On Testing of Individual Bioequivalence
本文在正态性假设下给出了精确的α水平检验，证明2×3交叉设计足以评估个体生物等效性，并通过模拟和实例验证了所提方法。
Abstract Individual bioequivalence has received much attention in the recent literature. One wants to determine whether it is suitable for a given individual to switch formulations from a reference drug to a test drug. Some researchers have argued that the formulation means, subject-by-formulation interaction, and within-subject variances should be included in a single measurement of inequivalence, and due to the complexity of the hypotheses there is a need to use a 2 × 3 or even higher-order crossover design for studies of this type. In this article exact level-α tests are first provided under normality assumptions, and a 2 × 3 crossover design is shown to be sufficient for assessing individual bioequivalence. Some simulations for the proposed test and two examples are presented.