Online Program

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Friday, September 14
Fri, Sep 14, 9:55 AM - 11:10 AM
Thurgood Marshall West
Two Years Later: Impacts of ICH E14 Revision on Cardiac Safety

Baseline Adjustment in Concentration-QTc Analysis Regarding Assay Sensitivity in 'Hybrid TQT' Study (300736)

Janell Chen, FDA/CDER 
*Dalong Huang, FDA/CDER 
Yi Tsong, CDER/FDA 

Keywords: Concentration-QTc Modeling, Assay Sensitivity, Baseline, hybrid TQT

The ICH E14 guidance acknowledges that there is no single best approach for baseline adjustment. Time-matched baseline and pre-dose baseline have been commonly used as a covariate in concentration-QTc (C-QTc) modeling for parallel and crossover study, respectively. Huang et al. (2017) showed that the C-QTc model using time-matched baseline has a low chance of showing assay sensitivity in parallel study.

This talk discusses different types of baseline adjustments (e.g. time-matched, pre-dose, and day-averaged) regarding assay sensitivity in the “hybrid TQT “ study using real and simulated moxifloxacin data and makes recommendations.