Anticancer agents often have a narrow therapeutic index (TI), requiring precise dosing to
ensure sufficient exposure for clinical activity while minimizing toxicity. These agents …

Despite advances in biomedical research that have deepened our understanding of cancer
hallmarks, resulting in the discovery and development of targeted therapies, the success …

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 …

The prospect of precision dosing in oncology is attractive for several reasons. Many
anticancer drugs display narrow therapeutic indices, where suboptimal therapy may lead to …

Background: Anticancer drugs are characterized by a narrow therapeutic window and
significant inter-patient variability in therapeutic and toxic effects. Current body surface area …

Purpose: Recommended phase II dose (RP2D) determination for combination therapy
regimens is a constrained optimization problem of maximizing antitumor activity within the …

There has been increased interest in optimizing dosing regimens for oncology products over
the past decade. Investigations to refine dosing regimens often occur after new drug …

Abstract Exposure–response (E–R) analyses are an integral component in the development
of oncology products. Characterizing the relationship between drug exposure metrics and …

The TGI model4, 5 accounts for the dynamics of tumor growth, antitumor drug effect, and
resistance to drug effect. The model describes tumor size (ie, sum of the longest diameters of …

Simple Summary Modern “adaptive therapy” approaches to cancer therapy rely on adjusting
the dose of drugs as the size of the tumor changes. They hold the promise of transforming …