| 摘要 |
<p>Provided is a method of evaluating biological equivalence whereby not only the biological equivalence between an original drug and a generic drug can be evaluated but also generic drugs can be compared with each other regarding the biological equivalence thereof. The biological equivalence between generic drugs is evaluated in accordance with formula (1). (1) (In formula (1), CCVCmax g stands for the calibration coefficient of variation of the maximum blood concentration, CCVTmax g stands for the calibration coefficient of variation of Cmax (the time to reach the maximum blood concentration), CCVT1/2 g stands for the calibration coefficient of variation of the half-life (T1/2), and CCVAUC g stands for the calibration coefficient of variation of AUC (the area under the (blood concentration - time) curve).</p> |
