Abstract Model-informed precision dosing (MIPD) stands as a significant development in
personalized medicine to tailor drug dosing to individual patient characteristics. MIPD moves …

Abstract Model-based approaches, including population pharmacokinetic-
pharmacodynamic modeling, have become an essential component in the clinical phases of …

Project Optimus is a US Food and Drug Administration Oncology Center of Excellence
initiative aimed at reforming the dose selection and optimization paradigm in oncology drug …

Given evidence that currently used dosing regimens are not tolerable for many patients with
cancer, the public has expressed an urgent need to optimize dosages for oncology drugs …

Exposure-response (ER) modeling frequently relies on the use of exposure metrics that
summarize drug concentrations over time. We present simulations to demonstrate that …

Ribociclib in combination with endocrine therapy (ET) is a globally approved treatment
option for patients with hormone receptor‐positive (HR+)/human epidermal growth factor …

This study aimed to analyze potential ethnic disparities in the dose–exposure–response
relationships of trilaciclib, a first-in-class intravenous cyclin-dependent kinase 4/6 inhibitor …

PURPOSE The advent of new therapeutic modalities highlighted deficiencies in the
traditional maximum tolerated dose approach for oncology drug dose selection and …

Visual predictive checks (VPC) are commonly used to evaluate pharmacometrics models.
However their performance may be hampered if patients with worse outcomes drop out …

Pralsetinib is a highly potent oral kinase inhibitor of oncogenic RET (rearranged during
transfection) fusions and mutations. Pralsetinib received approval from the United States …