A best practice framework for applying physiologically‐based pharmacokinetic modeling to pediatric drug development

Pediatric physiologically‐based pharmacokinetic (PBPK) models have broad application in the drug development process and are being used not only to project doses for clinical trials but increasingly to replace clinical studies. However, the approach has yet to become fully integrated in regulatory s...

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Detalles Bibliográficos
Autores principales: Johnson, Trevor N., Small, Ben G., Berglund, Eva Gil, Rowland Yeo, Karen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8452294/
https://www.ncbi.nlm.nih.gov/pubmed/34288581
http://dx.doi.org/10.1002/psp4.12678
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author Johnson, Trevor N.
Small, Ben G.
Berglund, Eva Gil
Rowland Yeo, Karen
author_facet Johnson, Trevor N.
Small, Ben G.
Berglund, Eva Gil
Rowland Yeo, Karen
author_sort Johnson, Trevor N.
collection PubMed
description Pediatric physiologically‐based pharmacokinetic (PBPK) models have broad application in the drug development process and are being used not only to project doses for clinical trials but increasingly to replace clinical studies. However, the approach has yet to become fully integrated in regulatory submissions. Emerging data support an expanded integration of the PBPK model informed approach in regulatory guidance on pediatrics. Best practice standards are presented for further development through interaction among regulators, industry, and model providers.
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spelling pubmed-84522942021-09-27 A best practice framework for applying physiologically‐based pharmacokinetic modeling to pediatric drug development Johnson, Trevor N. Small, Ben G. Berglund, Eva Gil Rowland Yeo, Karen CPT Pharmacometrics Syst Pharmacol Perspective Pediatric physiologically‐based pharmacokinetic (PBPK) models have broad application in the drug development process and are being used not only to project doses for clinical trials but increasingly to replace clinical studies. However, the approach has yet to become fully integrated in regulatory submissions. Emerging data support an expanded integration of the PBPK model informed approach in regulatory guidance on pediatrics. Best practice standards are presented for further development through interaction among regulators, industry, and model providers. John Wiley and Sons Inc. 2021-07-20 2021-09 /pmc/articles/PMC8452294/ /pubmed/34288581 http://dx.doi.org/10.1002/psp4.12678 Text en © 2021 The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://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 Perspective
Johnson, Trevor N.
Small, Ben G.
Berglund, Eva Gil
Rowland Yeo, Karen
A best practice framework for applying physiologically‐based pharmacokinetic modeling to pediatric drug development
title A best practice framework for applying physiologically‐based pharmacokinetic modeling to pediatric drug development
title_full A best practice framework for applying physiologically‐based pharmacokinetic modeling to pediatric drug development
title_fullStr A best practice framework for applying physiologically‐based pharmacokinetic modeling to pediatric drug development
title_full_unstemmed A best practice framework for applying physiologically‐based pharmacokinetic modeling to pediatric drug development
title_short A best practice framework for applying physiologically‐based pharmacokinetic modeling to pediatric drug development
title_sort best practice framework for applying physiologically‐based pharmacokinetic modeling to pediatric drug development
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8452294/
https://www.ncbi.nlm.nih.gov/pubmed/34288581
http://dx.doi.org/10.1002/psp4.12678
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