Quantitative approaches to drug development

This new work explore the distinction between conditional and unconditional covariate effects, an important nuance when models include correlated predictors like body weight and age. This work provides a framework to improve the clarity of dosing recommendations, ensuring they are robust and actionable for prescribers across diverse patient populations.

Phase I studies are increasingly used to assess drug QT liability, however early-phase trials often lack the strict controls for meal intake and sampling times found in dedicated “thorough QT” (TQT) studies. Without such standardization, significant variability can be introduced, potentially masking or exaggerating the perceived proarrhythmic risk.