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Therapeutic Innovation & Regulatory Science|June 10, 2022
Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in EuropeZachary Smith, Emily Botto, Kenneth GetzTherapeutic Innovation & Regulatory Science|June 10, 2022
Changes in Companion Diagnostic Labelling: Implementation of FDA's April 2020 Guidance for Industry for In Vitro CDx Labeling for Specific Oncology Therapeutic GroupsLisa Cooper, Joyce ChenTherapeutic Innovation & Regulatory Science|October 11, 2021
A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in ChinaNeal E Storm, Wen Chang, Tzu-Chieh Lin, et al.Therapeutic Innovation & Regulatory Science|July 18, 2019
Impact of FDA-Required Cardiovascular Outcome Trials on Type 2 Diabetes Clinical Study Initiation From 2008 to 2017Cameron M Kieffer, Andrew S RobertsonTherapeutic Innovation & Regulatory Science|July 18, 2019
Analyzing Upward Deviation of Actual vs Predicted Drug Sales in Japan for a Reasonable Drug-Pricing PolicyShoyo Shibata, Daigo Fukumoto, Takeshi Suzuki, et al.Therapeutic Innovation & Regulatory Science|July 16, 2019
Development and Validation of a Brief Measure of Self-Management Competence: The Self-Management Self-Test (SMST)Peter M Wehmeier, Theresa Fox, Johanna M Doerr, et al.Therapeutic Innovation & Regulatory Science|April 23, 2024
Unlocking the Potential: A Systematic Review of Master Protocol in PediatricsYimei Li, Robert Nelson, Rima Izem, et al.Therapeutic Innovation & Regulatory Science|April 18, 2024
Safety of Linagliptin in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Clinical TrialsHadir Aljohani, Fares S Alrubaish, Waad M Alghamdi, et al.Therapeutic Innovation & Regulatory Science|April 5, 2016
Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and MonitoringJ Stewart, W J Breslin, B K Beyer, et al.Therapeutic Innovation & Regulatory Science|September 12, 2017
Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons LearnedHaihao Sun, Jean W Temeck, Wiley Chambers, et al.Pageof 165