DNA barcoding and pharmacovigilance of herbal medicines

HJ de Boer, MC Ichim, SG Newmaster - Drug safety, 2015 - Springer
Pharmacovigilance of herbal medicines relies on the product label information regarding the
ingredients and the adherence to good manufacturing practices along the commercialisation …

Global safety monitoring of COVID-19 vaccines: how pharmacovigilance rose to the challenge

A Rudolph, J Mitchell, J Barrett… - … Advances in Drug …, 2022 - journals.sagepub.com
Pharmacovigilance (PV) came suddenly into the spotlight when several new vaccines,
developed as a response to the COVID-19 pandemic, received emergency authorisation …

Adverse events associated with JAK inhibitors in 126,815 reports from the WHO pharmacovigilance database

L Hoisnard, B Lebrun-Vignes, S Maury, M Mahevas… - Scientific Reports, 2022 - nature.com
Increasing number of Janus kinase (JAK) inhibitors have been approved for chronic
haematopoietic neoplasms and inflammatory/autoimmune diseases. We aimed to assess …

Case–non-case studies: principle, methods, bias and interpretation

JL Faillie - Therapies, 2019 - Elsevier
Case–non-case studies are among the methods used to assess drug safety by analyzing the
disproportionality of adverse drug reaction reports in pharmacovigilance databases. First …

Comparative assessment of the national pharmacovigilance systems in East Africa: Ethiopia, Kenya, Rwanda and Tanzania

A Barry, S Olsson, O Minzi, E Bienvenu, E Makonnen… - Drug safety, 2020 - Springer
Introduction The increased access to medicinal products in Africa is not well-matched with
the pharmacovigilance capacity to monitor drug safety. The objective of this study was to …

Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: a sco** review of the global literature

D Sartori, JK Aronson, GN Norén, IJ Onakpoya - Drug safety, 2023 - Springer
Abstract Introduction and Objective Signals of adverse drug reactions (ADRs) can be
supported by reports of ADRs and by interventional and non-interventional studies. The …

Feature engineering and machine learning for causality assessment in pharmacovigilance: Lessons learned from application to the FDA Adverse Event Reporting …

K Kreimeyer, O Dang, J Spiker, MA Muñoz… - Computers in Biology …, 2021 - Elsevier
Background Our objective was to support the automated classification of Food and Drug
Administration (FDA) Adverse Event Reporting System (FAERS) reports for their usefulness …

Improved statistical signal detection in pharmacovigilance by combining multiple strength-of-evidence aspects in vigiRank: retrospective evaluation against emerging …

O Caster, K Juhlin, S Watson, GN Norén - Drug safety, 2014 - Springer
Background 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 …

Pharmacovigilance bibliometrics: visualizing thematic development in the category of pharmacology and pharmacy in web of science

L Wang, W Feng, J Duan, J Liang - Frontiers in Pharmacology, 2021 - frontiersin.org
Introduction: Pharmacovigilance studies include monitoring and preventing the occurrence
of new, rare, or serious adverse drug reactions, making it possible to discover new safety …

Addressing the under-reporting of adverse drug reactions in public health programs controlling HIV/AIDS, Tuberculosis and Malaria: A prospective cohort study

YK Avong, B Jatau, R Gurumnaan, N Danat, J Okuma… - PLoS …, 2018 - journals.plos.org
Background Adverse Drug Reactions (ADRs) are a major clinical and public health problem
world-wide. The prompt reporting of suspected ADRs to regulatory authorities to activate …