FDA’s Perspective on the Physiologically Based Pharmacokinetic (PBPK) Analyses for Biopharmaceutics Applications
Banu Zolnik, from the Division of Biopharmaceutics/ONDP/OPQ/CDER/FDA, takes you through the FDA’s Perspective on PBPK Analyses for Biopharmaceutics Applications
- Current Regulatory Landscape
- General Considerations for Model Development and Evaluation
- PBPK Study Report for Biopharmaceutics Applications for Regulatory Submission
- and more!
Presented at SLP MIDD+ Virtual Conference March 3-4, 2021
DISCLAIMER: This presentation reflects the views of the presenters and should not be construed to represent the FDA’s views or policies.