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)

• Approaches in Establishing BE Safe Space for Oral Solid Dosage Form

  Chakraborty, Sumon

• Use of Mechanistic Modelling to Determine the Sensitivity of in vitro CQAs to Regional Lung Deposition and Predict PK for OIDPs

  Butler, Clare

• Studies to Further Establish PK as Central Tool for a Streamlined Approval of Generic Inhalation Drugs

  Bulitta, Jurgen; Hochhaus, Gunther

• Developing PBPK for Ocular Delivery

  Bolger, Michael

• User Friendly Tools for Population PK and PBPK modeling

  Bies, Robert S

• 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

• IVPT Studies with Sunscreen Products: Potential Regulatory Utility

  Hakeem, Susan

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

  Hartka, Kathryn