A Real‐World Pharmacovigilance Study of Fruquintinib Based on the FDA Adverse Event Reporting System (FAERS) Database
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DOI: 10.1002/cam4.71352
Abstract: Fruquintinib is a highly selective small‐molecule inhibitor that targets vascular endothelial growth factor receptors and is approved for the treatment of metastatic colorectal cancer. Given its increasing clinical adoption, a comprehensive pharmacovigilance evaluation of the… read more here.
Keywords: world pharmacovigilance; study fruquintinib; real world; fruquintinib based ... See more keywords
Immune checkpoint inhibitor‐induced vitiligo: A large‐scale real world pharmacovigilance study
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DOI: 10.1002/ijc.70159
Abstract: Although immune checkpoint inhibitors (ICI) have revolutionized cancer treatment paradigms, the associated immune‐related adverse events (irAEs)—specifically vitiligo, which has demonstrated emerging prognostic significance—require further investigation. Using the FAERS database (2015Q1–2024Q3), we conducted a large‐scale pharmacovigilance… read more here.
Keywords: cancer; immune checkpoint; pharmacovigilance; large scale ... See more keywords
Biases associated with epidermal necrolysis reporting in pharmacovigilance: An exploratory analysis using World Health Organization VigiBase
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DOI: 10.1002/pds.5399
Abstract: Possible biases in pharmacovigilance reporting may impact epidermal necrolysis (EN) and drugs associations. read more here.
Keywords: pharmacovigilance; epidermal necrolysis; biases associated; associated epidermal ... See more keywords
Artificial intelligence in pharmacovigilance: Do we need explainability?
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DOI: 10.1002/pds.5501
Abstract: With increasing deployment of complex and opaque machine learning algorithms (black boxes) to make decisions in areas that profoundly affect individuals such as underwriting, judicial sentencing, and robotic driving, are increasing calls for explanations of… read more here.
Keywords: explainability; black boxes; intelligence pharmacovigilance; artificial intelligence ... See more keywords
A global view of undergraduate education in pharmacovigilance
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DOI: 10.1007/s00228-017-2237-z
Abstract: PurposeThe aim of this study was to gain insight in current pharmacovigilance educational activities and to gather information on which topics should be included in the undergraduate pharmacovigilance core curriculum.MethodA web-based questionnaire was carried out… read more here.
Keywords: core curriculum; view undergraduate; undergraduate education; global view ... See more keywords
Infections associated with ruxolitinib: study in the French Pharmacovigilance database
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DOI: 10.1007/s00277-018-3242-8
Abstract: Dear Editor, Ruxolitinib, an orally bioavailable potent and selective inhibitor of Janus kinases (JAKs) 1 and 2, has been approved in Europe for the treatment of myelofibrosis and polycythemia vera. Ruxolitinib improves disease-related constitutional symptoms,… read more here.
Keywords: ruxolitinib; french pharmacovigilance; pharmacovigilance database; myelofibrosis ... See more keywords
Targeted therapies and adverse drug reactions in oncology: the role of clinical pharmacist in pharmacovigilance
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DOI: 10.1007/s11096-018-0653-5
Abstract: Background The majority of adverse drug reactions (ADRs) reported in the summary of product characteristics (SPCs) are based on pivotal clinical trials, performed under controlled conditions and with selected patients. Objectives (1) to observe ADRs… read more here.
Keywords: drug reactions; pharmacist; pharmacovigilance; adverse drug ... See more keywords
Current trends in pharmacovigilance: value and gaps of patient reporting
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DOI: 10.1007/s11096-018-0689-6
Abstract: The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any drug-related problems [1]. Broadly speaking, this definition relates to a… read more here.
Keywords: current trends; patient reporting; value; drug ... See more keywords
Developing a Crowdsourcing Approach and Tool for Pharmacovigilance Education Material Delivery
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DOI: 10.1007/s40264-016-0495-9
Abstract: The number of pharmacovigilance professionals worldwide is increasing with a high staff turnover. There is a constant stream of new colleagues with an interest or need to learn about the discipline. Consequently, there is an… read more here.
Keywords: education material; tool; pharmacovigilance education; pharmacovigilance ... See more keywords
The New Phase of ISoP
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DOI: 10.1007/s40264-017-0545-y
Abstract: The International Society of Pharmacovigilance (ISoP) underwent transformation last year when members adopted new statutes and elected a new leadership. Reform of ISoP was initiated by the previous Executive Committee (EC) and later ratified at… read more here.
Keywords: pharmacovigilance; new phase; society; phase isop ... See more keywords
Using Multiple Pharmacovigilance Models Improves the Timeliness of Signal Detection in Simulated Prospective Surveillance
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DOI: 10.1007/s40264-017-0555-9
Abstract: IntroductionProspective pharmacovigilance aims to rapidly detect safety concerns related to medical products. The exposure model selected for pharmacovigilance impacts the timeliness of signal detection. However, in most real-life pharmacovigilance studies, little is known about which… read more here.
Keywords: exposure; model; timeliness signal; pharmacovigilance ... See more keywords