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(127)
• Posters(7)
• Presentations(111)
• Papers(9)

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

  Peck, Carl

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

  Paudel, Kalpana

• IVPT Method Development, Validation, and Transfer

  Patel, Hiren

• Diffusion Cell Apparatus: Considerations for Design and Use I

  Patel, Ashvin

• 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

• Development of Methods for Evaluation of Formulation Differences and their Impact on Therapeutic Equivalence: Broadening the Therapeutic Scope

  Mohammed, Yousuf

• Modeling to Support Regulatory Needs of OIDPs

  Mohamed, Raja

• USP General Chapter Revision Process

  Marques, Margareth