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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

Velafermin (rhFGF-20) reduces the severity and duration of hamster cheek pouch mucositis induced by fractionated radiation

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In fact, dysregulation of the NLRP3 inflammasome is related to the pathogenesis of numerous inflammatory disorders, such as diabetic nephropathy (DN) [36], tumor necrosis factor receptor-associated periodic syndrome (TRAPS) [37], OA [38], and Alzheimers disease (AD) [39]