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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Diffusion Cell Apparatus: Considerations for Design and Use II
Lee, Luke
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Ophthalmic Drug Products: Leveraging M&S Approaches to Perform Inter-Species Predictions and Support Drug Product Development and Approval
Le Merdy, Maxime
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A Microdialysis Approach to Assess Dermal Pharmacokinetics of Topical Dermatological Drug Product
Kuzma, Benjamin; Senemar, Sharareh; Stagni, Grazia
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Impact of Food and Formulation on Bioequivalence: A Generic Industry Perspective
Kumar, Anita
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Industry Perspective: Regulatory Challenges in Development of Generic Long-Acting Injectables
Kohojkar, Ameya
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Formulation Considerations for Selecting an Appropriate RLD or RS
Kim, Timothy H
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Best Practices for Submitting Formulation Assessment Requests and Avoiding Information Requests: Tips for Submitting a Proposed Formulation Table
Kim, Elizabeth
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Utilizing Modelling Approaches to Support Regulatory Submission for Orally Inhaled Drug Products: Case Example
Kelly, Marc
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Evaluation of Dissolution Profile Similarity for Bioequivalence Assessment
Mousa, Youssef
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General Considerations for the Quantitative Sameness Evaluation of a Proposed Generic Formulation
Kaviratna, Anubhav