A comparative study of some statistical procedures in establishing therapeutic equivalence of nonsystemic drugs with binary endpoints

被引：0

作者：

Tu D. ^{[1
]}

机构：

[1] Clinical Trials Group, National Cancer Institute of Canada, Queen's University, Kingston, Ontario K7L 3N6

来源：

Drug information journal : DIJ / Drug Information Association | 1997年 / 31卷 / 4期

关键词：

Binary endpoints; Hauck-Anderson corrections; Monte-Carlo simulations; Therapeutic equivalence; Two one-sided tests procedure;

D O I：

10.1177/009286159703100428

中图分类号：

学科分类号：

摘要：

Traditionally, the bioequivalence of a generic drug with the innovator's product is assessed by comparing their pharmacokinetic profiles determined from the blood or plasma concentration-time curves. This method may only be applicable to formulations where blood drug or metabolite levels adequately characterize absorption and metabolism, not to the nonsystematic drugs categorized by the lack of systemic presence. When pharmacologic effects of the drugs can be easily measured, pharmacodynamic effect studies can be used to assess the therapeutic equivalence of nonsystemic drugs. When analytical methods or other tests cannot be developed to permit the use of the pharmacodynamic method, therapeutic equivalence clinical trials to compare one or several clinical endpoints may be the only suitable method of establishing therapeutic equivalence. This paper evaluates by Monte-Carlo simulations the fixed sample performances of some two one-sided tests procedures when the endpoints of the therapeutic equivalence trials are binary. © 1997, Drug Information Association. All rights reserved.

引用

页码：1291 / 1300

页数：9

共 14 条

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