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ON DEMAND [ISoP Webinar] – Physiologically Based Pharmacokinetic (PBPK) Applications in Model Informed Drug Development (MIDD) – Do You Know the Current Landscape of Regulatory Acceptance?

Model Informed Drug Development (MIDD) is essential in drug development and regulatory review, aiding in clinical trial design and dose selection. Physiologically Based Pharmacokinetic (PBPK) modeling, a key part of MIDD, assesses complex drug-drug interactions (DDIs) and supports diverse clinical studies.

Key Topics:

  • Role of MIDD in clinical trial design and dose selection.
  • Regulatory acceptance of PBPK modeling for complex DDIs.
  • FDA’s push for diverse and inclusive clinical trials.
  • Advances in PBPK models for predicting drug exposures across demographics.
  • Future challenges for PBPK models in regulatory decision-making and trial diversity.

발표자

  • Karen Rowland Yeo: Senior VP, Client & Regulatory Strategy, Certara
  • Eva Gil Berglund: Senior Director, Regulatory Strategy, Certara
  • Yuan Chen: Senior Fellow, Genentech

Register to access the on-demand version!

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