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. Special protocol assessment Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018 Subject(s): Clinical Protocols -- standardsClinical Trials as Topic -- standardsDrug ApprovalDrug Evaluation, Preclinical -- standardsResearch DesignCarcinogenicity Tests -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
3. S1B(R1) addendum to S1B testing for carcinogenicity of pharmaceuticals: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2022 Subject(s): Carcinogenicity Tests -- standardsDrug Evaluation, PreclinicalGovernment RegulationUnited StatesUnited States. Food and Drug Administration
