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首页> 外文期刊>European journal of pharmaceutical sciences >Geometric mean ratio-dependent scaled bioequivalence limits with leveling-off properties.
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Geometric mean ratio-dependent scaled bioequivalence limits with leveling-off properties.

机译：具有平整特性的几何平均比率依赖性比例生物等效性限值。

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In this study, novel approaches for the design of bioequivalence (BE) limits are developed. The new BE limits scale with intrasubject variability but only until a geometric mean ratio (GMR)-dependent plateau value and combine the classic (0.80-1.25) and expanded (0.70-1.43) BE limits into a single criterion. Plots of the extreme GMR values accepted as a function of coefficient of variation (CV) have a convex shape, similar to the classic unscaled 0.80-1.25 limits. The performance of the novel approaches in comparison to the classic unscaled 0.80-1.25 limits as well as the two expanded BE limits, i.e., 0.70-1.43 and 0.75-1.33 was assessed using simulated data. Two-period crossover BE investigations with 12, 24 or 36 subjects were simulated with assumptions of CV 10%, 20%, 30% or 40%. At low CV values, the performance of the novel BE limits is almost identical to the 0.80-1.25 criterion. On the contrary, the expanded BE limits are very permissive even at high GMR values. For high CV% values (30% and 40%), the new BE limits show a much greater probability of declaring BE when GMR = 1 in comparison to the classic 0.80-1.25 limits. In addition, when the drug products differ more than 25%, the new BE limits show much lower percentage of acceptance than the expanded 0.70-1.43 limits. One of the major advantages of the new BE limits is their gradual expansion with variability until a GMR-dependent plateau value. Finally, the continuity and leveling-off properties of the new BE limits make them suitable for the assessment of BE studies, irrespective of the level of variability encountered.
机译：在这项研究中，开发了设计生物等效性（BE）限值的新颖方法。新的BE限制标度具有受试者内部的可变性，但仅在几何平均比率（GMR）依赖的平稳值之前，并将经典（0.80-1.25）和扩展（0.70-1.43）的BE限制合并为一个标准。接受的最大GMR值作为变异系数（CV）的函数图具有凸形，类似于经典的未缩放0.80-1.25限制。使用模拟数据评估了新方法与经典的未缩放的0.80-1.25限值以及两个扩展的BE限值相比的性能，即0.70-1.43和0.75-1.33。在CV为10％，20％，30％或40％的假设下，模拟了12、24或36位受试者的两期交叉BE调查。在低CV值下，新型BE限值的性能几乎与0.80-1.25的标准相同。相反，即使在高GMR值下，扩展的BE限值也是非常宽松的。对于较高的CV％值（30％和40％），与经典的0.80-1.25限值相比，新的BE限值在GMR = 1时声明BE的可能性更大。此外，当药品差异超过25％时，新的BE限值显示出比接受的0.70-1.43限值低得多的接受百分比。新的BE限值的主要优点之一是它们具有可变性的逐渐扩展，直至达到GMR依赖性的稳定值为止。最后，新的BE限值的连续性和平稳特性使其适合于BE研究的评估，而不论遇到的变异程度如何。

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