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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.

DOI:10.1002/psp4.12300
PMID:29569837
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6063743/
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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Physiologically Based Pharmacokinetic Modeling in Pregnancy: A Systematic Review of Published Models.妊娠的生理药代动力学模型：已发表模型的系统评价。
Clin Pharmacol Ther. 2018 Dec;104(6):1110-1124. doi: 10.1002/cpt.1084. Epub 2018 May 6.
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A Physiologically Based Pharmacokinetic Model for Pregnant Women to Predict the Pharmacokinetics of Drugs Metabolized Via Several Enzymatic Pathways.用于预测经多种酶途径代谢的药物在孕妇体内药代动力学的基于生理的药代动力学模型。
Clin Pharmacokinet. 2018 Jun;57(6):749-768. doi: 10.1007/s40262-017-0594-5.
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Prediction of Fetal Darunavir Exposure by Integrating Human Ex-Vivo Placental Transfer and Physiologically Based Pharmacokinetic Modeling.
用于指导临床试验设计和监管决策的模型驱动药物发现与开发方法：中东和北非地区入门指南
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PBPK/PD Modeling of Nifedipine for Precision Medicine in Pregnant Women: Enhancing Clinical Decision-Making for Optimal Drug Therapy.硝苯地平用于孕妇精准医学的 PBPK/PD 模型：增强临床决策以实现最佳药物治疗。
Pharm Res. 2024 Jan;41(1):63-75. doi: 10.1007/s11095-023-03638-2. Epub 2023 Dec 4.
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Generic Workflow to Predict Medicine Concentrations in Human Milk Using Physiologically-Based Pharmacokinetic (PBPK) Modelling-A Contribution from the ConcePTION Project.使用基于生理的药代动力学（PBPK）模型预测人乳中药物浓度的通用工作流程——来自ConcePTION项目的贡献。
Pharmaceutics. 2023 May 11;15(5):1469. doi: 10.3390/pharmaceutics15051469.
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Physiologically Based Pharmacokinetic Modeling for Multiple Oral Administration Labetalol in Pregnant Women.基于生理的拉贝洛尔多次口服给药在孕妇中的药代动力学模型。
Pharm Res. 2023 Jul;40(7):1765-1775. doi: 10.1007/s11095-023-03523-y. Epub 2023 May 4.
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Toxicol Sci. 2023 Mar 20;192(1):59-70. doi: 10.1093/toxsci/kfad007.
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The MPRINT Hub Data, Model, Knowledge and Research Coordination Center: Bridging the gap in maternal-pediatric therapeutics research through data integration and pharmacometrics.MPRINT 中心数据、模型、知识和研究协调中心：通过数据集成和药物动力学研究弥合母婴治疗学研究的差距。
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