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Journal of Biopharmaceutical Statistics Volume 16, 2006 - Issue 4
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Original Articles

Multistage Designs for Vaccine Safety Studies

V. Dragalin Research Statistics Unit, GlaxoSmithKline, Collegeville, Pennsylvania, USACorrespondence[email protected]
&
V. Fedorov Research Statistics Unit, GlaxoSmithKline, Collegeville, Pennsylvania, USA
Pages 539-553 | Received 13 Mar 2006, Accepted 13 Mar 2006, Published online: 03 Sep 2006

Citations (7)

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. (2008) Response to Commentary. Journal of Biopharmaceutical Statistics 18:4, pages 644-645.
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Articles from other publishers (6)

Malede Mequanent Sisay, Camila Montesinos-Guevara, Alhadi Khogali Osman, Putri Widi Saraswati, Binyam Tilahun, Tadesse Awoke Ayele, Fariba Ahmadizar, Carlos E. Durán, Miriam C. J. M. Sturkenboom, Peter van de Ven & Daniel Weibel. (2023) COVID-19 Vaccine Safety Monitoring Studies in Low- and Middle-Income Countries (LMICs)—A Systematic Review of Study Designs and Methods. Vaccines 11:6, pages 1035.
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Stephen Senn. (2022) The design and analysis of vaccine trials for COVID ‐19 for the purpose of estimating efficacy . Pharmaceutical Statistics 21:4, pages 790-807.
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Jerald SadoffGlenda Gray, An VandeboschVicky CárdenasGeorgi ShukarevBeatriz GrinsztejnPaul A. GoepfertCarla TruyersHein FennemaBart SpiessensKim OffergeldGert ScheperKimberly L. TaylorMerlin L. RobbJohn TreanorDan H. BarouchJeffrey StoddardMartin F. RyserMary A. MarovichKathleen M. NeuzilLawrence Corey, Nancy CauwenberghsTamzin TannerKarin HardtJavier Ruiz-GuiñazúMathieu Le GarsHanneke Schuitemaker, Johan Van HoofFrank Struyf & Macaya Douoguih. (2021) Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. New England Journal of Medicine 384:23, pages 2187-2201.
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Jianing Di, Daniel Wang, H. Robert Brashear, Vladimir Dragalin & Michael Krams. (2016) Continuous event monitoring via a Bayesian predictive approach. Pharmaceutical Statistics 15:2, pages 109-122.
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Samir Lababidi, Andrea Sutherland, Barbara Krasnicka, Richard A Forshee & Steven A Anderson. (2015) Overall conceptual framework for studying the genetics of autoimmune diseases following vaccination: a regulatory perspective. Biomarkers in Medicine 9:11, pages 1107-1120.
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Jay Herson. 2014. Statistical Methods for Evaluating Safety in Medical Product Development. Statistical Methods for Evaluating Safety in Medical Product Development 293 318 .

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