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)

• Ophthalmic Drug Products: Leveraging M&S Approaches to Perform Inter-Species Predictions and Support Drug Product Development and Approval

  Le Merdy, Maxime

• A Microdialysis Approach to Assess Dermal Pharmacokinetics of Topical Dermatological Drug Product

  Kuzma, Benjamin; Senemar, Sharareh; Stagni, Grazia

• Impact of Food and Formulation on Bioequivalence: A Generic Industry Perspective

  Kumar, Anita

• Industry Perspective: Regulatory Challenges in Development of Generic Long-Acting Injectables

  Kohojkar, Ameya

• Formulation Considerations for Selecting an Appropriate RLD or RS

  Kim, Timothy H

• Best Practices for Submitting Formulation Assessment Requests and Avoiding Information Requests: Tips for Submitting a Proposed Formulation Table

  Kim, Elizabeth

• Utilizing Modelling Approaches to Support Regulatory Submission for Orally Inhaled Drug Products: Case Example

  Kelly, Marc

• Evaluation of Dissolution Profile Similarity for Bioequivalence Assessment

  Mousa, Youssef

• General Considerations for the Quantitative Sameness Evaluation of a Proposed Generic Formulation

  Kaviratna, Anubhav

• Key Aspects in Developing Appropriate IVRT Methods for Topical Generic Products: Advances and Challenges

  Kapanadze, Theo