S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals

Regulatory Resource: S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in July 1997. This document addresses two fundamental areas of genotoxicity testing: the identification of a standard set of assays to be conducted for registration, and the extent of confirmatory experimentation in any particular genotoxicity assay in the standard battery.

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