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)

• Sensitivity of Charcoal Block PK Metrics to Differences in Regional Deposition for Budesonide and Formoterol Fumarate Dihydrate

  Walenga, Ross; Tsakalozou, Eleftheria; Chopski, Steven; Fang, Lanyan; Zhao, Liang

• Dermal PBPK Model for Psoriatic Skin: Clobetasol Propionate Case Study

  Novakovic, Jasmina; Van Osdol, WW; Spires, J; Le Merdy, M; Tsakalozou, E; Ghosh, P; Lukacova, Viera

• Designing an In Vitro Study to Understand Release of API from the Dispersed Phase of Clobetasol Creams – Verification of the Mechanistic Emulsion Model in the MPML MechDermA

  Clarke, James; Murthy, Narasimha; Zhang, Yanling; Paterson, Daniel; Dancik, Yuri; Djehizian, Alexandre; Tsakalozou, Eleftheria; Ghosh, Priyanka; Alam, Khondoker; Polak, Sebastian

• Establishment of Preclinical Mechanistic In Vitro-In Vivo Correlations for Long-Acting Injectable Suspensions

  Silva, D; Bao, Q; Wan, B; Malavia, N; Burgess, D; Lukacova, V

• Development of an In Silico Model of Topical Acyclovir to Explore Formulation Design

  Spires, Jessica; Osdol, William Van; Lukacova, Viera

• 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