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)

• PBPK Modeling Approaches to the Female Reproductive Tract

  Bies, Robert

• Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products

  Bielski, Elizabeth

• Scientific Challenges Related to Establishing Q1/Q2 Sameness-An Industry Perspective

  Zhao, Liang

• Relevant Challenges with IVRT with Iron-Carbohydrate Complexes: Application to IVIVC Models

  Hartka, Kathryn

• IVPT Studies with Sunscreen Products: Potential Regulatory Utility

  Hakeem, Susan

• Considerations for Using Model Master Files

  Babiskin, Andrew

• Regulatory Perspective on Modeling Strategies Across Multiple Submissions

  Babiskin, Andrew; Yoon, Miyoung

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

  Babiskin, Andrew

• Use of PBPK Model to Evaluate Impact of Ophthalmic Drug Products Critical Quality Attributes of BA/BE Assessment

  Babiskin, Andrew

• Physiologically-based Absorption Modeling and Simulation used in Assessing Bioequivalence for Ophthalmic Products

  Babiskin, Andrew