4．Utilization of Real World Data for Post-marketing Pharmacovigilance Activity
نویسندگان
چکیده
منابع مشابه
Post-Marketing Safety Surveillance of the Salvia Miltiorrhiza Depside Salt for Infusion: A Real World Study
BACKGROUND Salvia Miltiorrhiza Depside Salt for Infusion (SMDS) is made of a group of highly purified listed drugs. However, its safety data is still reported limitedly. Compared with the clinical trials, its safety in the real world setting is barely assessed. OBJECTIVE To investigate the safety issues, including adverse events (AEs), adverse events related to SMDS (ADEs), and adverse drug r...
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INTRODUCTION According to the Italian National Report on drug use, thienopyridines (ticlopidine, clopidogrel and prasugrel) and ticagrelor represent the most prescribed antiplatelet agents, beside aspirin. The aim of this study was to analyse the safety profile of these drugs using data from spontaneous reporting of suspected adverse reactions (ADRs). METHODS Suspected ADRs for ticlopidine, c...
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Accurate and timely identification of post-marketing drug safety risks (the so-called “signals” in pharmacovigilance) is an important public health issue. While various computational methods have been proposed to analyze the diverse data sources employed for signal detection, still the challenge of effective drug monitoring and surveillance remains. On the other hand, there is an emerging belie...
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Digital signatures are ubiquitous in modern security infrastructures. Their lack of diversity in industrial settings makes most contemporary systems susceptible to quantum computer-aided attacks. Alternatives exist, among which a family of well-understood schemes with minimal security requirements: hash-based signatures. In addition to being quantum-safe, hash-based signatures are modular, prov...
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PURPOSE vigiRank is a data-driven predictive model for emerging safety signals. In addition to disproportionate reporting patterns, it also accounts for the completeness, recency, and geographic spread of individual case reporting, as well as the availability of case narratives. Previous retrospective analysis suggested that vigiRank performed better than disproportionality analysis alone. The ...
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ژورنال
عنوان ژورنال: Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku
سال: 2019
ISSN: 1342-0445,1882-790X
DOI: 10.3820/jjpe.24.31