Endrenyi L, Fritsch S, Yan W
University of Toronto, Department of Pharmacology, Ontario, Canada.
Int J Clin Pharmacol Ther Toxicol. 1991 Oct;29(10):394-9.
In bioequivalence studies, the maximum concentration (Cmax) is shown to reflect not only the rate but also the extent of absorption. Cmax is highly correlated with the area under the curve (AUC) contrasting blood concentration with time. Therefore, use of the Cmax/AUC ratio is recommended for assessing the equivalence of absorption rates. The ratio is independent of both intrasubject variations and possible differences in the extent of absorption and reflects only the contrast between the absorption and disposition rate constants (ka/k).
在生物等效性研究中,最大浓度(Cmax)不仅反映吸收速率,还反映吸收程度。Cmax与血药浓度-时间曲线下面积(AUC)高度相关。因此,建议使用Cmax/AUC比值来评估吸收速率的等效性。该比值不受个体内变异以及吸收程度可能存在的差异的影响,仅反映吸收速率常数与处置速率常数之间的对比(ka/k)。