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Broadening the reach of the FDA Sentinel system: A roadmap for integrating electronic health record data in a causal analysis framework.
Desai RJ, Matheny ME, Johnson K, Marsolo K, Curtis LH, Nelson JC, Heagerty PJ, Maro J, Brown J, Toh S, Nguyen M, Ball R, Dal Pan G, Wang SV, Gagne JJ, Schneeweiss S. Desai RJ, et al. Among authors: nelson jc. NPJ Digit Med. 2021 Dec 20;4(1):170. doi: 10.1038/s41746-021-00542-0. NPJ Digit Med. 2021. PMID: 34931012 Free PMC article. Review.
The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction.
Platt R, Carnahan RM, Brown JS, Chrischilles E, Curtis LH, Hennessy S, Nelson JC, Racoosin JA, Robb M, Schneeweiss S, Toh S, Weiner MG. Platt R, et al. Among authors: nelson jc. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:1-8. doi: 10.1002/pds.2343. Pharmacoepidemiol Drug Saf. 2012. PMID: 22262586
Characteristics of study design and elements that may contribute to the success of electronic safety monitoring systems.
Bell C, Chakravarty A, Gruber S, Heckbert SR, Levenson M, Martin D, Nelson JC, Pinheiro S, Psaty BM, Reich CG, Schneeweiss S, Shoaibi A, Toh S, Walker AM. Bell C, et al. Among authors: nelson jc. Pharmacoepidemiol Drug Saf. 2014 Nov;23(11):1223-5. doi: 10.1002/pds.3712. Epub 2014 Sep 29. Pharmacoepidemiol Drug Saf. 2014. PMID: 25263307 No abstract available.
Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System.
Chrischilles EA, Gagne JJ, Fireman B, Nelson J, Toh S, Shoaibi A, Reichman ME, Wang S, Nguyen M, Zhang R, Izem R, Goulding MR, Southworth MR, Graham DJ, Fuller C, Katcoff H, Woodworth T, Rogers C, Saliga R, Lin ND, McMahill-Walraven CN, Nair VP, Haynes K, Carnahan RM. Chrischilles EA, et al. Pharmacoepidemiol Drug Saf. 2018 Mar;27(3):263-271. doi: 10.1002/pds.4375. Epub 2018 Jan 10. Pharmacoepidemiol Drug Saf. 2018. PMID: 29318683
Sequential surveillance for drug safety in a regulatory environment.
Martin D, Gagne JJ, Gruber S, Izem R, Nelson JC, Nguyen MD, Ouellet-Hellstrom R, Schneeweiss S, Toh S, Walker AM. Martin D, et al. Among authors: nelson jc. Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):707-712. doi: 10.1002/pds.4407. Epub 2018 Mar 5. Pharmacoepidemiol Drug Saf. 2018. PMID: 29504168 No abstract available.
531 results