劲准Precision：2025年无缝1/2期肿瘤试验设计的考量与实践白皮书（英文版）

Regulatory planning provides a roadmap for maneuvering through the complex regulatory landscape, ensuring that the trial adheres to the stringent guidelines set forth by authorities such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). Understanding regulatory agency expectations for establishing relationships among dosing, safety, and efficacy is important for obtaining meaningful data. Studies are often designed so that phase 1 inclusion is for various advan