E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions & Answers

Regulatory Resource: E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions & Answers

Description:

Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the E14 guideline have resulted in the need for some clarification. This supplementary Questions and Answers document intends to clarify key issues.

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