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 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.
Lim
Nam-Kyoo
NK
Information and Statistics, Daejon University, Daejon, 300-716, Korea.
Park
Sang-Gue
SG
Stanek
Ed
E
D003198:Computer Simulation; D016001:Confidence Intervals; D018592:Cross-Over Studies; D006801:Humans; D016018:Least-Squares Analysis; D008297:Male; D015233:Models, Statistical; D009369:Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data*; D012107:Research Design / Q000706:statistics & numerical data*; D013810:Therapeutic Equivalency