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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:

 
Under the condition of GLP, the center has the qualifications of single dose toxicity of biological products, chemical drugs and traditional Chinese medicine (TCM) for rodent and non rodents (including non-human primates), repeated drug toxicity or rodents and rodents (including non-human primates) , genetic toxicity, safety pharmacology, local toxicity and immunogenicity test , which has completed more than 200 drug preclinical safety evaluation experiment. Currently, GLP qualification applications for reproductive toxicity, drug dependence, toxicokinetics and other pilot projects are being actively prepared. Other characteristic drug safety evaluations include: pediatric drug safety evaluation, traditional Chinese medicine injection safety evaluation, cell and gene therapy product safety evaluation, nano drug safety evaluation, etc.
 

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

 

Contact information:

Contact: He Jun

Address: No. 2 Nanwei Road, Xicheng District, Beijing

E-mail: jun_he92@163.com

Contact number: 010-63031049