A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care

The integration of 3D printing (3DP) technologies into personalized medicine manufacture at the point-of-care is garnering significant interest due to its potential to create tailored drug products with precise dosages and other unique attributes. Both preclinical and clinical studies have demonstra...

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Autores: Parramón Teixidó, Carlos Javier, Rodríguez Pombo, Lucía, Basit, Abdul W., Worsley, Anna, Cañete Ramírez, Carme, Álvarez Lorenzo, Carmen, Cabañas Poy, María Josep, Goyanes Goyanes, Álvaro
Tipo de recurso: artículo
Fecha de publicación:2025
País:España
Institución:Universidad de Santiago de Compostela (USC)
Repositorio:Minerva. Repositorio Institucional de la Universidad de Santiago de Compostela
Idioma:inglés
OAI Identifier:oai:minerva.usc.gal:10347/42477
Acceso en línea:https://hdl.handle.net/10347/42477
Access Level:acceso abierto
Palabra clave:3D printing
Regulatory
Personalized medications
Paediatrics
Printed pharmaceuticals and formulations
Quality control
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spelling A framework for conducting clinical trials involving 3D printing of medicines at the point-of-careParramón Teixidó, Carlos JavierRodríguez Pombo, LucíaBasit, Abdul W.Worsley, AnnaCañete Ramírez, CarmeÁlvarez Lorenzo, CarmenCabañas Poy, María JosepGoyanes Goyanes, Álvaro3D printingRegulatoryPersonalized medicationsPaediatricsPrinted pharmaceuticals and formulationsQuality controlThe integration of 3D printing (3DP) technologies into personalized medicine manufacture at the point-of-care is garnering significant interest due to its potential to create tailored drug products with precise dosages and other unique attributes. Both preclinical and clinical studies have demonstrated promising outcomes, including pharmacokinetic bioequivalence, improved patient acceptability, enhanced adherence, and the ability to produce consistent, reproducible dosage forms with accurate drug distribution. Some compounding pharmacies around the world are already incorporating 3DP into standard practice for simpler therapeutic treatments. However, further clinical evaluation is required for more complex treatments, such as multi-drug polypills. Conducting clinical trials involving 3DP technologies presents several challenges, including navigating evolving regulatory frameworks, addressing ethical and legal concerns, and complying with new point-of-care manufacturing guidelines. Although regulatory agencies are beginning to adapt their policies to accommodate 3DP, the absence of a comprehensive framework still creates uncertainty for pharmacists and healthcare providers. This article explores the planning and execution of clinical trials involving 3D printed medicines, with a focus on regulatory barriers, patient recruitment, compliance, and the integration of specialized equipment and expertise. It also discusses the implementation of 3DP for personalized drug manufacturing within hospital settings and offers guidance for obtaining clinical trial approval from the Spanish Agency for Medicine and Health Products (AEMPS). By providing these insights and recommendations, this article aims to support international harmonization and facilitate the adoption of 3DP technologies in clinical trials globally.SpringerUniversidade de Santiago de Compostela. Departamento de Farmacoloxía, Farmacia e Tecnoloxía FarmacéuticaUniversidade de Santiago de Compostela. Instituto de Materiais (iMATUS)20252025-05-0920252025-05-09journal articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10347/42477reponame:Minerva. Repositorio Institucional de la Universidad de Santiago de Compostelainstname:Universidad de Santiago de Compostela (USC)InglésengAgencia Estatal de Investigación http://dx.doi.org/10.13039/501100011033 Plan Estatal de Investigación Científica y Técnica y de Innovación 2021-2023 PID2023-149544OB-C22 IMPLEMENTACION CLINICA DE UNA PLATAFORMA INTELIGENTE DE IMPRESION 3D PARA LA OBTENCION DE MEDICAMENTOS INDIVIDUALIZADOSopen accesshttp://purl.org/coar/access_right/c_abf2© The Author(s) 2025. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.o rg/licenses/by/4.0/.http://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:minerva.usc.gal:10347/424772026-06-15T12:47:27Z
dc.title.none.fl_str_mv A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care
title A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care
spellingShingle A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care
Parramón Teixidó, Carlos Javier
3D printing
Regulatory
Personalized medications
Paediatrics
Printed pharmaceuticals and formulations
Quality control
title_short A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care
title_full A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care
title_fullStr A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care
title_full_unstemmed A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care
title_sort A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care
dc.creator.none.fl_str_mv Parramón Teixidó, Carlos Javier
Rodríguez Pombo, Lucía
Basit, Abdul W.
Worsley, Anna
Cañete Ramírez, Carme
Álvarez Lorenzo, Carmen
Cabañas Poy, María Josep
Goyanes Goyanes, Álvaro
author Parramón Teixidó, Carlos Javier
author_facet Parramón Teixidó, Carlos Javier
Rodríguez Pombo, Lucía
Basit, Abdul W.
Worsley, Anna
Cañete Ramírez, Carme
Álvarez Lorenzo, Carmen
Cabañas Poy, María Josep
Goyanes Goyanes, Álvaro
author_role author
author2 Rodríguez Pombo, Lucía
Basit, Abdul W.
Worsley, Anna
Cañete Ramírez, Carme
Álvarez Lorenzo, Carmen
Cabañas Poy, María Josep
Goyanes Goyanes, Álvaro
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universidade de Santiago de Compostela. Departamento de Farmacoloxía, Farmacia e Tecnoloxía Farmacéutica
Universidade de Santiago de Compostela. Instituto de Materiais (iMATUS)
dc.subject.none.fl_str_mv 3D printing
Regulatory
Personalized medications
Paediatrics
Printed pharmaceuticals and formulations
Quality control
topic 3D printing
Regulatory
Personalized medications
Paediatrics
Printed pharmaceuticals and formulations
Quality control
description The integration of 3D printing (3DP) technologies into personalized medicine manufacture at the point-of-care is garnering significant interest due to its potential to create tailored drug products with precise dosages and other unique attributes. Both preclinical and clinical studies have demonstrated promising outcomes, including pharmacokinetic bioequivalence, improved patient acceptability, enhanced adherence, and the ability to produce consistent, reproducible dosage forms with accurate drug distribution. Some compounding pharmacies around the world are already incorporating 3DP into standard practice for simpler therapeutic treatments. However, further clinical evaluation is required for more complex treatments, such as multi-drug polypills. Conducting clinical trials involving 3DP technologies presents several challenges, including navigating evolving regulatory frameworks, addressing ethical and legal concerns, and complying with new point-of-care manufacturing guidelines. Although regulatory agencies are beginning to adapt their policies to accommodate 3DP, the absence of a comprehensive framework still creates uncertainty for pharmacists and healthcare providers. This article explores the planning and execution of clinical trials involving 3D printed medicines, with a focus on regulatory barriers, patient recruitment, compliance, and the integration of specialized equipment and expertise. It also discusses the implementation of 3DP for personalized drug manufacturing within hospital settings and offers guidance for obtaining clinical trial approval from the Spanish Agency for Medicine and Health Products (AEMPS). By providing these insights and recommendations, this article aims to support international harmonization and facilitate the adoption of 3DP technologies in clinical trials globally.
publishDate 2025
dc.date.none.fl_str_mv 2025
2025-05-09
2025
2025-05-09
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/10347/42477
url https://hdl.handle.net/10347/42477
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.relation.none.fl_str_mv Agencia Estatal de Investigación http://dx.doi.org/10.13039/501100011033 Plan Estatal de Investigación Científica y Técnica y de Innovación 2021-2023 PID2023-149544OB-C22 IMPLEMENTACION CLINICA DE UNA PLATAFORMA INTELIGENTE DE IMPRESION 3D PARA LA OBTENCION DE MEDICAMENTOS INDIVIDUALIZADOS
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
http://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Springer
publisher.none.fl_str_mv Springer
dc.source.none.fl_str_mv reponame:Minerva. Repositorio Institucional de la Universidad de Santiago de Compostela
instname:Universidad de Santiago de Compostela (USC)
instname_str Universidad de Santiago de Compostela (USC)
reponame_str Minerva. Repositorio Institucional de la Universidad de Santiago de Compostela
collection Minerva. Repositorio Institucional de la Universidad de Santiago de Compostela
repository.name.fl_str_mv
repository.mail.fl_str_mv
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