Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use

Quantitative pharmacology (QP) applications in translational medicine, drug‐development, and therapeutic use were crowd‐sourced by the ASCPT Impact and Influence initiative. Highlighted QP case studies demonstrated faster access to innovative therapies for patients through 1) rational dose selection...

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Detalles Bibliográficos
Autores principales: Nayak, Satyaprakash, Sander, Oliver, Al‐Huniti, Nidal, de Alwis, Dinesh, Chain, Anne, Chenel, Marylore, Sunkaraneni, Soujanya, Agrawal, Shruti, Gupta, Neeraj, Visser, Sandra A.G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Perspectives
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5838712/
https://www.ncbi.nlm.nih.gov/pubmed/29330855
http://dx.doi.org/10.1002/cpt.978
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author Nayak, Satyaprakash
Sander, Oliver
Al‐Huniti, Nidal
de Alwis, Dinesh
Chain, Anne
Chenel, Marylore
Sunkaraneni, Soujanya
Agrawal, Shruti
Gupta, Neeraj
Visser, Sandra A.G.
author_facet Nayak, Satyaprakash
Sander, Oliver
Al‐Huniti, Nidal
de Alwis, Dinesh
Chain, Anne
Chenel, Marylore
Sunkaraneni, Soujanya
Agrawal, Shruti
Gupta, Neeraj
Visser, Sandra A.G.
author_sort Nayak, Satyaprakash
collection PubMed
description Quantitative pharmacology (QP) applications in translational medicine, drug‐development, and therapeutic use were crowd‐sourced by the ASCPT Impact and Influence initiative. Highlighted QP case studies demonstrated faster access to innovative therapies for patients through 1) rational dose selection for pivotal trials; 2) reduced trial‐burden for vulnerable populations; or 3) simplified posology. Critical success factors were proactive stakeholder engagement, alignment on the value of model‐informed approaches, and utilizing foundational clinical pharmacology understanding of the therapy.
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spelling pubmed-58387122018-03-07 Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use Nayak, Satyaprakash Sander, Oliver Al‐Huniti, Nidal de Alwis, Dinesh Chain, Anne Chenel, Marylore Sunkaraneni, Soujanya Agrawal, Shruti Gupta, Neeraj Visser, Sandra A.G. Clin Pharmacol Ther Perspectives Quantitative pharmacology (QP) applications in translational medicine, drug‐development, and therapeutic use were crowd‐sourced by the ASCPT Impact and Influence initiative. Highlighted QP case studies demonstrated faster access to innovative therapies for patients through 1) rational dose selection for pivotal trials; 2) reduced trial‐burden for vulnerable populations; or 3) simplified posology. Critical success factors were proactive stakeholder engagement, alignment on the value of model‐informed approaches, and utilizing foundational clinical pharmacology understanding of the therapy. John Wiley and Sons Inc. 2018-01-13 2018-03 /pmc/articles/PMC5838712/ /pubmed/29330855 http://dx.doi.org/10.1002/cpt.978 Text en © 2018 The Authors Clinical Pharmacology & Therapeutics 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 Perspectives
Nayak, Satyaprakash
Sander, Oliver
Al‐Huniti, Nidal
de Alwis, Dinesh
Chain, Anne
Chenel, Marylore
Sunkaraneni, Soujanya
Agrawal, Shruti
Gupta, Neeraj
Visser, Sandra A.G.
Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use
title Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use
title_full Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use
title_fullStr Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use
title_full_unstemmed Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use
title_short Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use
title_sort getting innovative therapies faster to patients at the right dose: impact of quantitative pharmacology towards first registration and expanding therapeutic use
topic Perspectives
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5838712/
https://www.ncbi.nlm.nih.gov/pubmed/29330855
http://dx.doi.org/10.1002/cpt.978
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