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S2(R1) - PharmaFacts
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Guidances - ICH Guidances

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

This guideline has been released for consultation under Step 2 of the ICH process on 6 March 2008.  This guidance replaces and combines the ICH S2A* and S2B* guidelines.  The purpose of the revision is to optimize the standard genetic toxicology battery for prediction of potential human risks, and to provide guidance on interpretation of results, with the ultimate goal of improving risk characterization for carcinogenic effects that have their basis in changes in the genetic material. The revised guidance 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.