:
- 101734078 (See catalog record)