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Journal of Biopharmaceutical Statistics Volume 18, 2008 - Issue 3
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Original Articles

Statistical Issues Including Design and Sample Size Calculation in Thorough QT/QTc StudiesFootnote∗

Joanne Zhang Division of Biometrics VI, Office of Biostatistics/Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USACorrespondence[email protected]
&
Stella G. Machado Division of Biometrics VI, Office of Biostatistics/Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
Pages 451-467 | Received 29 May 2007, Accepted 28 Feb 2008, Published online: 30 May 2008

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Balakrishna Hosmane, Charles Locke & Yi-Lin Chiu. (2013) The Joint Modeling of Drug and Positive Control Effects to Estimate Sample Size and Power in Crossover “Thorough” QT/QTc Studies. Journal of Biopharmaceutical Statistics 23:4, pages 871-880.
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Wenqing Li, Andrea Maes, Michelle Quinlan & Suraj Anand. (2013) Interdependence of Baseline Correction Method and Covariance Structure for Crossover TQT Studies. Journal of Biopharmaceutical Statistics 23:1, pages 82-97.
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Yi Tsong, Anna Sun & Seung-Ho Kang. (2013) Sample Size of Thorough QTc Clinical Trial Adjusted for Multiple Comparisons. Journal of Biopharmaceutical Statistics 23:1, pages 57-72.
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Yi Tsong. (2013) On the Designs of Thorough QT/QTc Clinical Trials. Journal of Biopharmaceutical Statistics 23:1, pages 43-56.
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Duolao Wang, Jorg Taubel & Radivoj Arezina. (2012) Comparison of Six Commonly Used QT Correction Models and Their Parameter Estimation Methods. Journal of Biopharmaceutical Statistics 22:6, pages 1148-1161.
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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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B Tyl, S Azzam, E Reinbolt, N Blanco, J Olbertz & W Wheeler. (2010) Choice of baseline in a multiple-dose thorough QT study (TQTS) – effect on analysis of moxifloxacin-induced QTc prolongation. Open Access Journal of Clinical Trials 2, pages 1-7.
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Zhaoling Meng, Hui Quan, Li Fan, Robert Kringle & Gordon Sun. (2010) Use of the Average Baseline Versus the Time-Matched Baseline in Parallel Group Thorough QT/QTc Studies. Journal of Biopharmaceutical Statistics 20:3, pages 665-682.
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Yi Tsong & Jinglin Zhong. (2010) Multiple Comparisons of Repeated Measured Response: Issues of Assessment of Prolongation of QT Interval in Thorough QT Trials. Journal of Biopharmaceutical Statistics 20:3, pages 613-623.
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SurajP. Anand, SharonC. Murray & GaryG. Koch. (2010) Sample Size Calculations for Crossover Thorough QT Studies: Satisfaction of Regulatory Threshold and Assay Sensitivity. Journal of Biopharmaceutical Statistics 20:3, pages 563-579.
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Balakrishna Hosmane, Charles Locke & Yi-Lin Chiu. (2010) Sample Size and Power Estimation in Thorough QT/QTc Studies with Parallel Group Design. Journal of Biopharmaceutical Statistics 20:3, pages 595-603.
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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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