Literature DB >> 22262587

The US Food and Drug Administration's Sentinel Initiative: expanding the horizons of medical product safety.

Melissa A Robb1, Judith A Racoosin, Rachel E Sherman, Thomas P Gross, Robert Ball, Marsha E Reichman, Karen Midthun, Janet Woodcock.   

Abstract

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Year:  2012        PMID： 22262587     DOI： 10.1002/pds.2311

Source DB:  PubMed          Journal:  Pharmacoepidemiol Drug Saf        ISSN： 1053-8569            Impact factor:   2.890


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  46 in total

Review 1.  Strategies for postmarketing surveillance of drugs and devices in patients with ESRD undergoing dialysis.

Authors:  Moshe Vardi; Robert W Yeh; Charles A Herzog; Wolfgang C Winkelmayer; Soko Setoguchi; David M Charytan
Journal:  Clin J Am Soc Nephrol       Date:  2013-08-22       Impact factor: 8.237

2.  Validity of diagnostic codes to identify cases of severe acute liver injury in the US Food and Drug Administration's Mini-Sentinel Distributed Database.

Authors:  Vincent Lo Re; Kevin Haynes; David Goldberg; Kimberly A Forde; Dena M Carbonari; Kimberly B F Leidl; Sean Hennessy; K Rajender Reddy; Pamala A Pawloski; Gregory W Daniel; T Craig Cheetham; Aarthi Iyer; Kara O Coughlin; Sengwee Toh; Denise M Boudreau; Nandini Selvam; William O Cooper; Mano S Selvan; Jeffrey J VanWormer; Mark I Avigan; Monika Houstoun; Gwen L Zornberg; Judith A Racoosin; Azadeh Shoaibi
Journal:  Pharmacoepidemiol Drug Saf       Date:  2013-06-25       Impact factor: 2.890

3.  Dose-specific adverse drug reaction identification in electronic patient records: temporal data mining in an inpatient psychiatric population.

Authors:  Robert Eriksson; Thomas Werge; Lars Juhl Jensen; Søren Brunak
Journal:  Drug Saf       Date:  2014-04       Impact factor: 5.606

4.  Carrell et al. respond to "Observational research and the EHR".

Authors:  David S Carrell; Scott Halgrim; Diem-Thy Tran; Diana S M Buist; Jessica Chubak; Wendy W Chapman; Guergana Savova
Journal:  Am J Epidemiol       Date:  2014-01-30       Impact factor: 4.897

5.  Commentary on Perez et al.: How to create a 21st century adverse event reporting system.

Authors:  Elad Sharon
Journal:  Clin Trials       Date:  2017-03-26       Impact factor: 2.486

6.  A Multidimensional Data Warehouse for Community Health Centers.

Authors:  Kislaya Kunjan; Tammy Toscos; Ayten Turkcan; Brad N Doebbeling
Journal:  AMIA Annu Symp Proc       Date:  2015-11-05

Review 7.  Leveraging the Capabilities of the FDA's Sentinel System To Improve Kidney Care.

Authors:  Sruthi Adimadhyam; Erin F Barreto; Noelle M Cocoros; Sengwee Toh; Jeffrey S Brown; Judith C Maro; Jacqueline Corrigan-Curay; Gerald J Dal Pan; Robert Ball; David Martin; Michael Nguyen; Richard Platt; Xiaojuan Li
Journal:  J Am Soc Nephrol       Date:  2020-10-19       Impact factor: 10.121

Review 8.  Impact of Real-World Data on Market Authorization, Reimbursement Decision & Price Negotiation.

Authors:  Alfredo Aram Pulini; Gabriela Martins Caetano; Henri Clautiaux; Laure Vergeron; Peter J Pitts; Gregory Katz
Journal:  Ther Innov Regul Sci       Date:  2020-08-28       Impact factor: 1.778

9.  Pharmacovigilance via Baseline Regularization with Large-Scale Longitudinal Observational Data.

Authors:  Zhaobin Kuang; Peggy Peissig; Vítor Santos Costa; Richard Maclin; David Page
Journal:  KDD       Date:  2017-08

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

Authors:  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; Jerry H Gurwitz
Journal:  Pharmacoepidemiol Drug Saf       Date:  2012-06-29       Impact factor: 2.890
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