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)

• Mechanistic Physiologically-Based Pharmacokinetic Modelling of Skin Permeation of Propylene Glycol from Clobetasol Propionate Cream Formulations with variable Propylene Glycol Content

  Maciel Tabosa, A; Dancik, Y; Thakur, K; Zhang, Y; Rangappa, S; Murthy, N; Tsakalozou, E; Ghosh, P; Polak, S; Clarke, J

• Dermal Drug Distribution in Normal and Psoriatic Skin Assessed in Silico via PBPK Modeling and Simulations

  Novakovic, J; van Osdol, WW; Spires, J; Le Merdy, M; Tsakalozou; E; Ghosh, P; Lukacova V

• Application of PBPK Modelling to Optimize IVPT Study Design and Predict the Impact of Formulation Changes on Skin Permeation

  Zhang, Y; Murthy, N; Rangappa, S; Paterson, D; Polak, S; Dancik, Y; Tsakalozou, E; Ghosh, P; Clarke, J

• Predicting Brinzolamide Ocular Response in Humans Using an Ocular PBPK-PD Modeling and Simulation

  Le Merdy, Maxime; Mullin, Jim; Tan, Ming-Liang; Lukacova, Viera

• Computational Fluid Dynamics Model Validation of Spray Characteristics from a Suspension-Based Pressurized Metered-Dose Inhaler

  Sul, Bora; Babiskin, Andrew; Walenga, Ross

• Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products

  Walenga, Ross; Babiskin, Andrew; Bhoopathy, Sid; Clark, James F; De Backer, Jan; Ducharme, Murray; Kelly, Marc; Le Merdy, Maxime; Yoon, Miyoung; Roy, Partha

• Predicting Human Dermal Drug Concentrations using PBPK Modeling and Simulation: Clobetasol Propionate Case Study

  Van Osdol, William; Novakovic, Jasmina; Le Merdy, Maxime; Tsakalozou, Eleftheria; Ghosh, Priyanka; Spires, Jessica; Lukacova, Viera

• Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary

  Tsakalozou, Eleftheria; Mohamed, Mohamed-Eslam F; Polak, Sebastian; Heimbach, Tycho

• RPEM: Randomized Monte Carlo Parametric Expectation Maximization Algorithm

  Chen, Rong; Schumitzky, Alan; Kryshchenko, Alona; Nieforth, Keith; Tomashevskiy, Michael; Hu, Shuhua; Garreau, Romain; Otalvaro, Julian; Yamada, Walter; Neely, Michael N

• Experience Learned and Perspectives on Using Model Integrated Evidence in the Regulatory Context for Generic Drug Products

  Tsakalozou, Eleftheria; Fang, Lanyan; Bi, Youwei; Van Den Heuvel, Michiel; Ahmed, Tausif; Tsang, Yu Chung; Lionberger, Robert; Rostami-Hodjegan, Amin; Zhao, Liang