Hauschke D, Steinijans V W, Diletti E
Department of Biometry, Byk Gulden Pharmaceuticals, Konstanz, Germany.
Int J Clin Pharmacol Ther Toxicol. 1992;30 Suppl 1:S37-43.
In bioequivalence assessment, the consumer risk of erroneously accepting bioequivalence is of primary concern. In order to control the consumer risk, the decision problem is formulated with bioinequivalence as hypothesis and bioequivalence as alternative. In the parametric approach, a split into two one-sided test problems and application of two-sample t-tests have been suggested. Rejection of both hypotheses at nominal alpha-level is equivalent to the inclusion of the classical (shortest) (1-2 alpha) 100%-confidence interval in the bioequivalence range. This paper demonstrates that the rejection of the two one-sided hypotheses at nominal alpha-level by means of nonparametric Mann-Whitney-Wilcoxon tests is equivalent to the inclusion of the corresponding distribution-free (1-2 alpha) 100%-confidence interval in the bioequivalence range. This distribution-free (nonparametric) approach needs weaker model assumptions and hence presents an alternative to the parametric approach.
在生物等效性评估中，错误接受生物等效性的消费者风险是首要关注的问题。为了控制消费者风险，决策问题被设定为以生物不等效性为原假设，生物等效性为备择假设。在参数方法中，有人建议将其拆分为两个单侧检验问题并应用双样本t检验。在名义α水平下同时拒绝两个原假设等同于将经典的（最短的）(1 - 2α)100%置信区间纳入生物等效性范围内。本文证明，通过非参数的曼 - 惠特尼 - 威尔科克森检验在名义α水平下拒绝两个单侧原假设等同于将相应的无分布(1 - 2α)100%置信区间纳入生物等效性范围内。这种无分布（非参数）方法需要较弱的模型假设，因此是参数方法的一种替代方法。
