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Navigating Non-interventional Post-authorization Studies in East Asia: Regulatory Challenges, Opportunities, and Future Directions
Navigating Non-interventional Post-authorization Studies in East Asia: Regulatory Challenges, Opportunities, and Future Directions
Post-authorization studies (PAS) are often mandated by regulatory authorities as a condition of marketing authorization of...
Incretin-Based Drugs and the Risk of Dementia Among Patients with Type 2 Diabetes
Incretin-Based Drugs and the Risk of Dementia Among Patients with Type 2 Diabetes
Incretin-based drugs, namely glucagon-like peptide 1 receptor agonists (GLP-1 RAs) and dipeptidyl peptidase 4 (DPP-4) inhi...
Strengthening Signal Detection in Pharmacovigilance by Using International Nonproprietary Name (INN) Stems
Strengthening Signal Detection in Pharmacovigilance by Using International Nonproprietary Name (INN) Stems
‘Stems’, which mark pharmacological relationships between substances, form the backbone of the International N...
Sexual Dysfunctions Associated with Proton Pump Inhibitors: Insights from VigiBase, the World Health Organization Pharmacovigilance Database
Sexual Dysfunctions Associated with Proton Pump Inhibitors: Insights from VigiBase, the World Health Organization Pharmacovigilance Database
Over the years, several observational studies and case reports have been published hypothesizing a potential association b...
A National Response to Warfarin Shortages: Evaluating Regulatory Substitution and Notified Shortages and Their Effects on Antithrombotic Dispensings, Pathology Monitoring and Adverse Event Trends in Australia
A National Response to Warfarin Shortages: Evaluating Regulatory Substitution and Notified Shortages and Their Effects on Antithrombotic Dispensings, Pathology Monitoring and Adverse Event Trends in Australia
Medicine shortages are an increasing threat to medicine safety and access. In Australia, a 7-month shortage of Coumadin 5-...
Medications Associated with Increased Risk of Hypoglycemia in Older Adults on Sulfonylureas: A High-Throughput Case-Crossover-Based Screening Study
Medications Associated with Increased Risk of Hypoglycemia in Older Adults on Sulfonylureas: A High-Throughput Case-Crossover-Based Screening Study
Sulfonylureas (SU) are widely used for diabetes management in older adults but can cause hypoglycemia, which may be worsen...
Systematic Review of Active Safety Surveillance of Vaccines and Medicines in Low- and Middle-Income Countries
Systematic Review of Active Safety Surveillance of Vaccines and Medicines in Low- and Middle-Income Countries
Functional active safety surveillance is essential for post-authorization assessment and life-cycle safety evidence genera...
Hepatic Effects, Potential Drug-Induced Liver Injury, and Other Liver Safety Considerations of Chimeric Antigen Receptor T-Cell (CAR-T) Therapy in the New Era of Expanding Non-oncology Indications: Literature Review and Expert Consensus
Hepatic Effects, Potential Drug-Induced Liver Injury, and Other Liver Safety Considerations of Chimeric Antigen Receptor T-Cell (CAR-T) Therapy in the New Era of Expanding Non-oncology Indications: Literature Review and Expert Consensus
Chimeric antigen receptor T-cell (CAR-T) therapy is a rapidly expanding key therapeutic category, originally pioneered for...
Unsuspected Adverse Drug Reactions to Dermatologic Medications: An Epidemiological Hypothesis-Free Screening Study of Real-World Data in Denmark
Unsuspected Adverse Drug Reactions to Dermatologic Medications: An Epidemiological Hypothesis-Free Screening Study of Real-World Data in Denmark
Many adverse drug reactions (ADRs) to dermatological drugs may be underrecognized due to limitations in traditional survei...
MCSG: A Method for Simultaneous Disproportionality Analysis and Background Rate Estimation in Large Pharmacovigilance Databases
MCSG: A Method for Simultaneous Disproportionality Analysis and Background Rate Estimation in Large Pharmacovigilance Databases
Databases for safety monitoring of medicinal products contain records of a huge number of pairings of drugs and adverse ev...
Narrative Search Engine for Case Series Assessment Supported by Artificial Intelligence Query Suggestions
Narrative Search Engine for Case Series Assessment Supported by Artificial Intelligence Query Suggestions
Manual identification of case narratives with specific relevant information can be challenging when working with large num...
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...
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...
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...
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...
Evaluation of Data Quality and Utility of the Japan Drug Information Institute in Pregnancy (JDIIP) Consultation Case Database for Pregnancy Pharmacovigilance
Evaluation of Data Quality and Utility of the Japan Drug Information Institute in Pregnancy (JDIIP) Consultation Case Database for Pregnancy Pharmacovigilance
Ensuring medication safety during pregnancy is crucial for protecting maternal and fetal health. However, fragmented data ...
Risk of New-Onset Atrial Fibrillation in Opioid Users: A Systematic Review and Meta-Analysis on 24,006,367 Participants
Risk of New-Onset Atrial Fibrillation in Opioid Users: A Systematic Review and Meta-Analysis on 24,006,367 Participants
Despite ongoing efforts, the prescription of opioids is still common. Long-term opioid use has been associated with an inc...
The Role of Adverse Event Follow-Up in Advancing the Knowledge of Medicines and Vaccines Safety: A Scoping Review
The Role of Adverse Event Follow-Up in Advancing the Knowledge of Medicines and Vaccines Safety: A Scoping Review
Adverse events (AEs) associated with medication and vaccine use are of significant concern in pharmacovigilance (PV), nece...
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...
Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study
Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study
Effectiveness and respiratory adverse events following coronavirus disease-2019 (COVID-19) vaccines have not been well inv...
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...
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