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
• You can connect with me on LinkedIn and send me a message ()
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