Individual Bioequivalence Tests under 3 X 2 Design Jung, Gyu-Jin; Lim, Nam-Kyoo; Park, Sang-Gue;
In recent years, more generic drug products became available. The current regulation for assessing the bioequivalence of two drug formulations is based on the concept of average bioequivalence. This approach has been indicated to be insufficient for assessing switchability between two drug formulations and US FDA has adopted individual bioequivalence as one of the bioequivalence criterion since 2001. The US FDA recommends that individual bioequivalence be assessed based on crossover design, while a crossover design may be used as an alternative design to reduce the length and cost of the study. In this paper, a statistical procedure for assessment of individual bioequivalence under crossover designs is proposed and some statistical points are discussed with crossover design and extra-reference design through simulation studies.