The bootstrap procedure in individual bioequivalence

作     者：Shao, J Chow, SC Wang, B 

作者机构：Univ Wisconsin Dept Stat Madison WI 53706 USA StatPlus Inc Yardley PA 19067 USA Merck & Co Inc Blue Bell PA 19422 USA 

出 版 物：《STATISTICS IN MEDICINE》 (医学统计学)

年 卷 期：2000年第19卷第20期

页      面：2741-2754页

核心收录：

学科分类：0710[理学-生物学] 1004[医学-公共卫生与预防医学(可授医学、理学学位)] 1001[医学-基础医学(可授医学、理学学位)] 0714[理学-统计学（可授理学、经济学学位）] 10[医学] 

主　　题：Models Statistical Therapeutic Equivalency Drugs Generic 模型 统计学 治疗等效 Sketches Pharmaceutical Preparations bootstrapping METHOD OF MOMENTS Generic Drugs Therapeutic Equivalency Testing Procedures Guidance United States Food and Drug Administration 

摘      要：A bootstrap-type hypothesis test procedure for assessing individual (or population) bioequivalence between two drug formulations is suggested in a draft guidance from the United States Food and Drug Administration (FDA). The purpose of this article is to study the unknown properties of this test procedure and propose some improved test procedures. We find that: the FDA s bootstrap computation is not correct;the power of the FDA s test can be very low;the use of the REML method suggested in the draft guidance does not have any advantage over the use of simpler methods such as the moment method;and the method of sample size determination in the draft guidance is inappropriate. We study the size and power of different bootstrap test procedures and suggest a method for sample size determination. It is our hope that this article will draw some attention to further research in this area, and eventually a satisfactory statistical method can be implemented for assessing individual (or population) bioequivalence. Copyright (C) 2000 John Wiley & Sons, Ltd.