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Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective.

作者信息

Manolis Efthymios, García-Arieta Alfredo, Lindahl Anders, Kotzagiorgis Evangelos, Limberg Jobst, Holte Øyvind, Paixao Paulo, Versantvoort Carolien, Tshinanu Flora Musuamba, Blake Kevin, Van Den Heuvel Michiel

机构信息

European Medicines Agency, Amsterdam, The Netherlands.

Spanish Agency of Medicines and Medical Devices, Madrid, Spain.

出版信息

CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):556-559. doi: 10.1002/psp4.12906. Epub 2023 Jan 11.

DOI:10.1002/psp4.12906
PMID:36628987
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10196408/
Abstract
摘要

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本文引用的文献

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Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility.科学和监管评估药物研发中机制计算药物和疾病模型：建立模型可信度。
CPT Pharmacometrics Syst Pharmacol. 2021 Aug;10(8):804-825. doi: 10.1002/psp4.12669. Epub 2021 Jul 13.
2
In Vivo Predictive Dissolution (IPD) and Biopharmaceutical Modeling and Simulation: Future Use of Modern Approaches and Methodologies in a Regulatory Context.体内预测性溶出（IPD）与生物药剂学建模和模拟：现代方法与技术在监管背景下的未来应用
Mol Pharm. 2017 Apr 3;14(4):1307-1314. doi: 10.1021/acs.molpharmaceut.6b00824. Epub 2017 Mar 1.
3
Physiologically based pharmacokinetic modeling in regulatory decision-making at the European Medicines Agency.在欧洲药品管理局的监管决策中应用基于生理学的药代动力学建模。
Clin Pharmacol Ther. 2017 Jul;102(1):98-105. doi: 10.1002/cpt.539. Epub 2016 Dec 26.
4
The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop.模型和模拟在药品开发和注册中的作用：来自 EFPIA/EMA 模型和模拟研讨会的结果。
CPT Pharmacometrics Syst Pharmacol. 2013 Feb 27;2(2):e31. doi: 10.1038/psp.2013.7.