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Model-Integrated Evidence for Generic Drug Development – Session 1A

Presenters and a panel discuss the regulatory utility and knowledge gaps related to implementing modeling and simulation (e.g., computational fluid dynamics coupled with physiologically-based pharmacokinetic (PBPK) models for orally inhaled products. Presentation titles include, “Current Limitations in Producing a Fully Mechanistic PBPK Model for a Highly Soluble Orally Inhaled Drug Product That Exhibits Slow Lung Absorption” and “Integrated Computational Fluid Dynamics-Physiology-Pharmacokinetics Tools for Development and Evaluation of Orally Inhaled Drug Products.”
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Model-Integrated Evidence for Generic Drug Development – Session 1B

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