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Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007–2020)
Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007–2020)
Surveys are commonly used to assess effectiveness of FDA-required risk evaluation and mitigation strategies (REMS) for dru...
An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance
An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance
During the signal detection process, statistical methods are used to identify drug–event combinations (DECs) which a...
Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient’s Perspective
Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient’s Perspective
There is a need for more extensive information about adverse drug reactions (ADRs) for patients than currently available, ...
Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand
Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand
In February 2021, New Zealand began its largest ever immunisation programme with the BNT162b2 mRNA coronavirus disease 201...
Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database
Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database
Previous pre-clinical and pharmacovigilance disproportionality analyses highlighted a safety signal of cutaneous ulcer wit...
The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls
The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls
Although relevant for precision pharmacovigilance, there are conflicting data on whether former preterm birth is associate...
Managing Cardiovascular and Cancer Risk Associated with JAK Inhibitors
Managing Cardiovascular and Cancer Risk Associated with JAK Inhibitors
Janus kinase inhibitors (JAKi) have enormous appeal as immune-modulating therapies across many chronic inflammatory diseas...
Disproportionality Analysis of Abemaciclib in the FDA Adverse Event Reporting System: A Real-World Post-Marketing Pharmacovigilance Assessment
Disproportionality Analysis of Abemaciclib in the FDA Adverse Event Reporting System: A Real-World Post-Marketing Pharmacovigilance Assessment
Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy in women with hormone receptor-positive, h...
Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study
Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study
Disproportionality analysis is traditionally used in spontaneous reporting systems to generate working hypotheses about po...
Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study
Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study
The ProCID study evaluated the efficacy and safety of three doses of a 10% liquid intravenous immunoglobulin (IVIg) prepar...
Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review
Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review
Pharmacovigilance programs protect patient health and safety by identifying adverse event signals through postmarketing su...
Cardiovascular Toxicity of Immune Checkpoint Inhibitors: A Guide for Clinicians
Cardiovascular Toxicity of Immune Checkpoint Inhibitors: A Guide for Clinicians
Immune checkpoint inhibitors (ICIs) have revolutionized the treatment and care of patients with cancer owing to unique fea...
Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance
Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance
Vaccine safety surveillance commonly includes a serial testing approach with a sensitive method for ‘signal generati...
Future of ChatGPT in Pharmacovigilance
Future of ChatGPT in Pharmacovigilance
Developed by OpenAI, ChatGPT is a sophisticated large language model (LLM) capable of...
Nephrotoxicity of Amoxicillin and Third-Generation Cephalosporins: An Updated Review
Nephrotoxicity of Amoxicillin and Third-Generation Cephalosporins: An Updated Review
Because of their broad-spectrum bactericidal activity, amoxicillin (AMX) and third-generation cephalosporins (TGC) are wid...
Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update
Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update
Underreporting is a major limitation of the voluntary reporting system of adverse drug reactions (ADRs). A 2009 systematic...