Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status

A comprehensive search in literature and published US Food and Drug Administration reviews was conducted to assess whether physiologically based pharmacokinetic (PBPK) modeling could be prospectively used to predict clinical food effect on oral drug absorption. Among the 48 resulted food effect pred...

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Detalles Bibliográficos
Autores principales: Li, Mengyao, Zhao, Ping, Pan, Yuzhuo, Wagner, Christian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Reviews
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5824104/
https://www.ncbi.nlm.nih.gov/pubmed/29168611
http://dx.doi.org/10.1002/psp4.12260
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author Li, Mengyao
Zhao, Ping
Pan, Yuzhuo
Wagner, Christian
author_facet Li, Mengyao
Zhao, Ping
Pan, Yuzhuo
Wagner, Christian
author_sort Li, Mengyao
collection PubMed
description A comprehensive search in literature and published US Food and Drug Administration reviews was conducted to assess whether physiologically based pharmacokinetic (PBPK) modeling could be prospectively used to predict clinical food effect on oral drug absorption. Among the 48 resulted food effect predictions, ∼50% were predicted within 1.25‐fold of observed, and 75% within 2‐fold. Dissolution rate and precipitation time were commonly optimized parameters when PBPK modeling was not able to capture the food effect. The current work presents a knowledgebase for documenting PBPK experience to predict food effect.
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spelling pubmed-58241042018-02-26 Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status Li, Mengyao Zhao, Ping Pan, Yuzhuo Wagner, Christian CPT Pharmacometrics Syst Pharmacol Reviews A comprehensive search in literature and published US Food and Drug Administration reviews was conducted to assess whether physiologically based pharmacokinetic (PBPK) modeling could be prospectively used to predict clinical food effect on oral drug absorption. Among the 48 resulted food effect predictions, ∼50% were predicted within 1.25‐fold of observed, and 75% within 2‐fold. Dissolution rate and precipitation time were commonly optimized parameters when PBPK modeling was not able to capture the food effect. The current work presents a knowledgebase for documenting PBPK experience to predict food effect. John Wiley and Sons Inc. 2017-11-23 2018-02 /pmc/articles/PMC5824104/ /pubmed/29168611 http://dx.doi.org/10.1002/psp4.12260 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 Reviews
Li, Mengyao
Zhao, Ping
Pan, Yuzhuo
Wagner, Christian
Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status
title Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status
title_full Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status
title_fullStr Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status
title_full_unstemmed Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status
title_short Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status
title_sort predictive performance of physiologically based pharmacokinetic models for the effect of food on oral drug absorption: current status
topic Reviews
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5824104/
https://www.ncbi.nlm.nih.gov/pubmed/29168611
http://dx.doi.org/10.1002/psp4.12260
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