Current Edition

T-peak to T-end: Additional Potential Biomarkers of Interest in the Field of Cardiac Safety

Timothy Callahan, PhD, Chief Scientific Officer at Biomedical
Systems, writes a paper on how regulatory interest and then,
by necessity, drug development and scientific interest on the
QT-interval acquired on the surface 12-lead electrocardiogram
(ECG), has increased. This process started following the release
of the Points to Consider memorandum by the Committee for
Proprietary Medicinal Products in Europe in 1997, followed by
the ratification of the ICH E14 guideline in 2005. While the
main goal of the E14 has been achieved, i.e., a safer drug
supply, it can be argued whether or not we are closer to finding
out how a drug causes Torsade de Pointes (TdP).….pdf