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SCI Abstract
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The Extent and Magnitude of Bias in Case-Crossover Studies of Real-World Non-transient Medications Patterns: A Simulation Study with Real-World Examples
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Exploring the Reliability of Detecting Drug–Drug Interactions that Increase the Risk of Gestational Diabetes in Adverse Event Reporting Systems
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Implementation and Results of Active Vaccine Safety Monitoring During the COVID-19 Pandemic in the UK: A Regulatory Perspective
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Characteristics and Risk Factors of Medication Incidents Across Stages of Medication Management in Residential Aged Care: A Longitudinal Cohort Study of 5700 Reported Incidents
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Drugs Withdrawn from the Canadian Market for Safety and Effectiveness Reasons, 1990–2024: A Cross-Sectional Study
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Comparative Risk of Acute Kidney Injury with Piperacillin–Tazobactam Plus Teicoplanin Versus Piperacillin–Tazobactam Plus Vancomycin: A Systematic Review and Meta-Analysis
Piperacillin–tazobactam combined with vancomycin is widely employed for broad-spectrum empiric coverage but has been...
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Algorithms to Identify Major Congenital Malformations in Routinely Collected Healthcare Data: A Systematic Review
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Implied ADR-Admissions: A Cohort Study Introducing a Novel Administrative Data Approach for Identifying Drug-Related Hospitalisations
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Characterizing the FDA Adverse Event Reporting System (FAERS) as a Network to Improve Pattern Discovery
In drug-safety monitoring systems, adverse events (AEs) associated with the use of medical products often consist of compl...
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Risk of Systemic Inflammatory Response Syndrome Following Preoperative Glucocorticoids Administration in Patients After Percutaneous Nephrolithotomy: A Retrospective Cohort Study
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The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally
The European Union (EU) regulatory network was at the forefront of the safety monitoring of COVID-19 vaccines during the p...
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A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review
The European Medicines Agency (EMA) maintains a list of designated medical events (DMEs), events that are inherently serio...
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Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis
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Dipeptidyl Peptidase-4 Inhibitors and the Risk of Gallbladder and Bile Duct Disease Among Patients with Type 2 Diabetes: A Population-Based Cohort Study
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Can We Ask ChatGPT About Drug Safety? Appropriateness of ChatGPT Responses to Questions About Drug Use and Adverse Reactions Received by Pharmacovigilance Centers
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Risk of Mortality Associated with Potentially Inappropriate Medication Use Including Opioids in Older Adults
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Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry
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Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India
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Predictors of Adverse Drug Reaction-Related Hospitalisations Among People with Dementia: A Retrospective Case-Control Study
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Post-Conceptional Exposure to Clomiphene Citrate and Congenital Malformations: A Cohort Study
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Trends in Use and Evidence of Adherence to Risk Evaluation and Mitigation Strategy Pregnancy Testing Requirements for Thalidomide, Lenalidomide, and Pomalidomide in the USA, 2000–2020
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Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making
Pharmacovigilance involves a continuous process of evaluating, monitoring and communicating the safety profile of a medici...
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Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study
Effectiveness and respiratory adverse events following coronavirus disease-2019 (COVID-19) vaccines have not been well inv...
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Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies
For signal detection studies investigating either drug safety or method evaluation, the choice of drug-outcome pairs needs...
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The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments
Health technology assessment (HTA) is a multidisciplinary process that determines the value of health technology at differ...
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Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project
The ConcePTION project aims to improve the way medication use during pregnancy is studied. This includes exploring the pos...
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