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An alternative definition of individual bioequivalence

机译：个体生物等效性的另一种定义

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Several definitions of individual bioequivalence of two formulations of a medical treatment (drug) have been proposed recently. These definitions attempt to adapt the criterion of average bioequivalence, which would be deficient if substantive treatment heterogeneity were present. In some of the proposed definitions, relatively large differences of means can be compensated by differences in the measurement-error variances. We propose a definition based on a simple latent-variable model which overcomes this anomaly and need not involve the U.S. Food and Drug Administration's 80/125 rule. Our approach is based on a moment-matching estimator of the discrepancy between the outcomes underlying the subjects' responses. The distribution of this estimator is a linear combination of independent χ2 variates; asymptotically, it can be approximated by a normal distribution. Evidence of individual bioequivalence corresponds to rejecting the hypothesis that the discrepancy is greater than a specified threshold. The approach is illustrated by reanalysing two bioequivalence trials.
机译：最近已经提出了两种治疗药物（药物）的个体生物等效性的几种定义。这些定义试图适应平均生物等效性的标准，如果存在实质性治疗异质性，这将是不足的。在某些建议的定义中，均值的较大差异可以通过测量误差方差的差异来补偿。我们提出了一个基于简单潜在变量模型的定义，该模型克服了这一异常现象，并且无需涉及美国食品药品监督管理局的80/125规则。我们的方法是基于受试者匹配结果之间差异的矩匹配估计。该估计量的分布是独立的χ2变量的线性组合；渐近地，可以用正态分布来近似。个体生物等效性的证据对应于否定差异大于指定阈值的假设。通过重新分析两个生物等效性试验来说明该方法。

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