Use your data collected during routine Phase I studies to assess cardiac safety early in drug development. Sufficient data will now be reviewed by the FDA and other regulators under the 2015 E14 Q&A document and may enable the FDA to grant a waiver of the traditional full TQT study based on early response analysis of the investigational product’s QT characterization.
This technique, has multiple benefits for biopharmaceutical client:
- Utilizing Early Precision QT offered by our partner iCardiac, can potentially save millions of dollars vs a traditional full TQT study
- Confirm or clarify an earlier in vitro or in vivo non-clinical cardiovascular safety finding
- De-risk a compound and increase the potential value of the development program prior to Phase II studies
- Rank order potential analog compounds in a library to bring forward the candidates with fewer cardiovascular risks into development
HPCTC is Implementing Early Precision QT in our Clinics: HPCTC is a participant in the iCardiac training and certification process, created to ensure the reliability and accuracy of the results and reduce risks.