Some issues in the design and analysis of equivalence trials

被引：0

作者：

Hauck, WW ^{[1
]}

Anderson, S ^{[1
]}

机构：

[1] Thomas Jefferson Univ, Div Clin Pharmacol, Biostat Sect, Philadelphia, PA 19107 USA

来源：

DRUG INFORMATION JOURNAL | 1999年 / 33卷 / 01期

关键词：

active control; bioequivalence; clinical equivalence; confidence intervals; intent-to-treat;

D O I：

暂无

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Given the number of approved drugs, it is increasingly the case that the comparison arm for a new drug or combination product is another drug or combination, that is, the trial uses an "active-control." Such active-controlled trials raise issues not seen in placebo-controlled trials. This note reviews and discusses some issues associated with the design and analysis of equivalence trials. Included are discussions of the choice of the equivalence allowance in designing the trial, and the roles of confidence intervals and intent-to-treat analyses.

引用

页码：109 / 118

页数：10

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