The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop

The European Medicines Agency (EMA) and the Federation of Pharmaceutical Industries and Associations (EFPIA) hosted a workshop on modeling and simulation (M&S).(1) Representatives from industry, academia, and regulatory agencies from Europe and beyond discussed the role of M&S in the develop...

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Autores principales: Manolis, E, Rohou, S, Hemmings, R, Salmonson, T, Karlsson, M, Milligan, P A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2013
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3600760/
https://www.ncbi.nlm.nih.gov/pubmed/23835942
http://dx.doi.org/10.1038/psp.2013.7
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author Manolis, E
Rohou, S
Hemmings, R
Salmonson, T
Karlsson, M
Milligan, P A
author_facet Manolis, E
Rohou, S
Hemmings, R
Salmonson, T
Karlsson, M
Milligan, P A
author_sort Manolis, E
collection PubMed
description The European Medicines Agency (EMA) and the Federation of Pharmaceutical Industries and Associations (EFPIA) hosted a workshop on modeling and simulation (M&S).(1) Representatives from industry, academia, and regulatory agencies from Europe and beyond discussed the role of M&S in the development and registration of medicinal products within plenary and breakout sessions (BOS). This manuscript summarizes the plenary discussion (Table 1) focusing on the European perspective. Deliverables from each BOS are included in separate papers.
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spelling pubmed-36007602013-04-09 The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop Manolis, E Rohou, S Hemmings, R Salmonson, T Karlsson, M Milligan, P A CPT Pharmacometrics Syst Pharmacol Perspective The European Medicines Agency (EMA) and the Federation of Pharmaceutical Industries and Associations (EFPIA) hosted a workshop on modeling and simulation (M&S).(1) Representatives from industry, academia, and regulatory agencies from Europe and beyond discussed the role of M&S in the development and registration of medicinal products within plenary and breakout sessions (BOS). This manuscript summarizes the plenary discussion (Table 1) focusing on the European perspective. Deliverables from each BOS are included in separate papers. Nature Publishing Group 2013-02 2013-02-27 /pmc/articles/PMC3600760/ /pubmed/23835942 http://dx.doi.org/10.1038/psp.2013.7 Text en Copyright © 2013 American Society for Clinical Pharmacology and Therapeutics http://creativecommons.org/licenses/by-nc-nd/3.0/ CPT: Pharmacometrics and Systems Pharmacology is an open-access journal published by Nature Publishing Group. This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/3.0/
spellingShingle Perspective
Manolis, E
Rohou, S
Hemmings, R
Salmonson, T
Karlsson, M
Milligan, P A
The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop
title The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop
title_full The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop
title_fullStr The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop
title_full_unstemmed The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop
title_short The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop
title_sort role of modeling and simulation in development and registration of medicinal products: output from the efpia/ema modeling and simulation workshop
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3600760/
https://www.ncbi.nlm.nih.gov/pubmed/23835942
http://dx.doi.org/10.1038/psp.2013.7
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