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)

• 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

• Development of a Dermal PBPK Modeling for an Ethinyl Estradiol-Containing Transdermal Delivery System

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

• Advancements in the Dermal Physiologically-based Pharmacokinetic (PBPK) Modeling under the Generics Drug User Fee Amendments (GDUFA) Program

  Tsakalozou, Eleftheria; Ni, Zhanglin; Zhao, Liang; Babiskin, Andrew

• Advancments in the Dermal Physiologically-based Pharmacokinetic (PBPK) Medeling under the Generics Drug User Fee Amendments (GDUFA) Program

  Tsakalozou, Eleftheria; Ni, Zhanglin; Babiskin, Andrew; Zhao, Liang