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孕妇药物剂量：应用生理基于药代动力学模型和模拟的挑战与机遇。

Drug Dosing in Pregnant Women: Challenges and Opportunities in Using Physiologically Based Pharmacokinetic Modeling and Simulations.

机构信息

Simcyp Limited (a Certara company), Sheffield, UK.

Department of Pharmacology and Toxicology, Radboud University Medical Centre, Radboud Institute for Molecular Life Sciences, Nijmegen, The Netherlands.

出版信息

CPT Pharmacometrics Syst Pharmacol. 2018 Feb;7(2):103-110. doi: 10.1002/psp4.12274. Epub 2018 Jan 31.

DOI:10.1002/psp4.12274
PMID:29349870
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5824116/
Abstract

The unmet medical need of providing evidence-based pharmacotherapy for pregnant women is recognized by the regulatory bodies. Physiologically based pharmacokinetic (PBPK) modeling offers an attractive platform to quantify anticipated changes in the pharmacokinetics (PKs) of drugs during pregnancy. Recent publications applying a pregnancy PBPK module to the prediction of maternal and fetal exposure of drugs are summarized. Future opportunities to use PBPK models to predict breast milk exposure and assess human fetotoxicity risks are presented.

摘要

监管机构认识到，为孕妇提供基于证据的药物治疗的需求尚未得到满足。基于生理学的药代动力学（PBPK）模型为量化药物在怀孕期间药代动力学（PKs）预期变化提供了一个有吸引力的平台。总结了最近应用妊娠 PBPK 模型预测药物在母体和胎儿暴露的出版物。提出了未来使用 PBPK 模型预测母乳暴露和评估人类胎儿毒性风险的机会。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67a7/5824116/95552c027e3d/PSP4-7-103-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67a7/5824116/fc879a973fd3/PSP4-7-103-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67a7/5824116/95552c027e3d/PSP4-7-103-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67a7/5824116/fc879a973fd3/PSP4-7-103-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67a7/5824116/95552c027e3d/PSP4-7-103-g002.jpg

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