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)

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

  Zhao, Liang (should be Arora S)

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

  Ayral, Geraldine

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

  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

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

  Zhao, Liang

• Formulation Drug Product Quality Attributes Additions in Dermal PBPK Model

  Babiskin, Andrew

• Mechanistic Modeling of Complex Injectables: Recommendations to Navigate Regulatory Challenges

  Andre, Kris

• Research Overview and Regulatory Experience on Mechanistic Modeling for Generic Dermatological Drug Products

  Alam, Khondoker

• Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products, Part 2

  Arora, Sumit

• Excipient Safety Assessment in Generic Drug Formulations: An Overview

  Agarwal, Stuti