化学药物非临床药代动力学研究 技术指导原则

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1、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、·····················································································2（一）总体要求··································································································2（二）生物样本的药物测定方法···························································

3、···········3（三）研究项目·········································································································4四、数据处理与分析····················································································9五、结果与评价·······································

4、···························································9六、常见问题与处理思路···························································································10七、参考文献·······························································································

5、·······························13八、附录（生物样品的分析方法）·············································································15九、著者·····································································································································2

6、1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

7、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、研究项目（血药浓度-时间曲线、吸收、分布、排泄、血浆蛋白结合、生物转化、对药物代谢酶活性的影响）、数据处理与分析、结果与评价等，并对研究中的一些常见问题及处理思路进行

8、了分析。1二、基本原则进行非临床药代动力学研究，要遵循以下基本原则：（一）试验目的明确（二）试验设计合理（三）分析方法可靠（四）所得参数全面，满足评价要求（五）对试验结果进行综合分析与评价（六）具体问题具体分析三、试验设计（一）总体要求1、受试物应提供受试物的名称、剂型、批号、来源、纯度、