GDUFA Research Outcomes

OA Models

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to computational modeling of absorption for orally administered drugs to support generic product development and assessment.

• All(163)
• Posters(20)
• Presentations(124)
• Papers(19)

• Establishing Bioequivalence Using Characterization Based Approaches for Topical Products – Challenges & Solutions

  Jani, Romit

• Use of PBPK in New Drug Development and Regulatory Review – Clinical Pharmacology Perspective

  Huang, Shiew-Mei

• Challenges in Processing PK Data from ANDA Submissions for BE Assessment and Current Perspectives on Updating the PK Data Standard

  Hu, Meng

• Equivalence Criteria for In Vitro BE Tests for Locally Acting Drug Products: The Earth Mover’s Distance Approach

  Hu, Meng

• Role of IVRT in Generic Drug Development

  Halus, Mark

• QMS: Study Integrity Considerations

  Haidar, Sam

• Accelerating LAI Generic Development Using Model-Integrated Bioequivalence

  Gobburu, Joga

• General Approach to the Safety Review of Pediatric Excipients

  Ghosh, Amrita

• A Model-Integrated Pathway to Explore Bioequivalence of LAI Products: Studies Using Paliperidone Palmitate

  Gajjar, Parmesh

• Integration of Biopredictive Dissolution and PBPK Models for Evaluation of GI Locally Acting Products: PART II

  Fotaki, Nikoletta