The International Council for Harmonisation has updated its carcinogenicity testing guideline with new recommendations on how sponsors can apply an integrative weight of evidence (WoE) approach to assessing the human carcinogenic risk for certain pharmaceuticals in lieu of conducting a two-year rat study.
The recommendations were finalized earlier this month and are published as an addendum integrated into the 1997 ICH S1B guideline on carcinogenicity testing. They encourage a more mechanism-based approach to...
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