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.

• All(163)
• Posters(20)
• Presentations(124)
• Papers(19)

• Modeling and Simulation Approaches of Topically Applied Drugs to Support Formulation Optimization, Clinical Development and Regulatory Assessment – Case Studies Discussion

  Polak, Sebastian

• Pathways for Receiving FDA’s Feedback on Formulations

  Phung, Truog-Vinh

• Challenges and Opportunities in the Development of IVRT and IVIVC of Complex Injectable Formulations

  Pepin, Xavier

• Common Deficiencies and Considerations on Setting Appropriate Specifications for Intravaginal Rings

  Paudel, Kalpana

• Nonregulatory Perspective: Challenges and Opportunities to Enhance Model Sharing upon Regulatory Use

  Peck, Carl

• Diffusion Cell Apparatus: Considerations for Design and Use I

  Patel, Ashvin

• IVPT Method Development, Validation, and Transfer

  Patel, Hiren

• Bioequivalence Considerations for In Vitro Release Test Methods of Ophthalmic Products

  Park, Eunjung

• Validation of Computational Predictions of Regional Lung Deposition

  Olsson, Bo

• Influence of Progressive Change in the Degree of Saturation of API on the Performance of Topical Products

  Murthy, S Narasimha