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《化学药物临床药代动力学研究技术指导原则_2005》由会员上传分享,免费在线阅读,更多相关内容在行业资料-天天文库。
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···························································································································56、提取回收
5、率··························································································································57、微生物学和免疫学分析·······························································································58、方法学质控·····················································
6、·····································································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·
7、··············································································································73、其他相关信息·····················································································································7三、药代动力学研究的具
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