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Author Details
Full Name
Michael Nguyen
Affiliation
Center for Drug Evaluation and Research
ORCID
Career Start Year
2010
Papers
43
H Index
17
Expertise
CM4AI Collaborator
PMID
Paper Title
Journal Title
Published Year
36252086
Monitoring Drug Safety in Pregnancy with Scan Statistics: A Comparison of Two Study Designs.
Epidemiology
2023
37391385
Six 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 Ther
2023
35871766
Novel methods for pregnancy drug safety surveillance in the FDA Sentinel System.
Pharmacoepidemiol Drug Saf
2023
36007092
Validation of Acute Pancreatitis Among Adults in an Integrated Healthcare System.
Epidemiology
2023
35839466
New-Onset Cancer Cases in FDA's Sentinel System: A Large Distributed System of US Electronic Healthcare Data.
Cancer Epidemiol Biomarkers Prev
2022
34931012
Broadening the reach of the FDA Sentinel system: A roadmap for integrating electronic health record data in a causal analysis framework.
NPJ Digit Med
2021
33712852
Electronic 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 Assoc
2021
33615330
A General Propensity Score for Signal Identification Using Tree-Based Scan Statistics.
Am J Epidemiol
2021
33885214
Validity of ICD-10-CM diagnoses to identify hospitalizations for serious infections among patients treated with biologic therapies.
Pharmacoepidemiol Drug Saf
2021
32279080
Using 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 Assoc
2020
31828887
Understanding utilization patterns of biologics and biosimilars in the United States to support postmarketing studies of safety and effectiveness.
Pharmacoepidemiol Drug Saf
2020
31736149
Quantifying how small variations in design elements affect risk in an incident cohort study in claims.
Pharmacoepidemiol Drug Saf
2020
33077615
Leveraging the Capabilities of the FDA's Sentinel System To Improve Kidney Care.
J Am Soc Nephrol
2020
32449261
Conducting prospective sequential surveillance in real-world dynamic distributed databases.
Pharmacoepidemiol Drug Saf
2020
31020732
Evaluating the use of bootstrapping in cohort studies conducted with 1:1 propensity score matching-A plasmode simulation study.
Pharmacoepidemiol Drug Saf
2019
31410932
Development of an algorithm to detect methotrexate wrong frequency error using computerized health care data.
Pharmacoepidemiol Drug Saf
2019
31483085
Identification of potential drug name confusion errors in the Sentinel System.
Pharmacoepidemiol Drug Saf
2019
31111340
Evaluation of Use of Technologies to Facilitate Medical Chart Review.
Drug Saf
2019
31055178
Applying 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 Epidemiol
2019
30747473
A new analytic tool developed to assess safe use recommendations.
Pharmacoepidemiol Drug Saf
2019
29318683
Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System.
Pharmacoepidemiol Drug Saf
2018
29860470
Assessment of Quadrivalent Human Papillomavirus Vaccine Safety Using the Self-Controlled Tree-Temporal Scan Statistic Signal-Detection Method in the Sentinel System.
Am J Epidemiol
2018
30074538
Data Mining for Adverse Drug Events With a Propensity Score-matched Tree-based Scan Statistic.
Epidemiology
2018
30120741
Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs.
Drug Saf
2018
30485777
The FDA Sentinel Initiative - An Evolving National Resource.
N Engl J Med
2018
29504168
Sequential surveillance for drug safety in a regulatory environment.
Pharmacoepidemiol Drug Saf
2018
28913963
Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0.
Pharmacoepidemiol Drug Saf
2017
29881732
Statistical Power for Postlicensure Medical Product Safety Data Mining.
EGEMS (Wash DC)
2017
28449973
Near real-time surveillance for Guillain-Barré syndrome after influenza vaccination among the Medicare population, 2010/11 to 2013/14.
Vaccine
2017
28964431
Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0.
Value Health
2017
26549364
Evaluation of the risk of venous thromboembolism after quadrivalent human papillomavirus vaccination among US females.
Vaccine
2016
26572776
Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System.
Pharmacoepidemiol Drug Saf
2016
26394725
Can Natural Language Processing Improve the Efficiency of Vaccine Adverse Event Report Review?
Methods Inf Med
2016
25769306
A vaccine study design selection framework for the postlicensure rapid immunization safety monitoring program.
Am J Epidemiol
2015
26209838
Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).
Vaccine
2015
26174895
Complementary use of passive surveillance and Mini-Sentinel to better characterize hemolysis after immune globulin.
Transfusion
2015
24422676
Intussusception risk after rotavirus vaccination in U.S. infants.
N Engl J Med
2014
24331080
Post-licensure rapid immunization safety monitoring program (PRISM) data characterization.
Vaccine
2013
22394993
Health outcomes of interest for evaluation in the Post-Licensure Rapid Immunization Safety Monitoring Program.
Vaccine
2012
22922172
Vaccine adverse event text mining system for extracting features from vaccine safety reports.
J Am Med Inform Assoc
2012
22262619
The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise.
Pharmacoepidemiol Drug Saf
2012
21709163
Text mining for the Vaccine Adverse Event Reporting System: medical text classification using informative feature selection.
J Am Med Inform Assoc
2011
20850534
Adverse events following influenza A (H1N1) 2009 monovalent vaccines reported to the Vaccine Adverse Event Reporting System, United States, October 1, 2009-January 31, 2010.
Vaccine
2010
1 - 43 of 43
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