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》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、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···················································································································

2、·································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······················

3、································································································21、特异性······································································································································32、标准曲线和定量范围··········

4、····························································································33、定量下限·································································································································44、精密度与准确度····················

5、·····························································································45、样品稳定性···························································································································56、提取回收率··························

6、································································································57、微生物学和免疫学分析·······························································································58、方法学质控··············································

7、············································································6（三）分析数据的记录与保存··························································································61、方法建立与确认的数据·································································

8、······························72、样品分析的数据···············································································································73、其他相关信息··································