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Journal of Biopharmaceutical Statistics Volume 20, 2010 - Issue 3: Continued Discussion in Design and Analysis of Thorough QTc Studies
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Original Articles

Sample Size Calculation for Thorough QT/QTc Study Considering Various Factors Related to Multiple Time Points

Zhaoling Meng Biostatistics and Programming, Sanofi-Aventis, Bridgewater, New Jersey, USACorrespondence[email protected]
,
Robert Kringle Biostatistics and Programming, Sanofi-Aventis, Bridgewater, New Jersey, USA
,
Xun Chen Biostatistics and Programming, Sanofi-Aventis, Bridgewater, New Jersey, USA
&
Peng-Liang Zhao Biostatistics and Programming, Sanofi-Aventis, Bridgewater, New Jersey, USA
Pages 580-594 | Received 01 Jul 2009, Accepted 02 Nov 2009, Published online: 21 Apr 2010

Citations (7)

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JamesD. Stamey, Fanni Natanegara & JohnW. Seaman$suffix/text()$suffix/text(). (2013) Bayesian Sample Size Determination for a Clinical Trial with Correlated Continuous and Binary Outcomes. Journal of Biopharmaceutical Statistics 23:4, pages 790-803.
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Articles from other publishers (6)

Yasushi Orihashi, Yuji Kumagai & Kazuhito Shiosakai. (2020) Novel concentration‐QTc models for early clinical studies with parallel placebo controls: A simulation study . Pharmaceutical Statistics 20:2, pages 375-389.
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Liang Fang, Winnie Weng, Lu Wang & Xiaoru Wu. 2019. Statistical Methods in Biomarker and Early Clinical Development. Statistical Methods in Biomarker and Early Clinical Development 275 299 .
Barbara Wiśniowska, Zofia Tylutki & Sebastian Polak. (2017) Thorough QT (TQT) studies: concordance with torsadogenesis and an evolving cardiac safety testing paradigm. Drug Discovery Today 22:10, pages 1460-1465.
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Arne Ring & Robert Schall. 2014. Statistical Methods for Evaluating Safety in Medical Product Development. Statistical Methods for Evaluating Safety in Medical Product Development 193 228 .
David Hoffman. (2014) Circadian Variation and Baseline Definition in Parallel-Group Thorough QT Studies. Therapeutic Innovation & Regulatory Science 48:2, pages 272-286.
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Joanne Zhang. (2011) Optimal Sample Size Allocation in a Thorough QTc Study. Drug Information Journal 45:4, pages 455-468.
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