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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 Calculations for Crossover Thorough QT Studies: Satisfaction of Regulatory Threshold and Assay Sensitivity

Suraj P. Anand Department of Statistics, North Carolina State University, Raleigh, North Carolina, USACorrespondence[email protected]
,
Sharon C. Murray Discovery Biometrics, Oncology, GlaxoSmithKline, Research Triangle Park, North Carolina, USA
&
Gary G. Koch Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Pages 563-579 | Received 21 Mar 2009, Accepted 01 Jun 2009, Published online: 21 Apr 2010

Citations (12)

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Read on this site (3)

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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Articles from other publishers (9)

Yasushi Orihashi & Yuji Kumagai. (2021) Concentration-QTc analysis with two or more correlated baselines. Journal of Pharmacokinetics and Pharmacodynamics 48:5, pages 615-622.
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Yasushi Orihashi, Shoichi Ohwada & Yuji Kumagai. (2021) Concentration–QTc analysis for single arm studies. Journal of Pharmacokinetics and Pharmacodynamics 48:2, pages 203-211.
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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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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 .
Arne Ring, Karin Rathgen, Joachim Stangier, Paul Reilly, Andreas Clemens & Jeffrey Friedman. (2013) Dabigatran Does Not Prolong the QT Interval with Supratherapeutic Exposure: a Thorough QT Study in Healthy Subjects. Clinical Drug Investigation 33:5, pages 333-342.
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Arne Ring, Tobias Brand, Sreeraj Macha, Kerstin Breithaupt-Groegler, Gudrun Simons, Beate Walter, Hans J Woerle & Uli C Broedl. (2013) The sodium glucose cotransporter 2 inhibitor empagliflozin does not prolong QT interval in a thorough QT (TQT) study. Cardiovascular Diabetology 12:1, pages 70.
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Samuel George, Ignacio Rodriguez, David Ipe, Philip T. Sager, Ihor Gussak & Branislav Vajdic. (2013) Computerized Extraction of Electrocardiograms From Continuous 12‐Lead Holter Recordings Reduces Measurement Variability in a Thorough QT Study. The Journal of Clinical Pharmacology 52:12, pages 1891-1900.
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Beth A. Davison, Gad Cotter, Hengrui Sun, Li Chen, John R. Teerlink, Marco Metra, G. Michael Felker, Adriaan A. Voors, Piotr Ponikowski, Gerasimos Filippatos, Barry Greenberg, Sam L. Teichman, Elaine Unemori & Gary G. Koch. (2011) Permutation criteria to evaluate multiple clinical endpoints in a proof-of-concept study: lessons from Pre-RELAX-AHF. Clinical Research in Cardiology 100:9, pages 745-753.
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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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