Methodological considerations in the design of trials for safety assessment of new drugs and chemical entities-Reference-Cited by-同舟云学术

Methodological considerations in the design of trials for safety assessment of new drugs and chemical entities

Published:2005-02-03 Issue:1 Volume:6 Page:
ISSN:1468-6708
Container-title:Current Controlled Trials in Cardiovascular Medicine
language:en
Short-container-title:Trials

Author:

Pater Cornel

Publisher

Springer Science and Business Media LLC

Subject

Cardiology and Cardiovascular Medicine

Link

http://link.springer.com/content/pdf/10.1186/1468-6708-6-1.pdf

Reference70 articles.

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3. Echt DS, Liebson PR, Mitchel B: Mortality and morbidity in patients receiving encainide, flecainide, or placebo: the Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1992, 324: 781-788.

4. Committee for Proprietary Medicinal Products: Points to Consider: The Assessment of the Potential for QT Interval Prolongation by Non-Cardiovascular Medicinal Products. The European Agency for Evaluation of Medicinal Products. 1997

5. The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. FDA – Draft 4. (June 10, 2004)

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