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ENGLISH

Drug Non-Clinical Evaluation Development Center

(National Key Laboratory of New Drug Safety Evaluation Research in Guangzhou)

01 Introduction

       Non-clinical drug evaluation research center (national key laboratory for new drug safety evaluation) is a drug research and development and safety evaluation technology platform (hereinafter referred to as the "center") established by guangzhou general institute of pharmaceutical research co., ltd. to undertake the national 1035 project. Since 1997, the center has been preparing for the establishment of GLP laboratory -- "national ninth five-year key project -- the establishment of national (guangzhou) key laboratory for new drug safety evaluation and research". In October 2000, it passed the national acceptance test and became one of the first batch of "1035 project "in China to engage in new drug safety evaluation and research institutions. In September 2004, it passed the GLP certification of CFDA, becoming the first GLP certification institution in south China. In 2010, it was fully certified by international AAALAC. It was the first institution in south China to be certified by AAALAC, and the first institution in south China to be certified by GLP and AAALAC and to pass the certification inspection for many times. For the fourth time in 2018 by GLP regular check, at the same time increase the reproductive toxicity test (Ⅰ section, Ⅱ section), genetic toxicity test (Ames; Microkernel; The company has obtained 3 GLP certifications and 8 non-clinical evaluation project certifications, and has entered the ranks of national advanced GLP institutions. It is capable of undertaking the full set of business capabilities such as the secondary development of innovative drugs, classic famous prescriptions and famous and excellent traditional Chinese medicines.

 

02 Qualification certification

 

GLP certification

AAALAC certification

Laboratory animal permit

 

03 Talent team

       The center has a talent cluster with excellent qualifications, with about 20% of doctoral candidates, 25% of master candidates, and 60% of senior talents. It has formed a research team with doctoral leaders, senior professional title staff, doctoral and master candidates as the core technical backbone, and a professional background with international AAALAC and GLP certifications. Personnel structure optimization sharply in recent years, introduced from national key universities such as Peking University, Dr Dr Dr, China pharmaceutical university, guangzhou university of Chinese medicine, tsinghua university, university college London, the Chinese university of Hong Kong and other quality graduate students and has many years experience in the backbone of a total of more than 30 people, professional involved and clinical medicine, preventive medicine, pharmacy, pharmacology, clinical test, veterinary medicine, experimental zoology, biological technology, etc., can carry out all new drug non-clinical evaluation before meet the needs of the research project. In addition, the center has 6 external senior consultants, including academicians and domestic well-known drug review experts, who provide professional technical guidance and consultation.

Guo Qiuping

Doctor, director of non-clinical drug evaluation research center, director of national key laboratory for new drug safety evaluation and research in guangzhou, member of quality assurance committee of Chinese toxicology society, member of experimental pharmacology committee of Chinese traditional medicine society, member of pharmacology and drug toxicology committee of guangdong province. Pharmacology and toxicology research work more than ten years, engaged in the research in drug evaluation of quality system and quality control has the original opinion, successively presided or participate in nearly 20 countries, topics, including tripterygium wilfordii compatible system toxicity and attenuated research, experiment with the Beagle dogs and dog disease patterns, the research and development platform, peppermint oil liver toxicity mechanism research projects; Preside over or participate in a number of new drug pharmacology and toxicology research, including the treatment of endometriosis, antidepressant drugs, anti-aids drugs, etc., many times to participate in the international and domestic drug pharmacology and toxicology of academic conference, and published over 20 articles, SCI article 3, have rich experience in drug preclinical safety evaluation of research and management of GLP experience.

Central team

Central doctoral team

 

04 Equipment

       As one of the first batch of new drug safety evaluation institutions in south China, it has perfect environmental and safety electronic monitoring system, advanced pharmaceutical test equipment and equipment, with a total area of 4,000 square meters. Among them, there are 690 square meters of functional laboratory, 2422 square meters of animal laboratory, 416 square meters of office area and 472 square meters of auxiliary facilities. It can accommodate 960 SPF grade mice, 2160 SPF grade rats, 600 SPF grade guinea pigs, 172 ordinary rabbits, 308 ordinary dogs and 66 ordinary monkeys.

  

  

  

  

 

05 Instruments

       The center is equipped with nearly 400 pieces of instruments and equipment that meet the needs of research work. All the instruments and equipment have undergone 3Q verification, metrological verification or calibration as required. All the instruments and equipment are properly placed and maintained by special personnel. With Waters, mass spectrometer, Hitachi automatic biochemical analyzer (7100), DSI telemetry system large animal implantation and receiver, LeicaCV5030 automatic sealing machine, automatic + ST5020 dyeing machine, + fluorescence microscope image analysis system, multiple microscope, whole sealing automatic dewatering machine, fully automatic blood analyzer, automatic blood coagulation analyzer, automatic blood biochemical analyzer, animals with fully automatic blood cell analyzer, Molecular Devices Emax enzyme standard instrument, Waters 2695 liquid chromatograph and a large number of advanced instruments and equipment.

  

  

 

06 Experience in project

       In recent years, the center has conducted a total of 890 studies on pharmacological and toxicological evaluation of drugs for 104 domestic and international pharmaceutical r&d institutions (including 186 studies on pharmacodynamics, 673 studies on safety evaluation and 31 studies on pharmacokinetics), involving 74 traditional Chinese medicines, 127 chemical drugs and 20 biological drugs. Among them, 35 first-class innovative drugs (3 internationally first-class innovative drugs) and 25 famous and excellent reevaluated drugs have passed all levels of inspections and reviews. To undertake the national "15th", "11th" and "13th five-year" major new drug innovation projects; He presided over the secondary development and reevaluation of famous and excellent Chinese patent medicines, such as huatuo zaibao pill, xiaoke pill, shujin jianwaiwan pill, angong niuhuang pill, kid-nourishing pill, baoying powder, kouyanqing granule, danhong huayu oral liquid. It provides key technical support for biomedical research and development in south China and plays an important role in promoting national drug research and development.

 

07 Service project

The center has several experienced project leaders, who can design customized or standard research programs according to drug characteristics and customer needs, and carry out drug safety evaluation test studies under GLP conditions that meet the requirements of SFDA, FDA, OECD, ICH and other regulations and technical requirements. The main services are as follows:

Drug safety evaluation study

acute toxicity

long-term toxicity

safety pharmacology

local toxicity

immunogenicity

genetic toxicity

reproductive toxicity

research on toxicokinetics

other security evaluation,etc

 

Study on pharmacodynamic evaluation of drugs

anti-inflammatory immunity

diabetes and complications

cardiovascular and cerebrovascular diseases

digestive diseases

endocrine system diseases

● low tumor

experimental animal model research

pharmacodynamic evaluation of analgesia

 

Pharmacokinetic studies

Pharmacokinetics; Drug absorption, distribution, metabolism and excretion in vitro; In vivo pharmacokinetics

  study on drug time curve

  Research on bioavailability and bioequivalence

  Research on organizational distribution

  drug excretion test

  Study on drug metabolism in vivo and in vitro

  enzyme kinetics study of metabolic enzymes in vitro/enzyme inhibition study/based on drug metabolic enzyme interaction study

  Watson v software system for biological samples management and data management

  establishment and verification of biological analysis methods

  Analysis of toxicokinetic samples and kinetic parameters calculated by Winnolin

  Analysis of pharmacokinetic samples and kinetic parameters calculated by Winnolin

 

Contact:Ph.D Guo:(8620)66284078

亚洲中文字幕久久无码
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