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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Challenges and Opportunities in the Development of IVRT and IVIVC of Complex Injectable Formulations
Pepin, Xavier
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Nonregulatory Perspective: Challenges and Opportunities to Enhance Model Sharing upon Regulatory Use
Peck, Carl
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Common Deficiencies and Considerations on Setting Appropriate Specifications for Intravaginal Rings
Paudel, Kalpana
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IVPT Method Development, Validation, and Transfer
Patel, Hiren
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Diffusion Cell Apparatus: Considerations for Design and Use I
Patel, Ashvin
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Bioequivalence Considerations for In Vitro Release Test Methods of Ophthalmic Products
Park, Eunjung
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Validation of Computational Predictions of Regional Lung Deposition
Olsson, Bo
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Influence of Progressive Change in the Degree of Saturation of API on the Performance of Topical Products
Murthy, S Narasimha
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Development of Methods for Evaluation of Formulation Differences and their Impact on Therapeutic Equivalence: Broadening the Therapeutic Scope
Mohammed, Yousuf
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Modeling to Support Regulatory Needs of OIDPs
Mohamed, Raja