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A critical review of methods to evaluate the impact of FDA regulatory actions.
Briesacher BA, Soumerai SB, Zhang F, Toh S, Andrade SE, Wagner JL, Shoaibi A, Gurwitz JH. Briesacher BA, et al. Among authors: shoaibi a. Pharmacoepidemiol Drug Saf. 2013 Sep;22(9):986-94. doi: 10.1002/pds.3480. Epub 2013 Jul 12. Pharmacoepidemiol Drug Saf. 2013. PMID: 23847020 Free PMC article. Review.
Response to the letter by Mol.
Briesacher BA, Soumerai SB, Zhang F, Toh S, Andrade SE, Wagner JL, Shoaibi A, Gurwitz JH. Briesacher BA, et al. Among authors: shoaibi a. Pharmacoepidemiol Drug Saf. 2014 Jan;23(1):106. doi: 10.1002/pds.3519. Pharmacoepidemiol Drug Saf. 2014. PMID: 24395548 No abstract available.
Validation of anaphylaxis in the Food and Drug Administration's Mini-Sentinel.
Walsh KE, Cutrona SL, Foy S, Baker MA, Forrow S, Shoaibi A, Pawloski PA, Conroy M, Fine AM, Nigrovic LE, Selvam N, Selvan MS, Cooper WO, Andrade S. Walsh KE, et al. Among authors: shoaibi a. Pharmacoepidemiol Drug Saf. 2013 Nov;22(11):1205-13. doi: 10.1002/pds.3505. Epub 2013 Sep 5. Pharmacoepidemiol Drug Saf. 2013. PMID: 24038742 Free PMC article.
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: shoaibi a. 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.
Validity of diagnostic codes to identify cases of severe acute liver injury in the US Food and Drug Administration's Mini-Sentinel Distributed Database.
Lo Re V 3rd, Haynes K, Goldberg D, Forde KA, Carbonari DM, Leidl KB, Hennessy S, Reddy KR, Pawloski PA, Daniel GW, Cheetham TC, Iyer A, Coughlin KO, Toh S, Boudreau DM, Selvam N, Cooper WO, Selvan MS, VanWormer JJ, Avigan MI, Houstoun M, Zornberg GL, Racoosin JA, Shoaibi A. Lo Re V 3rd, et al. Among authors: shoaibi a. Pharmacoepidemiol Drug Saf. 2013 Aug;22(8):861-72. doi: 10.1002/pds.3470. Epub 2013 Jun 25. Pharmacoepidemiol Drug Saf. 2013. PMID: 23801638 Free PMC article.
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. Among authors: shoaibi a. Pharmacoepidemiol Drug Saf. 2018 Mar;27(3):263-271. doi: 10.1002/pds.4375. Epub 2018 Jan 10. Pharmacoepidemiol Drug Saf. 2018. PMID: 29318683
Drug risk assessment and data reuse.
Iyasu S, Staffa J, Graham D, Shoaibi A, Levenson M, Chakravarty A, Hammad TA. Iyasu S, et al. Among authors: shoaibi a. Pharmacoepidemiol Drug Saf. 2014 Jan;23(1):107-8. doi: 10.1002/pds.3518. Pharmacoepidemiol Drug Saf. 2014. PMID: 24395549 No abstract available.
136 results