The FDA Advisory Committee met recently and spent an afternoon discussing CiPA. See full details, a transcript and more online here.
Slides now available for the CiPA Update meeting held on December 6, 2016. View them online here.
Two new manuscripts were recently published in PLOS One: “Electrocardiographic Biomarkers for Detection of Drug-Induced Late Sodium Current Block” as well as the companion methods paper “Automated Algorithm for J-Tpeak and Tpeak-Tend Assessment of Drug-Induced Proarrhythmia Risk”. Download the PDFs on our Publications page.
The ECG signals and clinical information of the two clinical studies are available at:
The source code of the automatic algorithm described in the methods paper is publicly available at https://github.com/FDA/ecglib
Check out the latest Science article featuring CiPA:
A painstaking overhaul for cardiac safety testing. Science 02 Sep 2016: Vol. 353, Issue 6303, pp. 976-977 DOI: 10.1126/science.353.6303.976