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...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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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. |
format | Online Article Text |
id | pubmed-7818440 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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