Why the study?
When lagged drug QTc effects (hysteresis) occur, linear direct effect concentration-QTc models may yield biased QTc estimates.
Failing to account for hysteresis in concentration-QTc models can yield biased QTc estimates, highlighting the need for appropriate identification methods in early clinical trials.
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Requires hysteresis checks in concentration-QTc models to limit bias; leaves open clinical validation of simulation methods.
Li et al. (2021) studied this question.
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