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(430)
• Posters(94)
• Presentations(218)
• Papers(118)

• 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

• 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

• PBPK Modeling of Transdermal Selegiline Disposition Discrepancy in Special Populations

  Puttrevu, Santosh Kumar

• An Integrated Multiscale-Multiphysics Modeling Ocular Drug Delivery and Pharmacokinetics pharmacological protection and treatment

  Przekwas, Andrzej; German, Carrie; Garimella, Teja

• 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