Center for Early Safety Assessment
2014-07-21 23:14:12 Author:admin
Early Safety Assessment & Research Center
    Early safety assessment & research center is responsible for supporting drug discovery by developing key studies that include general toxicity, clinical pathology and toxicological pathology. Up to today, the center has accomplished Non-GLP safety assessments for a good number of 1.1-class new drugs internally developed. Meanwhile, the center maintains good relationship with domestic first-class GLP laboratories for scientific communication.
General toxicity laboratory
    This lab is capable of conducting Non-GLP toxicity studies for new drugs. Major studies include single-dose/repeat-dose toxicity study on rodent and non-rodent animals, special toxicity study(hypersensitivity experiment, hemolytic experiment and irritate experiment, etc.), toxicokinetics study on rodent and non-rodent animals, and  cardiovascular functions by DSI telemetry testing on awake dogs (under development).
Clinical pathology laboratory
    In this lab, aided by advanced equipment and professional technical staff, a complete range of clinical pathological index detection has been developed: hematology, coagulation, and biochemistry index detection and analysis. A series of modern instruments are equipped: Hitachi 7180 automated biochemical analyzer, Sysmex CA510 automated blood coagulation analyzer, Sysmex XT2000IV automated hematology analyzer.
Pathology laboratory
    This lab is responsible for many functions including necropsy in various kinds of animals, paraffin section, HE staining and special staining, immunohistochemistry, and image capturing and analysis, etc. Led by veteran pathologists, young pathologists and technicians are proficient in using a complete set of pathological equipment and provide pathological support for the pharmacodynamics department. Instruments are Leica RM2235 rotary microtome, Leica HI1220 flattening and Leica HI1210 waterbath, Leica EG1150H paraffin embedding station and EG1150C cold plate, Leica ASP300S automated vacuum tissue processor, Leica ST5020 automated slide stainer, Leica CV 5030 Coverslipper, Olympus BX41 and Nikon E200 light microscope and micropublisher 5.0 RTV imaging system.



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