ICH S1B Carcinogenicity: testing for carcinogenicity of pharmaceuticals

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Current effective version

Adopted guideline

Reference numberCPMP/ICH/299/95
Published30/09/1997
Effective from01/03/1998
KeywordsCarcinogenic potential, long-term carcinogenicity study, rodent carcinogenicity studies, short or medium-term carcinogenity test, mechanistic studies, choice of species
DescriptionThis document provides 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.


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