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Author Details

Michael Nguyen
Center for Drug Evaluation and Research
2010
43
17
PMIDPaper TitleJournal TitlePublished Year
36252086Monitoring Drug Safety in Pregnancy with Scan Statistics: A Comparison of Two Study Designs.Epidemiology2023
37391385Six Years of the US Food and Drug Administration's Postmarket Active Risk Identification and Analysis System in the Sentinel Initiative: Implications for Real World Evidence Generation.Clin Pharmacol Ther2023
35871766Novel methods for pregnancy drug safety surveillance in the FDA Sentinel System.Pharmacoepidemiol Drug Saf2023
36007092Validation of Acute Pancreatitis Among Adults in an Integrated Healthcare System.Epidemiology2023
35839466New-Onset Cancer Cases in FDA's Sentinel System: A Large Distributed System of US Electronic Healthcare Data.Cancer Epidemiol Biomarkers Prev2022
34931012Broadening the reach of the FDA Sentinel system: A roadmap for integrating electronic health record data in a causal analysis framework.NPJ Digit Med2021
33712852Electronic phenotyping of health outcomes of interest using a linked claims-electronic health record database: Findings from a machine learning pilot project.J Am Med Inform Assoc2021
33615330A General Propensity Score for Signal Identification Using Tree-Based Scan Statistics.Am J Epidemiol2021
33885214Validity of ICD-10-CM diagnoses to identify hospitalizations for serious infections among patients treated with biologic therapies.Pharmacoepidemiol Drug Saf2021
32279080Using and improving distributed data networks to generate actionable evidence: the case of real-world outcomes in the Food and Drug Administration's Sentinel system.J Am Med Inform Assoc2020
31828887Understanding utilization patterns of biologics and biosimilars in the United States to support postmarketing studies of safety and effectiveness.Pharmacoepidemiol Drug Saf2020
31736149Quantifying how small variations in design elements affect risk in an incident cohort study in claims.Pharmacoepidemiol Drug Saf2020
33077615Leveraging the Capabilities of the FDA's Sentinel System To Improve Kidney Care.J Am Soc Nephrol2020
32449261Conducting prospective sequential surveillance in real-world dynamic distributed databases.Pharmacoepidemiol Drug Saf2020
31020732Evaluating the use of bootstrapping in cohort studies conducted with 1:1 propensity score matching-A plasmode simulation study.Pharmacoepidemiol Drug Saf2019
31410932Development of an algorithm to detect methotrexate wrong frequency error using computerized health care data.Pharmacoepidemiol Drug Saf2019
31483085Identification of potential drug name confusion errors in the Sentinel System.Pharmacoepidemiol Drug Saf2019
31111340Evaluation of Use of Technologies to Facilitate Medical Chart Review.Drug Saf2019
31055178Applying sequential surveillance methods that use regression adjustment or weighting to control confounding in a multisite, rare-event, distributed setting: Part 2 in-depth example of a reanalysis of the measles-mumps-rubella-varicella combination vaccine and seizure risk.J Clin Epidemiol2019
30747473A new analytic tool developed to assess safe use recommendations.Pharmacoepidemiol Drug Saf2019
29318683Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System.Pharmacoepidemiol Drug Saf2018
29860470Assessment of Quadrivalent Human Papillomavirus Vaccine Safety Using the Self-Controlled Tree-Temporal Scan Statistic Signal-Detection Method in the Sentinel System.Am J Epidemiol2018
30074538Data Mining for Adverse Drug Events With a Propensity Score-matched Tree-based Scan Statistic.Epidemiology2018
30120741Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs.Drug Saf2018
30485777The FDA Sentinel Initiative - An Evolving National Resource.N Engl J Med2018
29504168Sequential surveillance for drug safety in a regulatory environment.Pharmacoepidemiol Drug Saf2018
28913963Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0.Pharmacoepidemiol Drug Saf2017
29881732Statistical Power for Postlicensure Medical Product Safety Data Mining.EGEMS (Wash DC)2017
28449973Near real-time surveillance for Guillain-Barré syndrome after influenza vaccination among the Medicare population, 2010/11 to 2013/14.Vaccine2017
28964431Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0.Value Health2017
26549364Evaluation of the risk of venous thromboembolism after quadrivalent human papillomavirus vaccination among US females.Vaccine2016
26572776Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System.Pharmacoepidemiol Drug Saf2016
26394725Can Natural Language Processing Improve the Efficiency of Vaccine Adverse Event Report Review?Methods Inf Med2016
25769306A vaccine study design selection framework for the postlicensure rapid immunization safety monitoring program.Am J Epidemiol2015
26209838Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).Vaccine2015
26174895Complementary use of passive surveillance and Mini-Sentinel to better characterize hemolysis after immune globulin.Transfusion2015
24422676Intussusception risk after rotavirus vaccination in U.S. infants.N Engl J Med2014
24331080Post-licensure rapid immunization safety monitoring program (PRISM) data characterization.Vaccine2013
22394993Health outcomes of interest for evaluation in the Post-Licensure Rapid Immunization Safety Monitoring Program.Vaccine2012
22922172Vaccine adverse event text mining system for extracting features from vaccine safety reports.J Am Med Inform Assoc2012
22262619The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise.Pharmacoepidemiol Drug Saf2012
21709163Text mining for the Vaccine Adverse Event Reporting System: medical text classification using informative feature selection.J Am Med Inform Assoc2011
20850534Adverse events following influenza A (H1N1) 2009 monovalent vaccines reported to the Vaccine Adverse Event Reporting System, United States, October 1, 2009-January 31, 2010.Vaccine2010
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Collaborators

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Co-authored papers 13
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Co-authored papers 10
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Co-authored papers 4
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Co-authored papers 3
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Co-authored papers 2
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Co-authored papers 2
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Co-authored papers 2
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Co-authored papers 2
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Co-authored papers 2
American College of Medical Informatics, Department of Veteran Affairs, Harvard University T H Chan School of Public Health, Massachusetts Institute of Technology, The American Society for Clinical Investigation, University of Kentucky, Vanderbilt University Medical Center, Vanderbilt University Medical School
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