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Randomized optimal selection design for dose optimization
Date: October 8, 2025 PMID: PMC12505323 Category: N/A Authors: Shuqi Wang, Ying Yuan, Suyu Liu Abstract: The US Food and Drug Administration (FDA) launched Project Optimus to shift the objective of dose selection from the maximum tolerated dose to the optimal biological dose (OBD), optimizing the benefit-risk tradeoff. One approach recommended by the FDA's guidance is to conduct randomized trials comparing multiple doses. In this paper, using the selection design framewo
bgtaylor1
Nov 112 min read
BOP2-Comb: Bayesian Optimal Phase II Design for Optimizing Doses and Assessing Contribution of Components in Drug Combinations
Date: August 19, 2025 PMID: 10.1007/s43441-025-00860-5 Category: N/A Authors: Xiaohan Chi, Ying Yuan, Ruitao Lin Abstract: 40830695 Background: Personalized cancer treatment using combination therapies offers substantial therapeutic benefits over single-agent treatments in most cancers. However, unmet clinical needs and increasing market competition pressure drug developers to quickly optimize combination doses and clearly demonstrate the contribution of each component when d
bgtaylor1
Nov 112 min read
BARD: A seamless two-stage dose optimization design integrating backfill and adaptive randomization
Date: August 22, 2025 PMID: PMC12240483 Category: N/A Authors: Yixuan Zhao, Rachael Liu, Jianchang Lin, Ying Yuan Abstract: 40626646 One common approach for dose optimization is a two-stage design, which initially conducts dose escalation to identify the maximum tolerated dose, followed by a randomization stage where patients are assigned to two or more doses to further assess and compare their risk-benefit profiles to identify the optimal dose. A limitation of this approach
bgtaylor1
Nov 112 min read
COMIC: A Bayesian Dose Optimization Design for Drug Combination in Multiple Indications With Application to CAR-T Therapies
Date: May 2025 PMID: 40386962 Category: N/A Authors: Kai Chen, Kentaro Takeda, Ying Yuan Abstract: Project Optimus, initiated by the...
bgtaylor1
Jul 292 min read
COCA: a randomized Bayesian design integrating dose optimization and component contribution assessment for combination therapies
Date: April 2, 2025 PMID: 40552493 Category: N/A Authors: Xiaohan Chi, Ruitao Lin, Ying Yuan Abstract: In cancer treatment, the...
bgtaylor1
Jul 292 min read
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