Showing 21 - 40 results of 111 for search '(functional OR function) data analysis (fda)', query time: 0.17s Refine Results
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    Ophthalmic corticosteroids-related adverse events: the FDA adverse event reporting system (FAERS) database pharmacovigilance study by Chengzhi Liu, Xinyu Wang, Xusheng Cao

    Published 2024-12-01
    “…This study aims to investigate the safety profiles of ophthalmic corticosteroids through pharmacovigilance analysis using the FDA Adverse Event Reporting System (FAERS) database.MethodsWe conducted a retrospective analysis of ADR reports related to commonly used ophthalmic corticosteroids from the FAERS database, covering the period from Q1 2004 to Q4 2023. …”
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    Patient-reported outcome claims in European and United States orphan drug approvals by Szymon Jarosławski, Pascal Auquier, Borislav Borissov, Claude Dussart, Mondher Toumi

    Published 2018-01-01
    “…PRO-related language was extracted from the Summaries of Product Characteristics (SmPCs). Data were compared to a previously published analysis of the FDA approvals from the same time period. …”
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    Study Design and Data Analysis of Artificial Pancreas Device Systems with Closed-Loop Glucose-Sensing Insulin Delivery by Sravya B. Shankara, Yujia Liu, Qingfeng Zheng, Jing Guo, Guixia Wang, Bo Zhang

    Published 2021-01-01
    “…The recommendations cover specifics regarding patient population, clinical endpoints, and strategies for data analysis. However, the two pivotal studies that demonstrated the effectiveness of the FDA-approved MiniMed 670G hybrid closed-loop system were not typical randomized controlled trials as per FDA recommendations. …”
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    Functionally important respiratory symptoms and continued cigarette use versus e-cigarette switching: population assessment of tobacco and health study waves 2-6Research in context by James D. Sargent, Kristin Lauten, Kathryn C. Edwards, Susanne E. Tanski, Todd A. MacKenzie, Laura M. Paulin, Mary F. Brunette, Maciej L. Goniewicz, Amanda Malasky, Debra Stark, Fernando B. de Moura, Holly Griffin, Kimberly H. Nguyen, Eric Backlund, Heather L. Kimmel, John H. Kingsbury, Jenny E. Ozga, K Michael Cummings, Andrew Hyland

    Published 2025-01-01
    “…Methods: Longitudinal analysis of data from waves 2–6 (W2–W6; 2014–2021) of the Population Assessment of Tobacco and Health (PATH) Study, an observational cohort study that surveyed 5653 US adults ≥18 years without COPD/chronic bronchitis/emphysema. …”
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