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Therapeutic Innovation & Regulatory Science|July 14, 2025
Insights into Support Systems for Orphan Drug Development: A Comparative StudyYe Leng, Yu Tang, Weijie Yu, et al.
Therapeutic Innovation & Regulatory Science|February 14, 2025
Adoption Maturity Model for Risk-based Quality Management (RBQM) in Clinical TrialsMaria Florez, Abigail Dirks, Linda Sullivan, et al.
Therapeutic Innovation & Regulatory Science|December 17, 2024
Inside the Mind of the DMC: A Review of Principles and Issues with Case StudiesLizhao Ge, Toshimitsu Hamasaki, Scott R Evans
Therapeutic Innovation & Regulatory Science|February 7, 2025
Assessment of Local Pharmaceutical Manufacturing Sector in a Low-income Country: A Descriptive StudyTesfa Marew, Anteneh Belete, Frances J Richmond, et al.
Therapeutic Innovation & Regulatory Science|February 26, 2025
Promoting Diversity through an Understanding of Barriers and Drivers for Inclusive Clinical TrialsAnnick de Bruin, Jasmine Masullo, Shalome Sine, et al.
Therapeutic Innovation & Regulatory Science|March 8, 2025
An Evaluation of Time Spent Completing Electronically Collected Patient-Reported Outcomes in Clinical TrialsLucy Andersen, Michael Williams, Sheryl Pease, et al.
Therapeutic Innovation & Regulatory Science|August 31, 2024
Estimand Framework and Statistical Considerations for Integrated Analysis of Clinical Trial Safety DataKatarina Hedman, George Kordzakhia, Hongjian Li, et al.
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