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(127)
• Posters(7)
• Presentations(111)
• Papers(9)

• Development of PBPK Model for Predicting Food Impact on BE Assessment

  Shoyaib, Abdullah

• 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

• IVPT Data Challenges and Statistical Analysis

  Ghosh, Priyanka

• 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

• Industry Perspective: Incorporation of BE Modeling and LAI Development Challenges

  Fitzgerald, Michael

• Potential Impact of Gastric pH on Generic Drug Bioequivalence Evaluation

  Fan, Jianghong

• PBPK Absorption Modeling to Support Risk Assessment and Biowaiver for Generic Oral Products

  Wu, Fang