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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: jiang q. 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.
Statistical Evaluation of Drug Safety Data.
Xia HA, Jiang Q. Xia HA, et al. Among authors: jiang q. Ther Innov Regul Sci. 2014 Jan;48(1):109-120. doi: 10.1177/2168479013510917. Ther Innov Regul Sci. 2014. PMID: 30231415
Safety monitoring in clinical trials.
Yao B, Zhu L, Jiang Q, Xia HA. Yao B, et al. Among authors: jiang q. Pharmaceutics. 2013 Jan 17;5(1):94-106. doi: 10.3390/pharmaceutics5010094. Pharmaceutics. 2013. PMID: 24300399 Free PMC article.
Commentary: preserving confidentiality of interim data.
Chuang-Stein C, Jiang Q, Marchenko O. Chuang-Stein C, et al. Among authors: jiang q. Clin Trials. 2015 Feb;12(1):18-20. doi: 10.1177/1740774514562032. Epub 2014 Dec 5. Clin Trials. 2015. PMID: 25480540 No abstract available.
8,850 results