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高变异药生物等效性切磋中的dafabet网页版估计

2018-11-01 12:03 [大发888真人] 来源于:未知
导读:【干者】 于永沛; 阎小妍; 姚早; 夏季结到来; 【Author】 YU Yong-pei;YAN Xiao-yan;YAO Chen;XIA Jie-lai;College of Military Preventive Medicine,Medical University of the Air Force;Peking University Clinical Research I

  【干者】

  于永沛;

  阎小妍;

  姚早;

  夏季结到来;

  【Author】

  YU Yong-pei;YAN Xiao-yan;YAO Chen;XIA Jie-lai;College of Military Preventive Medicine,Medical University of the Air Force;Peking University Clinical Research Institution;Peking University First Hospital;

  【机构】

  空军军医父亲学军事预备医学院保健统计学教养研室;

  北边京父亲学临床切磋所;

  北边京父亲学第壹防治所;

  【摘要】 参比制剂校阅的平分生物等效性(reference-scaled average bioequivalence,RSABE)是高变异药物生物等效性评价的要紧方法。RSABE的等效性界值与参比制剂的集儿子体内变异相干,其等效性界值是壹个遂机变量,故此无法经度过副单侧检验的效力函数终止dafabet黄金版估计。高变异药物RSABE的dafabet黄金版估计当前尚无公认方法,本文结合实例伸见了平分生物等效性(ABE)和高变异药RSABE切磋设计中对dafabet黄金版的考虑和dafabet黄金版的估计经过,为申办方和切磋者终止生物等效性切磋中供参考。更多恢骈

  【Abstract】 Reference-scaled average bioequivalence( RSABE) is the preferred alternative approach of average bioequivalence( ABE) for highly variable drugs. As the bioequivalence limit of RSABE is scaled by intra-subject coefficient of variance( CV) which is a random variable,the limit is not a constant,so that the sample size calculations based on the power function of Schuirmann’s two one-sided tests procedure is not applicable for RSABE approach recommended by FDA. Sample size was obtained by simulations in most current trials for highly variable drugs. Here the procedure of sample size estimation for ABE and RSABE was presented through examples to provide a reference to bioequivalence trials.更多恢骈

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