生物等效性试验中的样本量计算
On sample size calculation in bioequivalence trials.
作者信息
Chow S C, Wang H
机构信息
StatPlus, Inc., 1790 Yardley-Langhorne Road, Yardley, Pennsylvania 19067, USA.
出版信息
J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.
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 or 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.
样本量计算在生物等效性试验中起着重要作用。在实际操作中,生物等效性研究通常在交叉设计或平行设计下进行,使用原始数据或对数转换后的数据。在本文中,我们讨论了交叉设计与使用原始数据或对数转换后的数据的平行设计在样本量计算方面的差异。推导了交叉设计以及使用原始数据或对数转换后的数据的平行设计下的样本量计算公式。并对这些公式之间的关系进行了简要讨论。