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

机译：EMA讲习班关于基于生理的药代动力学（PBPK）建模和模拟的鉴定和报告的报告

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摘要

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.¹ Published on July 21, 2016, the draft PBPK guideline is currently under the period of public comments.

机译：2016年11月21日，欧洲药品管理局（EMA）举办了一次研讨会，讨论其有关基于生理的药代动力学（PBPK）分析的资格和报告指南草案。^{1 发布于2016年7月21日， PBPK准则草案目前处于公众意见征询期。}

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期刊名称 CPT: Pharmacometrics Systems Pharmacology
作者
P Zhao;
展开▼
作者单位

展开▼
年(卷),期 2017(6),2
年度 2017
页码 71–72
总页数 2
原文格式 PDF
正文语种
中图分类药学;
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专利

1. Report from the EMA workshop on qualification and reporting of physiologically based pharmacokinetic (PBPK) modeling and simulation [J] . P Zhao CPT: Pharmacometrics & Systems Pharmacology . 2016,第2期

机译：EMA讲习班关于基于生理的药代动力学（PBPK）建模和模拟的鉴定和报告的报告
2. Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK [J] . C Wagner, J Grillo, P Zhao, CPT: Pharmacometrics & Systems Pharmacology . 2015,第4期

机译：基于生理的药代动力学（PBPK）建模在支持剂量选择中的应用：FDA关于PBPK的公开研讨会的报告
3. Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective [J] . Shebley Mohamad, Sandhu Punam, Emami Riedmaier Arian, Clinical Pharmacology and Therapeutics . 2018,第1期

机译：基于生理的药代动力学模型资格和报告报告程序，用于监管意见书：联盟视角
4. Application of physiologically based pharmacokinetic (PBPK) modeling to predict the distribution of trichloroethylene in different tissues of young male rats [C] . Sattar K.Alcasey, Elise M.Westmeyer, Jane Ellen Simmons, Bioengineering conference . 1999

机译：生理药代动力学（PBPK）模型在预测三氯乙烯在年轻雄性大鼠不同组织中的分布中的应用
5. Mechanistic Physiologically Based Pharmacokinetic (PBPK) Modeling of Renal and Systemic Disposition of Drugs and Metabolites [D] . Huang, Weize. 2020

机译：基于机械生理学的药代动力学（PBPK）肾脏肾和药物分配的建模
6. Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK [O] . C Wagner, P Zhao, Y Pan, 2015

机译：基于生理的药代动力学（PBPK）建模在支持剂量选择中的应用：FDA关于PBPK公开研讨会的报告
7. Investigations of the effects of different ventilation structures on physiologically based pharmacokinetic modeling (PBPK) simulations [O] . Yokley Karen A 2016

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8. Development of a Physiologically Based Pharmacokinetic/Pharmacodynamic (PBPK/PD) Minipig Model for Simulation of Low Level Multiple Route CW Agent Exposure [R] . Gearhart, J. M. , Yu, K. O. 2005

机译：开发基于生理学的药代动力学/药效学（pBpK / pD）minipig模型模拟低水平多路CW剂暴露

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

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