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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
The Extent and Magnitude of Bias in Case-Crossover Studies of Real-World Non-transient Medications Patterns: A Simulation Study with Real-World Examples
A case-crossover study is a self-controlled design most appropriate for evaluating transient medication exposures. However...
Navigating Medical Device Safety: Current Status, Challenges, and Future Regulatory Directions
Navigating Medical Device Safety: Current Status, Challenges, and Future Regulatory Directions
Medical devices are indispensable in modern healthcare. They enable the prevention, diagnosis, and treatment of diseases w...
External Comparator Studies: Performance of Four Missing Data-Handling Approaches, Stratified by Four Different Marginal Estimators
External Comparator Studies: Performance of Four Missing Data-Handling Approaches, Stratified by Four Different Marginal Estimators
Missing data and unmeasured confounding may bias results of external comparator (EC) studies. Previous research quantified...
R Value-Based Criteria Outperform Alkaline Phosphatase Less than Twice Normal in Identifying Hy’s Law Cases in Clinical Trials
R Value-Based Criteria Outperform Alkaline Phosphatase Less than Twice Normal in Identifying Hy’s Law Cases in Clinical Trials
It is unknown whether nR value [(ALT or AST/ULN) ÷ (AP/ULN)] ≥ 5 is better than alkaline phosphatase l...
Exploring the Reliability of Detecting Drug–Drug Interactions that Increase the Risk of Gestational Diabetes in Adverse Event Reporting Systems
Exploring the Reliability of Detecting Drug–Drug Interactions that Increase the Risk of Gestational Diabetes in Adverse Event Reporting Systems
Adverse event reporting systems are an important source of safety signals for drug use in pregnancy, but their usefulness ...
Implementation and Results of Active Vaccine Safety Monitoring During the COVID-19 Pandemic in the UK: A Regulatory Perspective
Implementation and Results of Active Vaccine Safety Monitoring During the COVID-19 Pandemic in the UK: A Regulatory Perspective
Yellow Card Vaccine Monitor (YCVM) was established by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to...
Characteristics and Risk Factors of Medication Incidents Across Stages of Medication Management in Residential Aged Care: A Longitudinal Cohort Study of 5700 Reported Incidents
Characteristics and Risk Factors of Medication Incidents Across Stages of Medication Management in Residential Aged Care: A Longitudinal Cohort Study of 5700 Reported Incidents
Problems with medication management are consistently identified as key concerns for the quality of residential aged care (...
Drugs Withdrawn from the Canadian Market for Safety and Effectiveness Reasons, 1990–2024: A Cross-Sectional Study
Drugs Withdrawn from the Canadian Market for Safety and Effectiveness Reasons, 1990–2024: A Cross-Sectional Study
At times it is necessary to withdraw drugs after they have been approved because of lack of effectiveness or safety concer...
Comparative Risk of Acute Kidney Injury with Piperacillin–Tazobactam Plus Teicoplanin Versus Piperacillin–Tazobactam Plus Vancomycin: A Systematic Review and Meta-Analysis
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...
Algorithms to Identify Major Congenital Malformations in Routinely Collected Healthcare Data: A Systematic Review
Algorithms to Identify Major Congenital Malformations in Routinely Collected Healthcare Data: A Systematic Review
Major congenital malformations (MCMs) are a primary outcome of interest in pregnancy safety studies. This study aimed to i...
Implied ADR-Admissions: A Cohort Study Introducing a Novel Administrative Data Approach for Identifying Drug-Related Hospitalisations
Implied ADR-Admissions: A Cohort Study Introducing a Novel Administrative Data Approach for Identifying Drug-Related Hospitalisations
Adverse drug reactions (ADRs) are a key contributor to unplanned hospitalisations, particularly in patients with polypharm...
Characterizing the FDA Adverse Event Reporting System (FAERS) as a Network to Improve Pattern Discovery
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...
Risk of Systemic Inflammatory Response Syndrome Following Preoperative Glucocorticoids Administration in Patients After Percutaneous Nephrolithotomy: A Retrospective Cohort Study
Risk of Systemic Inflammatory Response Syndrome Following Preoperative Glucocorticoids Administration in Patients After Percutaneous Nephrolithotomy: A Retrospective Cohort Study
Systemic inflammatory response syndrome (SIRS) is one of the most serious complications in patients undergoing percutaneou...
The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally
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...
A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review
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...
Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis
Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis
It is unclear which comparator is the most appropriate for bias reduction in disproportionality analyses based on spontane...
Dipeptidyl Peptidase-4 Inhibitors and the Risk of Gallbladder and Bile Duct Disease Among Patients with Type 2 Diabetes: A Population-Based Cohort Study
Dipeptidyl Peptidase-4 Inhibitors and the Risk of Gallbladder and Bile Duct Disease Among Patients with Type 2 Diabetes: A Population-Based Cohort Study
The use of dipeptidyl peptidase-4 (DPP-4) inhibitors may be associated with an increased risk of gallbladder and bile duct...
Can We Ask ChatGPT About Drug Safety? Appropriateness of ChatGPT Responses to Questions About Drug Use and Adverse Reactions Received by Pharmacovigilance Centers
Can We Ask ChatGPT About Drug Safety? Appropriateness of ChatGPT Responses to Questions About Drug Use and Adverse Reactions Received by Pharmacovigilance Centers
Funding No funding was received to assist in the preparation of thi...
Risk of Mortality Associated with Potentially Inappropriate Medication Use Including Opioids in Older Adults
Risk of Mortality Associated with Potentially Inappropriate Medication Use Including Opioids in Older Adults
As the population ages, understanding the potential risks associated with inappropriate medication use becomes increasingl...
Antipsychotic-Related DRESS Syndrome: Analysis of Individual Case Safety Reports of the WHO Pharmacovigilance Database
Antipsychotic-Related DRESS Syndrome: Analysis of Individual Case Safety Reports of the WHO Pharmacovigilance Database
Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is gaining attention in pharmacovigilance, but its ...
Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry
Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry
Available data regarding the safety and efficacy of sotrovimab in pregnant patients remain limited due to their exclusion ...
Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India
Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India
Evidence on the long-term safety of COVID-19 vaccines is scarce. Here, in continuation of our previously published results...
Predictors of Adverse Drug Reaction-Related Hospitalisations Among People with Dementia: A Retrospective Case-Control Study
Predictors of Adverse Drug Reaction-Related Hospitalisations Among People with Dementia: A Retrospective Case-Control Study
Adverse drug reactions (ADRs) are common among people with dementia; however, little is known about the magnitude and pred...
Post-Conceptional Exposure to Clomiphene Citrate and Congenital Malformations: A Cohort Study
Post-Conceptional Exposure to Clomiphene Citrate and Congenital Malformations: A Cohort Study
Clomiphene citrate is an ovulation inductor for which inadvertent post-conceptional exposures may occur in early pregnancy...
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
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
Lenalidomide, pomalidomide, and thalidomide are effective treatments for multiple myeloma but are teratogenic. To mitigate...
Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making
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...
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 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...
Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies
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...
The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments
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...
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
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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