S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals

Regulatory Resource: S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in July 1995. This document provides specific guidance and recommendations for in vitro and in vivo tests and on the evaluation of test results. It includes a glossary of terms related to genotoxicity tests to improve consistency in applications.

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