FDA’s Perspective on the Physiologically Based Pharmacokinetic (PBPK) Analyses for Biopharmaceutics Applications

Authors: Zolnik B
Conference: SLP MIDD+
Keywords: biopharmaceutics, FDA, MIDD (model-informed drug development), Model Development, Physiologically based pharmacokinetic (PBPK) modeling, Post-Approval/Generics, SLP MIDD+ Virtual Conference, SLP2021MIDD

Banu Zolnik, from the Division of Biopharmaceutics/ONDP/OPQ/CDER/FDA, takes you through the FDA’s Perspective on PBPK Analyses for Biopharmaceutics Applications

Topics covered:

  • Current Regulatory Landscape
  • General Considerations for Model Development and Evaluation
  • PBPK Study Report for Biopharmaceutics Applications for Regulatory Submission
  • and more!

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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.