A more powerful average bioequivalence analysis for the 22 crossover

被引:2
|
作者
Stefanescu, Catalina [1 ]
Mehrotra, Devan V. [2 ]
机构
[1] London Business Sch, London NW1 4SA, England
[2] Merck Res Labs, N Wales, PA USA
关键词
ANCOVA; bioequivalence; bootstrap; crossover trials;
D O I
10.1080/03610910701724045
中图分类号
O21 [概率论与数理统计]; C8 [统计学];
学科分类号
020208 ; 070103 ; 0714 ;
摘要
The 2 x 2 crossover is commonly used to establish average bioequivalence of two treatments. In practice, the sample size for this design is often calculated under a supposition that the true average bioavailabilities of the two treatments are almost identical. However, the average bioequivalence analysis that is subsequently carried out does not reflect this prior belief and this leads to a loss in efficiency. We propose an alternate average bioequivalence analysis that avoids this inefficiency. The validity and substantial power advantages of our proposed method are illustrated by simulations, and two numerical examples with real data are provided.
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页码:212 / 221
页数:10
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