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(430)
• Posters(94)
• Presentations(218)
• Papers(118)

• Local and Systemic Absorption Predictions of Nasal Inhaled Corticosteroids: A Combined Approach

  Schoroeter, Jeffry (should be Schroeter)

• A CFD-PBPK Approach to Simulate Deposition, Absorption, and Bioavailability of Intranasal Corticosteroids

  Schoroeter, Jeffry (should be Schroeter)

• Prediction II: Computational Fluid Dynamics, as part of a workshop titled Bridging the Gap from Science to Clinical Efficacy: Imaging, Modelling, and Physiology of Aerosols and the Lung

  Schoroeter, Jeffry (should be Schroeter)

• USP <1724> and <1002> Prospective Scope and Content

  Santos, Leandro

• IVPT Studies During Topical Product Development

  Santos, Leandro

• Effect of Formulation Differences on Critical Quality Attributes and Performance of the Complex Topical Products

  Sachdeva, Sameer

• A Modeling Approach to Predict Pharmacokinetic Endpoints of Sunscreen Products

  Roy, Kartik Ranjon

• Nonregulatory Perspective: What Can Be a Model Master File and How to Share It?

  Rostami-Hodjegan, Amin

• Improving Model Reusability via the Concept of Model Master File: What the Literature Data Tell Us

  Rostami, Amin

• Looking, Feeling and Modelling from the Outside In

  Roberts, Michael