Carcinogenicity study is an important part of non-clinical safety assessment of drugs, which is to identify the tumorigenic potential in animals and to evaluate the relevant risk in humans after long-term drug use. TriApex can provide standard carcinogenicity evaluation services.
1. TriApex has established comprehensive standard operating procedures for carcinogenicity studies, including tumor observations and measurements, animal euthanasia standards, and statistical analysis method for tumor incidence, and has established a rich background database.
2. TriApex is staffed by a team of experienced pathologists to provide professional diagnosis and comprehensive analysis of carcinogenic results.
3. TriApex provides scientific and case-by-case study designs based on product characteristics.
-Carcinogenicity study in transgenic mice (6 months)
-2-year carcinogenicity study in rats
-2-year carcinogenicity study in mice
TriApex can conduct carcinogenicity studies in rodents and 6-month carcinogenicity studies in Tg.rasH2 model (instead of 2-year carcinogenicity studies), which can meet the regulatory requirements of IND application and marketing of drugs.
TriApex has completed the simulative carcinogenicity studies in rasH2-Tg mice (6 months), SD rats and Wsitar rats (2 years). TriApex has established a database of spontaneous background lesions based on the data of general clinical signs, body weights, food consumption, clinical pathology and spontaneous tumors from different strains of rats, which provides reference for subsequent studies.