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
3. Some Early Stirrings (1950 ff.) of Concern about Environmental Mutagens Publication: John Wiley & Sons, 1997 Subject(s): Environmental ExposureMutagens Archival Collection: The Joshua Lederberg Papers (Profiles in Science)
4. Foreword to "The Mutagenicity of Pesticides-Concepts and Evaluation" Publication: M.I.T. Press, 1971 Subject(s): MutagensResearchHazardous Substances Archival Collection: The Joshua Lederberg Papers (Profiles in Science)
5. Chloramine Mutagenesis in Bacillus subtilis Publication: American Association for the Advancement of Science, 11 June 1976 Subject(s): Mutagens Archival Collection: The Joshua Lederberg Papers (Profiles in Science)
6. For the ICRF Annual Report, 1979: II. Retroviruses as Mutagens: Isolation of Revertants with Deletions and/or Insertions in the ASV Provirus in B31 Cells after Superinfection with MuLV Publication: Produced: 1979 Subject(s): Avian Sarcoma VirusesDNA, ViralMutagens Archival Collection: The Harold Varmus Papers (Profiles in Science)
