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Items: 1 to 50 of 72

1.

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.

Ther Innov Regul Sci. 2018 Mar;52(2):187-198. doi: 10.1177/2168479018755085.

PMID:
29714524
2.

Sources of Safety Data and Statistical Strategies for Design and Analysis: Real World Insights.

Marchenko O, Russek-Cohen E, Levenson M, Zink RC, Krukas-Hampel MR, Jiang Q.

Ther Innov Regul Sci. 2018 Mar;52(2):170-186. doi: 10.1177/2168479017739270. Epub 2017 Nov 16. Review.

PMID:
29714518
3.

Logistic Regression Likelihood Ratio Test Analysis for Detecting Signals of Adverse Events in Post-market Safety Surveillance.

Nam K, Henderson NC, Rohan P, Woo EJ, Russek-Cohen E.

J Biopharm Stat. 2017;27(6):990-1008. doi: 10.1080/10543406.2017.1295250. Epub 2017 Mar 27.

PMID:
28346083
4.

The importance of mRNA structure in determining the pathogenicity of synonymous and non-synonymous mutations in haemophilia.

Hamasaki-Katagiri N, Lin BC, Simon J, Hunt RC, Schiller T, Russek-Cohen E, Komar AA, Bar H, Kimchi-Sarfaty C.

Haemophilia. 2017 Jan;23(1):e8-e17. doi: 10.1111/hae.13107. Epub 2016 Dec 9.

5.

Checking distributional assumptions for pharmacokinetic summary statistics based on simulations with compartmental models.

Shen M, Russek-Cohen E, Slud EV.

J Biopharm Stat. 2017;27(5):756-772. doi: 10.1080/10543406.2016.1222535. Epub 2016 Sep 26.

PMID:
27669105
6.

CBER's Experience With Adaptive Design Clinical Trials.

Lin M, Lee S, Zhen B, Scott J, Horne A, Solomon G, Russek-Cohen E.

Ther Innov Regul Sci. 2016 Mar;50(2):195-203. doi: 10.1177/2168479015604181.

PMID:
30227002
7.

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

Mehrotra DV, Hemmings RJ, Russek-Cohen E; ICH E9/R1 Expert Working Group.

Clin Trials. 2016 Aug;13(4):456-8. doi: 10.1177/1740774516633115. Epub 2016 Feb 17.

PMID:
26908545
8.

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.

Clin Trials. 2016 Feb;13(1):105-9. doi: 10.1177/1740774515620613. Epub 2016 Jan 14. No abstract available.

PMID:
26768565
9.

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.

Pharmacoepidemiol Drug Saf. 2015 Dec;24(12):1304-12. doi: 10.1002/pds.3885. Epub 2015 Oct 13.

PMID:
26464236
10.
11.

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.

Biol Blood Marrow Transplant. 2015 May;21(5):780-92. doi: 10.1016/j.bbmt.2015.01.003. Epub 2015 Jan 30.

12.

Exact calculation of power and sample size in bioequivalence studies using two one-sided tests.

Shen M, Russek-Cohen E, Slud EV.

Pharm Stat. 2015 Mar-Apr;14(2):95-101. doi: 10.1002/pst.1666. Epub 2014 Dec 5.

PMID:
25477145
13.

Preclinical safety evaluation of human platelets treated with antimicrobial peptides in severe combined immunodeficient mice.

Bosch-Marcé M, Mohan KV, Gelderman MP, Ryan PL, Russek-Cohen E, Atreya CD.

Transfusion. 2014 Mar;54(3):569-76. doi: 10.1111/trf.12318. Epub 2013 Jun 30.

PMID:
23808572
14.

Multiple in silico tools predict phenotypic manifestations in congenital thrombotic thrombocytopenic purpura.

Hing ZA, Schiller T, Wu A, Hamasaki-Katagiri N, Struble EB, Russek-Cohen E, Kimchi-Sarfaty C.

Br J Haematol. 2013 Mar;160(6):825-37. doi: 10.1111/bjh.12214. Epub 2013 Jan 24.

PMID:
23346910
15.

Evaluation of tuberculosis diagnostics in children: 2. Methodological issues for conducting and reporting research evaluations of tuberculosis diagnostics for intrathoracic tuberculosis in children. Consensus from an expert panel.

Cuevas LE, Browning R, Bossuyt P, Casenghi M, Cotton MF, Cruz AT, Dodd LE, Drobniewski F, Gale M, Graham SM, Grzemska M, Heinrich N, Hesseling AC, Huebner R, Jean-Philippe P, Kabra SK, Kampmann B, Lewinsohn D, Li M, Lienhardt C, Mandalakas AM, Marais BJ, Menzies HJ, Montepiedra G, Mwansambo C, Oberhelman R, Palumbo P, Russek-Cohen E, Shapiro DE, Smith B, Soto-Castellares G, Starke JR, Swaminathan S, Wingfield C, Worrell C.

J Infect Dis. 2012 May 15;205 Suppl 2:S209-15. doi: 10.1093/infdis/jir879. Epub 2012 Apr 3.

16.

FDA perspectives on diagnostic device clinical studies for respiratory infections.

Russek-Cohen E, Feldblyum T, Whitaker KB, Hojvat S.

Clin Infect Dis. 2011 May;52 Suppl 4:S305-11. doi: 10.1093/cid/cir056. Review.

PMID:
21460289
17.

Simple sari cloth filtration of water is sustainable and continues to protect villagers from cholera in Matlab, Bangladesh.

Huq A, Yunus M, Sohel SS, Bhuiya A, Emch M, Luby SP, Russek-Cohen E, Nair GB, Sack RB, Colwell RR.

MBio. 2010 May 18;1(1). pii: e00034-10. doi: 10.1128/mBio.00034-10.

18.

Reproductive aging in Japanese quail, Coturnix japonica is associated with changes in central opioid receptors.

Ottinger MA, Corbitt C, Hoffman R, Thompson N, Russek-Cohen E, Deviche P.

Brain Res. 2006 Dec 18;1126(1):167-75. Epub 2006 Oct 12.

PMID:
17045975
19.
20.

FDA perspectives on potential microarray-based clinical diagnostics.

Tezak Z, Ranamukhaarachchi D, Russek-Cohen E, Gutman SI.

Hum Genomics. 2006 Jan;2(4):236-43.

22.

A SAS/IML program for simulating pharmacokinetic data.

Russek-Cohen E, Martinez MN, Nevius AB.

Comput Methods Programs Biomed. 2005 Apr;78(1):39-60.

PMID:
15780889
23.
24.

Temperature-driven Campylobacter seasonality in England and Wales.

Louis VR, Gillespie IA, O'Brien SJ, Russek-Cohen E, Pearson AD, Colwell RR.

Appl Environ Microbiol. 2005 Jan;71(1):85-92.

25.

Effects of milk urea nitrogen and other factors on probability of conception of dairy cows.

Guo K, Russek-Cohen E, Varner MA, Kohn RA.

J Dairy Sci. 2004 Jun;87(6):1878-85.

PMID:
15453505
26.
27.

Comparison of analytical methods and the influence of milk components on milk urea nitrogen recovery.

Peterson AB, French KR, Russek-Cohen E, Kohn RA.

J Dairy Sci. 2004 Jun;87(6):1747-50.

28.

Insulin-like growth factor-2 genotype, fat-free mass, and muscle performance across the adult life span.

Schrager MA, Roth SM, Ferrell RE, Metter EJ, Russek-Cohen E, Lynch NA, Lindle RS, Hurley BF.

J Appl Physiol (1985). 2004 Dec;97(6):2176-83. Epub 2004 Aug 6.

29.

Effect of differing facial characteristics on breathing resistance inside a respirator mask.

Rebar JE, Johnson AT, Scott WH, Russek-Cohen E, Caretti DM.

J Occup Environ Hyg. 2004 Jun;1(6):343-8.

PMID:
15238324
30.

Randomized trial of brief office-based interventions to reduce adolescent alcohol use.

Boekeloo BO, Jerry J, Lee-Ougo WI, Worrell KD, Hamburger EK, Russek-Cohen E, Snyder MH.

Arch Pediatr Adolesc Med. 2004 Jul;158(7):635-42.

PMID:
15237062
31.

Occurrence and distribution of Vibrio cholerae in the coastal environment of Peru.

Gil AI, Louis VR, Rivera IN, Lipp E, Huq A, Lanata CF, Taylor DN, Russek-Cohen E, Choopun N, Sack RB, Colwell RR.

Environ Microbiol. 2004 Jul;6(7):699-706.

PMID:
15186348
32.

Evaluation of chlorines' impact on biofilms on scratched stainless steel surfaces.

Lomander A, Schreuders P, Russek-Cohen E, Ali L.

Bioresour Technol. 2004 Sep;94(3):275-83.

PMID:
15182834
33.

Comparison of culling rates among dairy cows grouped on the basis of serologic status for bovine leukemia virus.

Rhodes JK, Pelzer KD, Johnson YJ, Russek-Cohen E.

J Am Vet Med Assoc. 2003 Jul 15;223(2):229-31.

PMID:
12875453
34.

Lead accumulation in feathers of nestling black-crowned night herons (Nycticorax nycticorax) experimentally treated in the field.

Golden NH, Rattner BA, Cohen JB, Hoffman DJ, Russek-Cohen E, Ottinger MA.

Environ Toxicol Chem. 2003 Jul;22(7):1517-24.

PMID:
12836976
35.

Direct detection of Vibrio cholerae and ctxA in Peruvian coastal water and plankton by PCR.

Lipp EK, Rivera IN, Gil AI, Espeland EM, Choopun N, Louis VR, Russek-Cohen E, Huq A, Colwell RR.

Appl Environ Microbiol. 2003 Jun;69(6):3676-80.

36.

Effect of patient priming and primary care provider prompting on adolescent-provider communication about alcohol.

Boekeloo BO, Bobbin MP, Lee WI, Worrell KD, Hamburger EK, Russek-Cohen E.

Arch Pediatr Adolesc Med. 2003 May;157(5):433-9.

PMID:
12742878
37.

Predictability of Vibrio cholerae in Chesapeake Bay.

Louis VR, Russek-Cohen E, Choopun N, Rivera IN, Gangle B, Jiang SC, Rubin A, Patz JA, Huq A, Colwell RR.

Appl Environ Microbiol. 2003 May;69(5):2773-85.

38.

Soil and plant effects on microbial community structure.

Buyer JS, Roberts DP, Russek-Cohen E.

Can J Microbiol. 2002 Nov;48(11):955-64.

PMID:
12556123
39.

Reduction of cholera in Bangladeshi villages by simple filtration.

Colwell RR, Huq A, Islam MS, Aziz KM, Yunus M, Khan NH, Mahmud A, Sack RB, Nair GB, Chakraborty J, Sack DA, Russek-Cohen E.

Proc Natl Acad Sci U S A. 2003 Feb 4;100(3):1051-5. Epub 2003 Jan 14.

40.

Genomic profiles of clinical and environmental isolates of Vibrio cholerae O1 in cholera-endemic areas of Bangladesh.

Zo YG, Rivera IN, Russek-Cohen E, Islam MS, Siddique AK, Yunus M, Sack RB, Huq A, Colwell RR.

Proc Natl Acad Sci U S A. 2002 Sep 17;99(19):12409-14. Epub 2002 Aug 30.

41.

Physiological response curve analysis using nonlinear mixed models.

Peek MS, Russek-Cohen E, Wait AD, Forseth IN.

Oecologia. 2002 Jul;132(2):175-180. doi: 10.1007/s00442-002-0954-0. Epub 2002 Jul 1.

PMID:
28547349
42.

Effects of density and perch availability on the immune status of broilers.

Heckert RA, Estevez I, Russek-Cohen E, Pettit-Riley R.

Poult Sci. 2002 Apr;81(4):451-7.

PMID:
11989743
43.

Evaluation of models to estimate urinary nitrogen and expected milk urea nitrogen.

Kohn RA, Kalscheur KF, Russek-Cohen E.

J Dairy Sci. 2002 Jan;85(1):227-33.

44.

Effect of sampling method on the representative recovery of microorganisms from the surfaces of aquacultured finfish.

Nedoluha PC, Owens S, Russek-Cohen E, Westhoff DC.

J Food Prot. 2001 Oct;64(10):1515-20.

PMID:
11601699
45.

Modified atmosphere packaged cheddar cheese shreds: influence of fluorescent light exposure and gas type on color and production of volatile compounds.

Colchin LM, Owens SL, Lyubachevskaya G, Boyle-Roden E, Russek-Cohen E, Rankin SA.

J Agric Food Chem. 2001 May;49(5):2277-82.

PMID:
11368589
46.

Stature as a prognostic factor in cystic fibrosis survival.

Beker LT, Russek-Cohen E, Fink RJ.

J Am Diet Assoc. 2001 Apr;101(4):438-42.

PMID:
11320950
47.

Intact soil-core microcosms compared with multi-site field releases for pre-release testing of microbes in diverse soils and climates.

Gagliardi JV, Angle JS, Germida JJ, Wyndham RC, Chanway CP, Watson RJ, Greer CW, McIntyre T, Yu HH, Levin MA, Russek-Cohen E, Rosolen S, Nairn J, Seib A, Martin-Heller T, Wisse G.

Can J Microbiol. 2001 Mar;47(3):237-52.

PMID:
11315115
48.

Analysis of fungal communities by sole carbon source utilization profiles.

Buyer JS, Roberts DP, Millner P, Russek-Cohen E.

J Microbiol Methods. 2001 May;45(1):53-60.

PMID:
11295197
49.

Postpartum iron status in nonlactating participants and nonparticipants in the special supplemental nutrition program for women, infants, and children.

Pehrsson PR, Moser-Veillon PB, Sims LS, Suitor CW, Russek-Cohen E.

Am J Clin Nutr. 2001 Jan;73(1):86-92.

PMID:
11124755
50.

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