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Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies
The paradigm of pediatric drug development has been evolving in a “carrot-and-stick”-based tactic to address population-specific issues. However, the off-label prescription of adult medicines to pediatric patients remains a feature of clinical practice, which may compromise the age-appropriate evalu...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10610377/ https://www.ncbi.nlm.nih.gov/pubmed/37896191 http://dx.doi.org/10.3390/pharmaceutics15102431 |
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author | Domingues, Cátia Jarak, Ivana Veiga, Francisco Dourado, Marília Figueiras, Ana |
author_facet | Domingues, Cátia Jarak, Ivana Veiga, Francisco Dourado, Marília Figueiras, Ana |
author_sort | Domingues, Cátia |
collection | PubMed |
description | The paradigm of pediatric drug development has been evolving in a “carrot-and-stick”-based tactic to address population-specific issues. However, the off-label prescription of adult medicines to pediatric patients remains a feature of clinical practice, which may compromise the age-appropriate evaluation of treatments. Therefore, the United States and the European Pediatric Formulation Initiative have recommended applying nanotechnology-based delivery systems to tackle some of these challenges, particularly applying inorganic, polymeric, and lipid-based nanoparticles. Connected with these, advanced therapy medicinal products (ATMPs) have also been highlighted, with optimistic perspectives for the pediatric population. Despite the results achieved using these innovative therapies, a workforce that congregates pediatric patients and/or caregivers, healthcare stakeholders, drug developers, and physicians continues to be of utmost relevance to promote standardized guidelines for pediatric drug development, enabling a fast lab-to-clinical translation. Therefore, taking into consideration the significance of this topic, this work aims to compile the current landscape of pediatric drug development by (1) outlining the historic regulatory panorama, (2) summarizing the challenges in the development of pediatric drug formulation, and (3) delineating the advantages/disadvantages of using innovative approaches, such as nanomedicines and ATMPs in pediatrics. Moreover, some attention will be given to the role of pharmaceutical technologists and developers in conceiving pediatric medicines. |
format | Online Article Text |
id | pubmed-10610377 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-106103772023-10-28 Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies Domingues, Cátia Jarak, Ivana Veiga, Francisco Dourado, Marília Figueiras, Ana Pharmaceutics Review The paradigm of pediatric drug development has been evolving in a “carrot-and-stick”-based tactic to address population-specific issues. However, the off-label prescription of adult medicines to pediatric patients remains a feature of clinical practice, which may compromise the age-appropriate evaluation of treatments. Therefore, the United States and the European Pediatric Formulation Initiative have recommended applying nanotechnology-based delivery systems to tackle some of these challenges, particularly applying inorganic, polymeric, and lipid-based nanoparticles. Connected with these, advanced therapy medicinal products (ATMPs) have also been highlighted, with optimistic perspectives for the pediatric population. Despite the results achieved using these innovative therapies, a workforce that congregates pediatric patients and/or caregivers, healthcare stakeholders, drug developers, and physicians continues to be of utmost relevance to promote standardized guidelines for pediatric drug development, enabling a fast lab-to-clinical translation. Therefore, taking into consideration the significance of this topic, this work aims to compile the current landscape of pediatric drug development by (1) outlining the historic regulatory panorama, (2) summarizing the challenges in the development of pediatric drug formulation, and (3) delineating the advantages/disadvantages of using innovative approaches, such as nanomedicines and ATMPs in pediatrics. Moreover, some attention will be given to the role of pharmaceutical technologists and developers in conceiving pediatric medicines. MDPI 2023-10-06 /pmc/articles/PMC10610377/ /pubmed/37896191 http://dx.doi.org/10.3390/pharmaceutics15102431 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Review Domingues, Cátia Jarak, Ivana Veiga, Francisco Dourado, Marília Figueiras, Ana Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies |
title | Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies |
title_full | Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies |
title_fullStr | Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies |
title_full_unstemmed | Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies |
title_short | Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies |
title_sort | pediatric drug development: reviewing challenges and opportunities by tracking innovative therapies |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10610377/ https://www.ncbi.nlm.nih.gov/pubmed/37896191 http://dx.doi.org/10.3390/pharmaceutics15102431 |
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