化学药物制剂人体生物利用度和生物等效性研究技术指导原则

tangminsky

目      录
一、概述···················································································································································1
二、生物利用度和生物等效性基本概念及应用·····························································2
三、生物利用度和生物等效性研究方法··············································································4
四、生物利用度和生物等效性研究具体要求···································································6
（一）生物样本分析方法的建立和确证·····································································6
（二）实验设计与操作·········································································································11
（三）数据处理及统计分析······························································································17
（四）结果的评价···················································································································20
（五）临床报告内容··············································································································21
五、特殊制剂······································································································································22
（一）口服缓控释制剂········································································································22
（二）特殊活性成分制剂···································································································24
（三）复方制剂························································································································25
六、结语················································································································································25
七、名词解释······································································································································25
八、参考文献·····································································································································26
九、著者················································································································································28