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Brodalumab: 5-Year US Pharmacovigilance Report
IntroductionBrodalumab is a human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult...
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Unveiling the future: precision pharmacovigilance in the era of personalized medicine
In the era of personalized medicine, pharmacovigilance faces new challenges and opportunities, demanding a shift from traditional approaches. This...
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Global trends in pharmacovigilance-related events: a 30-year analysis from the 2019 global burden of disease study
BackgroundEstablishing effective pharmacovigilance systems globally is challenging due to the need for comprehensive epidemiological data on...
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The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System
This article reflects on the 2010 pharmacovigilance legislation of the European Union (EU). Its legislative aim of better patient and public health...
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Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France
IntroductionIn 2021, the massive Covid-19 vaccination campaign in France was accompanied by an intensified pharmacovigilance monitoring of their...
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Current career situations of Chinese pharmacovigilance professionals working for pharmaceutical companies: an exploratory survey
BackgroundPharmacovigilance in China has experienced rapid development in the past 30 years. The implementation of Good Pharmacovigilance Practice in...
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Pharmacovigilance for rare diseases: a bibliometrics and knowledge-map analysis based on web of science
ObjectivesThe aims of this paper is to search and explore publications in the field of pharmacovigilance for rare diseases and to visualize general...
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Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis
Background and ObjectiveIt is unclear which comparator is the most appropriate for bias reduction in disproportionality analyses based on spontaneous...
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Machine Learning in Causal Inference: Application in Pharmacovigilance
Monitoring adverse drug events or pharmacovigilance has been promoted by the World Health Organization to assure the safety of medicines through a...
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Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project
BackgroundTo assess the causal relationship between a medicinal product and a reported event, relevant information needs to be present. Information...
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The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration
In pharmacovigilance, disproportionality analyses based on individual case safety reports are widely used to detect safety signals. Unfortunately,...
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Artificial Intelligence-Based Pharmacovigilance in the Setting of Limited Resources
With the rapid development of artificial intelligence (AI) technologies, and the large amount of pharmacovigilance-related data stored in an...
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Lost in Translation: A Multilingual Survey of Interlinguistic Variations in Terms Used in Pharmacovigilance
IntroductionAlthough English is the universal language of science, it is nevertheless the first language of only about 6% of the world’s population,...
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Intelligent Telehealth in Pharmacovigilance: A Future Perspective
Pharmacovigilance improves patient safety by detecting and preventing adverse drug events. However, challenges exist that limit adverse drug event...
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The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement
Background and aimDisproportionality analyses using reports of suspected adverse drug reactions are the most commonly used quantitative methods for...
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Assessment of pharmacovigilance activities among pharmacist interns in Nigeria: a cross-sectional study
BackgroundPharmacovigilance (PV) and adverse drug reaction (ADR) reporting is at the core of the services and functions of a pharmacist. Pharmacist...
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Postmarketing safety profile of brexanolone: a pharmacovigilance analysis based on FDA Adverse Event Reporting System (FAERS)
ObjectiveBrexanolone (Zulresso®) that was approved for the USA in March 2019 is indicated for the treatment of postpartum depression (PPD), but...
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Association between antidepressant use and delirium in older adults: an analysis of the World Health Organization’s global pharmacovigilance database
BackgroundPsychoactive drugs frequently cause delirium adverse events in older adults. However, few data on the relationship between antidepressants...
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COVID-19 mRNA Vaccines: A Retrospective Observational Pharmacovigilance Study
Background and ObjectiveCoronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus has caused millions of deaths worldwide. The mRNA vaccines...
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Exploring the Relationship Between Atorvastatin and Memory Loss: A Comprehensive Analysis Integrating Real-World Pharmacovigilance and Mendelian Randomization
Background and ObjectiveAtorvastatin is a drug widely used to prevent cardiovascular and cerebrovascular diseases. Current observational studies...
