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应用于群体药代动力学模型的概念:如何将开放系统药理学模型扩展到孕妇这一特殊人群。

Applied Concepts in PBPK Modeling: How to Extend an Open Systems Pharmacology Model to the Special Population of Pregnant Women.

机构信息

Department of Pediatric Clinical Pharmacology, University Children's Hospital Basel (UKBB), Basel, Switzerland.

Bayer AG, Clinical Pharmacometrics, Leverkusen, Germany.

出版信息

CPT Pharmacometrics Syst Pharmacol. 2018 Jul;7(7):419-431. doi: 10.1002/psp4.12300. Epub 2018 Apr 20.

Abstract

This tutorial presents the workflow of adapting an adult physiologically based pharmacokinetic (PBPK) model to the pregnant populations using the Open Systems Pharmacology (OSP) software suite (www.open-systems-pharmacology.org). This workflow is illustrated using a previously published PBPK model for metronidazole that is extrapolated to pregnancy by parameterizing and extending the model structure in terms of pregnancy-induced physiological changes. Importantly, this workflow can be applied to other scenarios where PBPK models need to be re-parameterized or structurally modified.

摘要

本教程介绍了使用 Open Systems Pharmacology(OSP)软件套件(www.open-systems-pharmacology.org)将成人生理药代动力学(PBPK)模型适配到妊娠人群的工作流程。该工作流程使用先前发表的甲硝唑 PBPK 模型进行说明,该模型通过参数化和扩展模型结构来描述妊娠引起的生理变化,从而外推至妊娠人群。重要的是,此工作流程可应用于需要重新参数化或结构修改 PBPK 模型的其他情况。

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