A Novel Approach to Visualize Risk Minimization Effectiveness: Peeping at the 2012 UK Proton Pump Inhibitor Label Change Using a Rapid Cycle Analysis Tool

Introduction Evaluation of risk minimization (RM) actions is an emerging area of regulatory science, often without tools to rapidly and systematically assess their effectiveness. Purpose The aim of this study was to evaluate whether chronographs, typically used for rapid signal detection in observat...

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Veröffentlicht in:	Drug safety 2019-11, Vol.42 (11), p.1365-1376
Hauptverfasser:	Sobel, Rachel E., Blackwell, William, Fram, David M., Bate, Andrew
Format:	Artikel
Sprache:	eng
Schlagworte:	Adolescent Adult Aged Aged, 80 and over Automation Behavior Biomedical materials Channeling Child Child, Preschool Data Display Drug Labeling Drug Safety and Pharmacovigilance Evaluation Female Fractures Health care Humans Infant Male Measuring instruments Medicine Medicine & Public Health Middle Aged Optimization Original Research Article Osteoporosis Patient safety Pharmacology/Toxicology Pharmacovigilance Product Surveillance, Postmarketing Proton pump inhibitors Proton Pump Inhibitors - adverse effects Protons Regulatory agencies Retrospective Studies Risk Risk assessment Risk Management Risk reduction Signal detection Surveillance United Kingdom Visualization Young Adult
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