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)

• Particle-based coarse-grained approach for simulating dry powder inhaler

  Liu, Xiaoyu; Sulaiman, Mostafa; Kolehmainen, Jari; Ozel, Ali; Sundaresan, Sankaran

• Computational Modeling of Drug Transport across the In Vitro Cornea

  Pak, Joseph; Chen, Zhijian; Sun, Kay; Przekwas, Andrzej; Walenga, Ross; Fan, Jianghong

• pksensi: An R Package to Apply Global Sensitivity Analysis in Physiologically Based Kinetic Modeling

  Hsieh, Nan Hung; Reisfeld, Brad; Chiu, Weihsueh

• Inactive Ingredient Database (IID) Overview

  Zuk, Susan

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

  Zhu, Hao

• 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