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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...
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...
International Trends in Adverse Drug Event-Related Mortality from 2001 to 2019: An Analysis of the World Health Organization Mortality Database from 54 Countries
International Trends in Adverse Drug Event-Related Mortality from 2001 to 2019: An Analysis of the World Health Organization Mortality Database from 54 Countries
Adverse drug events (ADEs) are becoming a significant public health issue. However, reports on ADE-related mortality are l...
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...
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...
Optimizing Signal Management in a Vaccine Adverse Event Reporting System: A Proof-of-Concept with COVID-19 Vaccines Using Signs, Symptoms, and Natural Language Processing
Optimizing Signal Management in a Vaccine Adverse Event Reporting System: A Proof-of-Concept with COVID-19 Vaccines Using Signs, Symptoms, and Natural Language Processing
The Vaccine Adverse Event Reporting System (VAERS) has already been challenged by an extreme increase in the number of ind...
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...
Chronic Obstructive Pulmonary Disease Adverse Event Signals Associated with Potential Inhibitors of Glutathione Peroxidase 1: A Sequence Symmetry Analysis
Chronic Obstructive Pulmonary Disease Adverse Event Signals Associated with Potential Inhibitors of Glutathione Peroxidase 1: A Sequence Symmetry Analysis
Prior molecular modelling analysis identified several medicines as potential inhibitors of glutathione peroxidase 1 (GPx1)...
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...
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