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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Effect of Formulation Differences on Critical Quality Attributes and Performance of the Complex Topical Products
Sachdeva, Sameer
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Nonregulatory Perspective: What Can Be a Model Master File and How to Share It?
Rostami-Hodjegan, Amin
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Improving Model Reusability via the Concept of Model Master File: What the Literature Data Tell Us
Rostami, Amin
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Predicting the Power of Food: Assessing Confidence in PBPK Modeling of Food Effect
Riedmaier, Arian Emami
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IVPT Data Analysis and Statistics
Rantou, Eleni
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A Research Strategy to Develop Efficient BE Approaches for Complex Generic Topical Products
Raney, Sam
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Cutaneous Pharmacokinetics-Based Techniques: Translating Scientific Advances to Regulatory Methods
Ramezanli, Tannaz
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QMS: Industry Perspectives
Powell, Kendall
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Modeling and Simulation Approaches of Topically Applied Drugs to Support Formulation Optimization, Clinical Development and Regulatory Assessment – Case Studies Discussion
Polak, Sebastian
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Pathways for Receiving FDA’s Feedback on Formulations
Phung, Truog-Vinh