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ICH S2(R1): Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use

ICH S2(R1) defines the standard battery of genotoxicity tests for pharmaceuticals intended for human use, supporting first-in-human trials and marketing…

What ICH S2(R1): Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use requires

ICH S2(R1) defines the standard battery of genotoxicity tests for pharmaceuticals intended for human use, supporting first-in-human trials and marketing applications…

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Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation (ICH) · Version: 1.0.0 · Last updated:

Primary source: https://database.ich.org/sites/default/files/S2%28R1%29%20Guideline.pdf

SHA-256 integrity: c50b0099aec522fe56907356e3f4acf30bbc1ec153facbf7610272b6170b5e56

Primary Citations — 5 traced to source

  • ICH Harmonised Tripartite Guideline S2(R1) Genotoxicity Testing and Data Interpretation November 2011
  • OECD Test Guideline 471 Bacterial Reverse Mutation Test

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