Unlocking the Power of PBPK Modeling: PBPK for First-in-Human and Beyond

Authors: Kilford P, Graves B
Software: GastroPlus®

The mechanistic translation of nonclinical pharmacokinetic data to humans can make or break the success of your clinical plan. It’s critical to understand how to get the insight you need to determine…

· What the clinical starting dose should be based on your nonclinical data
· What doses will be included in your first-in-human (FIH) study
· If you will achieve safety cover in nonclinical species
· If your drug product will benefit from micronization
· Whether you need to consider drug-drug interaction (DDI) studies
· Other challenges that may need to be addressed in clinical development

In this webinar, Becky Graves, Director of Simulation Studies at Simulations Plus, will explain how to leverage the FIH Simulator to gain these insights and more. She’ll walk through physiologically based pharmacokinetic (PBPK) best practices, and how you can build PBPK models to translate nonclinical data to accurately design your FIH clinical trial and beyond.

PRESENTER: Becky Graves, Director, Simulation Studies, Simulations Plus
MODERATOR: Peter Kilford, Associate Vice President, Software Business Development, Simulations Plus

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