[KSCI] Korea Science Citation Index Service

http://dx.doi.org/10.29220/CSAM.2020.27.6.641

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

Park, Sang-Gue (Department of Applied Statistics, Chung-Ang University)
Kim, Seunghyo (Department of Statistics, Graduate School of Chung-Ang University)
Choi, Ikjoon (Department of Pharmaceutical Industrial Management, Graduate School of Chung-Ang University)

Publication Information

Communications for Statistical Applications and Methods / v.27, no.6, 2020 , pp. 641-647 More about this Journal

Abstract

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.

Keywords

average bioequivalence; $3{\times}3$ crossover design; $3{\times}2$ crossover design; missing at random; missing data;

Citations & Related Records

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