Carcinogenicity Studies

Carcinogenicity studies are designed to evaluate the tumorigenic potential of pharmaceuticals where the drug product has a probability of prolonged exposure to humans. These studies are performed per the ICH S1 guideline and are required as part of an overall safety assessment package for these long-term use products. Carcinogenicity studies can run from six months up to two years and are typically conducted in conjunction with the later phases of clinical development.

Inotiv has extensive experience in the performance of carcinogenicity studies, including the two-year mouse and rat bioassay as well as the six-month transgenic mouse assay. The ICH S1 guideline allows for the six month Tg.rasH2 transgenic mouse study as an alternative to the two year mouse bioassay. This assay has many advantages over the traditional two-year study, including fewer number of animals, less test article requirement, and quicker overall study turnaround time. Inotiv has performed many of these alternative transgenic carcinogenicity studies and has board certified veterinary pathologists with experience in the histopathology examination from these animals.

Take advantage of our experienced team of scientists who will work with you to develop your study design and define the best model to advance your product and meet your strategic goals. Let Inotiv provide the insights you need for a successful carcinogenicity testing program.