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¥ 5.0
内容物的内容………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………历史............................................................................................................................................................................... Scope……………………………………………………………………………………………………....7 Application Procedure…………………………………………………………………………………......8 General Requirements of the Dossier………………………………………………………………….......8 Data要求…………………………………………………………………… REGISTRATION…………………………………………………………………………………11 Data Requirements for Full Registration…………………………………………………………….......11 Part I - General Documents ……………………………………………………………………………………….. 11 Part II - Product Profile ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………药物作为原材料（质量，安全性和非临床方面）………………………………15 B.生物制剂的制造过程，质量，安全性，功效和非临床方面…….27 1.1一般考虑…………………………………………………………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
生物学注册指南...
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