Carcinogenic test
Carcinogenic test is to investigate the potential carcinogenic effect of drugs in animals, so as to evaluate and predict its possible harm to human body. Concerns arising from data from any experimental studies, animal toxicity tests and human applications may indicate the need for carcinogenic testing; Drugs that the patient is expected to use for a long period of time should be tested for carcinogenicity in rodents. We took the lead in conducting carcinogenic tests under GLP conditions in China and established a carcinogenic test evaluation system. The test design fully complied with the guiding principles of FDA, ICH, CFDA and international GLP standards.
Category: Non-clinical safety evaluation
Medicines for human purposes
Carcinogenic test is to investigate the potential carcinogenic effect of drugs in animals, so as to evaluate and predict its possible harm to human body. Concerns arising from data from any experimental studies, animal toxicity tests and human applications may indicate the need for carcinogenic testing; Drugs that the patient is expected to use for a long period of time should be tested for carcinogenicity in rodents. We took the lead in conducting carcinogenic tests under GLP conditions in China and established a carcinogenic test evaluation system. The test design fully complied with the guiding principles of FDA, ICH, CFDA and international GLP standards.
Our Japanese veterinary pathologists (JCVP) and toxicity pathologists (JSTP) with nearly 30 years of experience in cancer diagnosis have rich experience in cancer diagnosis. With a first-class high-level pathology team in China; There are comprehensive and complete tumor markers to assist diagnosis. After years of practice, rich experience and historical comparative data have been accumulated, and a background database of spontaneous lesions in experimental animals has been established, including a photo library of spontaneous tumors.
Test type
2 years carcinogenic test in rats
18-24 months mouse carcinogenesis test
Carcinogenesis test of rasH2 transgenic mice for 6 months
6 months P53 gene knockout mice carcinogenic test
Tumorigenic/carcinogenic tests in immunodeficient mice (Cell therapy products)
Tumor markers assist in diagnosis
Epithelial cell source: Cytokeratin
Nerve tissue source: S-100, GFAP, Nurofilament
muscle fiber source: Actin smooth muscle
Source of neuroendocrine tissue: Chromogranin A
Fibrous connective tissue Source: Vimentin
