Early Development and The Dose Selection in the Immune-oncology
The Effective Statistician - in association with PSI
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Revolutionizing Dose Selection in Biotech Trials
This chapter explores the roles of statistical experts in oncology and immune-oncology drug development, focusing on innovative approaches to dose selection in early-phase studies. It emphasizes the shift from maximum tolerated doses to identifying optimal biologic doses and discusses advanced methodologies like the Bayesian Optimal Interval Design (Boeing), while considering ethical and regulatory implications.
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