RT Journal Article
T1 A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care
A1 Parramón Teixidó, Carlos Javier
A1 Rodríguez Pombo, Lucía
A1 Basit, Abdul W.
A1 Worsley, Anna
A1 Cañete Ramírez, Carme
A1 Álvarez Lorenzo, Carmen
A1 Cabañas Poy, María Josep
A1 Goyanes Goyanes, Álvaro
K1 3D printing
K1 Regulatory
K1 Personalized medications
K1 Paediatrics
K1 Printed pharmaceuticals and formulations
K1 Quality control
AB 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.
PB Springer
SN 2190-393X
YR 2025
FD 2025-05-09
LK https://hdl.handle.net/10347/42477
UL https://hdl.handle.net/10347/42477
LA eng
NO Parramon-Teixido, C.J., Rodríguez-Pombo, L., Basit, A.W. et al. A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care. Drug Deliv. and Transl. Res. (2025). https://doi.org/10.1007/s13346-025-01868-y
NO 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].
DS Minerva
RD 24 abr 2026