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.