摘要
在药物的第二、三阶段的临床试验时,药物的安全性和有效性是测验的主要指标。Hsu和Berger在药物各个剂量组的方差2σ都相等这一假设下,提出一种识别最小有效剂量的逐步置信区间方法。而方差齐性假设条件通常是不合理的,本文主要利用Stein两阶段抽样方法,给出方差无任何限制条件下识别最小有效剂量(MED)的逐步置信区间方法。
It is very important to be guaranteed that drug＇s safety and efficiency to the mankind in Phase II and III clinical trials. Recently Hsu and Berger （1999） proposed a stepwise confidence interval method in dose-finding of minimum effective dose （MED） for dose-response study under equal variances. This is often in doubt. A new way to find MED was proposed by employing the Stein＇s two-stage sampling method, the stepwise confidence procedure was proposed without any condition imposed on the variance. And the error rate is properly controlled.
出处
《药物评价研究》
CAS
2010年第1期58-62,共5页
Drug Evaluation Research
关键词
方差无限制
Stein两阶段抽样方法
逐步置信区间方法
no condition with variance
Stein＇s two-stage sampling method
stepwise confidence interval method
