群体药物动力学及其在新药研究中的应用

发布时间：2018-04-06 23:26

本文选题：群体药物动力学　切入点：新药研发　出处：《药学学报》2017年03期

【摘要】：群体药物动力学是将经典药物动力学的隔室模型与统计学原理相结合发展而来的一门新兴学科,近年来受到越来越多的重视。群体药物动力学在新药研发的各个阶段都具有重要作用。在早期临床前研究阶段,通过群体药物动力学分析可以实现药物动力学参数从动物到人的初步预测,优化临床试验设计方案,缩短新药从实验室到临床研究的时间;在临床试验及应用阶段,通过群体药物动力学研究可以全面考察影响患者药物动力学行为的相关因素,发现临床潜在的药物-药物相互作用。此外,群体药物动力学由于其对稀疏数据的强大分析能力在儿科药物开发中具有独特优势。本文阐述了群体药物动力学的发展历史、研究方法,并对其在新药研发过程中的应用进行综述。
[Abstract]:Population pharmacokinetics is a new subject which combines the compartments model of classical pharmacokinetics with the principle of statistics, and has been paid more and more attention in recent years.Population pharmacokinetics plays an important role in all stages of new drug development.In the early stage of preclinical research, the pharmacokinetic parameters from animal to human can be predicted by colony pharmacokinetic analysis, the design of clinical trial can be optimized, and the time of new drug from laboratory to clinical research can be shortened.In the phase of clinical trial and application, the related factors affecting the pharmacokinetic behavior of patients can be comprehensively investigated by colony pharmacokinetic study, and the clinical potential drug-drug interaction can be found.In addition, population pharmacokinetics has unique advantages in paediatric drug development due to its strong analytical ability to sparse data.In this paper, the history and research methods of population pharmacokinetics are reviewed, and its application in the process of new drug development is reviewed.
【作者单位】：北京大学药学院;
【基金】：北京大学/辉瑞定量药理学高级人才培训中心合作项目
【分类号】：R969.1

【相似文献】