DOI QR코드

DOI QR Code

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)
  • 투고 : 2020.07.27
  • 심사 : 2020.09.04
  • 발행 : 2020.11.30

초록

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.

키워드

참고문헌

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