Modeling and Interpreting QTc Prolongation in Clinical Pharmacology Studies

Author:

Patterson Scott D.,Jones Byron,Zariffa Névine

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug guides,Pharmacology (nursing)

Reference13 articles.

1. Fitzgerald G. Coxibs and cardiovascular disease. N Engl J Med. 2004;351:1709–1711.

2. Topol E. Failing the public health—refocoxib, Merck, and the FDA. N Engl J Med. 2004;351:1707–17093.

3. International Conference on Harmonisation Draft Consensus Guideline, Step 1. The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential for Non-Antiarrythmic Drugs. 2005. Available at: https://doi.org/www.fda.gov/cder/guidance

4. Jones B. Kenward MG. Design and Analysis of Cross-over Trials, 2nd ed. London: Chapman and Hall, CRC Press; 2003.

5. Statistical Analysis Software, SAS/STAT User’s Guide, Version 8. Cary, NC: SAS Institute: 1999.

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