化学药物非临床药代动力学研究.doc

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指导原则编号:
化学药物非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、基本原则···································································································································2
三、试验设计··································································································································2
(一)总体要求····················································································································2
(二)生物样本的药物测定方法··············································································3
(三)研究项目···············································································································4
四、数据处理与分析················································································································9
五、结果与评价··························································································································9
六、常见问题与处理思路····················