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)

• Bridging the Gap Between Regional Deposition and Systemic Pharmacokinetic Data of OINDPs with Modeling and Simulation

  Walenga, Ross

• Role of Computational Fluid Dynamics and Physiologically-Based Pharmacokinetic Modeling in Development of Orally Inhaled and Nasal Drug Products

  Walenga, Ross

• Credibility Establishment for Computational Fluid Dynamics Models of Complex Generic Drug Delivery

  Walenga, Ross

• Computational Fluid Dynamics Modeling of Nasally Administered Drug Products in Regulatory Science Research at the U.S. Food and Drug Administration

  Walenga, Ross

• Role of Computational Fluid Dynamics and Physiologically-Based Pharmacokinetic Modeling in Development of Orally Inhaled and Nasal Drug Products

  Walenga, Ross

• Impact of Orally Inhaled and Nasal Drug Product PBPK Models on Product Development and Regulatory Decision Making

  Walenga, Ross

• Computational Fluid Dynamics (CFD) Modeling for Product Development of Generic OINDPs and for Supporting Novel BE Approaches

  Walenga, Ross

• In Silico QbD for Dermal Topical Formulations via TCAT Model Simulations

  Spires, Jessica

• STATISTICAL EXPERIENCE AND CHALLENGES IN ASSESSING SIMILARITY OF DISSOLUTION PROFILES, PARTICAL SIZE DISTRIBUTIONS AND API SAMENESS

  Tsong, Yi

• Are We Ready to Apply Oral PBPK Modeling for BE Determination?

  Tsang, Yu Chung