carcinogenicity

Carcinogenicity studies

Pharmaceuticals are routinely tested for safety and efficacy during the drug development process before they are marketed. During this process, regulatory authorities require carcinogenicity studies for those pharmaceuticals which are intended to be administered continuously or intermittently over a prolonged period. Compounds with mutagenic potential or a structural alert indicating a putative carcinogenic effect or influence on cell proliferation also must be tested, even if they are only intended for short administration periods.

Carcinogenicity studies to determine a compound’s potential to cause cancer, according to the regulatory agencies, should include a two-year rodent bioassay and an additional in vivo carcinogenicity test (long-term carcinogenicity study in a second rodent species or a short- or medium-term study in an in vivo rodent test system). Together with our partners, we provide these testing strategies in compliance with international regulations to identify your compound’s tumorigenic potential in animals and to assess the relevant risk in humans for regulatory purposes.

Vivotecnia offers the following carcinogenicity studies:

Species: rat, mouse, hamster

Administration routes: oral, dietary, inhalation, dermal and subcutaneous

Mouse models engineered to have a predisposition to cancer need one less procarcinogenic event for cells to become transformed, thereby allowing them to respond more quickly to carcinogenic stimuli than wild-type animals.

  • p53+/- mouse for nondermal genotoxic pharmaceuticals
  • AC mouse for dermally administered pharmaceuticals
  • TgrasH2 mouse for nondermal, genotoxic or nongenotoxic pharmaceuticals

 

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Our team and Experience

Our team includes highly qualified senior study directors and technicians with broad expertise in the areas described below.

To conduct carcinogenicity studies requires an in-depth knowledge of the spontaneous frequency of certain pathological changes, as there may be substantial differences between species and strains. Our carcinogenicity group is skilled at performing histopathological assessments in rodent carcinogenicity studies, applying standard diagnostic criteria across the large numbers of tissues examined following RITA (Registry of Industrial Toxicology Animal-data) standards. Special preparations may be included in addition to standard staining methodology to further characterize any observed tissue lesions

carcinogenicity studies

CONTACT

For more information or a formal quotation, please send us a message and we will contact you as soon as possible.



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