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)

• Current Scientific Considerations to Verify Physiologically-Based Pharmacokinetic Models and Their Implications for Locally Acting Products

  Zhao, Liang; Seo, Paul; Lionberger, Robert

• Prediction of Food Effect on In Vitro Drug Dissolution into Biorelevant Media: Contributions of Solubility Enhancement and Relatively Low Colloid Diffusivity

  Polli, James E.

• Regulatory Science to Promote Access to Intrauterine Systems for Women in the United States

  Sharan, Satish; Wang, Yan; Donnelly, Mark; Zou, Yuan; Fang, Lanyan; Kim, Myong Jin; Zhao, Liang

• Development of a CFD-PK Nasal Spray Model with In Vivo Human Subject Validation

  Dutta, R; Kolanjiyil, AV; Golshahi, L; Longest, P

• Physiologically Based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development

  Lemerdy, Maxime; Tan, Mingliang; Babiskin, Andrew; Zhao, Liang

• Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches: A Workshop Overview

  Babiskin, Andrew; Wu, Fang; Mousa, Youssef; Tan, Ming-Liang; Tsakalozou, Eleftheria; Walenga, Ross; Yoon, Miyoung; Raney, Sam G; Polli, James E; Schwendeman, Anna; Krishnan, Vishalakshi; Fang, Lanyan; Zhao, Liang

• Validating CFD Predictions of Highly Localized Aerosol Deposition in Airway Models: In Vitro Data and Effects of Surface Properties

  Longest, Worth

• Effects of Subject-Variability on Nasally Inhaled Drug Deposition, Uptake, and Clearance

  Chari, Sriram; Sridhar, Karthik; Kleinstreuer, Clement

• A quasi-3D model of the whole lung: airway extension to the tracheobronchial limit using the constrained constructive optimization and alveolar modeling, using a sac–trumpet model

  Kannan, Ravishekar; Singh, Narender; Przekwas, Andrzej; Zhou, Xianlian; Walenga, Ross; Babiskin, Andrew

• Validating CFD Predictions of Nasal Spray Deposition: Inclusion of Cloud Motion Effects for Two Spray Pump Designs

  Kolanjiyil, Arun V; Hosseini, Sana; Alfaifi, Ali; Farkas, Dale; Walenga, Ross; Babiskin, Andrew; Hindle, Michael; Golshahi, Laleh; Longest, P Worth