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)

• Establishing Bioequivalence Using Characterization Based Approaches for Topical Products – Challenges & Solutions

  Jani, Romit

• Predictive Performance of PBPK Dose Estimates for Pediatric Trials

  Dallmann, Andre

• Use of PBPK in New Drug Development and Regulatory Review – Clinical Pharmacology Perspective

  Huang, Shiew-Mei

• Development of an In Vitro Method for In Vivo Prediction of Regional Deposition of Nasal Powders

  Holtgrewe, Nicholas; Walenga, Ross; Bielski, Elizabeth; Guo, Changning

• Correlating The In Vitro Dissolution Behavior Of Inhalation And Nasal Drug Products With In Vivo Performance: Pitfalls And Potential Solutions Using The Transwell System

  Hochhaus, Guenther

• Mathematical Models of Skin Penetration

  Heisig, Michael; Nagel, Arne; Wittum, Gabriel

• Parameter Sensitivity Analysis of a Two-Dimensional Skin Diffusion Model

  Heisig, Michael; Nagel, Arne; Wittum, Gabriel

• Mathematical Models of Skin Penetration

  Heisig, Michael; Nagel, Arne; Wittum, Gabriel

• Drug Permeation through Skin: A Challenging Application for High Performance Scientific Computing

  Heisig, M; Nagel, A; Wittum, G

• Mechanistic in Silico Inference of Dermal Absorption for Chemical Risk Assessment

  Troutman, John