Centre for Safety Evaluation and Research of Drugs

Comprehensive Introduction:

The New Drug Safety Evaluation and Research Center (GLP Center) is dedicated to the preclinical safety evaluation and pharmacodynamic evaluation of drugs, as well as the preclinical evaluation of medical devices and health products. In 2007, it passed the GLP qualification certification of CFDA, the International AAALAC accreditation and the National Laboratory Accreditation (CNAS).

Center is as the main complete unit in the national major drug discovery projects and 863 subjects of "the 11th five-year plan" and "the 12th five-year plan", to undertake the establishment of preclinical evaluation platform in "evaluation technology platform construction for international standard drug safety ", "establishment of evaluation technology platform for oral anti-diabetic drug preclinical pharmacodynamic" and "stem cell therapy of diabetes preclinical scheme optimization and clinical application research". The center undertook and completed the special project of Beijing Science and Technology Plan, "Construction of technical service platform for pre-clinical toxicology Evaluation of Drugs", the special research work of public welfare industry, "Study on the toxic effects of melamine and other substances on animals and their metabolism in vivo", and the special research work of Traditional Chinese medicine industry.

Service and Technology Support:

The center can also undertake the pre-clinical efficacy evaluation, and has completed the anti-tumor, pulmonary fibrosis, liver fibrosis, diabetes, hyperlipidemia, atherosclerosis, myocardial ischemia drugs, as well as the treatment of metabolic syndrome, Alzheimer's disease, rheumatoid arthritis, kidney injury, detoxification and other aspects of pharmacodynamic tests. So far, more than 150 new varieties have been evaluated for their preclinical efficacy, among which many new varieties such as inactivated SARS vaccine, EV71 vaccine, influenza vaccine and mesenchymal stem cells have been approved for clinical trials. The rigorous and standardized experimental design and strict experimental procedures have been highly appraised by drug reviewers.

The center can undertake biological evaluation of medical devices, pharmacokinetic studies, and pre-evaluation of efficacy and safety of food and health products. It has helped many medical device manufacturers to complete the evaluation of the effectiveness, metabolism and degradation, histocompatibility, systemic toxicity of coronary stents, hip replacement, cardiac electrodes, hemostatic materials and other aspects, and obtained relevant qualifications. Pre-assessment experiments on the food and health care efficacy and safety that can be conducted are: acute toxicity, chronic toxicity, 30 and 90 days feeding, function increasing bone density, fatigue resistance, oxidation resistance function, enhance immune function, auxiliary fall blood sugar, auxiliary fall hematic fat, auxiliary fall blood pressure,  lactation promotion, improve sleep, promote the growth and development, strengthen the function of kidney function, reproductive effect evaluation, etc.

The center can undertake all kinds of animal samples in clinical detection (blood routine, biochemical, routine urine and blood clotting index, etc.), pharmaceutical properties analysis (drug content, composition, purity, stability and melting time limit, and safety, pyrogen, abnormal toxicity, biological activity, etc.), supply for animal models of human diseases and other animal laboratory technical services.

biochemical analyzer	Coagulometer
blood analyser	urine analyzer
UPIC	liquid chromatograph
monitoring system of microporous plate	flow cytometer