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)

• Physiologically Based Pharmacokinetic Absorption Modeling to Support Bioequivalence Assessment for BCS Class III Drug Products

  Fang, Lanyan

• Leveraging Modeling and Simulation to Streamline Generic Drug Development and Assessment

  Fang, Lanyan

• Regulatory Applications and Research of Absorption Modeling for Pediatric Products

  Fang, Lanyan

• PK and Statistical Considerations for Steady State Bioequivalence Studies – FDA Perspective

  Fang, Lanyan (Lucy)

• In Vitro Evaluation of Regional Drug Deposition in Nasal Airways of Children Using Realistic Anatomical Replicas

  Esmaeili, A; Hosseini, S; Wilkins, J; Alfaifi, A; Dhapare, S; Walenga, R; Newman, B; Schuman, T; Edwards, D; Longest, W; Hindle, M; Golshahi, L

• Physiologically-Based Pharmacokinetic Pediatric Skin Model

  Edginton, Andrea; Yun, Esther; Hamadeh, Abdullah

• Development of a CFD PK Nasal Spray Model with In Vivo Human Subject Validation

  Dytta, R; Kolanjiyil, A; Golshahi, L; Longest, W

• Model-Integrated BE Approaches for Long-Acting Injectables

  Ducharme, Murray

• Model Integrated Equivalence for BE Assessment of Long Acting Injectables: In Silico Continuation to Steady State

  Ducharme, Murray

• Development Strategies for Generic Topical Products with Formulation Differences to Reference Listed Drug

  Dubey, Vaibhav