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)

• Considerations for IVRT Data and Information Submitted in ANDAs

  Ma, Tien

• The In Vitro Permeation Test (IVPT): Historical Perspective, Current Context, and Future Directions

  Maibach, Howard

• Building Mechanistic IVIVC

  Lukacova, Viera

• Case Study: Predicting Regional Lung Deposition of Pharmaceutical Aerosols with CFD

  Longest, Worth; Dutta, Rabijit

• Modeling Complex Particle Interactions in Dry Powder Inhaler

  Liu, Xiaoyu; Sulaiman, Mostafa; Kolehmainen, Jari; Ozel, Ali; Sundaresan, Sankaran

• 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