The revision to International Conference on Harmonisation S2(R1), detailed here, merges the two ICH S2A (dated 1995) and S2B (dated 1997) into a single document, which the organisation said provides a more streamlined set of guidelines.
“The purpose of the revision of this combined Guideline is to optimise 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 characterisation 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.