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Therapeutic Innovation & Regulatory Science|March 4, 2023
Evolution of Phase II Oncology Trial Design: from Single Arm to Master ProtocolZiji Yu, Liwen Wu, Veronica Bunn, et al.
Therapeutic Innovation & Regulatory Science|November 24, 2025
In Silico Clinical Trials in Drug Development: A Systematic ReviewBohua Chen, Lucia Chantal Schneider, Christian Röver, et al.
Therapeutic Innovation & Regulatory Science|December 30, 2025
Insights Informing Strategies for Optimizing the Collection of Clinical Trial DataKenneth Getz, Emily Botto, Ana Calduch Arques, et al.
Therapeutic Innovation & Regulatory Science|October 27, 2025
Hurry Up and Wait: Timelines and Takeaways from the Biomarker Qualification ProgramGrace Collins, Jeff D Allen, Hillary S Andrews, et al.
Therapeutic Innovation & Regulatory Science|November 7, 2025
Patient Insights into and Satisfaction with Treatment, Management, and Clinical Research of Hereditary HemochromatosisSonya Abraham, Soraya Benchikh El Fegoun, Matthieu Marty, et al.
Therapeutic Innovation & Regulatory Science|October 27, 2025
Regulatory Performance of African National Medicines Regulatory Authorities Achieving WHO Maturity Level 3: Identifying Best PracticesMercy Owusu-Asante, Delese Mimi Darko, Boitumelo Semete-Makokotieia, et al.
Therapeutic Innovation & Regulatory Science|October 23, 2025
Strategic Drivers Behind Early Withdrawal of Orphan Designations in the EU: A Retrospective Analysis (2000-2024)Luísa Bouwman, Micael Castanheira, Georges Siotis
Therapeutic Innovation & Regulatory Science|October 16, 2025
Quality of Reports on Drug Toxicity in Eudravigilance: A Safety Physician's PerspectiveJana Brajdih Čendak
Therapeutic Innovation & Regulatory Science|June 20, 2020
A Quantitative Study of US FDA Inspection Data for Drug Manufacturing SitesAjay Babu Pazhayattil, Marzena Ingram, Naheed Sayeed
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