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欧洲药品管理局（EMA）关于基于生理的药代动力学（PBPK）建模与模拟的鉴定及报告研讨会报告。

Report from the EMA workshop on qualification and reporting of physiologically based pharmacokinetic (PBPK) modeling and simulation.

作者信息

Zhao P

机构信息

US Food and Drug Administration, Silver Spring, Maryland, USA.

出版信息

CPT Pharmacometrics Syst Pharmacol. 2017 Feb;6(2):71-72. doi: 10.1002/psp4.12166. Epub 2017 Feb 3.

DOI:10.1002/psp4.12166
PMID:28035755
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5321806/
Abstract

On Nov 21, 2016, the European Medicines Agency (EMA) hosted a workshop to discuss its draft guideline on qualification and reporting of physiologically based pharmacokinetic (PBPK) analysis. Published on July 21, 2016, the draft PBPK guideline is currently under the period of public comments.

摘要

2016年11月21日，欧洲药品管理局（EMA）举办了一次研讨会，讨论其关于基于生理的药代动力学（PBPK）分析的鉴定和报告的指南草案。该PBPK指南草案于2016年7月21日发布，目前正处于征求公众意见阶段。

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本文引用的文献

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CPT Pharmacometrics Syst Pharmacol. 2015 Apr;4(4):226-30. doi: 10.1002/psp4.33. Epub 2015 Apr 17.
2
Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation.药品监管申报中的基于生理的模型：ABPI/MHRA基于生理的建模与模拟论坛成果
CPT Pharmacometrics Syst Pharmacol. 2015 Apr;4(4):221-5. doi: 10.1002/psp4.30. Epub 2015 Apr 2.