Department of Pediatrics, Division of Clinical Pharmacology & Therapeutics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
Clin Pharmacol Ther. 2012 Jul;92(1):40-9. doi: 10.1038/clpt.2012.64. Epub 2012 Jun 6.
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.
本综述总结了生理药代动力学（PBPK）建模和模拟（M&S）的现状及其在支持儿科药物研究中的应用。我们根据儿科 PBPK 方法和方法的演变，讨论了 PBPK 适合儿科药物开发和治疗药理学当前需求的原因，这些方法和方法最初是为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，以及获得稳健结果和更广泛采用儿科 PBPK M&S 的关键因素。
