化学药物非临床药代动力学研究技术指导原则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 ··································································································2 （一）总体要求 ······································································3 （二）生物样本的药物测定方法 ·········································································································4 （三）研究项目 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