Bioequivalence evaluation method of evaluating bioequivalence of a generic drug to the corresponding original drug

摘要

[Problem] There is provided a bioequivalence evaluation method not only of evaluating bioequivalence between an original drug and a corresponding generic drug but also of enabling to compare bioequivalence between generic drugs.;[Means of Solving the Problem] The bioequivalence between generic drugs is evaluated according to the Expression (1) wherein CCV_{Cmax g} stands for the calibration coefficient of variation of Cmax (the maximum blood concentration), CCV_{Tmax g} stands for the calibration coefficient of variation of Tmax (the time to maximum blood concentration), CCV_{T1/2 g} stands for the calibration coefficient of variation of the half-life (T_1/2), and CCV_{AUC g} stands for the calibration coefficient of variation of AUC (the blood concentration-area under the curve).