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: What Can Be a Model Master File and How to Share It?

  Rostami-Hodjegan, Amin

• Improving Model Reusability via the Concept of Model Master File: What the Literature Data Tell Us

  Rostami, Amin

• Predicting the Power of Food: Assessing Confidence in PBPK Modeling of Food Effect

  Riedmaier, Arian Emami

• IVPT Data Analysis and Statistics

  Rantou, Eleni

• A Research Strategy to Develop Efficient BE Approaches for Complex Generic Topical Products

  Raney, Sam

• Cutaneous Pharmacokinetics-Based Techniques: Translating Scientific Advances to Regulatory Methods

  Ramezanli, Tannaz

• QMS: Industry Perspectives

  Powell, Kendall

• 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