Comparison of Statistical Models Adjusting for Baseline in the Analysis of Parallel-Group Thorough QT/QTc Studies-Reference-Cited by-同舟云学术

Comparison of Statistical Models Adjusting for Baseline in the Analysis of Parallel-Group Thorough QT/QTc Studies

Published:2012-03-14 Issue:3 Volume:22 Page:438-462
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Sun Guowen (Gordon)¹,Quan Hui²,Kringle Robert³,Meng Zhaoling²

Affiliation:

1. a Biostatistics and Programming , Celgene Corporation, Summit , New Jersey , USA

2. b Biostatistics and Programming , Sanofi-Aventis , Bridgewater , New Jersey , USA

3. c Statistical Consultant , Birdsboro , Pennsylvania , USA

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543406.2010.544436

Reference12 articles.

1. New confidence bounds for QT studies

2. Statistical Assessment of QT/QTc Prolongation Based on Maximum of Correlated Normal Random Variables

3. Guidance for Industry ( 2005 ). ICH E14 Guidance. The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Nonantiarrhythmic Drugs. October. Available at: http://www.fda.gov (last accessed January, 2012) .

4. Guidance for Industry ( 2008 ). ICH E14 Guidance. The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Nonantiarrhythmic Drugs. Question and Answers. November. Available at: http://www.fda.gov (last accessed January, 2012) .

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