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Therapeutic Innovation & Regulatory Science|March 8, 2025
Regulatory, Translational, and Operational Considerations for the Incorporation of Biomarkers in Drug DevelopmentHeather Hatcher, Simona Stankeviciute, Chris Learn, et al.Therapeutic Innovation & Regulatory Science|March 13, 2025
Development of a Safety Toolkit to Influence Inclusion Barriers for Adolescents and Young Adults (AYA) in Adult Clinical TrialsDevona Williams, Julie Maidment, Pamela Concepcion, et al.Therapeutic Innovation & Regulatory Science|October 20, 2024
A Clustering Ensemble Method for Drug Safety Signal Detection in Post-Marketing SurveillanceShubhadeep Chakraborty, Ram TiwariTherapeutic Innovation & Regulatory Science|October 7, 2024
Pharmacometrics-Enhanced Bayesian Borrowing for Pediatric Extrapolation - A Case Study of the DINAMO TrialMartin Oliver Sailer, Dietmar Neubacher, Curtis Johnston, et al.Therapeutic Innovation & Regulatory Science|August 21, 2024
On the Application of Artificial Intelligence/Machine Learning (AI/ML) in Late-Stage Clinical DevelopmentKarl Köchert, Tim Friede, Michael Kunz, et al.Therapeutic Innovation & Regulatory Science|August 8, 2024
RegionSizeR- A Novel App for Regional Sample Size Planning in MRCTsGuannan Sun, Xin Sun, Huijuan Su, et al.Therapeutic Innovation & Regulatory Science|August 6, 2024
Leveraging Real-World Data in Safety Signal AssessmentVaishali Patadia, Katrin Manlik, Geoffrey Gipson, et al.Therapeutic Innovation & Regulatory Science|July 24, 2024
Draft Guideline for Industry to Manage Drug Shortages in JapanHiroaki Mamiya, Ken-Ichi Izutsu, Daichi MitaniTherapeutic Innovation & Regulatory Science|June 14, 2024
Statistical Analysis for Rating Scale in Clinical TrialsMengyao Shi, Shein-Chung ChowTherapeutic Innovation & Regulatory Science|May 4, 2024
Challenges and Lessons Learned in Autologous Chimeric Antigen Receptor T-Cell Therapy Development from a Statistical PerspectiveDaniel Li, Zhenzhen Xu, Shihua Wen, et al.Pageof 165