Therapeutic drugs may induce cancer or increase its incidence, these substances are considered as carcinogens. Assessment the carcinogenicity of drug candidates is an important step in the drug safety evaluation. Substances which have induced benign and malignant tumors in well performed experimental studies on animals are considered to be presumed or suspected human carcinogens, they are basically identified as having the potential to be hazardous unless there is strong evidence that the mechanism of tumor formation is not relevant for humans. Creative Animodel provides comprehensive carcinogenicity testing service to evaluate the tumor inducing liability of your drugs candidates and therefore reducing the potential risk and adverse effects of your pharmaceutical drugs.
At Creative Animodel, carcinogenesis assessments are performed in compliant with the international regulations. Our carcinogenicity assessment is generally fall into two categories:
|•||In vitro method:||Ames test|
|•||In vivo method:||Rodent dominant lethal study|
Ames test is typically carried out as contracted studies for in vitro carcinogenesis evaluation. It is a widely employed method that uses bacteria to test whether a given chemical/pharmaceuticals can cause mutations in the genetic materials of the test organism. A positive result indicates that the compound is mutagenic may act as a carcinogen. It is a quick and convenient way for knowing the carcinogenic potential of the give substance when compare to the in vivo assay. Although cancer is often linked to mutation, but not all compounds show positive in Ames test is carcinogen. In vivo animal model tests will add more strength on the final conclusion.
Long-term rodent carcinogenicity studies remain the primary in vivo method for assessing the carcinogenic potential of chemical compounds (including pharmaceuticals) to humans. The use of animal models to determine the carcinogenic potential of pharmaceuticals is a required part of evaluating the overall safety of many new drug products. The most commonly used species of laboratory animals for carcinogenicity testing are mouse and rat. In vivo test will provide more relevance regard to the performance of the give drug candidate in human and therefore are used in used in the hazard identification step of the risk assessment process.
Creative Animodel has dedicated in carcinogenicity assessment for decades and have extensive successful experience in identifying the carcinogenic characteristic of the pharmaceuticals, biopharmaceuticals, pesticides and other related chemical compounds. We will work closely with you to help design and execute the carcinogenicity studies in accordance to the latest regulations. The testing results will be feedback to you in time and to help with the decision making in your research or drug development.