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)

• Computational Modeling of Absorption from Complex Topical Formulations

  Spires, Jessica

• Virtual Bioequivalence Workflow

  Pellowe, M

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

  Singh, Gajendra

• A Predictive Multiscale Computational Tool for Simulation of Lung Absorption and Pharmacokinetics and Optimization of Pulmonary Drug Delivery

  Singh, Narender

• A Multiscale Computational Framework for Inhalation Pharmacology and Drug Development

  Singh, Narender; Kannan, Ravi; Przekwas, Andrzej

• Development of PBPK Model for Predicting Food Impact on BE Assessment

  Shoyaib, Abdullah

• 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