Russek-Cohen E - Search Results

1

U.S. Food and Drug Administration Reasoning in Approval Decisions When Efficacy Evidence Is Borderline, 2013-2018.

Janiaud P, Irony T, Russek-Cohen E, Goodman SN. Janiaud P, et al. Among authors: russek cohen e. Ann Intern Med. 2021 Nov;174(11):1603-1611. doi: 10.7326/M21-2918. Epub 2021 Sep 21. Ann Intern Med. 2021. PMID: 34543584

2

A US Food and Drug Administration perspective on evaluating medical products for Ebola.

Russek-Cohen E, Rubin D, Price D, Sun W, Cox E, Borio L. Russek-Cohen E, et al. Clin Trials. 2016 Feb;13(1):105-9. doi: 10.1177/1740774515620613. Epub 2016 Jan 14. Clin Trials. 2016. PMID: 26768565 No abstract available.

3

FDA perspectives on diagnostic device clinical studies for respiratory infections.

Russek-Cohen E, Feldblyum T, Whitaker KB, Hojvat S. Russek-Cohen E, et al. Clin Infect Dis. 2011 May;52 Suppl 4(Suppl 4):S305-11. doi: 10.1093/cid/cir056. Clin Infect Dis. 2011. PMID: 21460289 Free PMC article. Review.

4

National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: III. The 2014 Biomarker Working Group Report.

Paczesny S, Hakim FT, Pidala J, Cooke KR, Lathrop J, Griffith LM, Hansen J, Jagasia M, Miklos D, Pavletic S, Parkman R, Russek-Cohen E, Flowers ME, Lee S, Martin P, Vogelsang G, Walton M, Schultz KR. Paczesny S, et al. Biol Blood Marrow Transplant. 2015 May;21(5):780-92. doi: 10.1016/j.bbmt.2015.01.003. Epub 2015 Jan 30. Biol Blood Marrow Transplant. 2015. PMID: 25644957 Free PMC article.

5

Letter to the editor by the authors of Exact Calculation of Power and Sample Size in Bioequivalence Studies Using Two One-sided Tests, Pharmaceutical Statistics, DOI: 10.1002/pst.1666.

Shen M, Russek-Cohen E, Slud EV. Shen M, et al. Pharm Stat. 2015 May-Jun;14(3):272. doi: 10.1002/pst.1677. Epub 2015 Mar 21. Pharm Stat. 2015. PMID: 25807931

6

Seeking harmony: estimands and sensitivity analyses for confirmatory clinical trials.

Mehrotra DV, Hemmings RJ, Russek-Cohen E; ICH E9/R1 Expert Working Group. Mehrotra DV, et al. Clin Trials. 2016 Aug;13(4):456-8. doi: 10.1177/1740774516633115. Epub 2016 Feb 17. Clin Trials. 2016. PMID: 26908545

7

FDA perspectives on potential microarray-based clinical diagnostics.

Tezak Z, Ranamukhaarachchi D, Russek-Cohen E, Gutman SI. Tezak Z, et al. Hum Genomics. 2006 Jan;2(4):236-43. doi: 10.1186/1479-7364-2-4-236. Hum Genomics. 2006. PMID: 16460648 Free PMC article.

8

Sources of Safety Data and Statistical Strategies for Design and Analysis: Transforming Data Into Evidence.

Ma H, Russek-Cohen E, Izem R, Marchenko OV, Jiang Q. Ma H, et al. Among authors: russek cohen e. Ther Innov Regul Sci. 2018 Mar;52(2):187-198. doi: 10.1177/2168479018755085. Ther Innov Regul Sci. 2018. PMID: 29714524

9

CBER's Experience With Adaptive Design Clinical Trials.

Lin M, Lee S, Zhen B, Scott J, Horne A, Solomon G, Russek-Cohen E. Lin M, et al. Ther Innov Regul Sci. 2016 Mar;50(2):195-203. doi: 10.1177/2168479015604181. Ther Innov Regul Sci. 2016. PMID: 30227002

10

Quantifying the impact of time-varying baseline risk adjustment in the self-controlled risk interval design.

Li L, Kulldorff M, Russek-Cohen E, Kawai AT, Hua W. Li L, et al. Pharmacoepidemiol Drug Saf. 2015 Dec;24(12):1304-12. doi: 10.1002/pds.3885. Epub 2015 Oct 13. Pharmacoepidemiol Drug Saf. 2015. PMID: 26464236

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