ICH S1B Carcinogenicity: testing for carcinogenicity of pharmaceuticals

Table of contents

This 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.

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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