On sample size calculation in bioequivalence trials

被引：91

作者：

Chow, SC

Wang, HS

机构：

[1] StatPlus Inc, Yardley, PA 19067 USA

[2] Univ Wisconsin, Dept Stat, Madison, WI 53706 USA

来源：

JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS | 2001年 / 28卷 / 02期

关键词：

crossover design; parallel design; normal distribution; lognormal distribution; log transformation; robust;

D O I：

10.1023/A:1011503032353

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Sample size calculation plays an important role in bioequivalence trials. In practice, a bioequivalence study is usually conducted under a crossover design or a parallel design with raw data or log-transformed data. In this paper, we discuss the differences in sample size calculation between a crossover design and a parallel design with raw data ol log-transformed data. Formulas for sample size calculation under a crossover design and a parallel design with raw data or log-transformed data are derived. A brief discussion for the relationship among these formulas is given.

引用

页码：155 / 169

页数：15

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