买双色球还是7星彩 www.dphxdv.com.cn Dose exploratory test on rodent/non-rodent
Single-dose toxicity test on rodent/non-rodent
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.
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
Fertility and early embryonic development toxicity test I
Embryo-fetal developmental toxicity test II
Perinatal toxicity test III
Chromosome aberration experiment of CHL cells in vitro
Mouse bone marrow micronucleus experiment
Mouse lymphoma cell experiment
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.
Hemolysis test (in vitro and in vivo)
Allergy tests (ASA, PCA, ACA, GPMT, BT, etc.)
Stimulation test (vascular, muscle, skin, mucosa stimulation tests, etc.)
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.
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.)
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.
Cardiovascular system safety pharmacology test
Respiratory system safety pharmacological test
Central nervous system safety pharmacology test
Addition/supplement safety pharmacological test
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.
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