Carcinogenicity

Carcinogenicity Studies

Regulatory guidelines impose carcinogenicity testing of pharmaceuticals intended for long-term use. The objectives of carcinogenicity studies are to identify a tumorigenic potential in animals and to assess the relevant risk in humans. Any cause for concern derived from laboratory investigations, animal toxicology studies, and data in humans may lead to a need for carcinogenicity studies.

Carcinogenicity studies expose animals to the test compound for a major portion of their lifespan and assess for the development of non-neoplastic and neoplastic lesions in multiple organs and organ systems.

Since carcinogenicity studies are time consuming and resource intensive, they should be performed only when human exposure warrants the need for information from life-time studies in animals in order to assess carcinogenic potential.

The rasH2 Alternative Transgenic Model

The use of the rasH2 transgenic mouse model for carcinogenicity testing offers a shorter testing duration, fewer animals and a lower cost. Regulatory agencies routinely approve this study in place of a two year mouse carcinogenicity study. An expert from our safety assessment team can discuss this option with you in more detail after reviewing your needs.

Our team will work with you to design your carcinogenicity study by discussing the following:

  • Selection of a model
  • Route of administration
  • Dose level
  • Housing and feeding
  • Endpoints
  • Pathology