U.S. Food and Drug Administration | Module 7 – Case Study 5: Application of PBPK Models in Eliglustat Clinical Development @US_FDA | Uploaded 2 months ago | Updated 10 hours ago
Dr. Binfeng Xia with Sanofi U.S. shows how Physiologically Based Pharmokinetic (PBPK) models were used to support Eliglustat (Cerdelga) clinical development. Eliglustat is a glucosylceramide synthase inhibitor indicated for the long-term treatment of adult Gaucher Disease Type 1 (GD1) patients who are CYP2D6 extensive metabolizers, or intermediate metabolizers, or poor metabolizers.
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. Binfeng Xia with Sanofi U.S. shows how Physiologically Based Pharmokinetic (PBPK) models were used to support Eliglustat (Cerdelga) clinical development. Eliglustat is a glucosylceramide synthase inhibitor indicated for the long-term treatment of adult Gaucher Disease Type 1 (GD1) patients who are CYP2D6 extensive metabolizers, or intermediate metabolizers, or poor metabolizers.
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.
