POWER OF THE 2 ONE-SIDED TESTS PROCEDURE IN BIOEQUIVALENCE

被引：104

作者：

PHILLIPS, KF

机构：

[1] Department of Clinical and Scientific Affairs, Pfizer Pharmaceuticals, New York, 10017

来源：

JOURNAL OF PHARMACOKINETICS AND BIOPHARMACEUTICS | 1990年 / 18卷 / 02期

关键词：

bioequivalence; hypothesis testing; power; sample size;

D O I：

10.1007/BF01063556

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The power of the two one-sided tests procedure for testing bioequivalence is derived from the bivariate noncentral t distribution. Power curves are shown and their use in planning bioequivalence experiments discussed. Sample sizes computed in the usual manner from an analysis of variance are shown to be too small to assure a declaration of bioequivalence except under favorable conditions. © 1990 Plenum Publishing Corporation.

引用

页码：137 / 144

页数：8

共 6 条

[1] A NEW STATISTICAL PROCEDURE FOR TESTING EQUIVALENCE IN 2-GROUP COMPARATIVE BIOAVAILABILITY TRIALS [J].