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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···········································································································
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