GDUFA Research Outcomes

PBPK Models

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to physiologically-based pharmacokinetics (PBPK) computational modeling to support generic product development and assessment.

• All(360)
• Posters(77)
• Presentations(193)
• Papers(90)

• 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

• Looking, Feeling and Modelling from the Outside In

  Roberts, Michael

• PBPK Models of the Skin

  Roberts, Michael

• Topical Management of Inflammation & Pain with Diclofenac

  Roberts, Michael

• Correlation of Physicochemical Characteristics and in Vitro Permeation Tests (IVPT) Results for Acyclovir and Metronidazole Topical Products

  Roberts, Michael

• 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