Collection
Drug Safety
A collection of articles that are relevant to drug safety professionals.
Articles (28 in this collection)
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Physician Awareness of the Safe Use of Cyproterone Acetate in Europe: A Survey on the Effectiveness of Additional Risk Minimization Measures
Authors (first, second and last of 8)
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Rare Immune-Related Adverse Events (irAEs): Approach to Diagnosis and Management
Authors (first, second and last of 4)
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Evaluation of Physician Knowledge of Safety and Safe Use Information for Intravitreal Aflibercept Injection in Europe: A Second Survey of Physicians Following Dissemination of Updated Risk-Minimization Materials
Authors (first, second and last of 12)
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Strengthening the Pharmacovigilance System in Mexico: Implementation of VigiFlow and VigiLyze, as ICSR and Signal Detection Management Systems
Authors (first, second and last of 6)
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Recognition of Coroners’ Concerns to Prevent Future Deaths from Medicines: A Systematic Review
Authors (first, second and last of 6)
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A Science-Based Methodology Framework for the Assessment of Combination Safety Risks in Clinical Trials
Authors (first, second and last of 5)
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Value and Implementation of the Aggregate Safety Assessment Plan
Authors (first, second and last of 6)
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The Use of Artificial Intelligence in Pharmacovigilance: A Systematic Review of the Literature
Authors (first, second and last of 8)
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A Structured Methodology to Assess Safety Signal Strength and Inform Causality Assessment
Authors (first, second and last of 5)
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Potential Channeling Bias in the Evaluation of Cardiovascular Risk: The Importance of Comparator Selection in Observational Research
Authors (first, second and last of 7)
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Global Landscape of Benefit–Risk Considerations for Medicinal Products: Current State and Future Directions
Authors (first, second and last of 8)
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An Industry Survey on Managing the Pharmacovigilance System Master File in a Global Environment: The Need for a Pragmatic Approach
Authors (first, second and last of 7)
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Chaos to Clarity: Pragmatic Approaches to Overcome Challenges for Successful Implementation of Additional Risk Minimisation Measures in the European Union and the UK by a Marketing Authorisation Holder
Authors (first, second and last of 4)
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Digital Additional Risk Minimization Measures: An Exploratory Study Using Qualitative Feedback from Healthcare Professionals and Patients Across Six Countries
Authors (first, second and last of 6)
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Effectiveness of Additional Risk Minimization Measures for Atezolizumab in the European Union
Authors (first, second and last of 11)
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Leveraging Case Narratives to Enhance Patient Age Ascertainment from Adverse Event Reports
Authors (first, second and last of 8)
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Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe
Authors (first, second and last of 4)
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Building a Data Linkage Foundation for Mother–Child Pharmacoepidemiology Research
Authors (first, second and last of 7)
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A Comprehensive Methodology to Systematically Identify Drug Hypersensitivity and Anaphylactic Reactions in Clinical Trial Databases
Authors (first, second and last of 6)
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Electronic Reporting Systems in Pharmacovigilance: The Implementation of VigiFlow in Brazil
Authors (first, second and last of 9)
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Automation Opportunities in Pharmacovigilance: An Industry Survey
Authors (first, second and last of 6)
