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)

• Complex Generic Drug Products (CGDPs) with Complex Formulations Including Nanotechnology Products

  Cai, Bing; Kozak, Darby; Babiskin, Andrew

• Use of Mechanistic Modelling to Determine the Sensitivity of in vitro CQAs to Regional Lung Deposition and Predict PK for OIDPs

  Butler, Clare

• Studies to Further Establish PK as Central Tool for a Streamlined Approval of Generic Inhalation Drugs

  Bulitta, Jurgen; Hochhaus, Gunther

• Developing PBPK for Ocular Delivery

  Bolger, Michael

• Scientific Challenges Related to Establishing Q1/Q2 Sameness-An Industry Perspective

  Zhao, Liang

• Oral PBPK to Support BE Evaluation for Pediatric Drugs

  Guy, Richard

• IVPT Studies with Sunscreen Products: Potential Regulatory Utility

  Hakeem, Susan

• Relevant Challenges with IVRT with Iron-Carbohydrate Complexes: Application to IVIVC Models

  Hartka, Kathryn

• Challenges in Demonstrating API Sameness for Drug Products with Complex APIs

  Hochhaus, Guenther

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

  Babiskin, Andrew