Sample size determination in fixed-dose combination drug studies

被引：4
|
作者：
Sidik, K
Jonkman, JN
机构：
[1] Wyeth Res, Biometr Res, Princeton, NJ 08543 USA
[2] Mississippi State Univ, Dept Math & Stat, Mississippi State, MS 39762 USA
来源：
PHARMACEUTICAL STATISTICS | 2003年 / 2卷 / 04期
关键词：
binary response; combination drug; intersection-union test; min test;
D O I：
10.1002/pst.67
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
In this paper, the application of the intersection-union test method in fixed-dose combination drug studies is discussed. An approximate sample size formula for the problem of testing the efficacy of a combination drug using intersection-union tests is proposed. The sample sizes obtained from the formula are found to be reasonably accurate in terms of attaining the target power 1 - beta for a specified beta. Copyright (C) 2003 John Wiley Sons Ltd.
引用
收藏
页码：273 / 278
页数：6
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