Draft International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline S1 - Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals

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Summary

A change to the current ICH S1 guidance on rodent carcinogenicity testing is being considered. The goal of this potential change is to introduce a more comprehensive and integrated approach to address the risk of human carcinogenicity of small molecule pharmaceuticals, and to define conditions under which two-year rodent carcinogenicity studies add value to that assessment.