Model-Informed Population Pharmacokinetic Simulation of Osimertinib and Az5104 in a Virtual Indian Nsclc Cohort: Exposure Variability, QTCF Tail-Risk Quantification, and Risk-Stratified ECG Monitoring
Objective: Osimertinib is a third generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that has concentration-dependent QTc prolongation. Pivotal trials are under-representing Indian patients and they could differ in specific baseline characteristics (covariates) that are important for drug...