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Therapeutic Innovation & Regulatory Science|September 21, 2024
Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory AuthoritiesTakashi Hosono, Yuki Niwa, Masuo KondohTherapeutic Innovation & Regulatory Science|October 25, 2024
Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) DatabaseSiyuan Gao, Guanhao Zheng, Zhichao He, et al.Therapeutic Innovation & Regulatory Science|October 31, 2024
Pharmaceutical Company's Choices of Indication for the First Clinical Projects in Oncological Drug Development in the United StatesCan Wu, Shunsuke OnoTherapeutic Innovation & Regulatory Science|February 27, 2025
Toward an Extensible Regulatory Framework for N-of-1 to N-of-Few Personalized RNA Therapy DesignMélissa Bou-Jaoudeh, Gabriele Piaton-Breda, Florian Pereme, et al.Therapeutic Innovation & Regulatory Science|February 26, 2025
Designing a Patient Preference Study on Subcutaneous Medical Devices: Incorporating Health Authority Scientific Advice and Patient PerspectivesMarie Picci, Nigel S Cook, Byron Jones, et al.Therapeutic Innovation & Regulatory Science|February 26, 2025
The Data Monitoring Experience in Empagliflozin Randomized Clinical Trials Between 2011 and 2024Francine K Welty, Klaus G Parhofer, Marvin Konstam, et al.Therapeutic Innovation & Regulatory Science|February 25, 2025
Optimizing Quality Tolerance Limits Monitoring in Clinical Trials Through Machine Learning MethodsLei Yan, Ziji Yu, Liwen Wu, et al.Therapeutic Innovation & Regulatory Science|February 10, 2025
Verifying Clinical Benefit of New Anticancer Drugs After Regulatory Approval Based on Exploratory StudiesAkira Ito, Mamoru NarukawaTherapeutic Innovation & Regulatory Science|August 30, 2024
Insights into Early Interactions on Innovative Developments with European RegulatorsDavid W Uster, Valentina Cordo', Emmanuel Cormier, et al.Therapeutic Innovation & Regulatory Science|January 22, 2019
Role of Patients and Parents in Pediatric Drug DevelopmentVivian W L Tsang, Leanne West, Christine Woods, et al.Pageof 165