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This means that it does not have a natural model of action and may potentially cause unwanted side effects during long-term administration

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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Theyre able to make up and recoup costs from research and development and things of that sort