劲准Precision：2025年剂量优化：肿瘤药物研发中的关键策略白皮书（英文版）

Launched by the FDA in 2021, Project Optimus represents a fundamental shift in how early phase oncology dose evaluation is approached, moving away from MTD toward evidence-based, patientcentered dosing.4,5,6 The goal is to identify the OBD, defined as the dose that achieves a clinically meaningful therapeutic effect with acceptable safety and tolerability