Concentration-QT modelling in early clinical oncology settings: Simulation evaluation of performance.
Gael CantetAlienor BergesRhianna O'SullivanSarit Cohen-RabbieCorina DotaVincent DuboisGuillemette E BenoistHelen TomkinsonDinko RekićJoanna ParkinsonStein SchalkwijkPublished in: British journal of clinical pharmacology (2021)
C-QTc performance appeared limited using a 10 ms threshold, but acceptable against a 20 ms threshold. Selection of threshold may be informed by the benefit-risk balance in a specific disease area. Acceptable precision (i.e., confidence intervals) of the estimated ΔQTc, regardless of its magnitude, can be facilitated by pooling data from dose escalation and expansion cohorts.