化学药物临床药代动力学的研究技术指导原则.docVIP

化学药物临床药代动力学研究技术指导原则 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······················································································································21、特异性······································································································································32、标准曲线和定量范围······································································································33、定量下限·································································································································44、精密度与准确度·················································································································45、样品稳定性···························································································································56、提取回收率··························································································································57、微生物学和免疫学分析·······························································································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·······························································································72、样品分析的数据···············································································································73、其他相关信息·········································································································