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样本量确定:乘法模型以及生物等效性范围为0.9至1.11和0.7至1.43的扩展表格

Sample size determination: extended tables for the multiplicative model and bioequivalence ranges of 0.9 to 1.11 and 0.7 to 1.43.

作者信息

Diletti E, Hauschke D, Steinijans V W

机构信息

Department of Biometry, Byk Gulden Pharmaceuticals, Konstanz, Germany.

出版信息

Int J Clin Pharmacol Ther Toxicol. 1992;30 Suppl 1:S59-62.

PMID:1601533
Abstract

For the two-period crossover design and a multiplicative model (logarithmic normal distribution) the decision procedure of choice is based on the inclusion of the shortest 90%-confidence interval for the ratio of expected medians for test and reference in the equivalence range. This inclusion rule is equivalent to the two one-sided tests procedure. Sample sizes based on the power of the latter have been given by Diletti et al. [1991] for an equivalence range of 0.8 to 1.25. Corresponding tables for the tighter equivalence range of 0.9 to 1.11 as well as for the wider range of 0.7 to 1.43 are given in this amendment.

摘要

对于两阶段交叉设计和乘法模型(对数正态分布),选择的决策程序基于将测试组与参照组预期中位数之比的最短90%置信区间纳入等效范围内。此纳入规则等同于双侧单侧检验程序。Diletti等人[1991年]给出了基于后者功效的样本量,其等效范围为0.8至1.25。本修订案给出了更严格的等效范围0.9至1.11以及更宽范围0.7至1.43的相应表格。

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