Cao Li, Mathew Thomas
Department of Mathematics and Statistics, University of Maryland Baltimore County, 1000 Hilltop Circle, Baltimore, Maryland 21250, USA.
Biom J. 2008 Apr;50(2):205-11. doi: 10.1002/bimj.200710407.
For testing average bioequivalence, a simple test that improves upon the two-one sided test (TOST) is derived. The new test uses a critical value that is a non-increasing continuous function of the sample standard deviation, and the function is numerically obtained. Simulation results show that the resulting test performs well in terms of type I error probability; in particular, the test avoids the conservatism of the TOST. Consequently, the test provides better power compared to the TOST, especially when the variance becomes large. Numerical results also show that our test results in power that is very similar to the other improved tests available in the literature. An advantage of our improved test is that it is just as easy to carry out as the TOST. An example is used to illustrate the new test.
为了检验平均生物等效性,我们推导了一种改进双单侧检验(TOST)的简单检验方法。新检验使用的临界值是样本标准差的非增连续函数,该函数通过数值方法获得。模拟结果表明,所得检验在I型错误概率方面表现良好;特别是,该检验避免了TOST的保守性。因此,与TOST相比,该检验具有更高的检验效能,尤其是当方差变大时。数值结果还表明,我们的检验所得到的效能与文献中其他改进检验非常相似。我们改进检验的一个优点是,它与TOST一样易于实施。通过一个例子来说明这种新检验。