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)

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

  Ducharme, Murray

• Model-Integrated BE Approaches for Long-Acting Injectables

  Ducharme, Murray

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

  Dubey, Vaibhav

• Discussion with EMA PKWG and CVSWP: Levothyroxine NTI Classification and BE Approach

  Donnelly, Michael; Fang, Lanyan(Lucy)

• Demonstrating Bioequivalence with Inhalation Spray Drug Products

  Dhapare, Sneha

• Integrating Biopharmaceutic Data and Gastrointestinal Physiology Using Mechanistic Modeling

  Cristofoletti, Rodrigo

• ASME V&V 40 for Establishing Credibility of CFD Models

  Craven, Brent

• Opening Remarks to the FDA and the Center for Research on Complex Generics (CRCG) Workshop: Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches

  Corrigan-Curay, Jacqueline