ABSTRACT

The two one-sided tests (TOST) procedure is widely applied for assessing bioequivalence between two different drugs in clinical studies. The same notion can be applied to construct TOST method for establishing dispersion equivalence. In addition to the TOST extension, a uniformly most power test (UMPT) for equivalence in variability has been described in the literature. This article presents analytic and numerical comparisons to clarify the limitation and strength of the two procedures. The UMPT approach has comparatively superior control of Type I errors and demands more involved computations than the TOST method. To enhance the utility of the recommended UMPT procedure, a full set of computer algorithms are constructed to implement the described hypothesis testing and power calculation. Optimal sample size determinations are also developed for planning equivalence designs under different allocation and cost concerns. The suggested procedures are demonstrated with the data regarding the dispersion comparability between two measuring devices of breaking strengths in dental medicine.

摘要

两个单侧测试 (TOST) 程序被广泛应用于评估临床研究中两种不同药物之间的生物等效性。相同的概念可以应用于构建用于建立色散等价的 TOST 方法。除了 TOST 扩展外，文献中还描述了可变性等效性的一致最大功率检验 (UMPT)。本文介绍了分析和数值比较，以阐明这两种程序的局限性和强度。UMPT 方法对 I 类错误具有相对优越的控制能力，并且比 TOST 方法需要更多的计算。为了增强推荐的 UMPT 程序的实用性，构建了一套完整的计算机算法来实现所描述的假设检验和功率计算。还开发了最佳样本量确定，用于在不同分配和成本问题下规划等效设计。建议的程序通过有关牙科医学中两种断裂强度测量装置之间的分散可比性的数据进行了证明。