Sistema de Salut de Catalunya
Institut Català de la Salut
[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
Vall d'Hebron Barcelona Hospital Campus
2025-10-16T06:22:13Z
2025-10-16T06:22:13Z
2025-09
3D printing; Paediatrics; Personalized medications
Impresión 3D; Pediatría; Medicamentos personalizados
Impressió 3D; Pediatria; Medicaments personalitzats
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.
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].
Article
Published version
English
Medicina personalitzada; Imatgeria tridimensional en medicina; Assaigs clínics; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Precision Medicine; TECHNOLOGY, INDUSTRY, AND AGRICULTURE::Technology, Industry, and Agriculture::Technology::Printing, Three-Dimensional; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics::Clinical Studies as Topic::Clinical Trials as Topic; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::medicina de precisión; TECNOLOGÍA, INDUSTRIA Y AGRICULTURA::tecnología, industria y agricultura::tecnología::impresión tridimensional; 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
Springer
Drug Delivery and Translational Research;15
https://doi.org/10.1007/s13346-025-01868-y
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
Articles científics - HVH [3440]
