1.單次給藥毒性試驗 (Single-dose Toxicity Study)
1嚙齒類動物的單次給藥毒性試驗(Single-dose toxicology in rodents)
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)
實驗物種包括：小鼠、大鼠、犬、非人靈長類動物等(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(Reproductive and Developmental Toxicity Study)
生育力和早期胚胎發(fā)育毒性試驗（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（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（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)
AMES試驗(AMES Test)
染色體畸變試驗(Chromosome aberration test)
微核試驗(Micronucleus test)
5.局部毒性試驗(Local Toxicity Test)
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)
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(yīng)) (Allergy test: active systemic anaphylaxis, active cutaneous anaphylaxis, passive cutaneous anaphylaxis, photosensitization test)
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)
中樞神經(jīng)系統(tǒng)：小鼠一般行為試驗、小鼠自發(fā)活動試驗、小鼠轉(zhuǎn)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)
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)
