GDUFA Research Outcomes

OA Models

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to computational modeling of absorption for orally administered drugs to support generic product development and assessment.

• All(127)
• Posters(7)
• Presentations(111)
• Papers(9)

• 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

• PBPK Absorption Modeling and Virtual Bioequivalence to Support Generic Drug Development and Regulatory Decision Making for Oral Products

  Wu, Fang

• 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

• Utilizing Mechanistic Dermal Absorption Models to Assess Virtual BE

  Clarke, James

• A Population PK Based Model-Integrated BE Platform

  Chen, X; Nyberg, H; Assawasuwannakit, P; Ryeznik, Y; Karlsson, M

• Current Scientific Considerations in Modeling for In Vitro BE of Topically Administered Ophthalmics

  Chandran, Sajeev