Carcinogenicity experiment

Carcinogenicity testing is conducted to evaluate the potential carcinogenic effects of a drug in animals, thereby assessing and predicting its possible hazards to humans. Any concerns arising from experimental studies, animal toxicity tests, or data from human applications may indicate the need for carcinogenicity testing. Drugs expected to be used by patients over a long period should undergo carcinogenicity testing in rodent species. We were among the first in China to conduct carcinogenicity studies under GLP-compliant conditions and have established a comprehensive carcinogenicity evaluation system. The study designs fully comply with the guidelines of the FDA, ICH, and CFDA and adhere to international GLP standards.

Carcinogenicity experiment

Carcinogenicity testing is conducted to evaluate the potential carcinogenic effects of a drug in animals, thereby assessing and predicting its possible hazards to humans. Any concerns arising from experimental studies, animal toxicity tests, or data from human applications may indicate the need for carcinogenicity testing. Drugs expected to be used by patients over a long period should undergo carcinogenicity testing in rodent species. We were among the first in China to conduct carcinogenicity studies under GLP-compliant conditions and have established a comprehensive carcinogenicity evaluation system. The study designs fully comply with the guidelines of the FDA, ICH, and CFDA and adhere to international GLP standards.

 

We have a team of Japanese veterinary pathologists (JCVP) and toxicopathologists (JSTP) with nearly 30 years of experience in carcinogenicity testing and diagnosis, boasting extensive expertise in this field. Our pathology team is among the best in China, featuring high-level specialists. We offer comprehensive and sophisticated diagnostic support using tumor markers. Through years of practical experience, we have accumulated rich expertise and historical control data, and have established a database of spontaneous lesions in experimental animals, including an image library of spontaneously occurring tumors.

 

Test Type Types of Tumor Marker-Assisted Diagnosis

2-Year Carcinogenicity Study in Rats

Carcinogenicity Study in Mice Aged 18-24 Months

6-Month Carcinogenicity Study in rasH2 Transgenic Mice

Carcinogenicity Study in 6-Month-Old P53-Deficient Mice

Tumor/Carcinogenicity Study in Immunodeficient Mice (Cell Therapy Products)

Epithelial cell origin: Cytokeratin

Neural tissue markers: S-100, GFAP, Neurofilament

Myofiber source: Smooth muscle actin

Source of neuroendocrine tissue: Chromogranin A

Fibrous connective tissue origin: Vimentin