Model‐Informed Drug Development: Current US Regulatory Practice and Future Considerations

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Items 201–232 of 232

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2. Additional file 3 of Application of systems biology-based in silico tools to optimize treatment strategy identification in Still’s disease
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3. Additional file 1 of Application of systems biology-based in silico tools to optimize treatment strategy identification in Still’s disease
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5. The Significance of Model-Based Strategies in Drug Development throughout the Lifecycle and Regulatory Decision-Making
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6. Modeling and Simulation in Development and Regulatory Approval of Chimeric Antigen Receptor T‐Cell Therapies: An Analysis of European Medicines Agency Centralized Procedures From 2018 to 2024
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7. The Reservoir Effect: Implications for Safety and Regulation of Long-acting Injectables in Psychiatric Care
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8. Mechanistic modeling of allogeneic CAR-T cells and BH3-mimetics in oncology, supported by pharmacometrics software development
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9. Alternative posology for brolucizumab: a 6-week loading regimen is as effective as a 4-week regimen for the treatment of nAMD
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10. Delivery devices and container closure systems for co-formulated and co-administered biologics
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11. Bridging the operational gap in population pharmacokinetic-pharmacodynamic analysis: an international perspective on the 2025 Chinese group standard
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13. A Simulation‐Based Assessment of Dosage Regimen Appropriateness for Multiple Myeloma Medicines Reflecting Demographic and Ethnic Differences
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15. Mechanism-Based Pharmacokinetic and Pharmacodynamic Modeling
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16. Model-Informed Drug Development (MIDD) for Analgesics: Review of Applications, Regulatory Integration, and Emerging Directions
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17. What Machine Learning Adds to Pharmacometrics—and What Mechanistic Information It Risks Removing
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18. Mechanistic Accountability in Hybrid Physiologically Based Pharmacokinetic and Machine-Learning Models for Drug Development
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19. Model‐Informed Decision Making from Drug Discovery to Reimbursement: A Roadmap for Clinical Pharmacology in Value‐Based Healthcare
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20. Pharmacokinetic/Pharmacodynamic Translation and Model‐Informed Drug Development for Oligonucleotide Therapeutics
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21. Application of Model‐Informed Approaches in Neuroscience Drug Development and Regulatory Decision‐Making
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22. The Governance Gap: Democratizing Drug Development Through Decision Architecture
    Craig R. Rayner, Nancy E. Martin, Danielle Smith, Eliza Kruger, Carl M. J. Kirkpatrick, Goonaseelan Colin Pillai, Katy Moore, Darrell Nix, Cristina Donini, Jakob P. Cramer et al. · 2026 · Clinical Pharmacology & Therapeutics
23. A modular Safety-by-Design framework for RNA-LNP prioritization and mechanistically informed biological consistency assessment
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24. Natural language processing for drug discovery
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25. AI-integrated human-relevant alternatives to animal experimentation in drug development: Toward a predictive translational ecosystem, from in vitro and in silico models to clinical and real-world evidence
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26. Pediatric Developmental Safety Assessment and New Approach Methodologies: US FDA/Triangle CERSI Workshop Report
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27. Exposure–Response Relationships Change Meaning When Time, Tolerance, and Disease Progression Interact
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28. A Promising Mechanism Becomes a Medicine Only When Exposure, Biomarkers, and Clinical Context Converge
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29. Evidence Mapping of Model-Informed Drug Development Across Regulatory and Clinical Decisions
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30. Advancing Therapeutics for Children with Medical Complexity: The Role of Model‐Informed Precision Dosing and Genotype‐Stratified Trials
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31. The EMA Qualification Opinion for CYP Inhibition‐Mediated Drug–Drug Interaction Predictions: Implications for PBPK Credibility Assessment in the Era of ICH M15
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32. Mathematical modeling in mRNA therapeutics: towards a pathway to individualized treatment protocols
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