Sample Size Calculations for Crossover Thorough QT Studies: Satisfaction of Regulatory Threshold and Assay Sensitivity-Reference-Cited by-同舟云学术

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

Published:2010-04-06 Issue:3 Volume:20 Page:563-579
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Anand Suraj P.¹,Murray Sharon C.²,Koch Gary G.³

Affiliation:

1. a Department of Statistics , North Carolina State University , Raleigh, North Carolina, USA

2. b Discovery Biometrics, Oncology, GlaxoSmithKline , Research Triangle Park , North Carolina, USA

3. c Department of Biostatistics , University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543400903582000

Reference15 articles.

1. Planning controlled clinical trials on the basis of descriptive data analysis

2. A Bayesian Approach for Investigating the Risk of QT Prolongation

3. New confidence bounds for QT studies

4. On Power and Sample Size Calculation for QT Studies with Recording Replicates at Given Time Point

5. A Confidence Interval for the Maximal Mean QT Interval Change Caused by Drug Effect

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1. Concentration-QTc analysis with two or more correlated baselines;Journal of Pharmacokinetics and Pharmacodynamics;2021-05-12

2. Concentration–QTc analysis for single arm studies;Journal of Pharmacokinetics and Pharmacodynamics;2021-01-29

3. Novel concentration‐QTc models for early clinical studies with parallel placebo controls: A simulation study;Pharmaceutical Statistics;2020-12-08

4. Thorough QT (TQT) studies: concordance with torsadogenesis and an evolving cardiac safety testing paradigm;Drug Discovery Today;2017-10

5. Cardiovascular toxicity, especially QT/QTc prolongation;Statistical Methods for Evaluating Safety in Medical Product Development;2014-12-12

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