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)

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

  Zhu, Hao

• Overview of Workshop

  Zhao, Liang

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

  Zhao, Liang

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

  Gallicano, Keith

• 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

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

  Zhang, Lei

• IVRT Studies During Topical Product Development: Lifecycle Management for SUPAC-SS and Generics

  Yen, Cristina

• IVPT Studies with Sunscreen Products: Experimental Parameters

  Yang, Yang