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Therapeutic Innovation & Regulatory Science|June 20, 2020
Principles and Considerations for Responsible Sharing of Safety Information Via the Medical Information ChannelSashka Hristoskova, James Milligan, Jan De Wit, et al.Therapeutic Innovation & Regulatory Science|June 24, 2020
Spatial-Cluster Signal Detection in Medical Devices Using Likelihood Ratio Test MethodTingting Hu, Lan Huang, Jianjin Xu, et al.Therapeutic Innovation & Regulatory Science|June 25, 2020
Bayesian Meta-analysis of Safety Outcomes Using Blinded Clinical Trial DataEmily Goren, Li-An Lin, Robert O Blaustein, et al.Therapeutic Innovation & Regulatory Science|May 24, 2021
Proof of Concept: Drug Selection? Or Dose Selection? Thoughts on Multiplicity IssuesQian H Li, Qiqi Deng, Naitee TingTherapeutic Innovation & Regulatory Science|September 9, 2021
Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development PlansDominik Karres, Gregory Reaman, Franca Ligas, et al.Therapeutic Innovation & Regulatory Science|November 10, 2022
Analyzing Longitudinal Data from Glaucoma TrialsPhillip DinhTherapeutic Innovation & Regulatory Science|December 2, 2022
Bayesian Methods in Human Drug and Biological Products Development in CDER and CBERAlexei C Ionan, Jennifer Clark, James Travis, et al.Therapeutic Innovation & Regulatory Science|November 26, 2022
Analysis of Off-target Effects and Risk Assessment Leading from Preclinical to Clinical Trials of Gene-edited Therapeutic ProductsNaoki Yamada, Atsushi ArugaTherapeutic Innovation & Regulatory Science|January 18, 2023
Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices' Post-Market SurveillanceYijun Ren, Michele Bertoldi, Alan G Fraser, et al.Therapeutic Innovation & Regulatory Science|December 23, 2022
Changes in Medication Use During Pregnancy for Women with Chronic Conditions: An Analysis of Claims DataRohini K Hernandez, Sonja S Nakasian, Lisa Bollinger, et al.Pageof 165