Subjects: Carcinogenicity Tests -- standards - Digital Collections - National Library of Medicine Search Results

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Start Over Subjects Carcinogenicity Tests -- standards

1. 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 -- standards
Drug Evaluation, Preclinical
Government Regulation
United States
United States. Food and Drug Administration

2. 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 -- 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