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)

• The In Vitro Release Test (IVRT): Historical Perspective, Current Context, and Future Directions

  Shah, Vinod

• USP <1724> and <1002> Prospective Scope and Content

  Santos, Leandro

• IVPT Studies During Topical Product Development

  Santos, Leandro

• Effect of Formulation Differences on Critical Quality Attributes and Performance of the Complex Topical Products

  Sachdeva, Sameer

• 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

• 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