Chow Shein-Chung, Shao Jun, Wang Hansheng
Statplus Inc, Heston Hall, Suite 206, 1790 Yardley-Langhorne Road, Yardley, PA 19067, USA.
Stat Med. 2003 Jan 15;22(1):55-68. doi: 10.1002/sim.1345.
A statistical test is proposed for in vitro bioequivalence testing between drug products such as nasal aerosols and nasal sprays. The proposed test generalizes the one recommended in the FDA 1999 guidance to the situation where replicated observations obtained from each sampled canister or bottle of the drug product are available. The technique developed by Hyslop, Hsuan and Holder is used so that the proposed test is asymptotically accurate. The type I error probability and power of the proposed test are investigated through a simulation study. A method for determining the required sample size to achieve a desired power is also proposed. A numerical example is given for illustration.
提出了一种用于鼻用气雾剂和鼻喷雾剂等药品体外生物等效性测试的统计检验方法。所提出的检验方法将美国食品药品监督管理局（FDA）1999年指南中推荐的方法推广到了这样一种情形：从药品的每个采样罐或瓶中获得了重复观测值。采用了由希斯洛普、宣和霍尔德开发的技术，以使所提出的检验在渐近意义上是准确的。通过模拟研究考察了所提出检验的I型错误概率和功效。还提出了一种确定达到期望功效所需样本量的方法。给出了一个数值例子进行说明。
