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首页> 外文期刊>Statistics in medicine >Definition of individual bioequivalence: occasion-to-occasion versus mean switchability.
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Definition of individual bioequivalence: occasion-to-occasion versus mean switchability.

机译：个体生物等效性的定义：偶尔发生与平均可切换性之间的关系。

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摘要

Two moment-based scaled definitions of individual bioequivalence are discussed. Based on a mixed effects linear model, their evaluations respectively lead to an unweighted (theta(11)) and a parametric (theta(15)) metric. The two metrics are estimated with respect to study design and two estimation methods. Results show that the two IBE metrics perform equivalently in the fully replicated design. In the semi-replicated design, the definition of theta(11) may not be valid while the evaluation of theta(15) results in a reduction of the weights in the mean difference and switchability components of the metric. Percentage rejection rates in the latter design indicate that theta(11) is more conservative than theta(15). This is because there is an increase of about 15 per cent in the producer risk in theta(11) relative to theta(15) compared to a 7 per cent increase in the consumer risk in theta(15) relative to theta(11). A further disadvantage of the design is that there is a 33 per cent loss in the subject-by-treatment variance efficiency which is reflected in a similar amount of decreased sensitivity to departures from perfect bioequivalence even when more subjects are used to equalize the number of exposure occasions in the two designs. It is concluded that a mean switchability criterion may be more appropriate from an interpretability perspective, the bootstrap resampling method used to evaluate individual bioequivalence based on theta(11) may need to be bias-corrected and that the semi-replicated design should be used cautiously.
机译：讨论了两种基于矩的个体生物等效性的标度定义。基于混合效应线性模型，它们的评估分别得出未加权（theta（11））和参数（theta（15））度量。相对于研究设计和两种估计方法估计了两个指标。结果表明，两个IBE指标在完全复制的设计中具有同等的性能。在半复制设计中，theta（11）的定义可能无效，而theta（15）的评估导致度量的均值差和可切换性分量的权重降低。后一种设计中的拒绝百分率表明，theta（11）比theta（15）更保守。这是因为相对于theta（15），theta（11）的生产者风险增加了约15％，而相对于theta（11），theta（15）的消费者风险增加了7％。该设计的另一个缺点是，每个受试者的方差效率降低了33％，这反映出，即使使用更多的受试者来平衡完全生物等效性，其对偏离完美生物等效性的敏感度也会下降。两种设计都有曝光的场合。结论是，从可解释性的角度来看，平均可转换性标准可能更合适，用于基于theta（11）评估个体生物等效性的自举重采样方法可能需要进行偏差校正，并且应谨慎使用半复制设计。

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