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Global regulatory frameworks—especially the ICH S1 series guidelines—require structured carcinogenicity assessment: ICH S1A/S1B/S1C define when lifetime rodent studies are required Emphasis on hazard identification rather than direct human prediction Adoption of Weight-of-Evidence (WoE) approaches in ICH S1B(R1) The updated S1B(R1) guideline specifically encourages: Integration of mechanistic, exposure, and translational data Reduced reliance on 2-year rodent bioassays when justified Greater emphasis on human relevance and multi-factor evidence This shift reflects a broader regulatory evolution toward mechanism-based safety assessment rather than purely animal-driven hazard signals
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