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Advancing the science of patient input throughout the regulatory decision-making process.
- Published in:
- Learning Health Systems, 2017, v. 1, n. 3, p. n/a, doi. 10.1002/lrh2.10032
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- Publication type:
- Article
Real-world Effectiveness of mRNA COVID-19 Vaccines Among US Nursing Home Residents Aged ≥65 Years in the Pre-Delta and High Delta Periods.
- Published in:
- Open Forum Infectious Diseases, 2024, v. 11, n. 3, p. 1, doi. 10.1093/ofid/ofae051
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- Publication type:
- Article
Babesiosis Occurrence Among United States Medicare Beneficiaries, Ages 65 and Older, During 2006–2017: Overall and by State and County of Residence.
- Published in:
- Open Forum Infectious Diseases, 2021, v. 8, n. 2, p. 1, doi. 10.1093/ofid/ofaa608
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- Publication type:
- Article
Risk of Guillain-Barré Syndrome Following Recombinant Zoster Vaccine in Medicare Beneficiaries.
- Published in:
- 2021
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- Publication type:
- journal article
Innovative regulatory approaches to reduce sodium consumption: could a cap-and-trade system work?
- Published in:
- Nutrition Reviews, 2008, v. 66, n. 5, p. 280, doi. 10.1111/j.1753-4887.2008.00033.x
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- Publication type:
- Article
Adverse Event extraction from Structured Product Labels using the Event-based Text-mining of Health Electronic Records (ETHER) system.
- Published in:
- Health Informatics Journal, 2019, v. 25, n. 4, p. 1232, doi. 10.1177/1460458217749883
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- Publication type:
- Article
In silico analysis of autoimmune diseases and genetic relationships to vaccination against infectious diseases.
- Published in:
- BMC Immunology, 2014, v. 15, n. 1, p. 83, doi. 10.1186/s12865-014-0061-0
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- Publication type:
- Article
Early administration of COVID‐19 convalescent plasma with high titer antibody content by live viral neutralization assay is associated with modest clinical efficacy.
- Published in:
- American Journal of Hematology, 2022, v. 97, n. 6, p. 770, doi. 10.1002/ajh.26531
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- Publication type:
- Article
A Retrospective Review of Center for Biologics Evaluation and Research Advisory Committee Meetings in the Context of the FDA’s Benefit-Risk Framework.
- Published in:
- AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-023-00789-3
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- Publication type:
- Article
Babesiosis Occurrence among the Elderly in the United States, as Recorded in Large Medicare Databases during 2006–2013.
- Published in:
- PLoS ONE, 2015, v. 10, n. 10, p. 1, doi. 10.1371/journal.pone.0140332
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- Publication type:
- Article
Development and Validation of a Treatment Benefit Index to Identify Hospitalized Patients With COVID-19 Who May Benefit From Convalescent Plasma.
- Published in:
- JAMA Network Open, 2022, v. 5, n. 1, p. e2147375, doi. 10.1001/jamanetworkopen.2021.47375
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- Publication type:
- Article
Stroke Risk After COVID-19 Bivalent Vaccination Among US Older Adults.
- Published in:
- JAMA: Journal of the American Medical Association, 2024, v. 331, n. 11, p. 938, doi. 10.1001/jama.2024.1059
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- Publication type:
- Article
When can real‐world data generate real‐world evidence?
- Published in:
- Pharmacoepidemiology & Drug Safety, 2024, v. 33, n. 1, p. 1, doi. 10.1002/pds.5715
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- Publication type:
- Article
Use of Immunization Information Systems in Ascertainment of COVID-19 Vaccinations for Claims-Based Vaccine Safety and Effectiveness Studies.
- Published in:
- JAMA Network Open, 2023, v. 6, n. 5, p. e2313512, doi. 10.1001/jamanetworkopen.2023.13512
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- Publication type:
- Article
Quantitative Bias Analysis in Regulatory Settings.
- Published in:
- American Journal of Public Health, 2016, v. 106, n. 7, p. 1227, doi. 10.2105/AJPH.2016.303199
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- Publication type:
- Article
Surveillance for Guillain-Barré Syndrome After Influenza Vaccination Among the Medicare Population, 2009-2010.
- Published in:
- 2012
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- Publication type:
- Journal Article
Surveillance for Guillain-Barré Syndrome After Influenza Vaccination Among the Medicare Population, 2009-2010.
- Published in:
- American Journal of Public Health, 2012, v. 102, n. 10, p. 1921, doi. 10.2105/AJPH.2011.300510
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- Publication type:
- Article
Breast cancer risk and lifestyle differences among premenopausal and postmenopausal African-American women and white women.
- Published in:
- Cancer (0008543X), 2003, v. 97, n. S1, p. 280, doi. 10.1002/cncr.11020
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- Publication type:
- Article
Comparative Effectiveness of Influenza Vaccines Among US Medicare Beneficiaries Ages 65 Years and Older During the 2019–2020 Season.
- Published in:
- Clinical Infectious Diseases, 2021, v. 73, n. 11, p. e4251, doi. 10.1093/cid/ciaa1727
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- Publication type:
- Article
Recombinant Zoster Vaccine (Shingrix): Real-World Effectiveness in the First 2 Years Post-Licensure.
- Published in:
- Clinical Infectious Diseases, 2021, v. 73, n. 6, p. 941, doi. 10.1093/cid/ciab125
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- Publication type:
- Article
Neutralizing and Neuraminidase Antibodies Correlate With Protection Against Influenza During a Late Season A/H3N2 Outbreak Among Unvaccinated Military Recruits.
- Published in:
- Clinical Infectious Diseases, 2020, v. 71, n. 12, p. 3096, doi. 10.1093/cid/ciz1198
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- Publication type:
- Article
Statin Use and Risks of Influenza-Related Outcomes Among Older Adults Receiving Standard-Dose or High-Dose Influenza Vaccines Through Medicare During 2010–2015.
- Published in:
- Clinical Infectious Diseases, 2018, v. 67, n. 3, p. 378, doi. 10.1093/cid/ciy100
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- Publication type:
- Article
Effectiveness and Duration of Protection Provided by the Live-attenuated Herpes Zoster Vaccine in the Medicare Population Ages 65 Years and Older.
- Published in:
- Clinical Infectious Diseases, 2017, v. 64, n. 6, p. 785, doi. 10.1093/cid/ciw854
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- Publication type:
- Article
Summary of a Public FDA Workshop: Model Informed Drug Development Approaches for Immunogenicity Assessments.
- Published in:
- Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 2, p. 221, doi. 10.1002/cpt.2572
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- Publication type:
- Article
Stroke After Influenza Vaccines in Older Adults in the US, 2016 to 2019.
- Published in:
- JAMA Network Open, 2024, v. 7, n. 7, p. e2423926, doi. 10.1001/jamanetworkopen.2024.23926
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- Publication type:
- Article
Opportunities and challenges for applying model‐informed drug development approaches to gene therapies.
- Published in:
- CPT: Pharmacometrics & Systems Pharmacology, 2021, v. 10, n. 4, p. 286, doi. 10.1002/psp4.12597
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- Publication type:
- Article
Risk of Covid-19-Related Hospitalization and More Severe Outcomes in Medicare Beneficiaries Treated with Renin-Angiotensin-Aldosterone System Inhibitors for Hypertension.
- Published in:
- JGIM: Journal of General Internal Medicine, 2021, v. 36, n. 12, p. 3802, doi. 10.1007/s11606-021-07155-z
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- Publication type:
- Article
Modeling US blood donor deferrals under a policy of individual risk assessment for HIV risk sexual behavior.
- Published in:
- Transfusion, 2024, v. 64, n. 8, p. 1459, doi. 10.1111/trf.17916
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- Publication type:
- Article
HIV risk behavior profiles among men who have sex with men interested in donating blood: Findings from the Assessing Donor Variability and New Concepts in Eligibility study.
- Published in:
- Transfusion, 2023, v. 63, n. 10, p. 1872, doi. 10.1111/trf.17515
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- Publication type:
- Article
Predictive model for Zika virus RNA minipool nucleic acid testing in outbreak scenarios.
- Published in:
- 2019
- By:
- Publication type:
- journal article
Occurrence of hemolytic reactions on the same day as immune globulin product administrations during 2008 to 2014.
- Published in:
- 2018
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- Publication type:
- journal article
Occurrence of acute renal failure on the same day as immune globulin product administrations during 2008 to 2014.
- Published in:
- 2017
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- Publication type:
- journal article
Geographic exposure risk of variant Creutzfeldt-Jakob disease in US blood donors: a risk-ranking model to evaluate alternative donor-deferral policies.
- Published in:
- 2017
- By:
- Publication type:
- journal article
Posttransfusion purpura occurrence and potential risk factors among the inpatient US elderly, as recorded in large Medicare databases during 2011 through 2012.
- Published in:
- Transfusion, 2015, v. 55, n. 2, p. 284, doi. 10.1111/trf.12782
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- Publication type:
- Article
Immune globulins and same-day thrombotic events as recorded in a large health care database during 2008 to 2012.
- Published in:
- Transfusion, 2014, v. 54, n. 10pt1, p. 2553, doi. 10.1111/trf.12663
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- Publication type:
- Article
Transfusion-related acute lung injury and potential risk factors among the inpatient US elderly as recorded in Medicare claims data, during 2007 through 2011.
- Published in:
- Transfusion, 2014, v. 54, n. 9, p. 2182, doi. 10.1111/trf.12626
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- Publication type:
- Article
A stock-and-flow simulation model of the US blood supply.
- Published in:
- Transfusion, 2014, v. 54, n. 3pt2, p. 828, doi. 10.1111/trf.12392
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- Publication type:
- Article
Advancing risk assessment for emerging infectious diseases for blood and blood products: proceedings of a public workshop.
- Published in:
- Transfusion, 2013, v. 53, n. 2, p. 455, doi. 10.1111/j.1537-2995.2012.03808.x
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- Publication type:
- Article
Quantitative estimate of the risks and benefits of possible alternative blood donor deferral strategies for men who have had sex with men.
- Published in:
- Transfusion, 2009, v. 49, n. 6, p. 1102, doi. 10.1111/j.1537-2995.2009.02124.x
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- Publication type:
- Article
Use of proton pump inhibitors and risk of severe COVID‐19: A case–control study in United States Medicare beneficiaries.
- Published in:
- Pharmacotherapy, 2024, v. 44, n. 10, p. 803, doi. 10.1002/phar.4614
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- Publication type:
- Article
Assessment of risk of variant creutzfeldt‐Jakob disease (vCJD) from use of bovine heparin.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2020, v. 29, n. 5, p. 575, doi. 10.1002/pds.4982
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- Publication type:
- Article
A simulation study of the statistical power and signaling characteristics of an early season sequential test for influenza vaccine safety.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2019, v. 28, n. 8, p. 1077, doi. 10.1002/pds.4807
- By:
- Publication type:
- Article
Zostavax vaccine effectiveness among US elderly using real‐world evidence: Addressing unmeasured confounders by using multiple imputation after linking beneficiary surveys with Medicare claims.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2019, v. 28, n. 7, p. 993, doi. 10.1002/pds.4801
- By:
- Publication type:
- Article
Evaluating automated approaches to anaphylaxis case classification using unstructured data from the FDA Sentinel System.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2018, v. 27, n. 10, p. 1077, doi. 10.1002/pds.4645
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- Publication type:
- Article
Association of immune globulin intravenous and thromboembolic adverse events.
- Published in:
- American Journal of Hematology, 2017, v. 92, n. 4, p. E44, doi. 10.1002/ajh.24644
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- Publication type:
- Article
Hyperimmune globulins and same-day thrombotic adverse events as recorded in a large healthcare database during 2008-2011.
- Published in:
- American Journal of Hematology, 2013, v. 88, n. 12, p. 1035, doi. 10.1002/ajh.23559
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- Publication type:
- Article
Multistep Unified Models Using Prior Knowledge for the Prediction of Drug Clearance in Neonates and Infants.
- Published in:
- Journal of Clinical Pharmacology, 2018, v. 58, n. 7, p. 877, doi. 10.1002/jcph.1089
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- Publication type:
- Article
Evaluating oseltamivir prescriptions in Centers for Medicare and Medicaid Services medical claims records as an indicator of seasonal influenza in the United States.
- Published in:
- Influenza & Other Respiratory Viruses, 2018, v. 12, n. 4, p. 465, doi. 10.1111/irv.12552
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- Publication type:
- Article
Data quality and timeliness analysis for post-vaccination adverse event cases reported through healthcare data exchange to FDA BEST pilot platform.
- Published in:
- Frontiers in Public Health, 2024, p. 1, doi. 10.3389/fpubh.2024.1379973
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- Publication type:
- Article
Detection of human immunodeficiency virus, hepatitis C virus, and hepatitis B virus in postmortem blood specimens using infectious disease assays licensed for cadaveric donor screening.
- Published in:
- Transplant Infectious Disease, 2018, v. 20, n. 1, p. 1, doi. 10.1111/tid.12825
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- Publication type:
- Article