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Pharmacoepidemiology and Drug Safety

Cover image for Vol. 21 Issue S1

Supplement: The U.S. Food and Drug Administration's Mini-Sentinel Program

January 2012

Volume 21, Issue Supplement S1

Pages 1–303

Issue edited by: Richard Platt, Ryan Carnahan

  1. Original Reports

    1. Top of page
    2. Original Reports
    3. Miscellaneous
    1. You have free access to this content
      The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction (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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2343

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      The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety (pages 9–11)

      Melissa A. Robb, Judith A. Racoosin, Rachel E. Sherman, Thomas P. Gross, Robert Ball, Marsha E. Reichman, Karen Midthun and Janet Woodcock

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2311

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      The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program (pages 12–17)

      Susan Forrow, Daniel M. Campion, Lisa J. Herrinton, Vinit P. Nair, Melissa A. Robb, Marcus Wilson and Richard Platt

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2242

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      A policy framework for public health uses of electronic health data (pages 18–22)

      Deven McGraw, Kristen Rosati and Barbara Evans

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2319

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      Design considerations, architecture, and use of the Mini-Sentinel distributed data system (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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2336

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      Design considerations in an active medical product safety monitoring system (pages 32–40)

      Joshua J. Gagne, Bruce Fireman, Patrick B. Ryan, Malcolm Maclure, Tobias Gerhard, Sengwee Toh, Jeremy A. Rassen, Jennifer C. Nelson and Sebastian Schneeweiss

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2316

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      When should case-only designs be used for safety monitoring of medical products? (pages 50–61)

      Malcolm Maclure, Bruce Fireman, Jennifer C. Nelson, Wei Hua, Azadeh Shoaibi, Antonio Paredes and David Madigan

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2330

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      Challenges in the design and analysis of sequentially monitored postmarket safety surveillance evaluations using electronic observational health care data (pages 62–71)

      Jennifer C. Nelson, Andrea J. Cook, Onchee Yu, Clara Dominguez, Shanshan Zhao, Sharon K. Greene, Bruce H. Fireman, Steven J. Jacobsen, Eric S. Weintraub and Lisa A. Jackson

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2324

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      Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini-Sentinel pilot (pages 72–81)

      Andrea J. Cook, Ram C. Tiwari, Robert D. Wellman, Susan R. Heckbert, Lingling Li, Patrick Heagerty, Tracey Marsh and Jennifer C. Nelson

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2320

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      A systematic review of validated methods for identifying cerebrovascular accident or transient ischemic attack using administrative data (pages 100–128)

      Susan E. Andrade, Leslie R. Harrold, Jennifer Tjia, Sarah L. Cutrona, Jane S. Saczynski, Katherine S. Dodd, Robert J. Goldberg and Jerry H. Gurwitz

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2312

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      A systematic review of validated methods for identifying heart failure using administrative data (pages 129–140)

      Jane S. Saczynski, Susan E. Andrade, Leslie R. Harrold, Jennifer Tjia, Sarah L. Cutrona, Katherine S. Dodd, Robert J. Goldberg and Jerry H. Gurwitz

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2313

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      A systematic review of validated methods for identifying atrial fibrillation using administrative data (pages 141–147)

      Paul N. Jensen, Karin Johnson, James Floyd, Susan R. Heckbert, Ryan Carnahan and Sascha Dublin

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2317

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      A systematic review of validated methods for identifying lymphoma using administrative data (pages 203–212)

      Ronald A. Herman, Bradley Gilchrist, Brian K. Link and Ryan Carnahan

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2315

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      A systematic review of validated methods for identifying anaphylaxis, including anaphylactic shock and angioneurotic edema, using administrative and claims data (pages 240–247)

      Gary Schneider, Sumesh Kachroo, Natalie Jones, Sheila Crean, Philip Rotella, Ruzan Avetisyan and Matthew W. Reynolds

      Article first published 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 (pages 256–260)

      Natalie Jones, Gary Schneider, Sumesh Kachroo, Philip Rotella, Ruzan Avetisyan and Matthew W. Reynolds

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2338

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      A systematic review of validated methods for identifying acute respiratory failure using administrative and claims data (pages 261–264)

      Natalie Jones, Gary Schneider, Sumesh Kachroo, Philip Rotella, Ruzan Avetisyan and Matthew W. Reynolds

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2326

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

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2314

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      A protocol for active surveillance of acute myocardial infarction in association with the use of a new antidiabetic pharmaceutical agent (pages 282–290)

      Bruce Fireman, Sengwee Toh, Melissa G. Butler, Alan S. Go, Hylton V. Joffe, David J. Graham, Jennifer C. Nelson, Gregory W. Daniel and Joe V. Selby

      Article first published online: 19 JAN 2012 | DOI: 10.1002/pds.2337

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  2. Miscellaneous

    1. Top of page
    2. Original Reports
    3. Miscellaneous
    1. You have free access to this content
      The U.S. Food and Drug Administration's Mini-Sentinel Program (pages 1–303)

      Richard Platt and Ryan Carnahan

      Article first published online: 31 JAN 2012 | DOI: 10.1002/pds.3230

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