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There are 38182 results for: content related to: The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety

  1. Drug risk assessment and data reuse

    Pharmacoepidemiology and Drug Safety

    Volume 23, Issue 1, January 2014, Pages: 107–108, Solomon Iyasu, Judy Staffa, Dave Graham, Azadeh Shoaibi, Mark Levenson, Aloka Chakravarty and Tarek A. Hammad

    Version of Record online : 3 JAN 2014, DOI: 10.1002/pds.3518

  2. Multivariable confounding adjustment in distributed data networks without sharing of patient-level data

    Pharmacoepidemiology and Drug Safety

    Volume 22, Issue 11, November 2013, Pages: 1171–1177, Sengwee Toh, Marsha E. Reichman, Monika Houstoun, Xiao Ding, Bruce H. Fireman, Eric Gravel, Mark Levenson, Lingling Li, Erick Moyneur, Azadeh Shoaibi, Gwen Zornberg and Sean Hennessy

    Version of Record online : 22 JUL 2013, DOI: 10.1002/pds.3483

  3. Use of an active surveillance system by the FDA to observe patterns of quinine sulfate use and adverse hematologic outcomes in CMS Medicare data

    Pharmacoepidemiology and Drug Safety

    Volume 23, Issue 9, September 2014, Pages: 911–917, Monika Houstoun, Marsha E. Reichman, David J. Graham, Sumathi Nambiar, Hala Shamsuddin, S. Christopher Jones, Kelly Cao, Michael Wernecke, Chelsea Lam, Chris M. Worrall, Thomas E. MaCurdy and Jeffrey A. Kelman

    Version of Record online : 28 MAY 2014, DOI: 10.1002/pds.3644

  4. Trimethoprim–sulfonamide use during the first trimester of pregnancy and the risk of congenital anomalies

    Pharmacoepidemiology and Drug Safety

    Volume 25, Issue 2, February 2016, Pages: 170–178, Craig Hansen, Susan E. Andrade, Heather Freiman, Sascha Dublin, Katie Haffenreffer, William O. Cooper, T. Craig Cheetham, Sengwee Toh, De-Kun Li, Marsha A. Raebel, Jennifer L. Kuntz, Nancy Perrin, A. Gabriela Rosales, Shelley Carter, Pamala A. Pawloski, Elizabeth M. Maloney, David J. Graham, Leyla Sahin, Pamela E. Scott, John Yap and Robert Davis

    Version of Record online : 24 NOV 2015, DOI: 10.1002/pds.3919

  5. Characteristics of study design and elements that may contribute to the success of electronic safety monitoring systems

    Pharmacoepidemiology and Drug Safety

    Volume 23, Issue 11, November 2014, Pages: 1223–1225, Carlos Bell, Aloka Chakravarty, Susan Gruber, Susan R. Heckbert, Mark Levenson, David Martin, Jennifer C. Nelson, Simone Pinheiro, Bruce M. Psaty, Christian G. Reich, Sebastian Schneeweiss, Azadeh Shoaibi, Sengwee Toh and Alexander M. Walker

    Version of Record online : 29 SEP 2014, DOI: 10.1002/pds.3712

  6. Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug–outcome association

    Pharmacoepidemiology and Drug Safety

    Susan Gruber, Aloka Chakravarty, Susan R. Heckbert, Mark Levenson, David Martin, Jennifer C. Nelson, Bruce M. Psaty, Simone Pinheiro, Christian G. Reich, Sengwee Toh and Alexander M. Walker

    Version of Record online : 14 JUL 2016, DOI: 10.1002/pds.4065

  7. Cardiovascular and mortality risks in older Medicare patients treated with varenicline or bupropion for smoking cessation: an observational cohort study

    Pharmacoepidemiology and Drug Safety

    Volume 23, Issue 11, November 2014, Pages: 1205–1212, David J. Graham, Kunthel By, Stephen McKean, Andrew Mosholder, Cynthia Kornegay, Judith A. Racoosin, Jessica Young, Mark Levenson, Thomas E. MaCurdy, Chris Worrall and Jeffrey A. Kelman

    Version of Record online : 5 JUL 2014, DOI: 10.1002/pds.3678

  8. Validation of an algorithm to estimate gestational age in electronic health plan databases

    Pharmacoepidemiology and Drug Safety

    Volume 22, Issue 5, May 2013, Pages: 524–532, Qian Li, Susan E. Andrade, William O. Cooper, Robert L. Davis, Sascha Dublin, Tarek A. Hammad, Pamala A. Pawloski, Simone P. Pinheiro, Marsha A. Raebel, Pamela E. Scott, David H. Smith, Inna Dashevsky, Katherine Haffenreffer, Karin E. Johnson and Sengwee Toh

    Version of Record online : 21 JAN 2013, DOI: 10.1002/pds.3407

  9. Validity of health plan and birth certificate data for pregnancy research

    Pharmacoepidemiology and Drug Safety

    Volume 22, Issue 1, January 2013, Pages: 7–15, Susan E. Andrade, Pamela E. Scott, Robert L. Davis, De-Kun Li, Darios Getahun, T. Craig Cheetham, Marsha A. Raebel, Sengwee Toh, Sascha Dublin, Pamala A. Pawloski, Tarek A. Hammad, Sarah J. Beaton, David H. Smith, Inna Dashevsky, Katherine Haffenreffer and William O. Cooper

    Version of Record online : 3 JUL 2012, DOI: 10.1002/pds.3319

  10. Strategies addressing inadequate information on health factors in pharmacoepidemiology studies relying on healthcare databases: commentary from a public workshop

    Pharmacoepidemiology and Drug Safety

    Efe Eworuke, Fadia Shaya, David J. Graham, Jacqueline Major, Mark Levenson, Chih-Ying Chen, Kira Leishear and Simone Pinheiro

    Version of Record online : 7 JUL 2016, DOI: 10.1002/pds.4060

  11. Pediatric post-marketing safety systems in North America: assessment of the current status

    Pharmacoepidemiology and Drug Safety

    Volume 24, Issue 8, August 2015, Pages: 785–792, Ann W. McMahon, Gerold T. Wharton, Renan Bonnel, Mary DeCelle, Kimberley Swank, Daniela Testoni, Judith U. Cope, Phillip Brian Smith, Eileen Wu and Mary Dianne Murphy

    Version of Record online : 22 JUN 2015, DOI: 10.1002/pds.3813

    Corrected by:

    Erratum: Erratum: Pediatric post-marketing safety systems in North America: assessment of the current status

    Vol. 25, Issue 1, 110–111, Version of Record online: 8 JAN 2016

  12. 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

  13. Characterization of acetaminophen overdose-related emergency department visits and hospitalizations in the United States

    Pharmacoepidemiology and Drug Safety

    Volume 20, Issue 8, August 2011, Pages: 819–826, Angelika D. Manthripragada, Esther H. Zhou, Daniel S. Budnitz, Maribeth C. Lovegrove and Mary E. Willy

    Version of Record online : 3 FEB 2011, DOI: 10.1002/pds.2090

  14. Drug safety data mining with a tree-based scan statistic

    Pharmacoepidemiology and Drug Safety

    Volume 22, Issue 5, May 2013, Pages: 517–523, Martin Kulldorff, Inna Dashevsky, Taliser R. Avery, Arnold K. Chan, Robert L. Davis, David Graham, Richard Platt, Susan E Andrade, Denise Boudreau, Margaret J. Gunter, Lisa J. Herrinton, Pamala A. Pawloski, Marsha A. Raebel, Douglas Roblin and Jeffrey S. Brown

    Version of Record online : 20 MAR 2013, DOI: 10.1002/pds.3423

  15. Cardiovascular and mortality risk in elderly Medicare beneficiaries treated with olmesartan versus other angiotensin receptor blockers

    Pharmacoepidemiology and Drug Safety

    Volume 23, Issue 4, April 2014, Pages: 331–339, David J. Graham, Esther H. Zhou, Stephen McKean, Mark Levenson, Katlyn Calia, Kate Gelperin, Xiao Ding, Thomas E. MaCurdy, Chris Worrall and Jeffrey A. Kelman

    Version of Record online : 26 NOV 2013, DOI: 10.1002/pds.3548

  16. Paediatric post-marketing pharmacovigilance: comparison of the adverse event profile of vigabatrin prescribed to children and adults

    Pharmacoepidemiology and Drug Safety

    Volume 20, Issue 6, June 2011, Pages: 608–618, Beate Aurich-Barrera, Lynda Wilton, David Brown and Saad Shakir

    Version of Record online : 23 FEB 2011, DOI: 10.1002/pds.2105

  17. 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

  18. A critical review of methods to evaluate the impact of FDA regulatory actions

    Pharmacoepidemiology and Drug Safety

    Volume 22, Issue 9, September 2013, Pages: 986–994, Becky A. Briesacher, Stephen B. Soumerai, Fang Zhang, Sengwee Toh, Susan E. Andrade, Joann L. Wagner, Azadeh Shoaibi and Jerry H. Gurwitz

    Version of Record online : 12 JUL 2013, DOI: 10.1002/pds.3480

  19. Mini-Sentinel methods: framework for assessment of positive results from signal refinement

    Pharmacoepidemiology and Drug Safety

    Volume 23, Issue 1, January 2014, Pages: 3–8, David L. McClure, Marsha A. Raebel, W. Katherine Yih, Azadeh Shoaibi, Jerald E. Mullersman, Colin Anderson-Smits and Jason M. Glanz

    Version of Record online : 25 NOV 2013, DOI: 10.1002/pds.3547

  20. Misclassification in assessment of diabetogenic risk using electronic health records

    Pharmacoepidemiology and Drug Safety

    Volume 23, Issue 8, August 2014, Pages: 875–881, Almut G. Winterstein, Paul Kubilis, Steve Bird, Rhonda M. Cooper-DeHoff, Greg A. Nichols and Joseph A. Delaney

    Version of Record online : 12 JUN 2014, DOI: 10.1002/pds.3656