Assessing bioequivalence for highly variable drugs based on 3×3 crossover designs Park, Ji-Ae; Park, Sang-Gue;
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 crossover design and discusses it with the MFDS regulations. An illustrated example is also given.
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