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Safety Surveillance During Drug Development: Comparative Evaluation of Existing Regulations
Drug safety monitoring is essential for develo** efficient and safe treatments. It starts with preclinical toxicology studies and continues with...
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A Pilot, Predictive Surveillance Model in Pharmacovigilance Using Machine Learning Approaches
IntroductionThe identification of a new adverse event (AE) caused by a drug product is one of the key activities in the pharmaceutical industry to...
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Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance
IntroductionAs part of routine safety surveillance, thousands of articles of potential interest are manually triaged for review by safety...
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Use of the Sentinel System to Examine Medical Product Use and Outcomes During Pregnancy
While many pregnant individuals use prescription medications, evidence supporting product safety during pregnancy is often inadequate. Existing...
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Spatial multi-criteria decision analysis for the selection of sentinel regions in tick-borne disease surveillance
BackgroundThe implementation of cost-effective surveillance systems is essential for tracking the emerging risk of tick-borne diseases. In Canada,...
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Evaluation of an Infection surveillance program in residential aged care facilities in Victoria, Australia
BackgroundInfection surveillance is a key element of infection prevention and control activities in the aged care sector. In 2017, a standardised...
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Two decades of nonfatal injury data: a sco** review of the National Electronic Injury Surveillance System-All Injury Program, 2001–2021
BackgroundInjury is a leading cause of preventable morbidity and mortality in the USA. Ongoing surveillance is needed to understand changing injury...
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Surveillance of dermo-cosmetic products: a global cosmetovigilance system to optimise product development and consumer safety
BackgroundIn the absence of formal marketing authorisation, the manufacturers of cosmetic products are responsible for their compliance with the...
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Design of effective outpatient sentinel surveillance for COVID-19 decision-making: a modeling study
BackgroundDecision-makers impose COVID-19 mitigations based on public health indicators such as reported cases, which are sensitive to fluctuations...
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Distribution shift detection for the postmarket surveillance of medical AI algorithms: a retrospective simulation study
Distribution shifts remain a problem for the safe application of regulated medical AI systems, and may impact their real-world performance if...
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The Food and Drug Administration’s (FDA’s) Drug Safety Surveillance During the COVID-19 Pandemic
IntroductionOn 4 February, 2020, the Secretary of the Department of Health and Human Services declared a public health emergency related to...
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Safety of Brexanolone in Adults with Postpartum Depression: Postmarketing Surveillance Data
BackgroundBrexanolone is currently the only medication approved by the US FDA for the treatment of postpartum depression (PPD) in patients ≥15 years....
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Volume-based 18F-FDG PET/CT predicts prognosis and outcome of active surveillance for intra-abdominal desmoid tumor
PurposeDesmoid tumor (DT) is a rare monoclonal, fibroblastic proliferation characterized by a variable and often unpredictable clinical course....
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The development and application of a two-step surveillance process for Healthy China Initiative based on wide coverage interagency data
BackgroundHealthy China is a nationwide health strategy aiming at improving health from diverse dimensions, and strengthening high-quality...
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Post marketing surveillance of selected veterinary medicines in Tanzania mainland
BackgroundVeterinary medicines have been widely used for the prevention and treatment of animal diseases. Globally, the veterinary medicine industry...
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A multi-center cross-sectional study of Chinese Herbal Medicine-Drug adverse reactions using active surveillance in Singapore’s Traditional Chinese Medicine clinics
BackgroundThis study aimed to investigate the rates and causality of patient-reported adverse events (AEs) associated with concomitant Chinese Herbal...
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Epidemiology of Consumer-Product-Related Ocular Injuries in the Geriatric Population in the United States
IntroductionThe purpose of this study was to assess trends in consumer-product-related geriatric ocular injuries using National Electronic Injury...
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How to use the Surveillance, Epidemiology, and End Results (SEER) data: research design and methodology
In the United States (US), the Surveillance, Epidemiology, and End Results (SEER) program is the only comprehensive source of population-based...
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Marketing claims, promotional strategies, and product information on Malaysian e-cigarette retailer websites-a content analysis
BackgroundMarketing and sales of e-cigarettes are unregulated in Malaysia. We analyzed content displayed on e-cigarette retailer websites to identify...