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Article
Open AccessCurrent Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase®
A number of safety signals—complex regional pain syndrome (CRPS), postural orthostatic tachycardia syndrome (POTS), and chronic fatigue syndrome (CFS)—have emerged with human papillomavirus (HPV) vaccines, whi...
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Article
Open AccessGood Signal Detection Practices: Evidence from IMI PROTECT
Over a period of 5 years, the Innovative Medicines Initiative PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) project has addressed key research questions releva...
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Article
Performance of Stratified and Subgrouped Disproportionality Analyses in Spontaneous Databases
Disproportionality analyses are used in many organisations to identify adverse drug reactions (ADRs) from spontaneous report data. Reporting patterns vary over time, with patient demographics, and between diff...
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Article
Comparison of Statistical Signal Detection Methods Within and Across Spontaneous Reporting Databases
Most pharmacovigilance departments maintain a system to identify adverse drug reactions (ADRs) through analysis of spontaneous reports. The signal detection algorithms (SDAs) and the nature of the reporting da...
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Article
Open AccessUsing VigiBase to Identify Substandard Medicines: Detection Capacity and Key Prerequisites
Substandard medicines, whether the result of intentional manipulation or lack of compliance with good manufacturing practice (GMP) or good distribution practice (GDP), pose a significant potential threat to pa...
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Article
Authors’ Reply to Harpaz et al. Comment on: “Zoo or Savannah? Choice of Training Ground for Evidence-Based Pharmacovigilance”
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Article
Zoo or Savannah? Choice of Training Ground for Evidence-Based Pharmacovigilance
Pharmacovigilance seeks to detect and describe adverse drug reactions early. Ideally, we would like to see objective evidence that a chosen signal detection approach can be expected to be effective. The develo...
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Article
Open AccessImproved Statistical Signal Detection in Pharmacovigilance by Combining Multiple Strength-of-Evidence Aspects in vigiRank
Detection of unknown risks with marketed medicines is key to securing the optimal care of individual patients and to reducing the societal burden from adverse drug reactions. Large collections of individual ca...
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Article
Empirical Performance of the Calibrated Self-Controlled Cohort Analysis Within Temporal Pattern Discovery: Lessons for Develo** a Risk Identification and Analysis System
Observational healthcare data offer the potential to identify adverse drug reactions that may be missed by spontaneous reporting. The self-controlled cohort analysis within the Temporal Pattern Discovery frame...
