S2 (R1) Step 5 Genotoxicity testing and data ...
ICH guideline S2 (R1) on genotoxicity testing and data interpretation for pharmaceuticals intended for human use . Step 5 . Transmission to CHMP . March 2008 : Adoption by CHMP for release for consultation ; March 2008 . ... 3.2.1. Selection of top dose level .....8 3.2.2. Study design/Test protocol ...
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