Response Letter to the Editor: “Assumption Checking Before Application of the Prespecified QT Linear Mixed Effect Model is Essential”

摘要

In the Letter to the Editor regarding: “Assumption checkingis essential,” the authors questioned satisfaction ofassumptions required for applying the prespecified linearmixed effect (LME) model, and our conclusion on reconsideringthe LME model when drug-induced circadian rhythmchange is expected.1 We appreciate the authors’ investigationof exploratory plots. We believe the basic assumptionsare met in part (i) and consideration of exploring alternativemodels based on known pharmacology is warranted in part(ii) because exploratory plots may not be sensitive to identifyall characteristics of drug effects on QT.