Table 1.

Weight-of-evidence factors for consideration in a Carcinogenicity Assessment Document (adapted from (ICH, 2016)).

Weight of evidence factors
1. Knowledge of intended drug target and pathway pharmacology, secondary pharmacology, & drug target distribution in rats and humans
2. Genetic toxicology results
3. Histopathologic evaluation of repeated dose rat toxicology studies
4. Exposure margins in chronic rat toxicology studies
5. Metabolic profile
6. Evidence of hormonal perturbation
7. Immune suppression
8. Special studies and endpoints
9. Results of non-rodent chronic study
10. Transgenic mouse carcinogenicity study