U.S. Food and Drug Administration | Module 7 – Case Study 2: Model-Informed Clinical Development of Mosunetuzumab @US_FDA | Uploaded 2 months ago | Updated 1 hour ago
This study by Dr. Chi-Chung Li, Senior Principal Scientist with Genentech/Roche, shows how MIDD was used to support the clinical development of Mosunetuzumab, bispecific antibody.
This module is part of the educational series “Model-Informed Drug Development (MIDD): Methods Advancing Medical Products to Patients”. The educational content was developed for regulatory scientists by experts in the field in partnership with the Critical Path Institute and funded by FDA CDER Office of Translational Sciences. As part of Multidisciplinary Education and Exchange initiatives, CDER’s Quantitative Medicine Center of Excellence is making this resource accessible to all, supporting community-wide educational enrichment.
Disclaimer: The presentations in this educational series reflect the views of the presenters and should not be construed to represent FDA’s views or policies.
This study by Dr. Chi-Chung Li, Senior Principal Scientist with Genentech/Roche, shows how MIDD was used to support the clinical development of Mosunetuzumab, bispecific antibody.
This module is part of the educational series “Model-Informed Drug Development (MIDD): Methods Advancing Medical Products to Patients”. The educational content was developed for regulatory scientists by experts in the field in partnership with the Critical Path Institute and funded by FDA CDER Office of Translational Sciences. As part of Multidisciplinary Education and Exchange initiatives, CDER’s Quantitative Medicine Center of Excellence is making this resource accessible to all, supporting community-wide educational enrichment.
Disclaimer: The presentations in this educational series reflect the views of the presenters and should not be construed to represent FDA’s views or policies.
