Preclinical safety assessment
  • Single-dose toxicity testing
    Single-dose toxicity experiments will be designed or customized by drug characteristics and customer demands and implemented under GLP conditions which meet CFDA regulations and technical specifications, to satisfy IND or NDA requirements. Animal species include mouse, rats, rabbit, dog, non-human primate and etc. Administration routes cover oral, skin,subcutaneous injection,intraperitoneal injection, intramuscular injection, intravenous injection and etc..
    Services Available:

       Dose exploratory test on rodent/non-rodent

       Single-dose toxicity test on rodent/non-rodent

  • Repeat-dose toxicity testing

    Repeat-dose toxicity experiments will be designed or customized by drug characteristics and customer demands and implemented under GLP conditions which meet CFDA regulations and technical specifications, to satisfy IND or NDA  requirements. Animal species include mouse, rat, rabbit, dog, non-human primate and etc.. Administration routes cover oral, skin, subcutaneous injection,intraperitoneal injection, intramuscular injection intravenous injection, and etc. Administration cycles contain 1 month, 3 months, 6 months and 9 months.

    Services Available:

      Dose exploratory test on rodent/non-rodent

      Repeat-dose toxicity test on rodent/non-rodent

      Repeate-dose toxicity test accompanied by toxicokinetics study on rodent/non-rodent

  • Reproductive and Developmental toxicity testing
    Reproductive toxicity study experiments are equipped with TOX IVOS analyzer II – sperm analyzer, E200MV biological microscope (NIKON) and other advanced reproductive toxicity study apparatus. Reproductive toxicity assessment experiments can be implemented under GLP conditions which meet CFDA regulations and technical specifications according to drug characteristics and customer demands.
    Services Available:

       Fertility and early embryonic development toxicity test I

       Embryo-fetal developmental toxicity test II

       Perinatal toxicity test III

  • Genetic toxicity testing
    According to the CFDA guidelines, the genetic toxicity laboratory can provide reliable preliminary screening experiments in mutagenicity and possibly carcinogenic induced by new drugs to meet application requirements of customers.
    Services Available:

       Ames experiments

       Chromosome aberration experiment of CHL cells in vitro

       Mouse bone marrow micronucleus experiment

       Mouse lymphoma cell experiment

  • Local toxicity testing

    Local toxicity tests under GLP conditions that meet the regulatory and technical requirements of CFDA can be carried out to meet the requirements of applying for clinical trials or going public.

    Services Available:

       Hemolysis test (in vitro and in vivo)

       Allergy tests (ASA, PCA, ACA, GPMT, BT, etc.)

       Stimulation test (vascular, muscle, skin, mucosa stimulation tests, etc.)

  • Immunogenic testing

    It was equipped with experienced researchers and advanced instruments (multi-functional enzyme labeling device, BD flow cytometer, etc.) to provide excellent solutions for the study of immunogenicity and immunotoxicity of biotechnological drugs.

    Services Available:

       Immunogenicity (drug-resistant antibody detection and testing indicators including neutralizing antibody, antibody titer, etc.)

       Immunological toxicity (routine indicators: white blood cell amount and classification count, globulin level test, lymphoid tissue, thymus,

       spleen histopathological examination; Special indexes: detection of lymphocyte subsets, cytokines, IgG, IgM, etc.) 

  • Safety pharmacological testing

    The safety pharmacology group is able to provide drug non-clinical safety pharmacological studies under GLP conditions that meet CFDA regulatory requirements. The species of animal group include mice, rats, rabbits, dogs, monkeys, etc.and the administration routes include oral, skin, intradermal, subcutaneous, intraperitoneal, intramuscular and intravenous injections.
    The laboratory is equipped with DSI physiological signal telemetry system for awake animals, MP150 polysomnography, the spontaneous activity analysis system, the HV-4 constant temperature perfusion system for isolated organs, ZRY-2D intelligent pyrometer, ZB - 200 RotaRod system, ZH-300B RotaRod system, RB-200 intelligent hot plate, shuttle test and step-through test video analysis system, YY - Ⅲ anesthesia machine, iM8B VET veterinary multi-parameter monitor.

    Services Available:

        Cardiovascular system safety pharmacology test

        Respiratory system safety pharmacological test

        Central nervous system safety pharmacology test

        Addition/supplement safety pharmacological test

  • Toxicokinetics testing

    The research purpose of toxicokinetics is to learn the systemic exposure degree and duration time of subjects in toxicity tests under different dose levels and predict the potential risk of subjects in human exposure. Toxicokinetics is one of the important research contents of non-clinical toxicity tests and the research emphasis is to explain toxicity test results and predict human safety, rather than a simple description of the basic parameters characteristics of pharmacokinetics.

    Services Available:

        PK/TK/BE (biological analysis)                                        Bioavailability

        Tissue distribution                                                           Excretion of bile, urine and feces

        Determination of plasma protein binding rate          Induction / inhibition of hepatic enzyme in vitro

        Detection of in vitro liver enzyme inducement / inhibition by preclinical or clinical studies commissioned by 

        biological samples

GLP Business Phone:027-65524591-8141
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