ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals - Scientific guideline

HumanScientific guidelines

Guidance on approaches for evaluating the carcinogenic potential of pharmaceuticals. It embraces all pharmaceutical agents that need carcinogenicity testing as indicated in the ICH S1A.

Keywords: Carcinogenic potential, long-term carcinogenicity study, rodent carcinogenicity studies, short or medium-term carcinogenity test, mechanistic studies, choice of species

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