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)

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

  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

• Enhanced Understanding of Structure Performance Relationship Using Modeling and Simulation ��� A Case Study with Dapsone Topical Gel

  Tsakalozou, Eleftheria

• Applications of Mechanistic Modeling and Simulation Tools on the Performance of Locally Acting Complex Drug Products

  Tsakalozou, Eleftheria

• Considerations and Potential Regulatory Applications for a Model Master File

  Tsakalozou, Eleftheria

• Mechanistic Modeling and Simulation Approaches for Performance Prediction of Locally Acting Complex Drug Products

  Tsakalozou, Eleftheria

• Physiologically-Based Pharmacokinetic Modeling to support Bioequivalence and Drug Approval

  Tsakalozou, Eleftheria

• Dermal PBPK Modeling for a Transdermal Delivery System to Assess the Impact of the Application Site on In Vivo Performance

  Tsakalozou, Eleftheria