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