Bioequivalence trial with two generic drugs in 2 × 3 crossover design with missing data

The 2 × 3 crossover design, a modified version of the 3 × 3 crossover design, is considered to compare the bioavailability of two generic candidates with a reference drug.The 2 × 3 crossover design is more economically favorable due to decrease in the number of sequences, rather than conducting a 3×3 crossover trial or two separate 2 × 2 crossover trials.However, when using a higher-order crossover trial, the risk of drop-outs and withdrawals of subjects increases, so the suitable statistical inferences for missing data is needed.The bioequivalence model of a of 2 × 3 crossover trial with missing data is defined and the statistical procedures of assessing bioequivalence is proposed.An illustrated example of the 2 × 3 trial with missing data is also presented with discussion.