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)

• Approaches in Establishing BE Safe Space for Oral Solid Dosage Form

  Chakraborty, Sumon

• Use of Mechanistic Modelling to Determine the Sensitivity of in vitro CQAs to Regional Lung Deposition and Predict PK for OIDPs

  Butler, Clare

• Scientific Challenges Related to Establishing Q1/Q2 Sameness-An Industry Perspective

  Zhao, Liang

• Oral PBPK to Support BE Evaluation for Pediatric Drugs

  Guy, Richard

• IVPT Studies with Sunscreen Products: Potential Regulatory Utility

  Hakeem, Susan

• Relevant Challenges with IVRT with Iron-Carbohydrate Complexes: Application to IVIVC Models

  Hartka, Kathryn

• Challenges in Demonstrating API Sameness for Drug Products with Complex APIs

  Hochhaus, Guenther

• Novel Model-Integrated Designs for Bioequivalence Studies of LAI Products: A Complete Framework with the MonolixSuite

  Ayral, Geraldine

• Excipient Safety Assessment in Generic Drug Formulations: An Overview

  Agarwal, Stuti

• Expectations and Common Deficiencies for IVRT Studies Submitted in ANDAs for Ophthalmic Emulsion Products

  Abuznait, Alaa