Samara E, Granneman R
Department of Pharmacokinetics and Biopharmaceutics, Abbott Laboratories, Abbott Park, Illinois, USA.
Clin Pharmacokinet. 1997 Apr;32(4):294-312. doi: 10.2165/00003088-199732040-00003.
Population pharmacokinetic analysis is a relatively new approach which can be used to obtain important pharmacokinetic and pharmacodynamic information from sparse data sets routinely obtained in phase II and III clinical trials, these studies typically have many patients but few observations per patient. Similarly, this approach is beneficial for studies in which intensive blood sampling is not attainable, such as in children and patients with cancer and AIDS. It was not until the late 1980s and the early 1990s that this approach (which had been introduced by Sheiner and Beal approximately 20 years earlier) gained appreciable momentum. Today many pharmaceutical companies use this approach routinely, to differing extents, during their drug development process. Advocacy by the US Food and Drug Administration for pharmacokinetic screening during phase II and III studies was an important factor in the widespread adoption of this approach. A second factor was the gradual realisation that the approach can be cost effective in revealing clinically important information about the determinants of interpatient pharmacokinetic and pharmacodynamic variability in treated patients. However, several important issues remain to be resolved (such as the optimal study design, quality of the data and user-friendly software) which could determine the future role of the population approach in drug development.
群体药代动力学分析是一种相对较新的方法，可用于从II期和III期临床试验中常规获得的稀疏数据集中获取重要的药代动力学和药效学信息，这些研究通常有许多患者，但每位患者的观察数据较少。同样，这种方法对于无法进行密集采血的研究有益，例如儿童、癌症患者和艾滋病患者。直到20世纪80年代末和90年代初，这种方法（大约20年前由谢纳和比尔引入）才获得显著发展。如今，许多制药公司在其药物研发过程中不同程度地常规使用这种方法。美国食品药品监督管理局在II期和III期研究中倡导进行药代动力学筛查是这种方法广泛应用的一个重要因素。另一个因素是人们逐渐认识到，这种方法在揭示治疗患者中患者间药代动力学和药效学变异性决定因素的临床重要信息方面具有成本效益。然而，仍有几个重要问题有待解决（如最佳研究设计、数据质量和用户友好型软件），这些问题可能决定群体方法在药物研发中的未来作用。
