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The FDA's Final Rule on Expedited Safety Reporting: Statistical Considerations.
Wittes J, Crowe B, Chuang-Stein C, Guettner A, Hall D, Jiang Q, Odenheimer D, Xia HA, Kramer J. Wittes J, et al. Among authors: chuang stein c. Stat Biopharm Res. 2015 Jul 3;7(3):174-190. doi: 10.1080/19466315.2015.1043395. Epub 2015 Oct 9. Stat Biopharm Res. 2015. PMID: 26550466 Free PMC article.
Reporting Adverse Drug Reactions in Product Labels.
Crowe B, Chuang-Stein C, Lettis S, Brueckner A. Crowe B, et al. Among authors: chuang stein c. Ther Innov Regul Sci. 2016 Jul;50(4):455-463. doi: 10.1177/2168479016628574. Ther Innov Regul Sci. 2016. PMID: 30227021
Commentary: preserving confidentiality of interim data.
Chuang-Stein C, Jiang Q, Marchenko O. Chuang-Stein C, et al. Clin Trials. 2015 Feb;12(1):18-20. doi: 10.1177/1740774514562032. Epub 2014 Dec 5. Clin Trials. 2015. PMID: 25480540 No abstract available.
Recent Developments in the Prevention and Treatment of Missing Data.
Mallinckrodt C, Roger J, Chuang-Stein C, Molenberghs G, O'Kelly M, Ratitch B, Janssens M, Bunouf P. Mallinckrodt C, et al. Ther Innov Regul Sci. 2014 Jan;48(1):68-80. doi: 10.1177/2168479013501310. Ther Innov Regul Sci. 2014. PMID: 30231419
47 results