Guangzhou General Pharmaceutical Research Institute

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Click:3618 Date:2010-5-11 11:09:05

Pharmacology and Toxicology Services

Drug Non-clinical Evaluation Center of Guangzhou Institute of Pharmaceutical Industry
(The State key Lab. of Safety Evaluation on New Drug in Guangzhou )

Introduce

Drug Non-clinical Evaluation Center of Guangzhou Institute of Pharmaceutical Industry(The State key Lab. Of Safety Evaluation on New Drug in Guangzhou ) is one of the key state GLP laboratories in China, and this key state is approved by the State Food and Drug Administrations (SFDA), and being upgraded to US FDA GLP standards. The key state offers a full-range of in vivo and in vitro non-clinical safety evaluation programs. As the uniqueness of each product requires a case-by-case approach, we partner with clients to ensure that all study components meet specific program objectives. The key state is staffed with outstanding scientists, well trained technicians and staffs. GIPI has established a strategic partnership with a US company, NovaGloble Pharmaceuticals (www.ngpharm.com) to jointly provide Preclinical Drug Evaluation Services to US, Canada and EU biotechnology and pharmaceutical companies.

Joined Efforts to Provide Non-clinical Drug Safety
Evaluation CRO Services

NovaGlobe Pharmaceuticals and GPRI jointly provide non-clinical new drug safety evaluation services to US, Canada and EU biotechnology and pharmaceutical companies. NovaGlobe Pharmaceuticals is responsible for all activities of business development. NovaGlobe is also assisting non-clinical drug safety evaluation lab of GIPI to establish a FDA-compliant GLP quality system. Both partners will ensure that all operations and studies conducted in this lab fully would fully comply with FDA and EMEA regulatory requirements. Additionally, NovaGlobe will process and evaluate data and prepare study reports. GIPI is responsible for performing the studies on non-clinical new drug safety evaluation in its Guangzhou facility.

Study Componets

Wide Selection of Models
Various Routes of Administration:Dermal, Intraperitoneal, Intracardiac, Intraocular,
Intracranial, Oral, Intradermal, Subcutaneous, Intramuscular, Intravenous (bolus),
Intravenous (continuous infusion)
Clinical Pathology
Serum Chemistry, Hematology, Coagulation, Urinalysis
Anatomic Pathology
Histology/Histopathology, Paraffin/Plastic Sections, Immunohistochemistry
Additional Services
Model development
Study design development
GLP-compliant facilities
Dedicated, isolated study suites

Testing Services

Acute Toxicity (in vivo)
Range Finding
Up/Down
Limit Test
Maximum Tolerated Dose (MTD)
Fixed Dose
Local Tolerance
Repeat Exposure (in vivo)
Range Finding
Subacute/Subchronic/Chronic
Safety pharmacology
Genotoxicity (in vitro and in vivo)
In vitro Bacterial Mutagenicity
In vitro Mouse Lymphoma
In vitro Chromosomal Aberrations
In vivo Mouse Micronucleus
Tumorigenicity/Carcinogenicity
Blood and Tissue Sampling
Pharmacokinetics/Toxicokenitics
ADME

Immunotoxicity
Delayed-type Hypersensitivity
Immunogenicity/Anaphylaxis
Antibody Sampling

State-of-the-art facility will offer:
General Toxicology Services
Genotoxicity Services   
Safety Pharmacolody Services

Features include:
Integrated services – API synthesis to preclinical safety evaluation
38 animal rooms   
Dedicated client facilities   
Serum Chemistry
Hematology  
Coagulation   
Urinalysis

Laboratory Facilities:

Main Building of GIPI
Beagle dog R&D Center
Monkey rooms
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Drug Non-clinical Evaluation Center of Guangzhou Institute of Pharmaceutical Industry(The State key Lab. Of Safety Evaluation on New Drug in Guangzhou ) has constructed a mature toxicology facility in Guangzhou that, at 3,500 square meter. The facility will follow the “Guiding Principles in the use of nimals in Toxicology” and will operate to AAALAC standards and requirements.

Organization