Modeling and simulation have been recognized as valuable tools to assess biopharmaceutical performance. Applications of these tools in drug research and development have been reported increasingly.
Since 2004, the Office of Generic Drugs (OGD) at the US Food and Drug Administration (FDA) has started to apply these tools to support various regulatory activities.
This webinar provides a few examples of modeling and simulation in the OGD for the purpose of addressing biopharmaceutical performance questions for orally administered generic drug products.
Presenter:
Xinyuan (Susie) Zhang, Ph.D.
Staff Fellow
Office of Generic Drugs/CDER/FDA
Date: Wed, Nov 19, 2014 12:00 AM - 1:30 AM CST