Drug Dosing Recommendations for All Patients: A Roadmap for Change

Most drug labels do not contain dosing recommendations for a significant portion of real‐world patients for whom the drug is prescribed. Current label recommendations predominately reflect the population studied in pivotal trials that typically exclude patients who are very young or old, emaciated o...

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Autores principales: Powell, J. Robert, Cook, Jack, Wang, Yaning, Peck, Richard, Weiner, Dan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7818440/
https://www.ncbi.nlm.nih.gov/pubmed/32453862
http://dx.doi.org/10.1002/cpt.1923
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author Powell, J. Robert
Cook, Jack
Wang, Yaning
Peck, Richard
Weiner, Dan
author_facet Powell, J. Robert
Cook, Jack
Wang, Yaning
Peck, Richard
Weiner, Dan
author_sort Powell, J. Robert
collection PubMed
description Most drug labels do not contain dosing recommendations for a significant portion of real‐world patients for whom the drug is prescribed. Current label recommendations predominately reflect the population studied in pivotal trials that typically exclude patients who are very young or old, emaciated or morbidly obese, pregnant, or have multiple characteristics likely to influence dosing. As a result, physicians may need to guess the correct dose and regimen for these patients. It is now feasible to provide dose and regimen recommendations for these patients by integrating available scientific knowledge and by utilizing or modifying current regulatory agency‐industry practices. The purpose of this commentary is to explore several factors that should be considered in creating a process that will provide more effective, safe, and timely drug dosing recommendations for most, if not all, patients. These factors include the availability of real‐world data, development of predictive models, experience with the US Food and Drug Administration (FDA)’s pediatric exclusivity program, development of clinical decision software, funding mechanisms like the Prescription Drug Users Fee Act (PDUFA), and harmonization of global regulatory policies. From an examination of these factors, we recommend a relatively simple, efficient expansion of current practices designed to predict, confirm, and continuously improve drug dosing for more patients. We believe implementing these recommendations will benefit patients, payers, industry, and regulatory agencies.
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spelling pubmed-78184402021-01-29 Drug Dosing Recommendations for All Patients: A Roadmap for Change Powell, J. Robert Cook, Jack Wang, Yaning Peck, Richard Weiner, Dan Clin Pharmacol Ther White Papers Most drug labels do not contain dosing recommendations for a significant portion of real‐world patients for whom the drug is prescribed. Current label recommendations predominately reflect the population studied in pivotal trials that typically exclude patients who are very young or old, emaciated or morbidly obese, pregnant, or have multiple characteristics likely to influence dosing. As a result, physicians may need to guess the correct dose and regimen for these patients. It is now feasible to provide dose and regimen recommendations for these patients by integrating available scientific knowledge and by utilizing or modifying current regulatory agency‐industry practices. The purpose of this commentary is to explore several factors that should be considered in creating a process that will provide more effective, safe, and timely drug dosing recommendations for most, if not all, patients. These factors include the availability of real‐world data, development of predictive models, experience with the US Food and Drug Administration (FDA)’s pediatric exclusivity program, development of clinical decision software, funding mechanisms like the Prescription Drug Users Fee Act (PDUFA), and harmonization of global regulatory policies. From an examination of these factors, we recommend a relatively simple, efficient expansion of current practices designed to predict, confirm, and continuously improve drug dosing for more patients. We believe implementing these recommendations will benefit patients, payers, industry, and regulatory agencies. John Wiley and Sons Inc. 2020-07-12 2021-01 /pmc/articles/PMC7818440/ /pubmed/32453862 http://dx.doi.org/10.1002/cpt.1923 Text en © 2020 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the 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 White Papers
Powell, J. Robert
Cook, Jack
Wang, Yaning
Peck, Richard
Weiner, Dan
Drug Dosing Recommendations for All Patients: A Roadmap for Change
title Drug Dosing Recommendations for All Patients: A Roadmap for Change
title_full Drug Dosing Recommendations for All Patients: A Roadmap for Change
title_fullStr Drug Dosing Recommendations for All Patients: A Roadmap for Change
title_full_unstemmed Drug Dosing Recommendations for All Patients: A Roadmap for Change
title_short Drug Dosing Recommendations for All Patients: A Roadmap for Change
title_sort drug dosing recommendations for all patients: a roadmap for change
topic White Papers
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7818440/
https://www.ncbi.nlm.nih.gov/pubmed/32453862
http://dx.doi.org/10.1002/cpt.1923
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