Electrocardiographic assessment for therapeutic proteins—scientific discussion - 05/08/11
, Andrew Erdman, MD b, Desmond Padhi, PharmD c, Christine E. Garnett, PharmD d, Hong Zhao, PhD d, Shari L. Targum, MD d, Suchitra Balakrishnan, MD, PhD d, Colette Strnadova, PhD e, Norman Viner, MD e, Mary Jane Geiger, MD, PhD f, Christopher Newton-Cheh, MD, MPH g, h, Jeffrey Litwin, MD i, Michael K. Pugsley, PhD j, Philip T. Sager, MD k, Mitchell W. Krucoff, MD l, John K. Finkle, MD mRésumé |
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.
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Vol 160 - N° 4
P. 627-634 - octobre 2010 Retour au numéro
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