Montague Timothy H, Potvin Diane, Diliberti Charles E, Hauck Walter W, Parr Alan F, Schuirmann Donald J
GlaxoSmithKline, Inc., King of Prussia, PA, USA.
Pharm Stat. 2012 Jan-Feb;11(1):8-13. doi: 10.1002/pst.483. Epub 2011 Feb 10.
In 2008, this group published a paper on approaches for two-stage crossover bioequivalence (BE) studies that allowed for the reestimation of the second-stage sample size based on the variance estimated from the first-stage results. The sequential methods considered used an assumed GMR of 0.95 as part of the method for determining power and sample size. This note adds results for an assumed GMR = 0.90. Two of the methods recommended for GMR = 0.95 in the earlier paper have some unacceptable increases in Type I error rate when the GMR is changed to 0.90. If a sponsor wants to assume 0.90 for the GMR, Method D is recommended. Copyright © 2011 John Wiley & Sons, Ltd.
2008年，该团队发表了一篇关于两阶段交叉生物等效性（BE）研究方法的论文，该方法允许根据第一阶段结果估计的方差重新估计第二阶段的样本量。所考虑的序贯方法使用假设的几何均值比（GMR）为0.95作为确定检验效能和样本量方法的一部分。本注释补充了假设GMR = 0.90时的结果。早期论文中推荐的GMR = 0.95的两种方法，当GMR变为0.90时，第一类错误率会有一些不可接受的增加。如果申办者想假设GMR为0.90，推荐方法D。版权所有© 2011约翰威立父子有限公司。
