15化学药物非临床药代动力学研究技术指导原则.pdf

指导原则编号： 【H】 G P T 5 -1 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···························································································10 七、参考文献······························································································································13 八、附录（生物样品的分析方法）·············································································15 九、著者·····································································································································21 化学药物非临床药代动力学研究技术指导原则 一、概述 非临床药代动力学研究是通过动物体内、外和人体外的研究方法， 揭示药物在体内的动态变化规律，获得药物的基本药代动力学参数，阐 明药物的吸收、分布、代谢和排泄的过程和特点。 非临床药代动力学研究在新药研究开发的评价过程中起着重要作 用。在药效学和毒理学评价中，药物或活性代谢物浓度数据及其相关药 代动力学参数是产生、决定或阐明药效或毒性大小的基础，可提供药物 对靶器官效