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(360)
• Posters(77)
• Presentations(193)
• Papers(90)

• Continuous Skin Sampling Methods for the Assessment of Cutaneous PK-Based Bioequivalence

  Tiffner, Katrin; Boulgaropoulos, Beate; Birngruber, Thomas; Bodenlenz, Manfred; Lackner, Bettina; Raml, Reingard; Sinner, Frank

• IVRT Studies During Topical Product Development: Challenges in Method Development and Transfer

  Thakker, Kailas

• 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 Multiscale Computational Framework for Inhalation Pharmacology and Drug Development

  Singh, Narender; Kannan, Ravi; Przekwas, Andrzej

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

  Singh, Narender