U.S. Food and Drug Administration | Module 7 – Case Study 1: Optimizing CERA Pediatric Drug Development @US_FDA | Uploaded 2 months ago | Updated 18 minutes ago
Dr. Pascal Chanu talks about how MIDD is used to optimize a pediatric program. The drug discussed is CERA, which stands for continuous erythropoietin receptor activator. It’s an erythropoietin stimulating agent or ESA, which is indicated in anemia associated with chronic kidney disease.
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.
Dr. Pascal Chanu talks about how MIDD is used to optimize a pediatric program. The drug discussed is CERA, which stands for continuous erythropoietin receptor activator. It’s an erythropoietin stimulating agent or ESA, which is indicated in anemia associated with chronic kidney disease.
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.
