GDUFA Research Outcomes

PBPK Models

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to physiologically-based pharmacokinetics (PBPK) computational modeling to support generic product development and assessment.

• All(475)
• Posters(107)
• Presentations(231)
• Papers(137)

• Ocular PBPK/PD Modeling to Explore In Vitro Bioequivalence Approach for Brinzolamide Ophthalmic Suspensions

  Tan, Mingliang

• AI for Augmenting and Accelerating Computational Fluid Dynamics Predictions of Regional Lung Deposition

  Walenga, Ross

• Formulations in Flux: Simulating the Effect of Dynamic Formulation Composition Changes Following Application of Complex Topical Drug Products

  Clarke, James

• The Development and Framework of Model Master Files as a Regulatory Initiative

  Tsakalozou, Eleftheria

• Recommendations for Demonstrating Bioequivalence of Nasal Sprays: Scientific Thinking and Regulatory Research

  Boc, Susan

• Evaluating Charcoal Block Pharmacokinetics as a Surrogate for Regional Lung Drug Delivery in Orally Inhaled Drug Products

  Walenga, Ross; Feng, Kairui (Kevin); Hu, Meng; Babiskin, Andrew

• Model Integrated Evidence and Model Master File for Developing Orally Inhaled Drug Products

  Walenga, Ross

• Quantitative Studies to Inform PSG Development for Tiotropium Bromide Inhalation Spray, Metered

  Chopski, Steven; Babiskin, Andrew; Newman, Bryan; Dhapare, Sneha; Boc, Susan; Kakhi, Maziar; Walenga, Ross

• Adopting the Model Master File Framework to Enhance Modeling and Simulations Approaches for Regulatory Use

  Fang, Lanyan (Lucy)

• Advancing In Silico Methods and Future Opportunities for Understanding Impact of Compositional Differences on Performance

  Walenga, Ross