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)

• Clearing the Path for Modeling and Simulation in Drug Applications

  Lionberger, Robert

• Quantitative Medicine Innovations in the Generic Drug Program

  Lionberger, Robert

• Critical Roles for Locally Acting PBPK in Regulatory Decisions

  Lionberger, Robert

• CFD Lung Models for Drug Delivery

  Lin, Ching-Long

• Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use – Guidance Implementation in Q1/Q2 Assessment

  Li, Xinran

• IVPT Data Challenges in the Real World

  Lehman, Paul

• Diffusion Cell Apparatus: Considerations for Design and Use II

  Lee, Luke

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

  Lee, Jae

• 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