Comparison
Population pharmacokinetic and… vs Thorough QT study
Design
Review
Authors
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May refine QTc risk quantification in development; leaves open regulatory replacement of thorough QT studies pending validation.
Population PKPD modelling offers a superior paradigm for evaluating drug-induced QTc prolongation by integrating concentration-effect relationships, potentially overcoming limitations of the traditional thorough QT study.
France et al. (2014) studied this question.
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