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There are 51244 results for: content related to: The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program

  1. You have free access to this content
    Design considerations, architecture, and use of the Mini-Sentinel distributed data system

    Pharmacoepidemiology and Drug Safety

    Volume 21, Issue S1, January 2012, Pages: 23–31, Lesley H. Curtis, Mark G. Weiner, Denise M. Boudreau, William O. Cooper, Gregory W. Daniel, Vinit P. Nair, Marsha A. Raebel, Nicolas U. Beaulieu, Robert Rosofsky, Tiffany S. Woodworth and Jeffrey S. Brown

    Version of Record online : 19 JAN 2012, DOI: 10.1002/pds.2336

  2. You have free access to this content
    A policy framework for public health uses of electronic health data

    Pharmacoepidemiology and Drug Safety

    Volume 21, Issue S1, January 2012, Pages: 18–22, Deven McGraw, Kristen Rosati and Barbara Evans

    Version of Record online : 19 JAN 2012, DOI: 10.1002/pds.2319

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    Design for validation of acute myocardial infarction cases in Mini-Sentinel

    Pharmacoepidemiology and Drug Safety

    Volume 21, Issue S1, January 2012, Pages: 274–281, Sarah L. Cutrona, Sengwee Toh, Aarthi Iyer, Sarah Foy, Elizabeth Cavagnaro, Susan Forrow, Judith A. Racoosin, Robert Goldberg and Jerry H. Gurwitz

    Version of Record online : 19 JAN 2012, DOI: 10.1002/pds.2314

  4. You have free access to this content
    The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction

    Pharmacoepidemiology and Drug Safety

    Volume 21, Issue S1, January 2012, Pages: 1–8, Richard Platt, Ryan M. Carnahan, Jeffrey S. Brown, Elizabeth Chrischilles, Lesley H. Curtis, Sean Hennessy, Jennifer C. Nelson, Judith A. Racoosin, Melissa Robb, Sebastian Schneeweiss, Sengwee Toh and Mark G. Weiner

    Version of Record online : 19 JAN 2012, DOI: 10.1002/pds.2343

  5. Re-using Mini-Sentinel data following rapid assessments of potential safety signals via modular analytic programs

    Pharmacoepidemiology and Drug Safety

    Volume 22, Issue 10, October 2013, Pages: 1036–1045, Sengwee Toh, Jerry Avorn, Ralph B. D'Agostino Sr., Jerry H. Gurwitz, Bruce M. Psaty, Kenneth J. Rothman, Kenneth G. Saag, Miriam C. J. M. Sturkenboom, Jan P. Vandenbroucke, Almut G. Winterstein and Brian L. Strom

    Version of Record online : 7 AUG 2013, DOI: 10.1002/pds.3478

  6. Electronic clinical laboratory test results data tables: lessons from Mini-Sentinel

    Pharmacoepidemiology and Drug Safety

    Volume 23, Issue 6, June 2014, Pages: 609–618, Marsha A. Raebel, Kevin Haynes, Tiffany S. Woodworth, Gwyn Saylor, Elizabeth Cavagnaro, Kara O. Coughlin, Lesley H. Curtis, Mark G. Weiner, Patrick Archdeacon and Jeffrey S. Brown

    Version of Record online : 18 FEB 2014, DOI: 10.1002/pds.3580

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    Abstracts

    Pharmacoepidemiology and Drug Safety

    Volume 24, Issue S1, September 2015, Pages: 1–587,

    Version of Record online : 25 SEP 2015, DOI: 10.1002/pds.3838

  8. You have full text access to this OnlineOpen article
    The next frontier: Fostering innovation by improving health data access and utilization

    Clinical Pharmacology & Therapeutics

    Volume 98, Issue 5, November 2015, Pages: 514–521, KA Oye, G Jain, M Amador, R Arnaout, JS Brown, W Crown, J Ferguson, E Pezalla, JA Rassen, HP Selker, M Trusheim and G Hirsch

    Version of Record online : 10 SEP 2015, DOI: 10.1002/cpt.191

  9. A modular, prospective, semi-automated drug safety monitoring system for use in a distributed data environment

    Pharmacoepidemiology and Drug Safety

    Volume 23, Issue 6, June 2014, Pages: 619–627, Joshua J. Gagne, Shirley V. Wang, Jeremy A. Rassen and Sebastian Schneeweiss

    Version of Record online : 30 APR 2014, DOI: 10.1002/pds.3616

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    The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise

    Pharmacoepidemiology and Drug Safety

    Volume 21, Issue S1, January 2012, Pages: 291–297, Michael Nguyen, Robert Ball, Karen Midthun and Tracy A. Lieu

    Version of Record online : 19 JAN 2012, DOI: 10.1002/pds.2323

  11. Successful comparison of US Food and Drug Administration Sentinel analysis tools to traditional approaches in quantifying a known drug-adverse event association

    Clinical Pharmacology & Therapeutics

    Accepted manuscript online: 14 JUL 2016, Joshua J. Gagne, Xu Han, Sean Hennessy, Charles E. Leonard, Elizabeth A. Chrischilles, Ryan M. Carnahan, Shirley V. Wang, Candace Fuller, Aarthi Iyer, Hannah Katcoff, Tiffany S. Woodworth, Patrick Archdeacon, Tamra E. Meyer, Sebastian Schneeweiss and Sengwee Toh

    DOI: 10.1002/cpt.429

  12. Uptake of new drugs in the early post-approval period in the Mini-Sentinel distributed database

    Pharmacoepidemiology and Drug Safety

    Katrina Mott, David J. Graham, Sengwee Toh, Joshua J. Gagne, Mark Levenson, Yong Ma and Marsha E. Reichman

    Version of Record online : 4 MAY 2016, DOI: 10.1002/pds.4013

  13. Validation of anaphylaxis in the Food and Drug Administration's Mini-Sentinel

    Pharmacoepidemiology and Drug Safety

    Volume 22, Issue 11, November 2013, Pages: 1205–1213, Kathleen E. Walsh, Sarah L. Cutrona, Sarah Foy, Meghan A. Baker, Susan Forrow, Azadeh Shoaibi, Pamala A. Pawloski, Michelle Conroy, Andrew M. Fine, Lise E. Nigrovic, Nandini Selvam, Mano S. Selvan, William O. Cooper and Susan Andrade

    Version of Record online : 5 SEP 2013, DOI: 10.1002/pds.3505

  14. Validation of acute myocardial infarction in the Food and Drug Administration's Mini-Sentinel program

    Pharmacoepidemiology and Drug Safety

    Volume 22, Issue 1, January 2013, Pages: 40–54, Sarah L. Cutrona, Sengwee Toh, Aarthi Iyer, Sarah Foy, Gregory W. Daniel, Vinit P. Nair, Daniel Ng, Melissa G. Butler, Denise Boudreau, Susan Forrow, Robert Goldberg, Joel Gore, David McManus, Judith A. Racoosin and Jerry H. Gurwitz

    Version of Record online : 29 JUN 2012, DOI: 10.1002/pds.3310

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    Mini-Sentinel's systematic reviews of validated methods for identifying health outcomes using administrative and claims data: methods and lessons learned

    Pharmacoepidemiology and Drug Safety

    Volume 21, Issue S1, January 2012, Pages: 82–89, Ryan M. Carnahan and Kevin G. Moores

    Version of Record online : 19 JAN 2012, DOI: 10.1002/pds.2321

  16. Methods for using clinical laboratory test results as baseline confounders in multi-site observational database studies when missing data are expected

    Pharmacoepidemiology and Drug Safety

    Volume 25, Issue 7, July 2016, Pages: 798–814, Marsha A. Raebel, Susan Shetterly, Christine Y. Lu, James Flory, Joshua J. Gagne, Frank E. Harrell, Kevin Haynes, Lisa J. Herrinton, Elisabetta Patorno, Jennifer Popovic, Mano Selvan, Azadeh Shoaibi, Xingmei Wang and Jason Roy

    Version of Record online : 4 MAY 2016, DOI: 10.1002/pds.4015

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    A systematic review of validated methods for identifying anaphylaxis, including anaphylactic shock and angioneurotic edema, using administrative and claims data

    Pharmacoepidemiology and Drug Safety

    Volume 21, Issue S1, January 2012, Pages: 240–247, Gary Schneider, Sumesh Kachroo, Natalie Jones, Sheila Crean, Philip Rotella, Ruzan Avetisyan and Matthew W. Reynolds

    Version of Record online : 19 JAN 2012, DOI: 10.1002/pds.2327

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    A systematic review of validated methods for identifying pulmonary fibrosis and interstitial lung disease using administrative and claims data

    Pharmacoepidemiology and Drug Safety

    Volume 21, Issue S1, January 2012, Pages: 256–260, Natalie Jones, Gary Schneider, Sumesh Kachroo, Philip Rotella, Ruzan Avetisyan and Matthew W. Reynolds

    Version of Record online : 19 JAN 2012, DOI: 10.1002/pds.2338

  19. Invasive melanoma of the face: Management, outcomes, and the role of sentinel lymph node biopsy in 260 patients at a single institution

    Journal of Surgical Oncology

    Volume 103, Issue 5, 1 April 2011, Pages: 426–430, Anthony J. Chambers, Tania Murynka, John P. Arlette and J. Gregory Mckinnon

    Version of Record online : 28 DEC 2010, DOI: 10.1002/jso.21846

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    Intraoperative lymphatic mapping and sentinel lymph node dissection in breast cancer

    CA: A Cancer Journal for Clinicians

    Volume 50, Issue 5, September/October 2000, Pages: 279–291, Eddy C. Hsueh, Nora Hansen and Armando E. Giuliano

    Version of Record online : 16 JAN 2014, DOI: 10.1002/caac.6170500504