ICH S2 (R1) Genotoxicity testing and data interpretation for pharmaceuticals intended for human use

This document aims to optimize the standard genetic toxicology battery for prediction of potential human risks. It describes internationally agreed upon standards for follow-up testing and interpretation of positive results in vitro and in vivo in the standard genetic toxicology battery, including assessment of non relevant findings. This guidance does not apply to biologics.

Keywords: Genotoxicity, standard test battery, in vitro test, in vivo test, results interpretation

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