Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities

• Main Authors: Nidal Al‐Huniti (Author), Yan Feng (Author), Jingyu (Jerry) (Author), Zheng Lu (Author), Mario Nagase (Author), Diansong Zhou (Author), Jennifer Sheng (Author)
• Format: Book
• Published: Wiley, 2020-08-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Model‐informed drug development (MIDD) approaches have rapidly advanced in drug development in recent years. Additionally, the Prescription Drug User Fee Act (PDUFA) VI has specific commitments to further enhance MIDD. Tumor growth dynamic (TGD) modeling, as one of the commonly utilized MIDD approac...