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1.µ¥´Î¸øÒ©¶¾ÐÔÊÔÑé (Single-dose Toxicity Study)

A£®Äö³ÝÀදÎïµÄµ¥´Î¸øÒ©¶¾ÐÔÊÔÑé(Single-dose toxicology in rodents)

B£®·ÇÄö³ÝÀදÎïµ¥´Î¸øÒ©¶¾ÐÔÊÔÑé(Single-dose toxicology in non-rodents)

2.¶à´Î¸øÒ©¶¾ÐÔÊÔÑé(Repeated-dose Toxicity Study)

A£®ÊµÑéÎïÖÖ°üÀ¨£ºÐ¡Êó¡¢´óÊó¡¢È®¡¢·ÇÈËÁ鳤ÀදÎïµÈ(Species: mice, rats, canines, NHPs)

B£®¸øҩ;¾¶°üÀ¨£º¾­¿Ú¸øÒ©¡¢×¢Éä¸øÒ©¡¢¾­Æ¤¸øÒ©µÈ(Administration methods: oral, injection and percutaneous administration, etc. )

3.·¢Óý¼°ÉúÖ³¶¾ÐÔÊÔÑé(Reproductive and Developmental Toxicity Study)

A£®ÉúÓýÁ¦ºÍÔçÆÚÅßÌ¥·¢Óý¶¾ÐÔÊÔÑ飨I¶Î£©(Study of fertility and early embryonic development to implantation)

B£®ÅßÌ¥-Ì¥×з¢Óý¶¾ÐÔ¼°Ä¸Ì幦ЧÊÔÑ飨¢ò¶Î£©(Study for effects on embryo-fetal development)

C£®Î§²úÆÚ·¢Óý¶¾ÐÔºÍĸÌ幦ЧÊÔÑ飨¢ó¶Î£©£¨´ýÉ걨£©(Study for effects on pre-and postnatal development) (To be certified)

4.ÒÅ´«¶¾ÐÔÊÔÑé(Genetic Toxicity Study)

A£®AMESÊÔÑé(AMES Test)

B£®È¾É«Ìå»û±äÊÔÑé(Chromosome aberration test)

C£®Î¢ºËÊÔÑé(Micronucleus test)

5. ¾Ö²¿¶¾ÐÔÊÔÑé(Local Toxicity Test)

A£®´Ì¼¤ÐÔÊÔÑ飨Ѫ¹Ü´Ì¼¤¡¢¼¡Èâ´Ì¼¤¡¢Æ¤·ô´Ì¼¤¡¢Õ³Ä¤´Ì¼¤¡¢Æ¤·ô¸øÒ©¹â¶¾ÐÔ£©(Irritation test: venous stimulation test, muscle stimulation test, skin irritation test, mucosa irritation test and photo toxicity test)

B£®¹ýÃôÐÔÊÔÑé(×Ô¶¯È«Éí¹ýÃô¡¢×Ô¶¯Æ¤·ô¹ýÃô¡¢±»¶¯Æ¤·ô¹ýÃô¡¢Æ¤·ô¹â¹ýÃô·´Ó¦) (Allergy test: active systemic anaphylaxis, active cutaneous anaphylaxis, passive cutaneous anaphylaxis, photosensitization test)

C£®ÈÜѪÐÔÊÔÑé(Hemolysis test)

6. ÃâÒßÔ­ÐÔÊÔÑé(Immunogenicity test)

7. Çå¾²ÐÔÒ©ÀíÊÔÑ飨´óÊó¡¢Ð¡Êó¡¢È®¡¢·ÇÈËÁ鳤ÀදÎ(Safety Pharmacology: rats, mice, canines, NHPs)

A£®ÖÐÊàÉñ¾­ÏµÍ³£ºÐ¡ÊóÒ»Ñùƽ³£ÐÐΪÊÔÑ顢СÊó×Ô¾õ»î¶¯ÊÔÑ顢СÊóת°ôÊÔÑ顢СÊóãÐÏ´ßÃßÊÔÑé(Central Nervous System: general behavior test, spontaneous activities test, rotarod test, sodium pentobarbital-induced hypnosis activity test)

B£®ÐÄѪ¹Üϵͳ£º¸øÒ©Ç°ºóѪѹ¡¢ÐĵçµÈ(Cardiovascular system: change in blood and ECG before and after the dose)

C£®ºôÎüϵͳ£º¸øÒ©Ç°ºóºôÎüƵÂÊ¡¢ºôÎü·ù¶È(Respiratory system: change of respiratory rate and depth)

8. ¶¾´ú¶¯Á¦Ñ§ÊÔÑé(Toxicokinetics (TK) test)

9.Ö°©ÊÔÑ飨´ýÉ걨£©(Carcinogenicity test)(To be certified)

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