Application of the model‐informed drug development paradigm to datopotamab deruxtecan dose selection for late‐stage development

• Main Authors: Yasong Lu (Author), Shuang Liang (Author), Ying Hong (Author), Naoyuki Tajima (Author), Kashyap Patel (Author), Hanbin Li (Author), David R. Wada (Author), Jon Greenberg (Author), Adam Petrich (Author), Hong Zebger‐Gong (Author), Dale Shuster (Author), Pavan Vaddady (Author)
• Format: Book
• Published: Wiley, 2024-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract To replace the conventional maximum tolerated dose (MTD) approach, a paradigm for dose optimization and dose selection that relies on model‐informed drug development (MIDD) approaches has been proposed in oncology. Here, we report our application of an MIDD approach during phase I to inform...