生物学的同等性とバイオアベイラビリティのジャーナル

概要

Performance of Several Bioequivalence Metrics for Assessing the Rate and Extent of Absorption

Husam A. Bayoud and Adnan M. Awad

In this paper the problem of interest is the bioequivalence metrics and their role in assessing the rate and extent of absorption ratios of two drug formulations. Several bioequivalence metrics were proposed by several authors in the literature to estimate the similarity or dissimilarity of two drug formulations. The existing bioequivalence metrics are reviewed. A new bioequivalence metric is proposed and motivated. The performance, in terms of the statistical power, of the previously proposed and the new bioequivalence metrics is also evaluated by simulating cross-over bioequivalence trials.