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)

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

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

• 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

• The Impact Of Actuation Force On Droplet Size Distribution And Spray Duration Of Three Commercially Available Nasal Sprays

  Schroeter, Jeffry; Kimbell, Julia; Saluja, Bhawana; Delvadia, Renishkumar; Vallorz-III, Ernest; Sheth, Poonam

• PoPKAT: A Framework for Bayesian Population PBPK Analysis

  Reisfeld, Brad; Chiu, Weihsueh; Hsieh, Nanhung; Olschanowsky, Catherine; Bois, Frederic; Ghosh, Sudipto

• Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Gatifloxacin Solution Case Study

  Qaraghuli, Farah Al; Tan, Ming Liang; Walenga, Ross; Babiskin, Andrew; Zhao, Liang; Lukacova, Viera; Lemerdy, Maxime

• Evaluation of Methamphetamine and Amphetamine Disposition Discrepancy upon Selegiline Transdermal patch Administration in Healthy volunteers versus Special populations using PBPK modelling

  Puttrevu, Santoshkumar; Arora, Sumit; Polak, Sebastian; Patel, Nikunjkumar

• Qualitative Analysis of Generic and Reference LAI Drug PK Profiles Using Multivariate Score Space

  Paul, Prokash; Handelman, Garry; Kim, Jaeyeon; Yoon, Seongkyu