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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.

SUBMITTER: Mould DR 

PROVIDER: S-EPMC4369756 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Developing Exposure/Response Models for Anticancer Drug Treatment: Special Considerations.

Mould D R DR   Walz A-C AC   Lave T T   Gibbs J P JP   Frame B B  

CPT: pharmacometrics & systems pharmacology 20150121 1


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. Thi  ...[more]

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