QT Prolongation Guidance ICH E14 (Ep. 8)

This episode is a discussion of the FDA and ICH guidance E14 titled “Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs”. I start with background on the reason for these evaluations, then move to an overview of the key evaluations needed. I then discuss in some detail the thorough QT study and the concentration QT analysis. Then I provide some parting thoughts from my experiences with these analyses. Links discussed in the show: • ICH E14 Guidance (FDA website) • Scientific white paper on concentration – QTc modeling by Garnett et. al • Correction to publication • You can connect with me on LinkedIn and send me a message () • Send me a message • Sign up for my newsletter Copyright Teuscher Solutions LLC All Rights Reserved