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)

• GDUFA Research Update on Mechanistic Modeling Approaches for Generic Ophthalmic, Nasal, Implant and Injectable Drug Products

  Tan, Mingliang

• Physiologically-based Pharmacokinetic Modeling to Support Generic Ophthalmic Product Development and Regulatory Decision Making

  Tan, Mingliang

• Powder Fluidization in Dry Powder Inhalers

  Sulaiman, Mostafa; Liu, Xiaoyu; Kolehmainen, Jari; Ozel, Ali; Sundaresan, Sankaran

• IVPT Studies with Topical and Transdermal Products

  Stinchcomb, Audra

• PBPK Modeling of Dermal Penetration from Topical Formulations

  Spires, Jessica

• Computational Modeling of Absorption from Complex Topical Formulations

  Spires, Jessica

• Virtual Bioequivalence Workflow

  Pellowe, M

• A Predictive Multiscale Computational Tool for Simulation of Lung Absorption and Pharmacokinetics and Optimization of Pulmonary Drug Delivery

  Singh, Narender

• Effect of Varying Inflow Conditions on Pharmaceutical Powder Dynamics in Inhaler-like Flows

  Singh, Gajendra

• A Multiscale Computational Framework for Inhalation Pharmacology and Drug Development

  Singh, Narender; Kannan, Ravi; Przekwas, Andrzej