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The carcinogenicity studies of rodents are intended to determine the potential risk of a test article on the development of cancer during long-term exposure. In addition, compounds that have a mutagenic potential or a structural alert indicating a putative carcinogenic effect or influence on cell proliferation also must be tested, even if these compounds only intended for short administration periods. The data obtained from these studies are critical for regulatory agencies in their risk assessment of the test article.

Histopathologic evaluation of tissues from the exposed animals is a pivotal part of the risk assessment, relying on consistent application of standard diagnostic criteria in a large number of tissues examined. The pathologists at Creative Bioarray have many years of experience in assessing tissues from carcinogenicity studies. Together with our partners, we provide testing strategies in compliance with international regulations to identify the tumorigenic potential of your compounds in animals and to assess the relevant risk in humans for regulatory purposes.

Long-term Carcinogenicity Rodent Studies (2-year Rodent Bioassays)

Two-year rodent bioassays are widely considered to be the "gold standard" for experimental assessment of carcinogenicity. These studies involve exposure of rats or mice (=50 per sex) to drugs or chemicals for two years, followed by a comprehensive necropsy and complete microscopic evaluation of the tissues by a board-certified veterinary pathologist.

Strain selection can affect survivability and, consequently, the group size, statistical analysis and data interpretation. Routine carcinogenicity strains include:

  • Rats (Sprague Dawley, Han Wistar, F344)
  • Mouse (Swiss, B6C3F1, CD-1)

Short-term Mouse Models Studies (6-month Transgenic Mouse Studies)

Mouse models engineered to have cancer susceptibility need one less pro-carcinogenic event for cells to become transformed, making them respond more quickly to carcinogenic stimuli than wild-type animals. For example, rasH2 mice, which carry both the human Hras oncogene and the murine Ha-ras oncogene, are highly sensitive to tumor induction and serve as a suitable model for accelerated evaluation of carcinogenicity. At the end of the study, tissues are also evaluated by a board-certified veterinary pathologist.

There are three short-term transgenic mouse models in common use.

  • Tg.rasH2 mouse for nondermal, genotoxic or nongenotoxic pharmaceuticals
  • p53+/- mouse for nondermal, genotoxic pharmaceuticals
  • Tg.AC mouse for dermal pharmaceuticals

Our team includes highly qualified senior research directors and technicians with extensive expertise to evaluate carcinogenic potential through data collected from a 2-year rat study or a short-term mouse study using a transgenic model. When you choose Creative Bioarray, you will benefit from expert advice and support throughout your development program.

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