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.
-
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
-
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