化学药物临床药代动力学研究技术指导原则_2005.pdf

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1、指导原则编号：【H】GCL1-2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、···············································································································2（二）方法学确证······················································································································21、特异性···································

3、···································································································32、标准曲线和定量范围······································································································33、定量下限···························································

4、······································································44、精密度与准确度·················································································································45、样品稳定性··············································································

5、·············································56、提取回收率··························································································································57、微生物学和免疫学分析···························································································

6、····58、方法学质控··························································································································6（三）分析数据的记录与保存··························································································61、方法建立与确认的数据····························

7、···································································72、样品分析的数据···············································································································73、其他相关信息··················································································

8、···································7三、药代动力学研究的具