化学药物非临床药代动力学研究技术指导原则..doc

指导原则编号：【H 】 GPT5-1 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 对靶器官效应（药效或毒性）的依据；在药物制剂学研究中，非临床药 代动力学研究结果是评价药物制剂特性和质量的重要依据；在临床研究 中，非临床药代动力学研究结果能为设计和优化临床研究给药方案提供 有关参考信息。 本指导原则是供药物研究开发机构进行化学药品新药的非临床药 代动力学研究的参考，而不是新药申报的条框要求。研究者可根据不同 药物的特点，参考本指导原则，科学合理地进行试验设计，并对试验结 果进行综合评价。 本指导原则的主要内容包括进行非临床药代动力学研究的基本原 则、试验设计的总体要求、生物样品的药物分析方法、