Carcinogenicity Studies
JOINN is the facility with the most experience in conducting carcinogenicity studies of drugs in China. The carcinogenicity evaluation system of JOINN fully complies with international GLP management standards, and the experimental design is in line with the guidelines of the US FDA, ICH, OECD, and China’s NMPA. JOINN possesses the most experienced team of carcinogenicity pathologists in China, with a rich background in carcinogenicity study data, pathological diagnosis experience, and comprehensive analysis capabilities for carcinogenicity outcomes.
Types of Study
Long-term Carcinogenicity Study
- Two-year Rat Carcinogenicity Study
- Two-year Mouse Carcinogenicity Study
Short-term Carcinogenicity Study
- Six-month Tg.rasH2 Transgenic Mouse Carcinogenicity Study
Animal Strains
Rat Strains
- SD Rat
- Wistar Rat
Mouse Strains
- Tg.rasH2 Transgenic Mouse
Service Advantages
- The first facility in China to systematically accumulate background data for two-year rat carcinogenicity studies.
- The first facility in China to apply the LIMS system (Provantis) to carcinogenicity studies.
- JOINN has established comprehensive standard operating procedures for the statistical analysis of carcinogenicity study results, and is capable of conducting various survival and tumor analyses (Poly-3) that meet the requirements of NTP and FDA.
- JOINN is the first CRO in China to conduct 26-week carcinogenicity studies in Tg.rasH2 mice.
- JOINN is the facility in China that has completed the most carcinogenicity studies in rats and transgenic mice, with multiple carcinogenicity study protocols reviewed and approved by the FDA’s ECAC.
