S1B: Testing for Carcinogenicity of Pharmaceuticals

Regulatory Resource: S1B: Testing for Carcinogenicity of Pharmaceuticals

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in July 1997. This document provides guidance on the need to carry out carcinogenicity studies in both mice and rats, and guidance is also given on alternative testing procedures which may be applied without jeopardizing safety.

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