{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T17:54:42Z","timestamp":1792173282941,"version":"4.4.0"},"reference-count":279,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2023,10,6]],"date-time":"2023-10-06T00:00:00Z","timestamp":1696550400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001871","name":"Funda\u00e7\u00e3o para a Ci\u00eancia e Tecnologia","doi-asserted-by":"publisher","award":["PTDC\/NAN-MAT\/1431\/2021"],"award-info":[{"award-number":["PTDC\/NAN-MAT\/1431\/2021"]}],"id":[{"id":"10.13039\/501100001871","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001871","name":"Funda\u00e7\u00e3o para a Ci\u00eancia e Tecnologia","doi-asserted-by":"publisher","award":["2021.08095.BD"],"award-info":[{"award-number":["2021.08095.BD"]}],"id":[{"id":"10.13039\/501100001871","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.mdpi.com"],"crossmark-restriction":true},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>The paradigm of pediatric drug development has been evolving in a \u201ccarrot-and-stick\u201d-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.<\/jats:p>","DOI":"10.3390\/pharmaceutics15102431","type":"journal-article","created":{"date-parts":[[2023,10,6]],"date-time":"2023-10-06T08:29:12Z","timestamp":1696580952000},"page":"2431","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":65,"title":["Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8432-9839","authenticated-orcid":false,"given":"C\u00e1tia","family":"Domingues","sequence":"first","affiliation":[{"name":"Univ Coimbra, Laboratory of Drug Development and Technologies, Faculty of Pharmacy, 3000-548 Coimbra, Portugal"},{"name":"LAQV-REQUIMTE, Laboratory of Drug Development and Technologies, Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal"},{"name":"Univ Coimbra, Institute for Clinical and Biomedical Research (iCBR) Area of Environment Genetics and Oncobiology (CIMAGO), Faculty of Medicine, 3000-548 Coimbra, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivana","family":"Jarak","sequence":"additional","affiliation":[{"name":"Univ Coimbra, Laboratory of Drug Development and Technologies, Faculty of Pharmacy, 3000-548 Coimbra, Portugal"},{"name":"Institute for Health Research and Innovation (i3s), University of Porto, 4200-135 Porto, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisco","family":"Veiga","sequence":"additional","affiliation":[{"name":"Univ Coimbra, Laboratory of Drug Development and Technologies, Faculty of Pharmacy, 3000-548 Coimbra, Portugal"},{"name":"LAQV-REQUIMTE, Laboratory of Drug Development and Technologies, Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00edlia","family":"Dourado","sequence":"additional","affiliation":[{"name":"Univ Coimbra, Institute for Clinical and Biomedical Research (iCBR) Area of Environment Genetics and Oncobiology (CIMAGO), Faculty of Medicine, 3000-548 Coimbra, Portugal"},{"name":"Univ Coimbra, Center for Health Studies and Research of the University of Coimbra (CEISUC), Faculty of Medicine, 3000-548 Coimbra, Portugal"},{"name":"Univ Coimbra, Center for Studies and Development of Continuous and Palliative Care (CEDCCP), Faculty of Medicine, 3000-548 Coimbra, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8170-1113","authenticated-orcid":false,"given":"Ana","family":"Figueiras","sequence":"additional","affiliation":[{"name":"Univ Coimbra, Laboratory of Drug Development and Technologies, Faculty of Pharmacy, 3000-548 Coimbra, Portugal"},{"name":"LAQV-REQUIMTE, Laboratory of Drug Development and Technologies, Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,10,6]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"780","DOI":"10.1542\/peds.2015-0056","article-title":"Definition of a Pediatrician","volume":"135","author":"Rimsza","year":"2015","journal-title":"Pediatrics"},{"key":"ref_2","unstructured":"Appropriate ICH Expert Working Group (2023, July 12). 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