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)

• Inactive Ingredient Database (IID) Overview

  Zuk, Susan

• Modeling and Simulation to Support Appropriate Use of Long-Acting Antipsychotics

  Zhu, Hao

• Symposium 18: Partial Area Under the Curve Analysis in Generic & New Drug Development

  Gallicano, Keith

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

  Babiskin, Andrew

• Quantitative Methods and Modeling to Evaluate Alternative Approaches for COVID-19 Interrupted Bioequivalence Studies

  Zhao, Liang

• Quantitative Methods and Modeling to Support GDUFA Regulatory Science Research Program

  Zhao, Liang

• FEV1 Based Bioequivalence Study for Inhaled Corticosteroids

  Zhao, Liang

• Use of Modeling and Simulation to Support New BE Approaches

  Zhao, Liang

• Impact of Excipients on Drug Permeation to Support Biowaivers for Non-Q1/Q2 Products

  Bode, Chris

• Intestinal Influx Transporters: A Missing Piece in the Puzzle?

  Zhang, Lei