Pharmacovigilance studies without a priori hypothesis systematic review highlights inappropriate multiple testing correction procedures.
L Gaucher, P Sabatier, S Katsahian… - Journal of Clinical …, 2023 - Elsevier
Objective The purpose of this study was to systematically review the statistical methods used
in pharmacovigilance studies without a priori hypotheses. Study Design and Setting A …
in pharmacovigilance studies without a priori hypotheses. Study Design and Setting A …
Large-scale prediction of adverse drug reactions using chemical, biological, and phenotypic properties of drugs
Objective Adverse drug reaction (ADR) is one of the major causes of failure in drug
development. Severe ADRs that go undetected until the post-marketing phase of a drug …
development. Severe ADRs that go undetected until the post-marketing phase of a drug …
Signal detection and monitoring based on longitudinal healthcare data
M Suling, I Pigeot - Pharmaceutics, 2012 - mdpi.com
Post-marketing detection and surveillance of potential safety hazards are crucial tasks in
pharmacovigilance. To uncover such safety risks, a wide set of techniques has been …
pharmacovigilance. To uncover such safety risks, a wide set of techniques has been …
Pharmacovigilance signals of the opioid epidemic over 10 years: data mining methods in the analysis of pharmacovigilance datasets collecting adverse drug reactions …
In the past twenty years, the consumption of opioid medications has reached significant
proportions, leading to a rise in drug misuse and abuse and increased opioid dependence …
proportions, leading to a rise in drug misuse and abuse and increased opioid dependence …
Comparative analysis of pharmacovigilance methods in the detection of adverse drug reactions using electronic medical records
Objective Medication safety requires that each drug be monitored throughout its market life
as early detection of adverse drug reactions (ADRs) can lead to alerts that prevent patient …
as early detection of adverse drug reactions (ADRs) can lead to alerts that prevent patient …
Improving drug safety: From adverse drug reaction knowledge discovery to clinical implementation
Adverse drug reactions (ADRs) are a major public health concern, causing over 100,000
fatalities in the United States every year with an annual cost of $136 billion. Early detection …
fatalities in the United States every year with an annual cost of $136 billion. Early detection …
Safety of BRAF+ MEK inhibitor combinations: severe adverse event evaluation
Aim: The selective BRAF and MEK inhibitors (BRAFi+ MEKi) have substantially improved the
survival of melanoma patients with BRAF V600 mutations. However, BRAFi+ MEKi can also …
survival of melanoma patients with BRAF V600 mutations. However, BRAFi+ MEKi can also …
An evaluation of statistical approaches to postmarketing surveillance
Y Ding, M Markatou, R Ball - Statistics in Medicine, 2020 - Wiley Online Library
Safety of medical products presents a serious concern worldwide. Surveillance systems of
postmarket medical products have been established for continual monitoring of adverse …
postmarket medical products have been established for continual monitoring of adverse …
Network analysis for signal detection in spontaneous adverse event reporting database: application of network weighting Normalization to characterize cardiovascular …
Introduction Signal detection yields confirmed signals in only 2.1%, which imposes a heavy
burden on the pharmacovigilance system in the European Union. Objectives We aimed to …
burden on the pharmacovigilance system in the European Union. Objectives We aimed to …
Adverse drug reaction or innocent bystander? A systematic comparison of statistical discovery methods for spontaneous reporting systems
L Dijkstra, M Garling, R Foraita… - … and drug safety, 2020 - Wiley Online Library
Abstract Purpose Spontaneous reporting systems (SRSs) are used to discover previously
unknown relationships between drugs and adverse drug reactions (ADRs). A plethora of …
unknown relationships between drugs and adverse drug reactions (ADRs). A plethora of …