QT / QTc Analysis (TQT) for cardiac safety
A pioneer in exploring cardiac safety in early phase
PhinC Development has been a pioneer in the use of the concentration-response modeling approach to document QT-liability through intensive ECG monitoring from first-in-human studies to ICH E14 dedicated TQT study.
Since its revision in 2015, the ICH E14 guideline now accepts the use of C-R (Concentration-Response) approach applied to first-in-human studies as a possible alternative to the TQT study.
Indeed, the TQT is a resource intensive and expensive study dedicated only to ECG assessment per time point, and cannot be conducted until the potential therapeutic dose is characterized.
By contrast to this classical approach, C-R analysis considers all the ECG collected simultaneously with the systemic exposure to the drug.
Such evaluation has been shown to be sufficiently powerful and suitable in first-in-human studies, typically SAD (Single Ascending Dose) and MAD (Multiple Ascending Dose) studies performed on healthy volunteers to support a QT waiver for some drugs.
PhinC Development initiates preliminary C-R models, useful for predictions, which are essential for assessing the QT-interval prolongation risk, and if any, efficient adaptation of your regulatory ECG monitoring plan.
PhinC Development has long-term experience on QT/TQT studies conception and can thus help you limit any additional costs during the QT process.
Cardiabase-Banook, a partner of choice for TQT studies
PhinC Development has established a partnership with Cardiabase-Banook Group, the best cardiac core lab in Europe.
The company specializes in:
- data acquisition
- processing
- analysis
- reporting
- and archiving for digital and paper ECG
- as well as holter monitoring
Working with these cardiology experts ensures that you achieve state-of-the-art and regulation compliant TQT studies
For more information, please see the article Cardiac Safety sur le site de Cardiabas-Banook.
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