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Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database

期刊: DRUG SAFETY, 2023; 46 (9)

IntroductionPrevious pre-clinical and pharmacovigilance disproportionality analyses highlighted a safety signal of cutaneous ulcer with bisphosphonate......

An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance

期刊: DRUG SAFETY, 2023; 46 (11)

IntroductionDuring the signal detection process, statistical methods are used to identify drug-event combinations (DECs) which are disproportionately ......

Automatic Extraction of Comprehensive Drug Safety Information from Adverse Drug Event Narratives in the Korea Adverse Event Reporting System Using Natural Language Processing Techniques

期刊: DRUG SAFETY, 2023; 46 (8)

IntroductionConcerns have been raised over the quality of drug safety information, particularly data completeness, collected through spontaneous repor......

The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments

期刊: DRUG SAFETY, 2023; ()

Health technology assessment (HTA) is a multidisciplinary process that determines the value of health technology at different points in its lifecycle.......

Potential Risk Factors of Drug-Related Problems in Hospital-Based Mental Health Units: A Systematic Review

期刊: DRUG SAFETY, 2023; 46 (1)

Introduction Reducing the occurrence of drug-related problems is a global health concern. In mental health hospitals, drug-related problems are common......

Signals of Adverse Drug Reactions Communicated by Pharmacovigilance Stakeholders: A Scoping Review of the Global Literature

期刊: DRUG SAFETY, 2023; 46 (2)

Introduction and Objective Signals of adverse drug reactions (ADRs) can be supported by reports of ADRs and by interventional and non-interventional s......

What Factors Make EU Regulators Want to Communicate Drug Safety Issues Related to SGLT2 Inhibitors? An Online Survey Study

期刊: DRUG SAFETY, 2023; 46 (3)

IntroductionPrevious studies have found differences in the communication of safety issues among medicines regulatory agencies.ObjectivesTo explore (1)......

Quality of MedDRA® Coding in a Sample of COVID-19 Vaccine Medication Error Data

期刊: DRUG SAFETY, 2023; 46 (5)

Introduction In recent years, there has been increasing interest from regulatory agencies and scientific organisations into the recording, coding and ......

Nephrotoxicity of Amoxicillin and Third-Generation Cephalosporins: An Updated Review

期刊: DRUG SAFETY, 2023; 46 (8)

Because of their broad-spectrum bactericidal activity, amoxicillin (AMX) and third-generation cephalosporins (TGC) are widely used for the prophylaxis......

Provision and Characterization of a Corpus for Pharmaceutical, Biomedical Named Entity Recognition for Pharmacovigilance: Evaluation of Language Registers and Training Data Sufficiency

期刊: DRUG SAFETY, 2023; 46 (8)

Introduction and ObjectiveMachine learning (ML) systems are widely used for automatic entity recognition in pharmacovigilance. Publicly available data......

Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France

期刊: DRUG SAFETY, 2023; 46 (2)

Introduction Prenatal exposure to valproate and related substances is associated with a risk of malformations and/or neurodevelopmental disorders. In ......

Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis

期刊: DRUG SAFETY, 2023; 46 (1)

Introduction The currently licensed quadrivalent MenACWY-CRM conjugate vaccine presentation consists of two vials (lyophilized MenA and liquid MenCWY)......

Automated Classification of Quality Defect Issues Relating to Substandard Medicines Using a Hybrid Machine Learning and Rule-Based Approach

期刊: DRUG SAFETY, 2023; 46 (10)

Background and ObjectiveSubstandard medicines can lead to serious safety issues affecting public health; however, the nature of such issues can be wid......

Drug-Drug Interactions and the Risk of Emergency Hospitalizations: A Nationwide Population-Based Study

期刊: DRUG SAFETY, 2023; 46 (5)

BackgroundSeveral studies suggest a significant risk of hospitalization because of drug-drug interactions in the general population. However, to our k......

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