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)

• Prediction of Respimat® Inhaler Spray: Co-Flow Air Behavior

  Kakhi, Maziar

• PBPK Models: Opportunities for Enhancements

  Jusko, William

• Overview of Complex Generics Regulatory Perspective on Bioequivalence

  Jiang, Jeff

• PBPK Modeling for Different Locally-Administered Drug Products

  Jereb, Rebeka

• PBPK Modeling to Support Risk Assessment for Oral Drug Products, Including Waiver of Fed BE Studies

  Jereb, Rebeka

• Predictive Performance of PBPK Dose Estimates for Pediatric Trials

  Dallmann, Andre

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

  Jani, Romit

• 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