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The Frequency of Drug-Induced Liver Injury Due to Antibiotics Among Hospitalised Patients
The Frequency of Drug-Induced Liver Injury Due to Antibiotics Among Hospitalised Patients
Most epidemiological studies have found antibiotics to be the most common cause of drug-induced liver injury (DILI). It is...
Using Mixed Methods to Evaluate Risk Minimisation Programs in Europe and the USA: An Innovative Blueprint
Using Mixed Methods to Evaluate Risk Minimisation Programs in Europe and the USA: An Innovative Blueprint
Significant methodological shortcomings have been documented to date in risk minimisation program evaluations for medicina...
Off-the-Shelf Large Language Models for Causality Assessment of Individual Case Safety Reports: A Proof-of-Concept with COVID-19 Vaccines
Off-the-Shelf Large Language Models for Causality Assessment of Individual Case Safety Reports: A Proof-of-Concept with COVID-19 Vaccines
This study evaluated the feasibility of ChatGPT and Gemini, two off-the-shelf large language models (LLMs), to automate ca...
Evidence-Based Design of Prescription Medication Information: An Updated Scoping Review
Evidence-Based Design of Prescription Medication Information: An Updated Scoping Review
Well-designed prescription medication information (PMI), defined as materials which communicate the essential information ...
QT Interval, Antipsychotics and Correlates Among Patients with Schizophrenia: Cross-Sectional Data from the Multicentric Real-World FACE-SZ
QT Interval, Antipsychotics and Correlates Among Patients with Schizophrenia: Cross-Sectional Data from the Multicentric Real-World FACE-SZ
The life expectancy of patients with schizophrenia is reduced, partly due to cardiovascular diseases. Antipsychotics are a...
Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Exposed to Glatiramer Acetate Therapy: An Extended 4-Year Safety Update
Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Exposed to Glatiramer Acetate Therapy: An Extended 4-Year Safety Update
While glatiramer acetate (GA) is generally considered safe during pregnancy and breastfeeding, long-term data, particularl...
Mitigation and Management of Common Toxicities Associated with the Administration of CAR-T Therapies in Oncology Patients
Mitigation and Management of Common Toxicities Associated with the Administration of CAR-T Therapies in Oncology Patients
Chimeric antigen receptor T-cell (CAR-T) therapies are one of the main approaches among targeted cellular therapies. Despi...
Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database
Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database
Rheumatoid arthritis (RA) is commonly treated with Janus kinase inhibitors (JAKis) and anti-tumor necrosis factor-α (...
IQ DILI Consensus Opinion: Best Practices for Rechallenge Following Suspected Drug-Induced Liver Injury in Clinical Trials
IQ DILI Consensus Opinion: Best Practices for Rechallenge Following Suspected Drug-Induced Liver Injury in Clinical Trials
Rechallenge with study drug after suspected drug-induced liver injury (DILI) during drug development requires a comprehens...
REMS Logic Model: A Pragmatic Framework for Incorporating Drug Safety into Clinical Practice
REMS Logic Model: A Pragmatic Framework for Incorporating Drug Safety into Clinical Practice
More than 163 million Americans—or half of the nation—used at least one prescription ...
Evaluation of Mortality in Users of Pimavanserin Compared with Other Atypical Antipsychotics in Patients with Parkinson’s Disease Psychosis: An Update
Evaluation of Mortality in Users of Pimavanserin Compared with Other Atypical Antipsychotics in Patients with Parkinson’s Disease Psychosis: An Update
Pimavanserin is the only antipsychotic medication approved in the USA to specifically treat hallucinations and delusions a...
Risk Minimisation Measures of Advanced Therapy Medicinal Products Authorised in the EU Between 2009 and 2023: A Cross-Sectional Study
Risk Minimisation Measures of Advanced Therapy Medicinal Products Authorised in the EU Between 2009 and 2023: A Cross-Sectional Study
Because of the novelty of advanced therapy medicinal products (ATMPs), pro-active risk management is needed post-authorisa...
Investigating Risk of Cancer with Sodium-Glucose Cotransporter 2 Inhibitors: A Disproportionality Analysis in the WHO Global Pharmacovigilance Database Vigibase
Investigating Risk of Cancer with Sodium-Glucose Cotransporter 2 Inhibitors: A Disproportionality Analysis in the WHO Global Pharmacovigilance Database Vigibase
Use of sodium-glucose cotransporter 2 inhibitors (SGLT-2is) has significantly increased due to their cardiovascular benefi...
Signal Monitoring for Adverse Events Following Immunisation with COVID-19 Vaccines During the SARS-CoV-2 Pandemic: An Evaluation of the South African Surveillance System
Signal Monitoring for Adverse Events Following Immunisation with COVID-19 Vaccines During the SARS-CoV-2 Pandemic: An Evaluation of the South African Surveillance System
Monitoring of adverse events following immunisation (AEFI) is recommended for post-licensure surveillance. We investigated...
A Drug Similarity-Based Bayesian Method for Early Adverse Drug Event Detection
A Drug Similarity-Based Bayesian Method for Early Adverse Drug Event Detection
Biochemical drug similarity-based methods demonstrate successes in predicting adverse drug events (ADEs) in preclinical se...
A Mixed-Methods Evaluation to Identify Industry Knowledge Needs and Challenges in Health Product Defect and Recall Reporting in Singapore
A Mixed-Methods Evaluation to Identify Industry Knowledge Needs and Challenges in Health Product Defect and Recall Reporting in Singapore
Health product defects are complex issues affecting the quality standards of health products and indirectly impact public ...
Impact of Batoclimab Treatment on LDL-C with and Without Coadministration of Atorvastatin: Results from a Phase I Randomized Study in Healthy Participants
Impact of Batoclimab Treatment on LDL-C with and Without Coadministration of Atorvastatin: Results from a Phase I Randomized Study in Healthy Participants
Batoclimab is an anti-neonatal fragment crystallizable receptor monoclonal antibody in clinical development for the treatm...
Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making
Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making
Pharmacovigilance involves a continuous process of evaluating, monitoring and communicating the safety profile of a medici...
Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies
Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies
For signal detection studies investigating either drug safety or method evaluation, the choice of drug-outcome pairs needs...
The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments
The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments
Health technology assessment (HTA) is a multidisciplinary process that determines the value of health technology at differ...
Appeal for Increasing the Impact of Pharmacovigilance
Appeal for Increasing the Impact of Pharmacovigilance
Pharmacovigilance (PV) is defined as the science and activities related to detecting, assessing, understanding and prevent...
Risk of Major Bleeding Associated with Concomitant Direct-Acting Oral Anticoagulant and Clopidogrel Use: A Retrospective Cohort Study
Risk of Major Bleeding Associated with Concomitant Direct-Acting Oral Anticoagulant and Clopidogrel Use: A Retrospective Cohort Study
Combined anticoagulant-antiplatelet therapy is often indicated in adults with cardiovascular disease and atrial fibrillati...
SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes
SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes
Sodium–glucose cotransporter 2 (SGLT2) inhibitors are a relatively new class of antihyperglycemic agents, with the p...
Optimizing Signal Management in a Vaccine Adverse Event Reporting System: A Proof-of-Concept with COVID-19 Vaccines Using Signs, Symptoms, and Natural Language Processing
Optimizing Signal Management in a Vaccine Adverse Event Reporting System: A Proof-of-Concept with COVID-19 Vaccines Using Signs, Symptoms, and Natural Language Processing
The Vaccine Adverse Event Reporting System (VAERS) has already been challenged by an extreme increase in the number of ind...
The Unseen Hand: AI-Based Prescribing Decision Support Tools and the Evaluation of Drug Safety and Effectiveness
The Unseen Hand: AI-Based Prescribing Decision Support Tools and the Evaluation of Drug Safety and Effectiveness
The use of artificial intelligence (AI)-based tools to guide prescribing decisions is full of promise and may enhance pati...
The Role of ISoP in the Advancement of Pharmacovigilance in Low-and Middle-Income Countries (LMICs)
The Role of ISoP in the Advancement of Pharmacovigilance in Low-and Middle-Income Countries (LMICs)
In general, poor communication between patients and HCPs is another reason for under-reporting. In addition, poor or ineff...
A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry
A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry
Published data on the safety of natural medical cannabis (MC) when used in the real-world clinical practice setting are la...
An Overview of Regression Models for Adverse Events Analysis
An Overview of Regression Models for Adverse Events Analysis
Over the last few years, several review articles described the adverse events analysis as sub-optimal in clinical trials. ...
Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers
Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers
Adverse drug reactions (ADRs) can be reported by Health Care Professionals (HCPs; e.g., physicians, pharmacists) and non-H...
Chronic Obstructive Pulmonary Disease Adverse Event Signals Associated with Potential Inhibitors of Glutathione Peroxidase 1: A Sequence Symmetry Analysis
Chronic Obstructive Pulmonary Disease Adverse Event Signals Associated with Potential Inhibitors of Glutathione Peroxidase 1: A Sequence Symmetry Analysis
Prior molecular modelling analysis identified several medicines as potential inhibitors of glutathione peroxidase 1 (GPx1)...
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