Electrocardiographic assessment for therapeutic proteins--scientific discussion.
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.
Duke Scholars
Altmetric Attention Stats
Dimensions Citation Stats
Published In
DOI
EISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- Proteins
- Practice Guidelines as Topic
- Humans
- Electrocardiography
- Cardiovascular System & Hematology
- Biomedical Research
- Arrhythmias, Cardiac
- 3201 Cardiovascular medicine and haematology
- 1117 Public Health and Health Services
- 1102 Cardiorespiratory Medicine and Haematology
Citation
Published In
DOI
EISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- Proteins
- Practice Guidelines as Topic
- Humans
- Electrocardiography
- Cardiovascular System & Hematology
- Biomedical Research
- Arrhythmias, Cardiac
- 3201 Cardiovascular medicine and haematology
- 1117 Public Health and Health Services
- 1102 Cardiorespiratory Medicine and Haematology