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

Sang-Gue Park, Seunghyo Kim, Ikjoon Choi
2020 Communications for Statistical Applications and Methods  
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
more » ... uitable 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. Keywords: average bioequivalence, 3 × 3 crossover design, 3 × 2 crossover design, missing at random, missing data
doi:10.29220/csam.2020.27.6.641 fatcat:vohaki5pifcgjlaq4kdoxr55o4