群体药物动力学及其在新药研究中的应用

Population pharmacokinetics and its application in new drug research

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。

Population pharmacokinetics is an emerging discipline developed from the combination of classical pharmacokinetic compartment model and statistics principles, which has been received more and more attention in recent years. Population pharmacokinetics plays important roles in all stages of new drug research. In the early preclinical phase, population pharmacokinetic analysis can help to achieve the preliminary prediction of parameters from animal to human, optimize clinical trial designs, and shorten the time required for new drugs from laboratory to clinical trials. In clinical trials and applications stage, population pharmacokinetic research can help researchers investigate the related covariates that affecting pharmacokinetic behavior of patients comprehensively, and find potential drug-drug interactions in clinical. In addition, population pharmacokinetics has a unique advantage in pediatric drug development due to its strong analysis ability of sparse data. This paper provides a summary on the history and methods of population pharmacokinetics, and the application in new drug discovery and development.