Realizing the promise of Project Optimus: Challenges and emerging opportunities for dose optimization in oncology drug development

• Main Authors: Wei Gao (Author), Jiang Liu (Author), Blerta Shtylla (Author), Karthik Venkatakrishnan (Author), Donghua Yin (Author), Mirat Shah (Author), Timothy Nicholas (Author), Yanguang Cao (Author)
• Format: Book
• Published: Wiley, 2024-05-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract Project Optimus is a US Food and Drug Administration Oncology Center of Excellence initiative aimed at reforming the dose selection and optimization paradigm in oncology drug development. This project seeks to bring together pharmaceutical companies, international regulatory agencies, acade...