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(430)
• Posters(94)
• Presentations(218)
• Papers(118)

• Advancing the Use of Model-Integrated Evidence in Generic Drug Development and Assessment

  Zhao, Liang

• The Development and Framework of MMF as a Regulatory Initiative

  Zhao, Liang

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

  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

• 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

• IVPT Studies with Sunscreen Products: Experimental Parameters

  Yang, Yang

• Using PBPK Model to Support Risk Assessment for Oral Products, from a Regulatory Perspective

  Wu, Fang