title: Developing Exposure/Response Models for Anticancer Drug Treatment: Special Considerations.
abstract: Anticancer agents often have a narrow therapeutic index (TI), requiring precise dosing to ensure sufficient exposure for clinical activity while minimizing toxicity. These agents frequently have complex pharmacology, and combination therapy may cause schedule-specific effects and interactions. We review anticancer drug development, showing how integration of modeling and simulation throughout development can inform anticancer dose selection, potentially improving the late-phase success rate. This article has a companion article in Clinical Pharmacology & Therapeutics with practical examples.
authors.affiliation: Projections Research Phoenixville, Pennsylvania, USA.
authors.forename: D R
authors.initials: DR
authors.lastname: Mould
authors.affiliation: Roche Pharma Research and Early Development, Modeling & Simulation, Pharmaceutical Sciences, Roche Innovation Center Basel F. Hoffmann-La Roche, Basel, Switzerland.
authors.forename: A-C
authors.initials: AC
authors.lastname: Walz
authors.affiliation: Roche Pharma Research and Early Development, Modeling & Simulation, Pharmaceutical Sciences, Roche Innovation Center Basel F. Hoffmann-La Roche, Basel, Switzerland.
authors.forename: T
authors.initials: T
authors.lastname: Lave
authors.affiliation: Amgen Thousand Oaks, California, USA.
authors.forename: J P
authors.initials: JP
authors.lastname: Gibbs
authors.affiliation: Projections Research Phoenixville, Pennsylvania, USA.
authors.forename: B
authors.initials: B
authors.lastname: Frame