Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK

The US Food and Drug Administration (FDA) public workshop, entitled “Application of Physiologically-based Pharmacokinetic (PBPK) Modeling to Support Dose Selection focused on the role of PBPK in drug development and regulation. Representatives from industry, academia, and regulatory agencies discuss...

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Detalles Bibliográficos
Autores principales: Wagner, C, Zhao, P, Pan, Y, Hsu, V, Grillo, J, Huang, SM, Sinha, V
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BlackWell Publishing Ltd 2015
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4429576/
https://www.ncbi.nlm.nih.gov/pubmed/26225246
http://dx.doi.org/10.1002/psp4.33
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author Wagner, C
Zhao, P
Pan, Y
Hsu, V
Grillo, J
Huang, SM
Sinha, V
author_facet Wagner, C
Zhao, P
Pan, Y
Hsu, V
Grillo, J
Huang, SM
Sinha, V
author_sort Wagner, C
collection PubMed
description The US Food and Drug Administration (FDA) public workshop, entitled “Application of Physiologically-based Pharmacokinetic (PBPK) Modeling to Support Dose Selection focused on the role of PBPK in drug development and regulation. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary and panel discussions. This report summarizes the discussions and provides current perspectives on the application of PBPK in different areas, including its utility, predictive performance, and reporting for regulatory submissions.
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spelling pubmed-44295762015-05-13 Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK Wagner, C Zhao, P Pan, Y Hsu, V Grillo, J Huang, SM Sinha, V CPT Pharmacometrics Syst Pharmacol Perspective The US Food and Drug Administration (FDA) public workshop, entitled “Application of Physiologically-based Pharmacokinetic (PBPK) Modeling to Support Dose Selection focused on the role of PBPK in drug development and regulation. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary and panel discussions. This report summarizes the discussions and provides current perspectives on the application of PBPK in different areas, including its utility, predictive performance, and reporting for regulatory submissions. BlackWell Publishing Ltd 2015-04 2015-04-17 /pmc/articles/PMC4429576/ /pubmed/26225246 http://dx.doi.org/10.1002/psp4.33 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-nd/4.0/ This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
spellingShingle Perspective
Wagner, C
Zhao, P
Pan, Y
Hsu, V
Grillo, J
Huang, SM
Sinha, V
Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK
title Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK
title_full Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK
title_fullStr Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK
title_full_unstemmed Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK
title_short Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK
title_sort application of physiologically based pharmacokinetic (pbpk) modeling to support dose selection: report of an fda public workshop on pbpk
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4429576/
https://www.ncbi.nlm.nih.gov/pubmed/26225246
http://dx.doi.org/10.1002/psp4.33
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