Skip to content
Carcinogenicity Studies
Carcinogenicity studies involve long-term treatment of animals, usually in rodents, with a therapeutic compound to determine the potential of it causing cancer.
Carcinogenicity Studies
Carcinogenicity studies are usually performed over the course of 2 years in rats or mixed background mice. Animals of both sexes are usually included in carcinogenicity studies.
Clear Evidence of Carcinogenicity
Compounds under this category demonstrate a clear, dose-related increased risk of development of neoplasm or cancer with use.
Some Evidence of Carcinogenicity
Compounds under this category demonstrate some increased risk of development of neoplasm or cancer with use.
Equivocal Evidence of Carcinogenicity
Compounds under this category demonstrate a marginal increased risk of development of neoplasm or cancer with use.
No Evidence of Carcinogenicity
Compounds under this category demonstrate no increased risk of development of neoplasm or cancer with use.
Inadequate Study of Carcinogenicity
Compounds under this category have not been studied sufficiently to determine if they cause cancer or neoplasms with use.
Carcinogenicity Testing and Chronic Toxicity
Our pharmacology team can perform short-term (2 weeks), medium-term (13 weeks) and long-term (2 year) studies in rats and mice with various routes of administration. Our services include ongoing blood parameter analysis (CBC, chemistries), body weights, food intake, clinical observation, behavioral testing and terminal tissue collection with fully in house histology and histopathological analysis.
Long-term Carcinogenicity Testing Models
2-year Chronic Carcinogenicity Testing
Long-term chronic dosing studies can be performed in mixed background mice (ex. B6C3F1) or in outbred strains (Swiss outbred, CD-1).
6-month Carcinogenicity Testing in Genetically Modified Models
Shorter monitoring studies can be performed in animals genetically sensitive to neoplastic transformation such as the rasH2 or p53+/-.
Frequently Asked Questions
Long-term safety assessment of potential therapeutics is critical to successful drug development.