H-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 20070823.docVIP

精品资料 精品资料 PAGE / NUMPAGES 精品资料 指导原则编号： 【 H】G C L 2 - 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 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··········································································