The International Council for Harmonisation (ICH) recently announced that its S1B(R1) addendum outlining a “weight of evidence” (WoE) approach to assess the human carcinogenic risk for certain pharmaceuticals in lieu of conducting a two-year rat study has reached Step 4 and is awaiting sign-off by regulators.
The document contains several changes from the Step 2 guideline released in May 2021. (RELATED: To speed drug development, ICH proposes reducing rat carcinogenicity testing, Regulatory Focus 14 May 2021)
Since the publication of the original S1B guideline on carcinogenicity testing in 1998, “scientific advances toward elucidation of mechanisms of carcinogenicity, greater understanding of the limitations of rodent models, and several retrospective analyses of pharmaceutical datasets indicate that 2-year rat carcinogenicity studies might not add value to human carcinogenicity risk assessment in some cases and the carcinogenic potential could have been assessed adequately based on a comprehensive assessment of all available pharmacological, biological, and toxicological data,” said an ICH announcement…
