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)

• Cutaneous Pharmacokinetics-Based Techniques: Translating Scientific Advances to Regulatory Methods

  Ramezanli, Tannaz

• PBPK Modeling of Transdermal Selegiline Disposition Discrepancy in Special Populations

  Puttrevu, Santosh Kumar

• An Integrated Multiscale-Multiphysics Modeling Ocular Drug Delivery and Pharmacokinetics pharmacological protection and treatment

  Przekwas, Andrzej; German, Carrie; Garimella, Teja

• QMS: Industry Perspectives

  Powell, Kendall

• Modeling and Simulation Approaches of Topically Applied Drugs to Support Formulation Optimization, Clinical Development and Regulatory Assessment – Case Studies Discussion

  Polak, Sebastian

• Pathways for Receiving FDA’s Feedback on Formulations

  Phung, Truog-Vinh

• Challenges and Opportunities in the Development of IVRT and IVIVC of Complex Injectable Formulations

  Pepin, Xavier

• Nonregulatory Perspective: Challenges and Opportunities to Enhance Model Sharing upon Regulatory Use

  Peck, Carl

• Common Deficiencies and Considerations on Setting Appropriate Specifications for Intravaginal Rings

  Paudel, Kalpana

• PBPK Modeling of Dermally Applied Drug Products to Support Clinical Development and Regulatory Assessment

  Patel, Nikunkkumar