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基于生理学的药代动力学(PBPK)模型指导下的儿科临床用药指南:特殊人群的实用方法。

Physiologically Based Pharmacokinetic (PBPK) Model-Informed Dosing Guidelines for Pediatric Clinical Care: A Pragmatic Approach for a Special Population.

机构信息

Department of Pharmacology and Toxicology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.

Intensive Care and Department of Pediatrics Surgery, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.

出版信息

Paediatr Drugs. 2023 Jan;25(1):5-11. doi: 10.1007/s40272-022-00535-w. Epub 2022 Oct 6.

Abstract

Physiologically based pharmacokinetic (PBPK) modeling can be an attractive tool to increase the evidence base of pediatric drug dosing recommendations by making optimal use of existing pharmacokinetic (PK) data. A pragmatic approach of combining available compound models with a virtual pediatric physiology model can be a rational solution to predict PK and hence support dosing guidelines for children in real-life clinical care, when it can also be employed by individuals with little experience in PBPK modeling. This comes within reach as user-friendly PBPK modeling platforms exist and, for many drugs and populations, models are ready for use. We have identified a list of drugs that can serve as a starting point for pragmatic PBPK modeling to address current clinical dosing needs.

摘要

生理药代动力学(PBPK)模型可以通过充分利用现有的药代动力学(PK)数据,成为增加儿科药物剂量推荐证据基础的有吸引力的工具。将可用的化合物模型与虚拟儿科生理模型相结合的实用方法,是一种合理的解决方案,可以预测 PK,从而为现实临床护理中的儿童提供剂量指南,即使对于在 PBPK 建模方面经验有限的个人,也可以使用该方法。这是因为现在有了用户友好的 PBPK 建模平台,并且对于许多药物和人群,模型已经可以使用。我们已经确定了一系列可以作为实用 PBPK 建模起点的药物,以解决当前的临床剂量需求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e02/9810680/b49c8fc1239a/40272_2022_535_Fig1_HTML.jpg

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