dc.contributor
Institut Català de la Salut
dc.contributor
[Parramon-Teixido CJ] Servei de Farmàcia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Departamento de Farmacología, Farmacia y Tecnología Farmacéutica, I+D Farma (GI-1645), Facultad de Farmacia, Instituto de Materiales (iMATUS) and Health Research Institute of Santiago de Compostela (IDIS), Universidade de Santiago de Compostela, Santiago de Compostela, Spain. [Rodríguez-Pombo L, Alvarez-Lorenzo C] Departamento de Farmacología, Farmacia y Tecnología Farmacéutica, I+D Farma (GI-1645), Facultad de Farmacia, Instituto de Materiales (iMATUS) and Health Research Institute of Santiago de Compostela (IDIS), Universidade de Santiago de Compostela, Santiago de Compostela, Spain. [Basit AW] Department of Pharmaceutics, UCL School of Pharmacy, University College London, London, UK. FABRX Ltd, Henwood House, Henwood, Ashford, Kent, UK. FABRX Artificial Inteligente, Santiago de Compostela, Spain. [Worsley A] FABRX Ltd, Henwood House, Henwood, Ashford, Kent, UK. FABRX Artificial Inteligente, Santiago de Compostela, Spain. [Cañete-Ramírez C, Cabañas-Poy MJ] Servei de Farmàcia, Vall d’Hebron Hospital Universitari, Barcelona, Spain
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Basit, Abdul
dc.contributor.author
Worsley, Anna
dc.contributor.author
Cañete-Ramírez, Carme
dc.contributor.author
Alvarez-Lorenzo, Carmen
dc.contributor.author
Parramón-Teixidó, Carlos Javier
dc.contributor.author
Rodríguez Pombo, Lucía
dc.contributor.author
Cabañas Poy, Mª José
dc.date.accessioned
2025-10-24T10:41:22Z
dc.date.available
2025-10-24T10:41:22Z
dc.date.issued
2025-10-16T06:22:13Z
dc.date.issued
2025-10-16T06:22:13Z
dc.identifier
Parramon-Teixido CJ, Rodríguez-Pombo L, Basit AW, Worsley A, Cañete-Ramírez C, Alvarez-Lorenzo C, et al. A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care. Drug Deliv Transl Res. 2025 Sep;15:3078–3097.
dc.identifier
http://hdl.handle.net/11351/13867
dc.identifier
10.1007/s13346-025-01868-y
dc.identifier
001484411900001
dc.identifier.uri
https://hdl.handle.net/11351/13867
dc.description.abstract
3D printing; Paediatrics; Personalized medications
dc.description.abstract
Impresión 3D; Pediatría; Medicamentos personalizados
dc.description.abstract
Impressió 3D; Pediatria; Medicaments personalitzats
dc.description.abstract
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.
dc.description.abstract
Open Access funding provided thanks to the CRUE-CSIC agreement with Springer Nature. MCIN [PID2023-149544OB-C22], FEDER and Xunta de Galicia [ED431C 2024/09].
dc.format
application/pdf
dc.relation
Drug Delivery and Translational Research;15
dc.relation
https://doi.org/10.1007/s13346-025-01868-y
dc.rights
Attribution 4.0 International
dc.rights
http://creativecommons.org/licenses/by/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Medicina personalitzada
dc.subject
Imatgeria tridimensional en medicina
dc.subject
Assaigs clínics
dc.subject
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Precision Medicine
dc.subject
TECHNOLOGY, INDUSTRY, AND AGRICULTURE::Technology, Industry, and Agriculture::Technology::Printing, Three-Dimensional
dc.subject
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics::Clinical Studies as Topic::Clinical Trials as Topic
dc.subject
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::medicina de precisión
dc.subject
TECNOLOGÍA, INDUSTRIA Y AGRICULTURA::tecnología, industria y agricultura::tecnología::impresión tridimensional
dc.subject
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::métodos epidemiológicos::características de los estudios epidemiológicos::estudios clínicos como asunto::ensayos clínicos como asunto
dc.title
A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
