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. The R1 revision rationalised the testing strategy from previous separate ICH S2A and S2B guidelines into a unified framework. The standard battery consists of: (1) a test for gene mutation in bacteria (Ames test, OECD TG 471); (2) an in vivo assessment of genotoxicity in rodents (e.g. micronucleus or comet assay, OECD TG 474 or 489); plus either (3a) an in vitro mammalian cell test for chromosomal damage or (3b) integration of the in vivo assay with general toxicology. Compliance is foundational to safety evaluation and feeds into ICH M7 mutagenic impurity assessment.
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: 1dc781289679a184804bb7455cea176db95a24eac9c84cba0454808ef49c59f0
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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