Hospices Civils de Lyon, Groupement Hospitalier Nord, Service de Pharmacie, Lyon, France.
CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Évolutive, Villeurbanne, France.
J Clin Pharmacol. 2022 Feb;62(2):158-170. doi: 10.1002/jcph.1993. Epub 2021 Dec 3.
Population pharmacokinetics consists of analyzing pharmacokinetic (PK) data collected in groups of individuals. Population PK is widely used to guide drug development and to inform dose adjustment via therapeutic drug monitoring and model-informed precision dosing. There are 2 main types of population PK methods: parametric (P) and nonparametric (NP). The characteristics of P and NP population methods have been previously reviewed. The aim of this article is to answer some frequently asked questions that are often raised by scholars, clinicians, and researchers about P and NP population PK methods. The strengths and limitations of both approaches are explained, and the characteristics of the main software programs are presented. We also review the results of studies that compared the results of both approaches in the analysis of real data. This opinion article may be informative for potential users of population methods in PK and guide them in the selection and use of those tools. It also provides insights on future research in this area.
群体药代动力学分析是对个体群体中的药代动力学(PK)数据进行分析。群体 PK 广泛用于指导药物开发,并通过治疗药物监测和模型指导的精准给药来调整剂量。有两种主要的群体 PK 方法:参数(P)和非参数(NP)。P 和 NP 群体方法的特点之前已经有过综述。本文的目的是回答学者、临床医生和研究人员经常提出的一些关于 P 和 NP 群体 PK 方法的常见问题。解释了两种方法的优缺点,并介绍了主要软件程序的特点。我们还回顾了比较两种方法在分析真实数据结果的研究。本文可为 PK 领域中群体方法的潜在使用者提供信息,并指导他们选择和使用这些工具。它还为该领域的未来研究提供了思路。