1. M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018 Subject(s): Carcinogenicity Tests -- standardsCarcinogensChemistry, PharmaceuticalDNA Damage -- geneticsDrug Contamination -- prevention & controlMutagenicity Tests -- standardsMutagensAcrylonitrile -- toxicityAniline Compounds -- toxicityBenzyl Compounds -- toxicityBis(Chloromethyl) Ether -- toxicityEthyl Chloride -- toxicityHydrazines -- toxicityHydrogen Peroxide -- toxicityMethyl Chloride -- toxicityNitrobenzenes -- toxicityNo-Observed-Adverse-Effect LevelQuality ControlToxicity Tests -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. M7(R2) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2023 Subject(s): CarcinogensDrug Contamination -- prevention & controlDrug DevelopmentDrug IndustryGovernment RegulationMutagenicity TestsMutagensUnited StatesUnited States. Food and Drug Administration
