U.S. Food and Drug Administration | MIDD Training Module 2 – Part Two @US_FDA | Uploaded 2 months ago | Updated 8 hours ago
Stacy Tannenbaum, the lead of the Pharmacometrics Group in the US for Astellas Pharma Global Development, discusses disease progression modeling, pharmacokinetic/pharmacodynamic modeling, quantitative systems pharmacology, and clinical trial simulation. She also describes properties of a useful model and what modelling cannot do.

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.