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)

• IVPT Data Challenges in the Real World

  Lehman, Paul

• In Silico Study of the Effect of Including Lactose Fines in Modeling Dry Powder Inhaler Performance

  Lee, Jae

• Diffusion Cell Apparatus: Considerations for Design and Use II

  Lee, Luke

• Ophthalmic Drug Products: Leveraging M&S Approaches to Perform Inter-Species Predictions and Support Drug Product Development and Approval

  Le Merdy, Maxime

• A Microdialysis Approach to Assess Dermal Pharmacokinetics of Topical Dermatological Drug Product

  Kuzma, Benjamin; Senemar, Sharareh; Stagni, Grazia

• Impact of Food and Formulation on Bioequivalence: A Generic Industry Perspective

  Kumar, Anita

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

  Cai, Bing; Kozak, Darby; Babiskin, Andrew

• On the Importance of Liquid Motion in Nasal Spray Delivery

  Kolanjiyil, A; Golshahi, L; Longest, W

• Industry Perspective: Regulatory Challenges in Development of Generic Long-Acting Injectables

  Kohojkar, Ameya

• Best Practices for Submitting Formulation Assessment Requests and Avoiding Information Requests: Tips for Submitting a Proposed Formulation Table

  Kim, Elizabeth