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.
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Current Scientific Considerations in Modeling for In Vitro BE of Topically Administered Ophthalmics
Chandran, Sajeev
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Approaches in Establishing BE Safe Space for Oral Solid Dosage Form
Chakraborty, Sumon
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Use of Mechanistic Modelling to Determine the Sensitivity of in vitro CQAs to Regional Lung Deposition and Predict PK for OIDPs
Butler, Clare
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Scientific Challenges Related to Establishing Q1/Q2 Sameness-An Industry Perspective
Zhao, Liang
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Oral PBPK to Support BE Evaluation for Pediatric Drugs
Guy, Richard
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IVPT Studies with Sunscreen Products: Potential Regulatory Utility
Hakeem, Susan
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Relevant Challenges with IVRT with Iron-Carbohydrate Complexes: Application to IVIVC Models
Hartka, Kathryn
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Challenges in Demonstrating API Sameness for Drug Products with Complex APIs
Hochhaus, Guenther
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Novel Model-Integrated Designs for Bioequivalence Studies of LAI Products: A Complete Framework with the MonolixSuite
Ayral, Geraldine
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Excipient Safety Assessment in Generic Drug Formulations: An Overview
Agarwal, Stuti