Carcinogenicity Studies
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
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Our team and Experience
Our team includes both highly qualified senior study director and technicians with wide expertise in the following areas.
The performance of carcinogenicity studies requires an extensive knowledge of the spontaneous frequency of certain pathological changes, since it may be substantial differences between species and strains. Our carcinogeniticy 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. In addition to standard staining methodology, special preparations may be included to further characterize lesions seen in the tissues.
Methodology
Carcinogenicity Studies for Human Pharmaceuticals
- ICH S1A. Guideline on the need for carcinogenicity studies of pharmaceuticals, March 1996.
- ICH S1B. Testing for carcinogenicity of pharmaceuticals, July 1997.
- ICH S1C Dose selection for carcinogenicity studies of pharmaceuticals, March 1995
- ICH S1C (R) Addendum to dose selection for carcinogenicity studies of pharmaceuticals: Addition of a limit dose and related notes, July 1997
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