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 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

• Development of an Ocular Physiologically-Based Pharmacokinetic Model to Describe the Impact of Formulation Attributes on the Disposition of an Antibiotic Applied on the Rabbit Eye

  Tsakalozou, Eleftheria; LeMerdy, Maxime; Babiskin, Andrew; Zhao, Liang

• 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