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)

• 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

• In Vitro Bioequivalence Testing of Nasal Sprays Using Multiple AnatomicallyCorrect Nasal Airway Models

  Golshahi, L; Manniello, M; Hosseini, S; Alfaifi, A; Schuman, T; Hindle, M; Longest, W; Sandell, D

• Accelerating LAI Generic Development Using Model-Integrated Bioequivalence

  Gobburu, Joga

• General Approach to the Safety Review of Pediatric Excipients

  Ghosh, Amrita

• A Model-Integrated Pathway to Explore Bioequivalence of LAI Products: Studies Using Paliperidone Palmitate

  Gajjar, Parmesh

• Industry Perspective: Incorporation of BE Modeling and LAI Development Challenges

  Fitzgerald, Michael