TY - JOUR
T1 - Regulatory Science for Advanced Pharmaceutical Technologies: Evidence Standards for Non-Traditional Dosage Systems
AU - Paolo Ricci
AU - Marco De Luca
AU - Giulia Ferraro
AU - Antonio Russo
JF - EAMD 3
Y1 - 0
VL - 0
IS - 0
SP - 188
N2 - Advanced pharmaceutical technologies are reshaping the meaning of a dosage form. Products such as personalised 3D-printed tablets, long-acting injectable depots, implantable systems, nanoparticulate carriers, and digitally enabled drug-device combinations no longer fit neatly within the traditional categories of tablet, capsule, or simple injection. Their performance depends not only on chemical composition, but also on architecture, spatial distribution, release programming, device function, and sometimes digital feedback. The regulatory challenge is that evidence standards for pharmaceutical products were largely built around assumptions of batch uniformity, reproducible manufacturing, conventional dissolution, standardised stability testing, and population-level bioequivalence. These assumptions remain essential for many products, but they may be insufficient when the dosage form is personalised, structurally heterogeneous, programmable, implantable, or integrated with sensors. This creates uncertainty for both regulators and developers because the critical evidence needed to demonstrate quality, safety, and performance is not always clearly defined. This review critically examines how current regulatory expectations apply to non-traditional dosage systems and where they fail to capture technology-specific risks. It focuses on evidence standards across chemistry, manufacturing, and controls; non-clinical performance testing; clinical evaluation; and post-market evidence generation. The aim is not to propose lower evidentiary thresholds, but to argue for standards that are better aligned with the mechanisms by which advanced dosage systems achieve therapeutic performance. The review concludes that regulatory science must move from a one-size-fits-all model toward a flexible, risk-proportionate system for advanced pharmaceutical technologies. Such a system should preserve high standards for patient protection while allowing evidence requirements to vary according to product complexity, novelty, exposure duration, reversibility, and clinical uncertainty. International coordination, structured regulator-innovator dialogue, and post-market learning will be essential to prevent regulatory evidence standards from lagging behind pharmaceutical innovation.
UR - https://pubsys.eshragh.co/m525744711
ER -