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(475)
• Posters(107)
• Presentations(231)
• Papers(137)

• Determination of CYP2D6 Phenotyping for Metoprolol using CYP2D6 Genotype-derived Activity Score: Results from a Prospective, Clinical Trial

  Thomas, C D; Monsely, S A; El Rouby, N; Kim, S; Lingineni, K; Langaee, T; Langaee, T; Gong, Y; Johnson, J A; Schmidit, S O; Fyre, R F; Cavallari, L H

• Evaluating Influence Of Critical Quality Attributes Of Metronidazole Topical Gel On Bioequivalence Using The Dermal Virtual Bioequivalence (VBE) Module In Simcyp Simulator

  Telaprolu, K C; Arora, S; Clarke, J; Dancik, Y; Tsakalozou, E; Ghosh, P; Alam, K; Roberts, M S; Polak, S

• Modeling In Vitro and In Vivo Human Skin Permeation of Eutectic Mixtures of Local Anesthetics Using PBPK Modeling: Development of Dermal IVIVE for Lidocaine 2.5% w/w and Prilocaine 2.5% w/w Cream (EMLA� Cream)

  Telaprolu, K; Polak, S; Tsakalozou, Eleftheria; Ghosh, Priyanka; Alam, Khondoker; Dabbaghi, M; Namjoshi, S; Mohammed, Y; Grice, J; Roberts, M

• A User Friendly Platform To Simulate And Assess Generic Drug Pharmacokinetics

  Cribari, Kelsey

• Steps Towards Microscopic Simulations Of Skin Penetration

  Sontak, E; Holmes, A; Pastore, M; Studier, H; Abd, E; Grice, J; Roberts, M; Brandner, J; Heisig, M; Nagel, A; Wittum, G

• Development of In Vitro-In Vivo Correlation for Long Acting Injectible Microsphere Formulations

  Shahraz, Azar; Mullin, James; Lukacova, Viera; Bolger, Michael; Woltosz, Walt

• A Physiologically-Based Pharmacokinetic Model to Estimate Absorption and Bioavailability of Corticosteroid Nasal Sprays

  Schroeter, J; Rose, M; Kimbell, J; Chopski, S; Walenga, R

• Effect of Polydispersity on PBPK Model Simulations of Intranasal Corticosteroid Sprays

  Schroeter, Jeffrey; Rose, Morgan; Kimbell, Julia; Chopski, Steven; Walenga, Ross

• A Physiologically-Based Pharmacokinetic Model Framework To Estimate Systemic Bioavailability Of Fluticasone Propionate Nasal Spray

  Schroeter, Jeffry; Stricklin, Daniela; Kimbell, Julia; Delvadia, Renishkumar; Zhang, Xinyuan

• A CFD-PBPK Model to Simulate Nasal Absorption and Systemic Bioavailability of Intranasal Fluticasone Propionate

  Schroeter, Jeffry; Kimbell, Julia; Walenga, Ross; Babiskin, Andrew; Delvadia, Renishkumar