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Liu B, Sun Y, Xu G, et al
Metformin and body weight
Thats 35 lbs down on the scale, but the mirror tells an even better story
Global regulatory frameworksespecially the ICH S1 series guidelinesrequire 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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