Published on 11/21/2018 9:22:00 AM
ASCPT Members-Only Webinar Presented by the Regulatory Science (RS) Community
Title: Using Concentration – QTc as the Primary Analysis in TQT & Phase 1 Studies: Considerations, Methods and Case Studies; and an Introduction to Comprehensive in vitro Proarrhythmia Assessment (CiPA) initiative
Date and Time: Wednesday, November 28, 2018 at 1:00 PM ET
Speaker: Dr. Christine Garnett
Moderators: Dr. Gopichand Gottipati and Dr. Apurvasena Parikh
Description: This talk will present on some of the important considerations such as study design features, C-QTc modeling objectives, approaches and challenges, exploratory analyses, pre-specified linear mixed effects model, general concepts of model development and evaluation and the expectation for modeling analysis plans and reports. The talk will also include relevant case studies and inform applications across small molecules, large molecules and therapeutic areas. In the last part of the talk, updates on the current ongoing efforts related to the clinical assessment of QT prolongation under the Comprehensive in vitro Proarrhythmia Assessment (CiPA) initiative will be presented.
Registration Link: https://attendee.gotowebinar.com/register/8958383532450509569