安全性研究評價服務(Drug Safety Evaluation Service)

1.單次給藥毒性試驗 (Single-dose Toxicity Study)
A.嚙齒類動物的單次給藥毒性試驗(Single-dose toxicology in rodents)
B.非嚙齒類動物單次給藥毒性試驗(Single-dose toxicology in non-rodents)
2.多次給藥毒性試驗(Repeated-dose Toxicity Study)
A.實驗物種包括:小鼠、大鼠、犬、非人靈長類動物等(Species: mice, rats, canines, NHPs)
B.給藥途徑包括:經口給藥、注射給藥、經皮給藥等(Administration methods: oral, injection and percutaneous administration, etc. )
3.發育及生殖毒性試驗(Reproductive and Developmental Toxicity Study)
A.生育力和早期胚胎發育毒性試驗(I段)(Study of fertility and early embryonic development to implantation)
B.胚胎-胎仔發育毒性及母體功能試驗(Ⅱ段)(Study for effects on embryo-fetal development)
C.圍產期發育毒性和母體功能試驗(Ⅲ段)(待申報)(Study for effects on pre-and postnatal development) (To be certified)
4.遺傳毒性試驗(Genetic Toxicity Study)
A.AMES試驗(AMES Test)
B.染色體畸變試驗(Chromosome aberration test)
C.微核試驗(Micronucleus test)
5. 局部毒性試驗(Local Toxicity Test)
A.刺激性試驗(血管刺激、肌肉刺激、皮膚刺激、粘膜刺激、皮膚給藥光毒性)(Irritation test: venous stimulation test, muscle stimulation test, skin irritation test, mucosa irritation test and photo toxicity test)
B.過敏性試驗(主動全身過敏、主動皮膚過敏、被動皮膚過敏、皮膚光過敏反應) (Allergy test: active systemic anaphylaxis, active cutaneous anaphylaxis, passive cutaneous anaphylaxis, photosensitization test)
C.溶血性試驗(Hemolysis test)
6. 免疫原性試驗(Immunogenicity test)
7. 安全性藥理試驗(大鼠、小鼠、犬、非人靈長類動物)(Safety Pharmacology: rats, mice, canines, NHPs)
A.中樞神經系統:小鼠一般行為試驗、小鼠自發活動試驗、小鼠轉棒試驗、小鼠閾下催眠試驗(Central Nervous System: general behavior test, spontaneous activities test, rotarod test, sodium pentobarbital-induced hypnosis activity test)
B.心血管系統:給藥前后血壓、心電等(Cardiovascular system: change in blood and ECG before and after the dose)
C.呼吸系統:給藥前后呼吸頻率、呼吸幅度(Respiratory system: change of respiratory rate and depth)
8. 毒代動力學試驗(Toxicokinetics (TK) test)
9.致癌試驗(待申報)(Carcinogenicity test)(To be certified)


蘇州華測