Bioequivalence trials with the incomplete 3 x 3 crossover design

In bioequivalence trials, one often considers two or more generic products with the original one. The 3 x 3 crossover design can be adopted to evaluate the two generic candidates with a brand name drug, rather than conducting two separate 2 x 2 crossover trials. Dropouts, however, are more likely to...

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Bibliographic Details
Published in:Biometrical journal 2005-10, Vol.47 (5), p.635-643
Main Authors: Lim, Nam-Kyoo, Park, Sang-Gue, Stanek, Ed
Format: Article
Language:English
Subjects:
Computer Simulation
Confidence Intervals
Cross-Over Studies
Humans
Least-Squares Analysis
Male
Models, Statistical
Neoplasms - drug therapy
Neoplasms - radiotherapy
Neoplasms - surgery
Randomized Controlled Trials as Topic - methods
Randomized Controlled Trials as Topic - statistics & numerical data
Research Design - statistics & numerical data
Therapeutic Equivalency
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Summary:In bioequivalence trials, one often considers two or more generic products with the original one. The 3 x 3 crossover design can be adopted to evaluate the two generic candidates with a brand name drug, rather than conducting two separate 2 x 2 crossover trials. Dropouts, however, are more likely to occur due to various administrative reasons when we consider a higher order crossover design. A modified method, which was originally given by Chow and Shao (1997), is extended to compare two generic products with a reference in the incomplete 3 x 3 crossover design. A simulation study and discussion are also presented.
ISSN:0323-3847
DOI:10.1002/bimj.200410144