As drug products are developed to treat both known and emerging human diseases and conditions, determining the safety of these new chemicals become of increasing importance and necessity. Carcinogenicity studies aim to assess potential human cancer risk prior to drug approval. Therapeutic drugs may induce cancer or increase its incidence. These substances are considered as carcinogens. Carcinogens are classified as genotoxic or non-genotoxic carcinogens according to their mode of action. Genotoxic carcinogens initiate carcinogenesis by direct interaction with DNA, resulting in DNA damage or chromosomal aberrations that can be detected by genotoxicity tests. Non-genotoxic carcinogens are agents that do not directly interact with DNA and are believed to enhance tumor development by affecting gene expression, signal transduction, and/or cell proliferation.
Carcinogenicity Studies at Creative Animodel
Pharmacologic and toxicologic evaluation of a new drug in animals is an important part of the pharmaceutical development process prior to its first-time use in humans. Creative Animodel can conduct drug carcinogenicity assessments in animals to help ensure the safety of drug product in human populations.
Long-term carcinogenicity studiesAccording to the regulatory agencies, the potential for a compound to cause cancer should be assessed with a two-year rodent bioassay. The objective of these long-term studies is to observe animals in the major part of their life-span for the development of neoplastic lesions after exposure to a test substance. Our long-term carcinogenicity species include:
1) Sprague-Dawley and/or Wistar Han rats
2) CD-1 mice
Short-term carcinogenicity studiesThe current ICH carcinogenicity testing guidelines require a lifetime rodent bioassay, plus an additional lifetime or short-term assay in a second species. Creative Animodel has developed a number of genetically modified mouse models to facilitate the quick and accurate detection of chemical carcinogens. The mice develop tumors much more rapidly than wild-type mice as the transgenic modifications involve genes critical to the carcinogenic process. Our transgenic models include:
1) Tg.AC mouse for dermal drugs
2) p53 +/- mouse for known genotoxic compounds
3) Tg.rasH2 mouse for genotoxic/non-genotoxic compounds
Creative Animodel provides carcinogenicity 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. If you have any needs, please feel free to contact us. We look forward to cooperation with you in the near future.
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