GDUFA Research Outcomes
PBPK Models
-
Development of In Vitro-In Vivo Correlation for Long Acting Injectible Microsphere Formulations
Shahraz, Azar; Mullin, James; Lukacova, Viera; Bolger, Michael; Woltosz, Walt
-
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 to Estimate Absorption and Bioavailability of Corticosteroid Nasal Sprays
Schroeter, J; Rose, M; Kimbell, J; Chopski, S; Walenga, R
-
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
-
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