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Therapeutic Innovation & Regulatory Science|October 10, 2025
Regulatory Experiences with the Use of Multiple Imputation for Missing Data in a Phase 3 Confirmatory TrialMouna Sassi-Sayadi, Pierre Verweij, Peter CornelisseTherapeutic Innovation & Regulatory Science|October 4, 2025
A Review of Trials for Unsuccessful Pediatric Drug Development Programs Submitted to the US Food and Drug Administration 2015-2022Sherbet Samuels, Mark Seaton, Susan M Abdel-Rahman, et al.Therapeutic Innovation & Regulatory Science|August 16, 2025
Adaptive Design with Bayesian Informed Interim Decisions: Application To a Randomized Trial of Mechanical Circulatory SupportR Mukherjee, N Muehlemann, Y Gao, et al.Therapeutic Innovation & Regulatory Science|August 16, 2025
Impact of Protocol Amendments, Personnel Experience and Social Determinants of Health on Study Protocol Adherence in Clinical Trials with Combination ProductsK N Cilley, A O Kaliaev, M A MalikovaTherapeutic Innovation & Regulatory Science|August 7, 2025
Advancing Global Harmonization: Implementing Global Dose Form Attributes for Medicinal Products IdentificationEmelie Ahnfelt, Olof Lagerlund, Jenny Klint, et al.Therapeutic Innovation & Regulatory Science|February 17, 2026
Assumption-Agnostic Deep Learning Framework for Holistic Clinical Trial MonitoringShaoming Yin, Zheyang Wu, Jianchang LinTherapeutic Innovation & Regulatory Science|February 3, 2023
Challenges in Implementing Futility Schemes, with Reference to AducanumabPaul Gallo, Satrajit RoychoudhuryTherapeutic Innovation & Regulatory Science|February 11, 2026
Ensuring Integrity of the Medicaid Drug Rebate ProgramPriyanka A Abraham, Joseph T Kannarkat, Benjamin N Rome, et al.Therapeutic Innovation & Regulatory Science|February 3, 2026
Hierarchical Transit Compartment Model to Describe Absorption Delay in Orally Administered Drugs in Heterogeneous PopulationsAbhisek Chakraborty, Anirban ChakrabortyTherapeutic Innovation & Regulatory Science|August 2, 2025
Enhancing Development Strategies Through Early Scientific Advice from HTA Agencies-Experiences, Expectations and Best Practices from Health Technology DevelopersTing Wang, Neil McAuslanePageof 165