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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

Use of the Average Baseline Versus the Time-Matched Baseline in Parallel Group Thorough QT/QTc Studies

Zhaoling Meng Biostatistics and Programming, Sanofi-Aventis, Bridgewater, New Jersey, USACorrespondence[email protected]
,
Hui Quan Biostatistics and Programming, Sanofi-Aventis, Bridgewater, New Jersey, USA
,
Li Fan Biostatistics and Programming, Sanofi-Aventis, Bridgewater, New Jersey, USA
,
Robert Kringle Biostatistics and Programming, Sanofi-Aventis, Bridgewater, New Jersey, USA
&
Gordon Sun Biostatistics and Programming, Sanofi-Aventis, Bridgewater, New Jersey, USA
Pages 665-682 | Received 01 Jul 2009, Accepted 12 Nov 2009, Published online: 21 Apr 2010

Citations (15)

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Read on this site (3)

Dalong (Patrick) Huang, Janell Chen & Yi Tsong. (2021) Baseline selection in concentration-QTc modeling: impact on assay sensitivity. Journal of Biopharmaceutical Statistics 31:2, pages 168-179.
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Guowen (Gordon) Sun, Hui Quan, Robert Kringle & Zhaoling Meng. (2012) Comparison of Statistical Models Adjusting for Baseline in the Analysis of Parallel-Group Thorough QT/QTc Studies. Journal of Biopharmaceutical Statistics 22:3, pages 438-462.
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Zhaoling Meng, Robert Kringle, Xun Chen & Peng-Liang Zhao. (2010) Sample Size Calculation for Thorough QT/QTc Study Considering Various Factors Related to Multiple Time Points. Journal of Biopharmaceutical Statistics 20:3, pages 580-594.
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Articles from other publishers (12)

Jeppe Ekstrand Halkjær Madsen, Thomas Scheike & Christian Pipper. (2023) Unbiased and efficient estimation of causal treatment effects in crossover trials. Biometrical Journal 65:8.
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Yuhao Deng, Fangyi Chen, Yang Li, Kaihuan Qian, Rui Wang & Xiao‐Hua Zhou. (2021) A powerful test for the maximum treatment effect in thorough QT/QTc studies. Statistics in Medicine 40:8, pages 1947-1959.
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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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Kaifeng Lu. (2014) An efficient analysis of covariance model for crossover thorough QT studies with period-specific pre-dose baselines. Pharmaceutical Statistics 13:6, pages 388-396.
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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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Kaifeng Lu. (2013) An efficient analysis of covariance model for crossover thorough QT studies with period-specific baseline days. Pharmaceutical Statistics 12:4, pages 192-200.
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Kaifeng Lu. (2012) An efficient and robust analysis of covariance model for baseline adjustment in parallel‐group thorough QT/QTc studies. Statistics in Medicine 32:14, pages 2406-2418.
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Claus Graff. (2013) Choice of Baseline in Parallel Thorough QT Studies. Drug Safety 36:6, pages 389-392.
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Joanne Zhang, Qianyu Dang & Marek Malik. (2013) Baseline Correction in Parallel Thorough QT Studies. Drug Safety 36:6, pages 441-453.
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Henry H. Holzgrefe, Georg Ferber, Royce Morrison, Olivier Meyer, Andrea Greiter‐Wilke & Thomas Singer. (2013) Characterization of the Human QT Interval: Novel Distribution‐Based Assessment of the Repolarization Effects of Moxifloxacin. The Journal of Clinical Pharmacology 52:8, pages 1222-1239.
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CHARLES M. BEASLEY, Jr.CHARLES BENSON, JESSIE Q. XIA, S. STANLEY YOUNG, HARRY HABER, MALCOLM I. MITCHELL & CORINA LOGHIN. (2011) Systematic Decrements in QTc between the First and Second Day of Contiguous Daily ECG Recordings under Controlled Conditions. Pacing and Clinical Electrophysiology 34:9, pages 1116-1127.
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Lawrence Z. Satin, Todd A. Durham & J. Rick Turner. (2011) Assessing a Drug’s Proarrhythmic Liability: An Overview of Computer Simulation Modeling, Nonclinical Assays, and the Thorough QT/QTc Study. Drug Information Journal 45:3, pages 357-375.
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