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(360)
• Posters(77)
• Presentations(193)
• Papers(90)

• 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

• Regulatory Perspective on Modeling Strategies Across Multiple Submissions

  Babiskin, Andrew; Yoon, Miyoung

• Regulatory Perspective: What Can Be a Model Master File and How to Share It?

  Zhao, Liang

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

  Zhao, Liang

• Regulatory Challenges and Opportunities for Model-based Approaches for Patient Pharmacokinetic (PK) Studies with Sparse Sampling Design

  Zhao, Liang

• Challenges in Using PBPK Models for Locally Acting Drug Products to Inform Regulatory Decision Making

  Zhao, Liang

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

  Yen, Cristina