Yee K F
Biometrics. 1986 Dec;42(4):961-5.
Methods are given for deriving the lower and upper bounds of the probabilities for rejecting bioequivalence. Except when two formulations are nearly equal, the lower and upper bounds become very close and thus give an exact probability. The methods can be used in two- or higher-way crossover or parallel groups designs. One can also determine the sample size from the equations. The results are compared with the probabilities obtained by simulation.
给出了推导拒绝生物等效性概率的下限和上限的方法。除非两种制剂几乎相等，下限和上限会变得非常接近，从而给出精确概率。这些方法可用于双向或更高阶交叉或平行组设计。也可以从这些方程中确定样本量。将结果与通过模拟获得的概率进行比较。
