400-6699-117转1000
您好,欢迎您查看分析测试百科网,请问有什么帮助您的?
分析测试百科网 认证会员,请放心拨打!
参考报价: | 面议 | 型号: | 安全性研究评价服务(Drug Safety Evaluation Service) |
品牌: | 科斯莫生物 | 产地: | 天津 |
关注度: | 3 | 信息完整度: | |
样本: | 典型用户: | 暂无 |
400-6699-117转1000
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)
安全性研究评价服务(Drug Safety Evaluation Service)信息由天津科斯莫生物技术有限公司为您提供,如您想了解更多关于安全性研究评价服务(Drug Safety Evaluation Service)报价、型号、参数等信息,欢迎来电或留言咨询。
注:该产品未在中华人民共和国食品药品监督管理部门申请医疗器械注册和备案,不可用于临床诊断或治疗等相关用途