Carcinogenicity Studies

Carcinogenicity Studies for Human Pharmaceuticals

In the process of drug development, pharmaceuticals are routinely tested for safety and efficacy before they
are being marketed. Within this process, carcinogenicity studies are required by the regulatory authorities for
those pharmaceuticals which are intended to be administered continuously or intermittently over a prolonged
period, in addition to compounds with a mutagenic potential or a structural alert indicating a putative
carcinogenic effect, or influence on cell proliferation have to be tested, even if it is intended for a short period
of administration.

According to the regulatory agencies, the potential for a compound to cause cancer should be assessed with
a two year rodent bioassay in addition to an additional in vivo test for carcinogenicity (Long-term
carcinogenicity study in a second rodent species or short or medium-term in vivo rodent test systems)
Together with in our partners, we provide these testing strategies in compliance with the international
regulations, to identify the tumorigenic potential of your compound in animals and to assess the relevant risk
in humans for regulatory purposes.

Vivotecnia offers the following studies for the analysis of carcinogenicity:

Species: rat, mouse, hamster

Routes of administration: oral, dietary, inhalation, dermal and subcutaneous

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

 p53+/- mouse for non-dermal genotoxic pharmaceuticals

 TG.AC mouse for dermally administered pharmaceuticals

 TgrasH2 mouse for non-dermal, genotoxic or non-genotoxic pharmaceuticals

Carcinogenicity studies for Chemicals

Chemical carcinogens are substances or mixtures which have the potential to induce cancer to humans under certain conditions and for prolonged or excessive periods of exposure. Chemical carcinogens can be natural chemicals, synthetic compounds or mixtures of both, that are produced or used for industrial, agricultural or commercial purposes.
The 2001 European Commission proposal for the Registration, Evaluation and Authorisation of Chemicals REACH) aims to improve public and environmental health by assessing the toxicity of, and restricting exposure to, potentially toxic chemicals. The requirements for carcinogenicity testing of Industrial Chemicals, regulated by REACH, are based on a tiered approach according to which, , a two-year carcinogenicity assay may be required for certain chemicals produced at >1000 metric tonnes per year. In addition, some chemicals that are found to be genotoxic will also require testing.



carcinogenicity studies

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