Author

Shu-Pang Huang

2 papers indexed here

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Open access Oct 2026

From Phase Ib/II to Seamless Phase II/III: A Simulation-Based Discussion of Design Strategies for Dose Optimization and Confirmatory Phase.

Overall, DO can be effectively implemented at multiple stages of clinical development and should balance statistical rigor, development speed, practical feasibility, and the suitability of the endpoints used for dose selection.

An-Nan Deng, Xiao-Chen Zhu, Hai-Yang Sheng et al. · Clinical pharmacology and th... · 0 citations

Open access Sep 2026

BEACON: An Adaptive Bayesian Early-Phase Oncology Trial Design Integrating Dose Optimization and Proof-of-Concept Across Survival and Binary Endpoints.

Conventional dose selection in oncology, which focuses on the maximum tolerated dose (MTD), has certain limitations for targeted agents and immunotherapies, where the efficacy-toxicity relationship may not be monotonic. Regulatory initiatives such as FDA's Project Optimus highlight the need for improved dose optimizati...

Yi-Ke Tang, Feng Tian, Xiao-Chen Zhu et al. · Pharmaceutical statistics · 0 citations