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Drug Non-clinical Evaluation and Research Center
Time:2017-10-19 Views:

Research field: Biological medicine
Tel:020-22698388、18928860179
E-mail: yangwei0719@163.com
Address: No.18 Gaohu Road, Conghua economic development zone high-tech industrial park, Guangzhou, Guangdong)

 

Introduction:
The institute is engaged in the professional technical services that are in accordance with national GLP and international AAALAC, which include new drug research and development, new drug screening, pharmacological efficacy, drug safety evaluation (GLP), preclinical pharmacokinetic study, new drug registration and application, human disease and animal model preparation and research, etc. Our experimental animal objects include rats, mice, guinea pigs, rabbits, dogs, monkeys, pigs and so on. The Institute offers drug non-clinical evaluation of key technical services for pharmaceutical production enterprises, and takes Guangdong as the center, radiates from domestic to foreign countries.
The research center team has carried out pre-clinical pharmacology and toxicology evaluations of more than 50 one class innovative drugs, 30 biological products, more than 200 chemical drugs, more than 300 Chinese medicines or natural medicines. All the applied projects were successfully passed the national review, and we have gained the praise from the units received our services because we have offered big support for them to gain clinical approval documents. Especially in 2016 we supported the service received unit to develop the first one class clinical approval document of Chinese medicine in Guangdong for this five years, which was a breakthrough for Guangdong Province in one class new drug clinical approval.

 

Research Areas:
(1) non-clinical drug safety evaluation (conform to international and domestic GLP and international AAALAC certification requirements): including but not limited to acute toxicity, long-term toxicity, safety pharmacology, topical toxicity, immunogenicity, genotoxicity, reproductive toxicity, carcinogenic test , toxicokinetics test, etc;
(2) Non-clinical efficacy of new drugs (conform to international AAALAC and take the implementation GLP as reference): including but not limited to anti-inflammatory immunity, diabetes and complications, cancer, digestive diseases, cardiovascular and cerebrovascular diseases, endocrine system diseases, autoimmune diseases, neurobehavioral, ophthalmic drug pharmacodynamics studies and so on;
(3) Nonclinical pharmacokinetic studies (conform to international AAALAC and take the implementation GLP as reference): drug profile, absorption, tissue distribution, excretion, metabolism, drug interactions, bioequivalence, etc;
(4) Others: biological drug pharmacy research and monoclonal antibody in the pilot study, the new drug druggability screening evaluation study, drug registration and application, animal medical testing, animal disease model research, etc.


Research Personnel:
There are 12 employees in the center, three are with senior high tittles, 4 are with subtropical high titles, and are with intermediate titles. Five of them are Ph. D., 4 are maters, 1 is post doctorate, 1 is doctoral candidate, and 1 is master graduate students. The research team includes 1 FDA expert, 1 international GLP expert, 2 national new drug review experts, 1 innovation and entrepreneurial team of Guangdong Academy of Sciences, 1 leading talent of Guangdong Province and 1 leading talent of Guangdong Provincial Academy of Sciences.
Center officer: Wei Yang(Ph.D. supervisor, professor)
PI: Wei Yang( Ph.D. supervisor, professor), Jufeng Wang(Reseacher), Xiaofei Wang(Ph.D.), Baiquan Xiao(Ph.D.), Zhong Han(Ph.D.), Xialing Lei(senior engineer), Yuankeng Huang(senior engineer), Jianmin Guo(engineer), Lu Liu(engineer), Hong Zhang(,Mater)
Students: Limei Wang(Master)

 

Recognized Qualifications :
(1) The Institute has received the AAALAC international qualification certificate, and we are the only one drug non-clinical evaluation and research center in south China that passes international AAALAC certified non-clinical evaluation in the field of a variety of experimental animals (mice, rats, guinea pigs, rabbits, dogs, pigs, monkeys, etc.) at the first single time of pharmacology, toxicology, medicine, new drug screening research and cellular biology research business.

 

 

(2) We have obtained CFDA GLP certification on nine full qualification certifications, we are still the only one to have this certifications in southern China by now.

 

Publications: 
Ever since 2016 till now, our center has published 63 papers at home and abroad, 5 SCI and core papers, and 2 cooperation professional articles.
1. Zhong Han Xia-Ling Lei Hong Zhang Lu Liu Zhi-Sen Chen Wei Yang Zhao-Rong Lun, evaluating the safety of forsythin from Forsythia suspensa leaves by acute and sub-chronic oral administration in rodent models ,Asian Pacific Journal of Tropical Medicine, 2017, 10(1):47-51
2. Wei Yang(chief editor), Experimental monkey physiology and histopathology autopsy and its application in medical research, Sun Yat-sen University Press, 2016.06
3. Wei Yang(associate editor), Central nervous system diseases of primate animal model surgery, Sun Yat-sen University Press, to be published .

 
 
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