Awareness of, and Compliance with, Domperidone Revised Labeling After a Risk-Minimization Activity in Europe
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DOI: 10.1007/s40261-019-00831-3
Abstract: Background and ObjectiveRisk-minimization measures (RMM), including label revisions were implemented in Europe for domperidone because of evidence of increased incidence of cardiac arrhythmia and sudden cardiac death. In accordance with the guideline on good pharmacovigilance practices,… read more here.
Keywords: revised labeling; domperidone; compliance; risk minimization ... See more keywords
Risk Minimization for a Portfolio of Buildings Considering Risk Aversion
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DOI: 10.1061/(asce)st.1943-541x.0002250
Abstract: AbstractThis paper uses probabilistic models and minimization of certain risk measures to expose risk aversion and optimal retrofit strategies for an existing building portfolio. A case study is pr... read more here.
Keywords: risk aversion; risk minimization; risk; portfolio ... See more keywords
The impact of risk minimization measures on compliance and prescribing practices of flupirtine in Germany
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DOI: 10.1080/03007995.2018.1499507
Abstract: Abstract Objective: In response to safety concerns, risk minimization measures (RMM) for flupirtine were implemented in Europe in 2013 to reduce hepatotoxicity risk. This study aims to characterize compliance and prescribing practices of flupirtine before… read more here.
Keywords: risk minimization; implementation; compliance; minimization measures ... See more keywords
Assessment of the implementation of risk minimization measures for bosentan: a retrospective study
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DOI: 10.1080/14740338.2024.2391497
Abstract: ABSTRACT Background Bosentan is associated with adverse hepatic effects. To minimize such risk, regulators implemented risk minimization measures (RMMs), including testing for liver injury biomarkers (alanine and aspartate transaminase and bilirubin) prior to therapy initiation… read more here.
Keywords: throughout therapy; risk; risk minimization; minimization measures ... See more keywords
Patient Preferences for Rituximab Additional Risk Minimization Measures: Results From an International Online Survey.
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DOI: 10.1097/pts.0000000000000919
Abstract: OBJECTIVE Patients' opinions are essential in optimizing risk minimization measures (RMMs) because they bring their real-life experience of disease management and medicines' use into the regulatory assessments. The aim of the survey launched in 2018… read more here.
Keywords: patient; risk minimization; risk; online survey ... See more keywords
Comparing regulatory guidance on risk minimization/mitigation and the Reporting recommendation Intended for pharmaceutical Risk Minimization Evaluation Studies checklist
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DOI: 10.1111/bcp.16259
Abstract: The latest country‐specific regulatory guidance for assessing effectiveness of risk minimization measures (RMM) strategies was identified across five continents—Africa (Egypt, South Africa), Asia (Australia, China, Japan, South Korea, Singapore), Europe (EU‐27, United Kingdom), North America… read more here.
Keywords: guidance; regulatory guidance; japan; risk minimization ... See more keywords
Gradient Learning under Tilted Empirical Risk Minimization
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DOI: 10.3390/e24070956
Abstract: Gradient Learning (GL), aiming to estimate the gradient of target function, has attracted much attention in variable selection problems due to its mild structure requirements and wide applicability. Despite rapid progress, the majority of the… read more here.
Keywords: risk minimization; empirical risk; gradient learning; gradient ... See more keywords