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)

• Mathematical Models of Skin Penetration

  Heisig, Michael; Nagel, Arne; Wittum, Gabriel

• Parameter Sensitivity Analysis of a Two-Dimensional Skin Diffusion Model

  Heisig, Michael; Nagel, Arne; Wittum, Gabriel

• Mathematical Models of Skin Penetration

  Heisig, Michael; Nagel, Arne; Wittum, Gabriel

• Drug Permeation through Skin: A Challenging Application for High Performance Scientific Computing

  Heisig, M; Nagel, A; Wittum, G

• Mechanistic in Silico Inference of Dermal Absorption for Chemical Risk Assessment

  Troutman, John

• A Workflow for Mechanistic Dermal Model Optimization and In Vitro-In Vivo Inference

  Hamadeh, Abdullah

• Role of IVRT in Generic Drug Development

  Halus, Mark

• QMS: Study Integrity Considerations

  Haidar, Sam

• Leveraging In Vitro Bioequivalence Tests for Locally-Acting Suspension Nasal Sprays with Three Anatomically-Correct Replicas of Human Nasal Airways Representing Intersubject Variability

  Golshahi, L; Alfaifi, A; Hosseini, S; Esmaeili, A; Hindle, M; Longest, W; Schuman T

• Pathways to Establish Bioequivalence and Facilitate Development of Innovative and Generic Intranasal Drug Delivery Products: In vitro Anatomically Correct Nasal Models

  Golshahi, Laleh