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)

• Effect of Varying Inflow Conditions on Pharmaceutical Powder Dynamics in Inhaler-like Flows

  Singh, Gajendra

• Prediction of Human Pharmacokinetics Utilizing In Vitro Chewing Method and Physiologically Based Pharmacokinetic (PBPK) Analyses for Abuse-Deterrent Hydrocodone Bitartrate Extended Release Tablets

  Sharan, Satish

• Application of Modeling and Simulation in Establishing Appropriate Bioequivalence Limits for Complex Formulations

  Sharan, Satish

• Evaluation Of Residual Levonorgestrel As Potential Bioequivalence Metric For A Long Acting Intrauterine System Using Quantitative Modeling And Simulation Approach

  Sharan, Satish

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

  Shah, Vinod

• Local and Systemic Absorption Predictions of Nasal Inhaled Corticosteroids: A Combined Approach

  Schoroeter, Jeffry

• A CFD-PBPK Approach to Simulate Deposition, Absorption, and Bioavailability of Intranasal Corticosteroids

  Schoroeter, Jeffry

• Prediction II: Computational Fluid Dynamics, as part of a workshop titled Bridging the Gap from Science to Clinical Efficacy: Imaging, Modelling, and Physiology of Aerosols and the Lung

  Schoroeter, Jeffry

• USP <1724> and <1002> Prospective Scope and Content

  Santos, Leandro

• IVPT Studies During Topical Product Development

  Santos, Leandro