Image7.TIF | | 2018 |
Image6.TIF | | 2018 |
Image5.TIF | | 2018 |
Image4.TIF | | 2018 |
Image3.TIF | | 2018 |
Image2.TIF | | 2018 |
Image1.TIF | | 2018 |
DataSheet2.ZIP | | 2018 |
DataSheet1.ZIP | | 2018 |
Safety Signal Detection in the Drug Development Process | Advances in Medical Technologies and Clinical Practice Book Series | |
Mendelian randomization: a novel approach for the prediction of adverse drug events and drug repurposing opportunities | | |
Scientific and Regulatory Considerations in Product Development | | |
Philippines | | |
FDA's Sentinel Initiative: Active Surveillance to Identify Safety Signals | | |
Patient Safety – Automated Detection and Reporting | Translational Bioinformatics | 2012 |
Regulatory Affairs and Marketing Approval | | 2011 |
5. JADER from Pharmacovigilance Point of View | Japanese Journal of Pharmacoepidemiology/Yakuzai Ekigaku | 2014 |
Clinical Relation Extraction Toward Drug Safety Surveillance Using Electronic Health Record Narratives: Classical Learning Versus Deep Learning | JMIR Public Health and Surveillance | 2018 |
Validating a Framework for Coding Patient-Reported Health Information to the Medical Dictionary for Regulatory Activities Terminology: An Evaluative Study | JMIR Medical Informatics | 2018 |
Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project | PLoS ONE | 2015 |
AZDrugMiner: An Information Extraction System for Mining Patient-Reported Adverse Drug Events in Online Patient Forums | Lecture Notes in Computer Science | 2013 |
Pharmacovigilance of Biosimilars: Global Experience and Perspective | AAPS Advances in the Pharmaceutical Sciences Series | 2018 |
Population-Based Observational Study of Adverse Drug Event-Related Mortality in the Super-Aged Society of Japan | Drug Safety | 2021 |
Anaplastic lymphoma kinase tyrosine kinase inhibitor-induced hepatic failure in lung cancer patients: A study of signal mining and analysis of the FDA adverse event reporting system database | Journal of Clinical Pharmacy and Therapeutics | 2021 |
Safety signals for QT prolongation or Torsades de Pointes associated with azithromycin with or without chloroquine or hydroxychloroquine | Research in Social and Administrative Pharmacy | 2021 |
Association of eszopiclone, zaleplon, or zolpidem with complex sleep behaviors resulting in serious injuries, including death | Pharmacoepidemiology and Drug Safety | 2020 |
Leveraging Human Genetics to Identify Safety Signals Prior to Drug Marketing Approval and Clinical Use | Drug Safety | 2020 |
In Response to Is Topical Epinephrine Safe for Hemostasis in Endoscopic Sinus Surgery? | Laryngoscope | 2020 |
Evaluation of disability in patients exposed to fluoroquinolones | BMC Pharmacology & Toxicology | 2020 |
Injection Site Reactions in the Federal Adverse Event Reporting System (FAERS) Post-Marketing Database Vary Among Biologics Approved to Treat Moderate-To-Severe Psoriasis | Dermatology and Therapy | 2020 |
Data-Driven Extraction of Quantitative Multi-dimensional Associations of Cardiovascular Drugs and Adverse Drug Reactions | Advances in Intelligent Systems and Computing | 2020 |
Incretins in obesity and diabetes | Annals of the New York Academy of Sciences | 2020 |
Association of Noninfectious Pneumonia With Ustekinumab Use | JAMA Dermatology | 2019 |
Inflammatory bowel disease associated with the combination treatment of nivolumab and metformin: data from the FDA adverse event reporting system | Cancer Chemotherapy and Pharmacology | 2019 |
Comparison of 71 bipolar disorder pharmacotherapies for kidney disorder risk: The potential hazards of polypharmacy | Journal of Affective Disorders | 2019 |
Acute kidney injury with sodium-glucose co-transporter-2 inhibitors: A meta-analysis of cardiovascular outcome trials | Diabetes, Obesity and Metabolism | 2019 |
A comparative analysis of the safety profile of direct oral anticoagulants using the FDA adverse event reporting system | European Journal of Haematology | 2019 |
Real-World Data Approaches for Early Detection of Potential Safety and Effectiveness Signals for Generic Substitution: A Metoprolol Extended-Release Case Study | Journal of Clinical Pharmacology | 2019 |
Assessing the Association Between Dipeptidyl Peptidase 4 Inhibitor Use and Inflammatory Bowel Disease Through Drug Adverse Event Reporting | Diabetes Care | 2019 |
Opioid Misuse in Older Women | Journal of the American Geriatrics Society | 2019 |
Adverse Drug Events Detection in Clinical Notes by Jointly Modeling Entities and Relations Using Neural Networks | Drug Safety | 2019 |
Association Between Data Sources and US Food and Drug Administration Drug Safety Communications | JAMA Internal Medicine | 2019 |
Oral antineoplastic agents: assessment of safety and dose adjustments in clinical practice | Expert Opinion on Drug Safety | 2019 |
Adverse Drug Reaction Risk Measures: A Comparison of Estimates from Drug Surveillance and Randomised Trials | Pharmaceutical Medicine | 2019 |
Dipeptidyl peptidase-4 inhibitors: Anti-diabetic drugs with potential effects on cancer | Diabetes and Metabolic Syndrome: Clinical Research and Reviews | 2019 |
Medication-Related Dizziness in the Older Adult | | 2019 |
Drug Information Association Pharmacovigilance and Risk Management Strategies 2017: Overview of the Generic Drug Program and Surveillance | Therapeutic Innovation and Regulatory Science | 2019 |
Evaluation of Natural Language Processing (NLP) systems to annotate drug product labeling with MedDRA terminology | Journal of Biomedical Informatics | 2018 |
Tenofovir Alafenamide for the Treatment of Chronic Hepatitis B Monoinfection | Pharmacotherapy | 2018 |
Spontaneous Reporting on Adverse Events by Consumers in the United States: An Analysis of the Food and Drug Administration Adverse Event Reporting System Database | Drugs - Real World Outcomes | 2018 |