.png){kind=icon}
End-to-end compliance with ICH S7 Guidelines
These studies are designed to identify the undesirable pharmacodynamic properties of a compound relevant to human safety in three areas — Cardiovascular, Respiratory and the Central Nervous System.
New ICH E14/S7B Q&A Guideline: Remove clinical TQT burden with high-quality double-negative preclinical data
With the release of the new ICH E14/S7B Q&As, for the first time, preclinical in vitro and ECG data can now be used to impact clinical ECG study design. Compounds that are deemed a low risk based on preclinical data (hERG and in vivo QT) allow sponsors more options to substitute the human Thorough QT (TQT) trial with ECGs collected in Phase I, reducing the overall industry TQT burden for low-risk compounds. We have in place the new quality standards for both hERG and the ECG telemetry studies that demonstrate achievement of sensitivity to detect QT changes equivalent to what can be achieved through testing in the clinic. Moreover, we have been at the forefront of numerous Q&A industry groups and presentations and are publication coauthors on the Q&As. Let us educate you on how to best apply the new guidance to your drug development portfolio.
