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