Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation

Under the remit of the Ministerial Industry Strategy Group (MISG), the Association of the British Pharmaceutical Industry (ABPI) and Medicines and Healthcare products Regulatory Agency (MHRA) hosted a meeting to explore physiologically based pharmacokinetic modeling and simulation, focusing on the c...

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Detalles Bibliográficos
Autores principales: Shepard, T, Scott, G, Cole, S, Nordmark, A, Bouzom, F
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BlackWell Publishing Ltd 2015
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4429575/
https://www.ncbi.nlm.nih.gov/pubmed/26225245
http://dx.doi.org/10.1002/psp4.30
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author Shepard, T
Scott, G
Cole, S
Nordmark, A
Bouzom, F
author_facet Shepard, T
Scott, G
Cole, S
Nordmark, A
Bouzom, F
author_sort Shepard, T
collection PubMed
description Under the remit of the Ministerial Industry Strategy Group (MISG), the Association of the British Pharmaceutical Industry (ABPI) and Medicines and Healthcare products Regulatory Agency (MHRA) hosted a meeting to explore physiologically based pharmacokinetic modeling and simulation, focusing on the clinical component of regulatory applications. The meeting took place on 30 June 2014 with international representatives from industry, academia, and regulatory agencies. Discussion topics were selected to be complementary to those discussed at an earlier US Food and Drug Administration (FDA) meeting. This report summarizes the meeting outcomes, focusing on the European regulatory perspective.
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spelling pubmed-44295752015-05-13 Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation Shepard, T Scott, G Cole, S Nordmark, A Bouzom, F CPT Pharmacometrics Syst Pharmacol Perspective Under the remit of the Ministerial Industry Strategy Group (MISG), the Association of the British Pharmaceutical Industry (ABPI) and Medicines and Healthcare products Regulatory Agency (MHRA) hosted a meeting to explore physiologically based pharmacokinetic modeling and simulation, focusing on the clinical component of regulatory applications. The meeting took place on 30 June 2014 with international representatives from industry, academia, and regulatory agencies. Discussion topics were selected to be complementary to those discussed at an earlier US Food and Drug Administration (FDA) meeting. This report summarizes the meeting outcomes, focusing on the European regulatory perspective. BlackWell Publishing Ltd 2015-04 2015-04-02 /pmc/articles/PMC4429575/ /pubmed/26225245 http://dx.doi.org/10.1002/psp4.30 Text en © 2015 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Perspective
Shepard, T
Scott, G
Cole, S
Nordmark, A
Bouzom, F
Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation
title Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation
title_full Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation
title_fullStr Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation
title_full_unstemmed Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation
title_short Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation
title_sort physiologically based models in regulatory submissions: output from the abpi/mhra forum on physiologically based modeling and simulation
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4429575/
https://www.ncbi.nlm.nih.gov/pubmed/26225245
http://dx.doi.org/10.1002/psp4.30
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