- Celerion hosts a series of Clinical Discussion Forums throughout the year at a variety of global locations. Join us for an evening of scientific discussion and networking.
Clinical Discussion Forums
Hotel La Jolla
Aug 2, 2016
So You Want a TQT Waiver? Highlights from the April 2016 FDA CSRC Meeting
Elliot Offman MSc, Senior Director, Clinical Pharmacology
Lorraine Rusch PhD, Vice President, Commercial Development
Translating the recent ICHE14 exposure response analysis proposals into
- Design considerations for the alternative to a TQT.
- Statistical PK PD analysis in a dose-escalation study to support an alternative to the TQT.
Specific regulatory questions under consideration for exposure response analysis designs:
- When is a positive control required in an alternative design cardiovascular safety assessment study?
- What potential alternatives to moxifloxacin could be considered in these alternate study designs?
- New emerging ECG biomarkers under development to characterize arrhythmia liability.