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H-化学药物临床药代动力学研究技术指导原则 20070823.doc

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精品资料精品资料 PAGE / NUMPAGES 精品资料指导原则编号：【 H】G C L 1 - 2 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·····