Traditional dose selection strategy for oncology drugs is often radical.However,with the development of small molecule targeted therapies,biologics and immunotherapies,exploring the optimal dose and schedule is crucial to ensure patients'access to the most safe and effective treatments.Model-informed drug development(MIDD)integrates physiology,pharmacology and disease process by using modeling and simulation methods,to guide new drug study design and dose optimization,which has been extensively used in the development of oncology drugs.In this article,the application of MIDD in oncology drug dose selection is discussed,focusing on its application on dose selection in early clinical research,late clinical research,combination therapy,specific populations and dose optimization after marketing,and the challenges of MIDD application are also briefly discussed.
model-informed drug developmentoncologydose selectionexposure-response relationshipbiomarker
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