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)

• Building Mechanistic IVIVC

  Lukacova, Viera

• Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use – Guidance Implementation in Q1/Q2 Assessment

  Li, Xinran

• IVPT Data Challenges in the Real World

  Lehman, Paul

• Diffusion Cell Apparatus: Considerations for Design and Use II

  Lee, Luke

• 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

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

  Kim, Elizabeth

• Formulation Considerations for Selecting an Appropriate RLD or RS

  Kim, Timothy H