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编1..docVIP

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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编1..doc

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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编1.

指导原则编号：【H】GCL4-1 化学药物和生物制品临床试验的生物统计学技术指导原则二○○五年三月目录一、概述···················································································································································1 二、整个临床试验的基本考虑··································································································1 (一)探索性试验和确证性试验·······························································································1 (二)观察指标····································································································································2 (三)偏倚的控制······························································································································4 三、试验设计中的基本考虑········································································································8 (一)试验设计的类型····················································································································8 (二)多中心试验·······························································································································10 (三)比较的类型·······························································································································10 (四)样本量········································································································································11 (五)资料的收集·····························································································································12 四、试验进行中的基本考虑······································································································12 (一)期中分析···································································································································12 (二)试验方案的修改···········································································································