A Simulation Study to Evaluate the Performance of Different Exposure Response Analyzes Using Concentration-QTc Data

• Activity Number: 243 - Contributed Poster Presentations: Biopharmaceutical Section
• Type: Contributed
• Date/Time: Monday, July 31, 2017 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Dalong Huang*
• Companies: FDA
• Keywords: ICH E14 ; exposure response ; QTc ; linear mixed model

Abstract

The ICH E14 clinical guidance was revised in December 2015. It now enables the use of exposure response (ER) analysis applied to early phase clinical data to provide definitive evidence of the lack of a QT effect of a drug in development.

A simulation study was conducted to evaluate performance of different ER analyses using concentration QTc data and make recommendations on appropriate ER analyses.