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)

• 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

• Simulating the Effect of Propylene Glycol on Acyclovir (Zovirax® Cream, 5%) Permeation Across the Skin Using a Physiologically Based Pharmacokinetic (PBPK) Model of In Vitro Flow-through Skin Permeation

  Arora, S; Patel, N; Polak, S; Jamei, M; Tsakalozou, E; Ghosh, P; Alam, K; Liu, X; Namjoshi, S; Grice, J; Mohammed, Y; Roberts, M

• Development of a CFD PK Nasal Spray Model with In Vivo Human Subject Validation

  Dutta, R; Kolanjiyil, AV; Golshahi, L; Longest, W

• In-Silico Investigation of the Cutaneous Pharmacokinetics of Acyclovir from Creams Containing Acyclovir and a Penetration Enhancer

  Wittum, Rebecca; Wang, Junxi; Mohammed, Yousuf; Namjoshi, Sarika; Grice, Jeffrey; Ghosh, Priyanka; Raney, Sam; Roberts, Michael; Nagel, Arne; Wittum, Gabriel

• Droplet Evaporation from a Solution-Based Metered Dose Inhaler: A Computational Approach

  Walenga, Ross; Conti, Denise; Oguntimein, Oluwamurewa; Delvadia, Renishkumar; Rygg, Alex; Babiskin, Andrew

• Modeling Approach for Assessing the Impact of Physicochemical Properties on Bioequivalence of Cyclosporine Ophthalmic Emulsion

  Walenga, Ross; Babiskin, Andrew; Absar, Mohammad; Zhang, Xinyuan; Zhao, Liang; Lionberger, Robert

• Simulating the Dermal Permeation of Clobetasol-17 Propionate from a Topical Formulation

  Van Osdol, W; Dong, J; Spires, J

• Development and Application of a Dermal PBPK Modeling for Ethinyl Estradiol-Containing Transdermal Delivery Systems to Predict Exposure for Different Application Sites

  Tsakalozou, Eleftheria; Alam, Khondoker; Babiskin, Andrew; Fang, Lanyan (Lucy); Zhao, Liang

• PBPK Modeling of Percutaneous Pharmacokinetics for Tazarotene and Tretinoin Creams: Applicability and Challenges

  Tsakalozou, Eleftheria; Alam, Khondoker; Babiskin, Andrew; Zhao, Liang