安全性研究评价

安全性研究评价服务(Drug Safety Evaluation Service)

安全性研究评价服务(Drug Safety Evaluation Service)

一般毒理学研究、刺激、过敏、溶血试验、发育及生殖毒理学、遗传毒性、免疫毒性研究、安全药理研究、毒代动力学研究。

1.单次给药毒性试验 (Single-dose Toxicity Study)

A.啮齿类动物的单次给药毒性试验(Single-dose toxicology in rodents)

B.非啮齿类动物单次给药毒性试验(Single-dose toxicology in non-rodents)

2.多次给药毒性试验(Repeated-dose Toxicity Study)

A.实验物种包括:小鼠、大鼠、犬、非人灵长类动物等(Species: mice, rats, canines, NHPs)

B.给药途径包括:经口给药、注射给药、经皮给药等(Administration methods: oral, injection and percutaneous administration, etc. )

3.发育及生殖毒性试验(Reproductive and Developmental Toxicity Study)

A.生育力和早期胚胎发育毒性试验(I段)(Study of fertility and early embryonic development to implantation)

B.胚胎-胎仔发育毒性及母体功能试验(Ⅱ段)(Study for effects on embryo-fetal development)

C.围产期发育毒性和母体功能试验(Ⅲ段)(待申报)(Study for effects on pre-and postnatal development) (To be certified)

4.遗传毒性试验(Genetic Toxicity Study)

A.AMES试验(AMES Test)

B.染色体畸变试验(Chromosome aberration test)

C.微核试验(Micronucleus test)

5. 局部毒性试验(Local Toxicity Test)

A.刺激性试验(血管刺激、肌肉刺激、皮肤刺激、粘膜刺激、皮肤给药光毒性)(Irritation test: venous stimulation test, muscle stimulation test, skin irritation test, mucosa irritation test and photo toxicity test)

B.过敏性试验(主动全身过敏、主动皮肤过敏、被动皮肤过敏、皮肤光过敏反应) (Allergy test: active systemic anaphylaxis, active cutaneous anaphylaxis, passive cutaneous anaphylaxis, photosensitization test)

C.溶血性试验(Hemolysis test)

6. 免疫原性试验(Immunogenicity test)

7. 安全性药理试验(大鼠、小鼠、犬、非人灵长类动物)(Safety Pharmacology: rats, mice, canines, NHPs)

A.中枢神经系统:小鼠一般行为试验、小鼠自发活动试验、小鼠转棒试验、小鼠阈下催眠试验(Central Nervous System: general behavior test, spontaneous activities test, rotarod test, sodium pentobarbital-induced hypnosis activity test)

B.心血管系统:给药前后血压、心电等(Cardiovascular system: change in blood and ECG before and after the dose)

C.呼吸系统:给药前后呼吸频率、呼吸幅度(Respiratory system: change of respiratory rate and depth)

8. 毒代动力学试验(Toxicokinetics (TK) test)

9.致癌试验(待申报)(Carcinogenicity test)(To be certified)