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.
-
Equivalence Criteria for In Vitro BE Tests for Locally Acting Drug Products: The Earth Mover’s Distance Approach
Hu, Meng
-
Development of PBPK Model for Predicting Food Impact on BE Assessment
Shoyaib, Abdullah
-
Role of IVRT in Generic Drug Development
Halus, Mark
-
QMS: Study Integrity Considerations
Haidar, Sam
-
Accelerating LAI Generic Development Using Model-Integrated Bioequivalence
Gobburu, Joga
-
IVPT Data Challenges and Statistical Analysis
Ghosh, Priyanka
-
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
-
Potential Impact of Gastric pH on Generic Drug Bioequivalence Evaluation
Fan, Jianghong