附件一9化学药物临床药代动力学研究技术指导原则.doc

化学药物临床药代动力学研究 技术指导原则 二○○五年三月 目 录 一、概述·························· ? 1 二、药代动力学研究生物样品分析方法的建立和确证·······2 （一）常用分析方法·····················2 （二）方法学确证·······················2 1、特异性···························3 2、标准曲线和定量范围····················3 3、定量下限·························4 4、精密度与准确度······················4 5、样品稳定性·······················5 6、提取回收率························5 7、微生物学和免疫学分析··················5 8、方法学质控························6 （三）分析数据的记录与保存·················6 1、方法建立与确认的数据··················7 2、样品分析的数据······················7 3、其他相关信息·······················7 三、药代动力学研究的具体内容·····