ICH E14 Overview
Adoption October 2005
ICH E14 Overview
ICH E14 responds to the fact cardiac safety issues have become the number one reason for drug non-approval and the removal of existing drugs on the market. The ICH E14 is a QT guidance about the proarrhythmic potential of drugs.
Adopted in October 2005 with key aspects:
- Consistent QTc Measurement to determine QTc prolongation during treatment
- Use of a central ECG Lab
- Standardization and validated equipment
- Few Expert Readers to reduce variability
- Digital database for submission
- Submission of annotated ECG waveforms
Click here to download a copy of the ICH E14
