Electrocardiographic assessment for therapeutic proteins--scientific discussion.
Journal Article (Journal Article;Review)
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.
Full Text
Duke Authors
Cited Authors
- Rodriguez, I; Erdman, A; Padhi, D; Garnett, CE; Zhao, H; Targum, SL; Balakrishnan, S; Strnadova, C; Viner, N; Geiger, MJ; Newton-Cheh, C; Litwin, J; Pugsley, MK; Sager, PT; Krucoff, MW; Finkle, JK
Published Date
- October 2010
Published In
Volume / Issue
- 160 / 4
Start / End Page
- 627 - 634
PubMed ID
- 20934555
Electronic International Standard Serial Number (EISSN)
- 1097-6744
Digital Object Identifier (DOI)
- 10.1016/j.ahj.2010.07.001
Language
- eng
Conference Location
- United States