Improving Preclinical and Clinical Regulatory Submissions Through Enhanced ECG Interval and Arrhythmia Assessment
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Live Date: Thursday, March 1, 2018
Duration: 1 hour
During this webinar, sponsored by VivaQuant, experts review advances in ECG safety assessment including reductions in interval measurement variability, reductions in confidence limits in concentration effect models and accurate reporting of up to 20 common arrhythmias.
The clinical perspective will be delivered by Dr. Jay W. Mason. He discusses reductions in interval measurement variability and confidence limits in concentration effect models and reviews the implications for clinical TQT studies and Phase I (IQ-CSRC) studies supporting TQT waivers, stressing why tighter confidence limits and more accurate measurements matter.
Following, Mike Gralinski, CEO of CorDynamics, offers a preclinical perspective on the potential of incorporating detailed assessment of arrhythmias for every cardiovascular study, and shares his thoughts on how and when this additional information should be leveraged. He discusses the value of knowledge versus liability of disclosure, the potential value of pre-study arrhythmia screening and incorporating baseline/control arrhythmia assessment.
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