Bioequivalence Trials with the Incomplete 3 × 3 Crossover Design

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

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Veröffentlicht in:Biometrical journal 2005-10, Vol.47 (5), p.635-643
Hauptverfasser: Lim, Nam-Kyoo, Park, Sang-Gue, Stanek, Ed
Format: Artikel
Sprache:eng
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Zusammenfassung:In bioequivalence trials, one often considers two or more generic products with the original one. The 3 × 3 crossover design can be adopted to evaluate the two generic candidates with a brand name drug, rather than conducting two separate 2 × 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 × 3 crossover design. A simulation study and discussion are also presented. (© 2005 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)
ISSN:0323-3847
1521-4036
DOI:10.1002/bimj.200410144