Assessing bioequivalence for highly variable drugs based on 3×3 crossover designs

Title & Authors
Assessing bioequivalence for highly variable drugs based on 3×3 crossover designs
Park, Ji-Ae; Park, Sang-Gue;

Abstract
Bioequivalence trials based on higher order crossover designs have recently been conducted for highly variable drugs since the Ministry of Korea Food and Drug Safety (MFDS) added new regulations in 2013 to widen bioequivalence limits for highly variable drugs. However, a statistical discussion of higher order crossover designs have not been discussed yet. This research proposes the statistical inference of bioequivalence based on $\small{3{\times}3}$ crossover design and discusses it with the MFDS regulations. An illustrated example is also given.
Keywords
bioequivalence;highly variable drugs;generic drug;original drug;$\small{3{\times}3}$ crossover design;
Language
Korean
Cited by
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