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S5(R3) - ICH
database.ich.orgTOXICITY FOR HUMAN PHARMACEUTICALS. S5(R3) Final version . Adopted on 18 February 2020 . This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process.
S2 (R1) Step 5 Genotoxicity testing and data interpretation …
www.ema.europa.euThis guidance is intended to apply only to products being developed as human pharmaceuticals. 1.2. Background . The recommendations from the latest Organization for Economic Co- operation and Development (OECD) guidelines and the reports from the International Workshops on Genotoxicity Testing (IWGT)