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(475)
• Posters(107)
• Presentations(231)
• Papers(137)

• 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

• Using Physiologically-Based Pharmacokinetic Absorption Modeling to Support Biopharmaceutics Classification System Class 3 Drug Waiver

  Wu, Fang

• Application of PBPK Modeling in Regulatory Submission: FDA Experience on Generic Drugs

  Wu, Fang

• Role of GDUFA Research on Resolving Technical and Regulatory Challenges for Complex Generic Drug Development and Approval

  Wang, Yan

• Considerations for the Qualitative Sameness Evaluation of a Proposed Generic Formulation

  Wang, Yan

• Mechanistic Modeling to Support Development and Approval of Non-Orally Administered Generic Drug Products

  Walenga, Ross