Khalil Feras, Läer Stephanie
Department of Clinical Pharmacy and Pharmacotherapy, Heinrich-Heine University of Düsseldorf, 40225 Düsseldorf, Germany.
J Biomed Biotechnol. 2011;2011:907461. doi: 10.1155/2011/907461. Epub 2011 Jun 1.
The concept of physiologically based pharmacokinetic (PBPK) modeling was introduced years ago, but it has not been practiced significantly. However, interest in and implementation of this modeling technique have grown, as evidenced by the increased number of publications in this field. This paper demonstrates briefly the methodology, applications, and limitations of PBPK modeling with special attention given to discuss the use of PBPK models in pediatric drug development and some examples described in detail. Although PBPK models do have some limitations, the potential benefit from PBPK modeling technique is huge. PBPK models can be applied to investigate drug pharmacokinetics under different physiological and pathological conditions or in different age groups, to support decision-making during drug discovery, to provide, perhaps most important, data that can save time and resources, especially in early drug development phases and in pediatric clinical trials, and potentially to help clinical trials become more "confirmatory" rather than "exploratory".
基于生理的药代动力学（PBPK）建模概念多年前就已提出，但尚未得到广泛应用。然而，随着该领域出版物数量的增加，对这种建模技术的兴趣和应用不断增长。本文简要展示了PBPK建模的方法、应用和局限性，并特别关注讨论PBPK模型在儿科药物开发中的应用以及一些详细描述的实例。尽管PBPK模型确实存在一些局限性，但PBPK建模技术的潜在益处巨大。PBPK模型可用于研究不同生理和病理条件下或不同年龄组的药物药代动力学，支持药物研发过程中的决策制定，最重要的是，提供可节省时间和资源的数据，尤其是在药物开发早期阶段和儿科临床试验中，并有可能帮助临床试验更具“确证性”而非“探索性”。
