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)

• Considerations for Using Model Master Files

  Babiskin, Andrew

• Regulatory Perspective on Modeling Strategies Across Multiple Submissions

  Babiskin, Andrew; Yoon, Miyoung

• Regulatory Perspective: Challenges and Opportunities to Enhance Model Sharing upon Regulatory Use

  Babiskin, Andrew

• Use of PBPK Model to Evaluate Impact of Ophthalmic Drug Products Critical Quality Attributes of BA/BE Assessment

  Babiskin, Andrew

• Physiologically-based Absorption Modeling and Simulation used in Assessing Bioequivalence for Ophthalmic Products

  Babiskin, Andrew

• Novel Model-Integrated Designs for Bioequivalence Studies of LAI Products: A Complete Framework with the MonolixSuite

  Ayral, Geraldine

• Modeling Dermal Drug Absorption from Complex Semisolid Formulations: Insights from Multi-Phase, Multi-Layer MechDermA Model

  Zhao, Liang (should be Arora S)

• Integrating Topical Drug Product Quality Attributes Within Physiologically-based Pharmacokinetic Models

  Zhao, Liang

• Modeling Dermal Drug Absorption from Complex Semisolid Formulations: Insights from Multi-Phase, Multi-Layer MechDermA Model

  Zhao, Liang

• Simulating the Effect of Propylene Glycol on Acyclovir (Zovirax® Cream, 5%) Permeation Across the Skin Using a Physiologically Based Pharmacokinetic (PBPK) Model of In Vitro Flow-through Skin Permeation

  Arora, S; Patel, N; Polak, S; Jamei, M; Tsakalozou, E; Ghosh, P; Alam, K; Liu, X; Namjoshi, S; Grice, J; Mohammed, Y; Roberts, M