Physiologically based pharmacokinetic modeling in regulatory decision-making at the European Medicines Agency-Reference-Cited by-同舟云学术

Physiologically based pharmacokinetic modeling in regulatory decision-making at the European Medicines Agency

Published:2016-12-26 Issue:1 Volume:102 Page:98-105
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Luzon E¹,Blake K¹,Cole S²³⁴,Nordmark A⁴⁵,Versantvoort C³⁶,Berglund E Gil³⁵

Affiliation:

1. European Medicines Agency (EMA); London UK

2. Medicines and Healthcare products Regulatory Agency (MHRA); London UK

3. Pharmacokinetics Working Party (PKWP), EMA; London UK

4. Modelling and Simulation Working Group (MSWG), EMA; London UK

5. Medical Products Agency (MPA); Uppsala Sweden

6. Medicines Evaluation Board (MEB), Utrecht, Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/cpt.539/fullpdf

Reference13 articles.

1. European Commission Notice to Applicants Volume 2A Procedures for marketing authorisation 2015 http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a_chap1_201507.pdf

2. Predicting the effect of cytochrome P450 inhibitors on substrate drugs: analysis of physiologically based pharmacokinetic modeling submissions to the US Food and Drug Administration;Wagner;Clin. Pharmacokinet.,2015

3. Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review;Zhao;Clin. Pharmacol. Ther.,2011

4. Application of physiologically based pharmacokinetic (PBPK) modeling to support dose selection: report of an FDA Public Workshop on PBPK;Wagner;CPT Pharmacometrics Syst. Pharmacol.,2015

5. Physiologically based models in regulatory submissions: output from the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation;Shepard;CPT Pharmacometrics Syst. Pharmacol.,2015

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