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In Utero Exposure to Antibiotics and Risk of Serious Infections in the First Year of Life
In Utero Exposure to Antibiotics and Risk of Serious Infections in the First Year of Life
Given the high prevalence of antibiotic prescription during pregnancy in France and previous studies suggesting an increas...
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...
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...
Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems
Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems
Medical science has often used adult males as the standard to establish pathological conditions, their transitions, diagno...
Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study
Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study
The Food and Drug Administration Adverse Event Reporting System (FAERS) is a vital source of new drug safety information, ...
Exploring the Role of Guidelines in Contributing to Medication Errors: A Descriptive Analysis of National Patient Safety Incident Data
Exploring the Role of Guidelines in Contributing to Medication Errors: A Descriptive Analysis of National Patient Safety Incident Data
Clinical guidelines can contribute to medication errors but there is no overall understanding of how and where these occur...
Drug-Drug Interactions Between Glucagon-Like Peptide 1 Receptor Agonists and Oral Medications: A Systematic Review
Drug-Drug Interactions Between Glucagon-Like Peptide 1 Receptor Agonists and Oral Medications: A Systematic Review
Glucagon-like peptide 1 receptor agonists (GLP1RAs) are used in the treatment of diabetes and obesity. Their slowing effec...
Correction to: Patient-Reported Reasons for Antihypertensive Medication Change: A Quantitative Study Using Social Media
Correction to: Patient-Reported Reasons for Antihypertensive Medication Change: A Quantitative Study Using Social Media
Author notesCristina MicalePresent address: Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, ...
Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative
Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative
The elderly demographic is the fastest-growing segment of the world’s population and is projected to exceed 1.5 bill...
Enhancing Transparency in Defining Studied Drugs: The Open-Source Living DiAna Dictionary for Standardizing Drug Names in the FAERS
Enhancing Transparency in Defining Studied Drugs: The Open-Source Living DiAna Dictionary for Standardizing Drug Names in the FAERS
In refining drug safety signals, defining the object of study is crucial. While research has explored the effect of differ...
Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use
Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use
The relative treatment benefit of a drug for patients during development, marketing authorization review, or after approva...
Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project
Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project
To assess the causal relationship between a medicinal product and a reported event, relevant information needs to be prese...
Risk of Major Bleeding Associated with Concomitant Direct-Acting Oral Anticoagulant and Clopidogrel Use: A Retrospective Cohort Study
Risk of Major Bleeding Associated with Concomitant Direct-Acting Oral Anticoagulant and Clopidogrel Use: A Retrospective Cohort Study
Combined anticoagulant-antiplatelet therapy is often indicated in adults with cardiovascular disease and atrial fibrillati...
Appeal for Increasing the Impact of Pharmacovigilance
Appeal for Increasing the Impact of Pharmacovigilance
Pharmacovigilance (PV) is defined as the science and activities related to detecting, assessing, understanding and prevent...
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...
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...
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...
SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes
SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes
Sodium–glucose cotransporter 2 (SGLT2) inhibitors are a relatively new class of antihyperglycemic agents, with the p...
The Unseen Hand: AI-Based Prescribing Decision Support Tools and the Evaluation of Drug Safety and Effectiveness
The Unseen Hand: AI-Based Prescribing Decision Support Tools and the Evaluation of Drug Safety and Effectiveness
The use of artificial intelligence (AI)-based tools to guide prescribing decisions is full of promise and may enhance pati...
The Role of ISoP in the Advancement of Pharmacovigilance in Low-and Middle-Income Countries (LMICs)
The Role of ISoP in the Advancement of Pharmacovigilance in Low-and Middle-Income Countries (LMICs)
In general, poor communication between patients and HCPs is another reason for under-reporting. In addition, poor or ineff...
A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry
A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry
Published data on the safety of natural medical cannabis (MC) when used in the real-world clinical practice setting are la...
An Overview of Regression Models for Adverse Events Analysis
An Overview of Regression Models for Adverse Events Analysis
Over the last few years, several review articles described the adverse events analysis as sub-optimal in clinical trials. ...
Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers
Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers
Adverse drug reactions (ADRs) can be reported by Health Care Professionals (HCPs; e.g., physicians, pharmacists) and non-H...
The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations
The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations
Over the past 2 years, several drugs have been approved for coronavirus disease 2019 (COVID-19) treatment, but their safet...
Cognitive Safety is Largely Ignored in Clinical Drug Trials: A Study of Registered Study Protocols
Cognitive Safety is Largely Ignored in Clinical Drug Trials: A Study of Registered Study Protocols
The number of reports on suspected drug-induced memory impairment submitted to the US Food and Drug Administration increas...