S2 Genotoxicity Studies
S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
The ICH Harmonised Guideline was finalized under Step 4 in November 2011. It replaces and combines the ICH S2A and S2B Guidelines.
The S2A Guideline on Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals was finalized under Step 4 in July 1995. This document provided specific guidance and recommendations for in vitro and in vivo tests and on the evaluation of test results. It includes a glossary of terms related to genotoxicity tests to improve consistency in applications.
The S2B Guideline on Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals was finalized under Step 4 in July 1997. This document addressed two fundamental areas of genotoxicity testing: the identification of a standard set of assays to be conducted for registration, and the extent of confirmatory experimentation in any particular genotoxicity assay in the standard battery. 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.
Date of Step 4: 9 November 2011
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Document (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
