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On the use of 2×3 dual design in assessing bioequivalence model with carryover effect
Journal of the Korean Data & Information Science Society 2018;29:1565-74
Published online November 30, 2018
© 2018 Korean Data and Information Science Society.

Hwa Hyoung Woo1 · Sang-Gue Park2 · Woori Ko3

1College of General Education, Chung-Ang University
2Department of Applied Statistics, Chung-Ang University
3Department of Statistics, Graduate School of Chung-Ang University
Correspondence to: Professor, Department of Applied Statistics, Seoul 06974, Korea. E-mail: spark@cau.ac.kr
Received October 30, 2018; Revised November 16, 2018; Accepted November 16, 2018.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
A 2×2 crossover design is the traditional statistical design for assessing bioequivalence between original drug and generic drug. Recently 2×k higher crossover designs are getting popular for assessing the bioequivalence of highly variable drug. Higher order crossover designs allow inference of drug effect even in the presence of a carryover effect. 2×3 crossover design is preferred for economical and ethical reasons compared to 2×4 crossover design, and it provides the inference of drug effect effectively with carryover effect. An illustrated example is also discussed with standard on pharmaceutical equivalence study of MFDS.
Keywords : 2×3 dual design, bioequivalence assessment, carryover effect, generic drug, highly variable drug.