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Product Twins, Process Twins, Patient Twins, and Regulatory Twins in Pharmaceutical Digital Twin Systems
Digital twin technology is increasingly used across pharmaceutical science, pharmaceutical manufacturing, precision medicine, and regulatory science. However, the same term is now applied to systems with very different simulated objects, including drug products, manufacturing processes, patients, and regulatory workflows. This semantic expansion has created a need for clearer conceptual organisation. The central problem addressed in this article is that pharmaceutical digital twin research has developed faster than its classification language. A tablet dissolution model, a continuous manufacturing simulator, a virtual patient population, and a compliance-monitoring model may all be described as digital twins, even though they support different decisions and require different validation logics. Without classification, comparison across studies becomes imprecise. This article proposes a four-category taxonomy of pharmaceutical digital twin systems. The categories are Product Twins, Process Twins, Patient Twins, and Regulatory Twins. The classification is grounded in the primary object of simulation and the principal decision function supported by the twin. The proposed taxonomy shows that digital twins should not be treated as a single technological class. Product Twins primarily simulate drug-product behaviour, Process Twins simulate manufacturing operations, Patient Twins simulate therapeutic response in individuals or populations, and Regulatory Twins simulate or support regulatory evaluation and oversight. Distinguishing these categories is a necessary step toward mature pharmaceutical digital twin science.
Journal of Applied Pharmaceutical Technologies and Systems
Original Research | Open access | 10 July 2025 | Article: 182
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Advanced Characterization of Bio-Nano Systems Advanced Drug Delivery Technologies Automation, Robotics and Digitalization in Pharmaceutical Manufacturing Bio-Nano Environmental Monitoring and Remediation Bio-Nano Interfaces and Interactions Bio-Nano Reproducibility, Standardization, Quality and Regulation Bio-Nano Systems Bio-Nano Technologies for Food, Agriculture and Industrial Biotechnology Bio-Nano Translation, Scale-up and Manufacturing Bio-enabled and Bio-inspired Nanoscale Materials Bioactive Scaffolds and Biomimetic Materials Biocompatibility, Biodistribution and Degradation Bioelectronics and Nano-Bioelectronics Biological Information Transfer and Bio-inspired Communication Systems Biologics Manufacturing Technologies Biomaterials Biopharmaceutical Processing and Manufacturing Biosensors, Nanosensors and Bioanalytical Platforms Clinical and Biomedical Technologies Computational Modeling and Simulation of Bio-Nano Systems Controlled, Targeted and Responsive Delivery Platforms Data and Reporting Standards Diagnostic and Therapeutic Applications Drug Delivery Systems Drug Formulation and Dosage-form Development Environmental Fate and Risk Evaluation of Bio-Nano Materials Good Manufacturing Practice (GMP) and Manufacturing Compliance Green Pharmaceutical Engineering and Resource Efficiency Green and Sustainable Synthesis of Nanomaterials Interdisciplinary Health Sciences Lab-on-chip and Micro/Nanofluidic Systems Lyophilization Machine Learning and Data-driven Methods for Bio-Nano Systems Medical and Dental Applications Modeling, Simulation and Computational Methods for Pharmaceutical Processes Molecular and Nanoscale Communication Nano-Bio Imaging and Contrast Agents Nano-enabled Biomedical Technologies Nano-enabled Drug Delivery Nanobiotechnology and Bionanotechnology Nanomaterials for Biomedical and Biological Applications Nanomedicine and Nano-enabled Therapeutic Systems Nanopharmaceuticals Nanotechnology Nanotechnology in Dentistry and Oral Health Nanotoxicology and Bio-Nano Safety Assessment Open Science Optical and Photonic Bio-Nano Systems Pharmaceutical Contamination Control Pharmaceutical Engineering Pharmaceutical Manufacturing Sustainability Pharmaceutical Manufacturing Systems Pharmaceutical Manufacturing Technologies Pharmaceutical Materials and Excipients Pharmaceutical Nanotechnology Pharmaceutical Packaging and Container-closure Systems Pharmaceutical Particle Engineering and Processing Pharmaceutical Process Development Pharmaceutical Process Monitoring and Real-time Quality Assurance Pharmaceutical Process Optimization Pharmaceutical Process Validation Pharmaceutical Production Systems Pharmaceutical Production Technologies Pharmaceutical Quality Control and Quality Assurance Pharmaceutical Regulatory Science and Validation Studies Pharmaceutical Scale-up and Technology Transfer Pharmaceutical Stability, Storage and Cold Chain Pharmaceutical Supply, Distribution, Traceability and Serialization Pharmaceutical Technology Point-of-care Technologies Process Analytical Technology (PAT) Publication Ethics Quality and Production Technologies Quality by Design (QbD) and Design of Experiments Research Integrity Smart Materials with Nanoscale Structure or Function Sterile Manufacturing and Aseptic Processing Theranostics Tissue Engineering and Regenerative Medicine Translational Research Translational and Industrial Pharmaceutical Studies Wearable and Implantable Biointerfaces




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