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