Saperstein S, Edgren R A, Lee G J, Jung D, Fratis A, Kushinsky S, Mroszczak E, Dorr A
Syntex Laboratories, Inc., Palo Alto, CA.
Contraception. 1989 Nov;40(5):581-90. doi: 10.1016/0010-7824(89)90130-3.
Two oral contraceptive drugs, Formulation A and Formulation B, both of similar hormonal content, were compared with each other to determine if they were bioequivalent. Both drugs contain 1 mg of norethindrone (NET) and 0.035 mg of ethinyl estradiol (EE). Application of an interval test for the ratio of the computed parameter means demonstrated equivalence for the two formulations with respect to the 0-24 hour area under the plasma level versus time curve (AUC24), the total area under the curve (AUCtot) and for the maximum plasma concentration (Cmax) for both ethinyl estradiol and norethindrone. The data support the hypothesis for bioequivalence of the two formulations with respect to total absorption.
两种口服避孕药制剂A和制剂B，激素含量相似，对它们进行比较以确定是否生物等效。两种药物均含有1毫克炔诺酮（NET）和0.035毫克炔雌醇（EE）。对计算出的参数均值之比进行区间检验表明，两种制剂在血浆水平-时间曲线下0至24小时的面积（AUC24）、曲线下总面积（AUCtot）以及炔雌醇和炔诺酮的最大血浆浓度（Cmax）方面具有等效性。数据支持两种制剂在总吸收方面生物等效的假设。
