Use of Modeling and Simulation in the Design and Conduct of Pediatric Clinical Trials and the Optimization of Individualized Dosing Regimens

Mathematical models of drug action and disease progression can inform pediatric pharmacotherapy. In this tutorial, we explore the key issues that differentiate pediatric from adult pharmacokinetic (PK) / pharmacodynamic (PD) studies, describe methods to calculate the number of participants to be enr...

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Detalles Bibliográficos
Autores principales: Stockmann, C, Barrett, JS, Roberts, JK, Sherwin, CMT
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2015
Materias:
Tutorials
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4716585/
https://www.ncbi.nlm.nih.gov/pubmed/26783499
http://dx.doi.org/10.1002/psp4.12038
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author Stockmann, C
Barrett, JS
Roberts, JK
Sherwin, CMT
author_facet Stockmann, C
Barrett, JS
Roberts, JK
Sherwin, CMT
author_sort Stockmann, C
collection PubMed
description Mathematical models of drug action and disease progression can inform pediatric pharmacotherapy. In this tutorial, we explore the key issues that differentiate pediatric from adult pharmacokinetic (PK) / pharmacodynamic (PD) studies, describe methods to calculate the number of participants to be enrolled and the optimal times at which blood samples should be collected, and therapeutic drug monitoring methods for individualizing pharmacotherapy. The development of pediatric‐specific drug dosing dashboards is also highlighted, with an emphasis on clinical‐relevance and ease of use.
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spelling pubmed-47165852016-01-18 Use of Modeling and Simulation in the Design and Conduct of Pediatric Clinical Trials and the Optimization of Individualized Dosing Regimens Stockmann, C Barrett, JS Roberts, JK Sherwin, CMT CPT Pharmacometrics Syst Pharmacol Tutorials Mathematical models of drug action and disease progression can inform pediatric pharmacotherapy. In this tutorial, we explore the key issues that differentiate pediatric from adult pharmacokinetic (PK) / pharmacodynamic (PD) studies, describe methods to calculate the number of participants to be enrolled and the optimal times at which blood samples should be collected, and therapeutic drug monitoring methods for individualizing pharmacotherapy. The development of pediatric‐specific drug dosing dashboards is also highlighted, with an emphasis on clinical‐relevance and ease of use. John Wiley and Sons Inc. 2015-11-13 2015-11 /pmc/articles/PMC4716585/ /pubmed/26783499 http://dx.doi.org/10.1002/psp4.12038 Text en © 2015 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‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) 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 Tutorials
Stockmann, C
Barrett, JS
Roberts, JK
Sherwin, CMT
Use of Modeling and Simulation in the Design and Conduct of Pediatric Clinical Trials and the Optimization of Individualized Dosing Regimens
title Use of Modeling and Simulation in the Design and Conduct of Pediatric Clinical Trials and the Optimization of Individualized Dosing Regimens
title_full Use of Modeling and Simulation in the Design and Conduct of Pediatric Clinical Trials and the Optimization of Individualized Dosing Regimens
title_fullStr Use of Modeling and Simulation in the Design and Conduct of Pediatric Clinical Trials and the Optimization of Individualized Dosing Regimens
title_full_unstemmed Use of Modeling and Simulation in the Design and Conduct of Pediatric Clinical Trials and the Optimization of Individualized Dosing Regimens
title_short Use of Modeling and Simulation in the Design and Conduct of Pediatric Clinical Trials and the Optimization of Individualized Dosing Regimens
title_sort use of modeling and simulation in the design and conduct of pediatric clinical trials and the optimization of individualized dosing regimens
topic Tutorials
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4716585/
https://www.ncbi.nlm.nih.gov/pubmed/26783499
http://dx.doi.org/10.1002/psp4.12038
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