SCI Abstract

search
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...
Drugs Withdrawn from the Canadian Market for Safety and Effectiveness Reasons, 1990–2024: A Cross-Sectional Study
Drugs Withdrawn from the Canadian Market for Safety and Effectiveness Reasons, 1990–2024: A Cross-Sectional Study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...
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...
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...
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...
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...
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...