Regulators around the world require carcinogenicity studies for new therapies intended for long-term use, for chemicals expected to have prolonged human exposure and for any compound showing a carcinogenic potential. These studies are generally performed during clinical development or before marketing authorization or in some cases post approval (for drugs intended for the treatment of patients with limited options or with clearly demonstrable added value).
A complete histopathological examination of all groups, followed by a peer review, is performed by a highly experienced team of certified pathologists.
Preliminary studies
Palatability study
- Species: rat, mouse
- Administration route: oral
Preliminary 4- and 13-week toxicity study
- Species: rat, mouse
- Administration routes: oral, subcutaneous
Long-term carcinogenicity studies
Carcinogenicity study
- Species: rat, mouse
- Administration routes: oral, subcutaneous
- Toxicokinetic can be included
Combined chronic toxicity-carcinogenicity study
- Species: rat
- Administration routes: oral, subcutaneous
- Toxicokinetic can be included
