Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop

On May 19, 2016, the US Food and Drug Administration (FDA) hosted a public workshop, entitled “Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation.”1 The topic of mechanistic oral absorption modeling, which is one of the major applications of...

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Autores principales: Zhang, X, Duan, J, Kesisoglou, F, Novakovic, J, Amidon, GL, Jamei, M, Lukacova, V, Eissing, T, Tsakalozou, E, Zhao, L, Lionberger, R
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Perspectives
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5572334/
https://www.ncbi.nlm.nih.gov/pubmed/28571121
http://dx.doi.org/10.1002/psp4.12204
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author Zhang, X
Duan, J
Kesisoglou, F
Novakovic, J
Amidon, GL
Jamei, M
Lukacova, V
Eissing, T
Tsakalozou, E
Zhao, L
Lionberger, R
author_facet Zhang, X
Duan, J
Kesisoglou, F
Novakovic, J
Amidon, GL
Jamei, M
Lukacova, V
Eissing, T
Tsakalozou, E
Zhao, L
Lionberger, R
author_sort Zhang, X
collection PubMed
description On May 19, 2016, the US Food and Drug Administration (FDA) hosted a public workshop, entitled “Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation.”1 The topic of mechanistic oral absorption modeling, which is one of the major applications of physiologically based pharmacokinetic (PBPK) modeling and simulation, focuses on predicting oral absorption by mechanistically integrating gastrointestinal transit, dissolution, and permeation processes, incorporating systems, active pharmaceutical ingredient (API), and the drug product information, into a systemic mathematical whole‐body framework.2
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spelling pubmed-55723342017-08-30 Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop Zhang, X Duan, J Kesisoglou, F Novakovic, J Amidon, GL Jamei, M Lukacova, V Eissing, T Tsakalozou, E Zhao, L Lionberger, R CPT Pharmacometrics Syst Pharmacol Perspectives On May 19, 2016, the US Food and Drug Administration (FDA) hosted a public workshop, entitled “Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation.”1 The topic of mechanistic oral absorption modeling, which is one of the major applications of physiologically based pharmacokinetic (PBPK) modeling and simulation, focuses on predicting oral absorption by mechanistically integrating gastrointestinal transit, dissolution, and permeation processes, incorporating systems, active pharmaceutical ingredient (API), and the drug product information, into a systemic mathematical whole‐body framework.2 John Wiley and Sons Inc. 2017-07-11 2017-08 /pmc/articles/PMC5572334/ /pubmed/28571121 http://dx.doi.org/10.1002/psp4.12204 Text en © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/4.0/) 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 Perspectives
Zhang, X
Duan, J
Kesisoglou, F
Novakovic, J
Amidon, GL
Jamei, M
Lukacova, V
Eissing, T
Tsakalozou, E
Zhao, L
Lionberger, R
Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop
title Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop
title_full Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop
title_fullStr Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop
title_full_unstemmed Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop
title_short Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop
title_sort mechanistic oral absorption modeling and simulation for formulation development and bioequivalence evaluation: report of an fda public workshop
topic Perspectives
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5572334/
https://www.ncbi.nlm.nih.gov/pubmed/28571121
http://dx.doi.org/10.1002/psp4.12204
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