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Topic-Contributed Paper Session

Challenges and Opportunities in Dose Optimization for Oncology Drug Development

Tue, Aug 6, 10:30 AM - 12:20 PM

Ivan ChanChair

Biopharmaceutical Section

4 Presentations

DOD-BART: Machine Learning-Based Dose Optimization Design Incorporating Patient-Level Prognostic Factors via Bayesian Additive Regression Trees

10:35 AM - 10:55 AM

Exposure-Response based Multi-Attribute Clinical Utility Score Framework to Facilitate Optimal Dose Selection for Oncology Drugs

10:55 AM - 11:15 AM

Shuyu Chu (BMS)

MERIT: Design and Sample Size Determination for Multiple-dose Randomized Phase II Trials for Dose Optimization

11:15 AM - 11:35 AM

Regulatory Perspective of Dose Optimization of Oncology Products

11:35 AM - 11:55 AM

Joyce Cheng (FDA)

Discussant

Yan Xu

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