Before the candidate drugs selected in drug research and development trials enter clinical trials, rigorous preclinical safety studies should be carried out to evaluate their potential toxicity, among which carcinogenicity study is one of the main contents of safety evaluation. Creative Biolabs offers a variety of carcinogenicity tests to assess the toxicity of new drugs and their subsequent safety in humans, accelerating your drug development.
Carcinogenicity is the ability or tendency of a chemical to induce tumors (benign or malignant), increase their incidence or malignancy, or shorten the time of tumor occurrence when it enters the body through various routes. Carcinogenicity studies are studies that use animal models to assess the carcinogenic potential of drugs. The purpose of carcinogenicity studies is to identify the tumorigenic potential in animals and to evaluate the relevant risk in humans. In general, pharmaceuticals intended to be used continuously for at least six months or intermittently for the treatment of chronic or recurrent conditions (e.g., allergic rhinitis, depression, and anxiety) require carcinogenicity studies. In addition, carcinogenicity studies may also be required If (a) the agent is a member of a chemical class known to be carcinogenic; (b) positive or equivocal evidence of mutagenicity is found in genetic toxicology studies; and/or (c) other evidence suggesting possible carcinogenicity is identified in subchronic toxicology bioassays.
Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has established standardized international guidelines for evaluating potential human health risks for pharmaceuticals, including carcinogenic toxicity, genotoxicity, immunotoxicity, and reproductive toxicity. The current ICH carcinogenicity testing guidelines primarily include 2-year carcinogenic bioassays in rodents and an additional in vivo carcinogenicity tests. In most cases, the carcinogenic potential is evaluated by a 2-year bioassay in rats and mice; however, it does not always provide further value for carcinogenicity risk assessment, therefore, 2-year bioassay in rodents are often combined with 6-month oncogenic bioassays in genetically engineered (rasH2 or p53 knockout) mice. However, the use of animals for carcinogenicity testing of drugs is not only time-consuming and costly, but also requires a large number of animals, and also imposes high demands on the skills of the experimental personnel. In this regard, rapid, simple, and inexpensive in vitro assays will greatly assist in the carcinogenicity detection of drugs on animals. More importantly, when the in vitro tests used are sufficiently specific and sensitive, they can be used as strategy for high-throughput carcinogenic screening.
At Creative Biolabs, we have established a rich library of in vitro models that can be used to study the carcinogenicity of drugs to be tested, such as various primary cells, murine cell lines, genetically engineered cell lines, 3D cells, and organoids. The cell transformation assay is now increasingly important by incubating test compounds with selected cell lines and then analyzing whether these treated cells exhibit characteristics associated with carcinogenesis in vivo. The indicators for the method include whether the treated cells have acquired immortality, whether the morphology has changed, whether the growth pattern has changed, changes or not of the genetic stability, whether anchorage-independent growth has occurred, and whether a tumor would be formed after the treated cells are injected subcutaneously into the nude mice.
In accordance with international regulations to identify the tumorigenic potential of your compounds and to assess the relevant risk in humans, Creative Biolabs is a global contractor for preclinical research in pharmaceuticals with a very professional scientific team. Our toxicologists and toxicology technicians have extensive experience in carcinogenicity research, so we can ensure a one-stop, consistent service to help you complete your research. If you need any help, please feel free to contact us.
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