Physiologically Based Pharmacokinetic (PBPK) Modeling in Children
Physiologically Based Pharmacokinetic (PBPK) Modeling in Children
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DOI：
10.1038/clpt.2012.64
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发表时间：
2012-07-01
影响因子：
6.7
通讯作者：
Meibohm, B.
中科院分区：
文献类型：
--
作者：
Barrett, J. S.;Alberighi, O. Della Casa;Meibohm, B.
本文综述了基于生理的药代动力学（PBPK）建模与仿真（M&S）的研究现状及其在儿科药物研究中的应用。鉴于儿科PBPK方法和方法的发展，我们解决了PBPK适合当前儿科药物开发和药物治疗需求的原因，这些方法和方法最初是为了毒理学评估而开发的。还讨论了目前使用PBPK支持儿科药物开发和注册的信心程度，以及对儿科PBPK M&S的稳健结果和更广泛采用至关重要的关键因素。
This review summarizes the present status of physiologically based pharmacokinetic (PBPK) modeling and simulation (M&S) and its application in support of pediatric drug research. We address the reasons that PBPK is suited to the current needs of pediatric drug development and pharmacotherapy in light of the evolution in pediatric PBPK methodologies and approaches, which were originally developed for the purpose of toxicologic evaluation. Also discussed is the current degree of confidence in using PBPK to support pediatric drug development and registration and the key factors essential for robust results and broader adoption of pediatric PBPK M&S.