化学药物制剂人体生物利用度和生物等效性研究

《化学药物制剂人体生物利用度和生物等效性研究》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

1、指导原则编号：【H】GCL2-1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二○○五年三月目录一、概述···················································································································································1二、生物利用度和生物等效性基本概念及应用·······················································

2、······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

3、）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················································

4、···································································20（五）临床报告内容··············································································································21五、特殊制剂···················································································

5、···················································22（一）口服缓控释制剂········································································································22（二）特殊活性成分制剂···································································································

6、24（三）复方制剂························································································································25六、结语················································································································································

7、25七、名词解释······································································································································25八、参考文献·································································································································

8、····26九、著者·····································