1.單次給藥毒性試驗(yàn) (Single-dose Toxicity Study)
1嚙齒類(lèi)動(dòng)物的單次給藥毒性試驗(yàn)(Single-dose toxicology in rodents)
非嚙齒類(lèi)動(dòng)物單次給藥毒性試驗(yàn)(Single-dose toxicology in non-rodents)
2.多次給藥毒性試驗(yàn)(Repeated-dose Toxicity Study)
實(shí)驗(yàn)物種包括:小鼠、大鼠、犬、非人靈長(zhǎng)類(lèi)動(dòng)物等(Species: mice, rats, canines, NHPs)
給藥途徑包括:經(jīng)口給藥、注射給藥、經(jīng)皮給藥等(Administration methods: oral, injection and percutaneous administration, etc. )
3.發(fā)育及生殖毒性試驗(yàn)(Reproductive and Developmental Toxicity Study)
生育力和早期胚胎發(fā)育毒性試驗(yàn)(I段)(Study of fertility and early embryonic development to implantation)
胚胎-胎仔發(fā)育毒性及母體功能試驗(yàn)(Ⅱ段)(Study for effects on embryo-fetal development)
圍產(chǎn)期發(fā)育毒性和母體功能試驗(yàn)(Ⅲ段)(待申報(bào))(Study for effects on pre-and postnatal development) (To be certified)
4.遺傳毒性試驗(yàn)(Genetic Toxicity Study)
AMES試驗(yàn)(AMES Test)
染色體畸變?cè)囼?yàn)(Chromosome aberration test)
微核試驗(yàn)(Micronucleus test)
5.局部毒性試驗(yàn)(Local Toxicity Test)
刺激性試驗(yàn)(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)
過(guò)敏性試驗(yàn)(主動(dòng)全身過(guò)敏、主動(dòng)皮膚過(guò)敏、被動(dòng)皮膚過(guò)敏、皮膚光過(guò)敏反應(yīng)) (Allergy test: active systemic anaphylaxis, active cutaneous anaphylaxis, passive cutaneous anaphylaxis, photosensitization test)
溶血性試驗(yàn)(Hemolysis test)
6.免疫原性試驗(yàn)(Immunogenicity test)
7.安全性藥理試驗(yàn)(大鼠、小鼠、犬、非人靈長(zhǎng)類(lèi)動(dòng)物)(Safety Pharmacology: rats, mice, canines, NHPs)
中樞神經(jīng)系統(tǒng):小鼠一般行為試驗(yàn)、小鼠自發(fā)活動(dòng)試驗(yàn)、小鼠轉(zhuǎn)棒試驗(yàn)、小鼠閾下催眠試驗(yàn)(Central Nervous System: general behavior test, spontaneous activities test, rotarod test, sodium pentobarbital-induced hypnosis activity test)
心血管系統(tǒng):給藥前后血壓、心電等(Cardiovascular system: change in blood and ECG before and after the dose)
呼吸系統(tǒng):給藥前后呼吸頻率、呼吸幅度(Respiratory system: change of respiratory rate and depth)
8.毒代動(dòng)力學(xué)試驗(yàn)(Toxicokinetics (TK) test)
9.致癌試驗(yàn)(待申報(bào))(Carcinogenicity test)(To be certified)