| Literature DB >> 20934555 |
Ignacio Rodriguez1, Andrew Erdman, Desmond Padhi, Christine E Garnett, Hong Zhao, Shari L Targum, Suchitra Balakrishnan, Colette Strnadova, Norman Viner, Mary Jane Geiger, Christopher Newton-Cheh, Jeffrey Litwin, Michael K Pugsley, Philip T Sager, Mitchell W Krucoff, John K Finkle.
Abstract
Electrocardiographic monitoring is an integral component of the clinical assessment of cardiac safety of all compounds in development. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 guideline recommends a dedicated study to evaluate drug-induced effects on cardiac repolarization ("thorough QT/QTc study"). There has been limited published information on QT interval changes secondary to therapeutic proteins; however, in theory, biologic therapies may affect cardiac electrical activity either directly or indirectly. This article summarizes scientific discussions of members of the Cardiac Safety Research Consortium and includes possible approaches to consider for the clinical evaluation of drug-induced QT prolongation in development programs of therapeutic proteins.Entities:
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Year: 2010 PMID： 20934555 DOI： 10.1016/j.ahj.2010.07.001
Source DB: PubMed Journal: Am Heart J ISSN： 0002-8703 Impact factor: 4.749