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)

• Mathematical Modeling of the Heterogeneous Distributions of Nanomedicines in Solid Tumors

  He, Hua; Liu, Can; Liu, Yuhui; Liu, Xiaoquan; Wu, Yun; Fan, Jianghong; Zhao, Liang; Cao, Yanguang

• Impact of Vehicle Physicochemical Properties on Modeling-Based Predictions of Cyclosporine Ophthalmic Emulsion Bioavailability and Tear Film Breakup Time

  Walenga, Ross; Babiskin, Andrew; Zhang, Xinyuan; Absar, Mohammad; Zhao, Liang; Lionberger, Robert

• Prediction of In Vitro Drug Dissolution into Fed-state Biorelevant Media: Contributions of Solubility Enhancement and Relatively Low Colloid Diffusivity

  Polli, James E.

• Effects of Dose Loading Conditions and Device Geometry on the Transport and a Aerosolization in Dry Powder Inhalers: A Simulation Study

  Sulaiman, Mostafa; Liu, Xiaoyu; Sundaresan, Sankaran

• Comparing MDI and DPI Aerosol Deposition Using In Vitro Experiments and a New Stochastic Individual Path (SIP) Model of the Conducting Airways

  Longest, Worth; Tian, Geng; Walenga, Ross; Hindle, Michael

• Diffusion Modelling of Percutaneous Absorption Kinetics. Predicting Urinary Excretion from In Vitro Skin Permeation Tests (IVPT) for an Infinite Dose

  Liu, Xin; Yousef, Shereen; Anissimov, Yuri; Van Der Hoek, John; Hoek, John; Tsakalozou, Eleftheria; Ni, Zhanglin; Grice, Jeffrey; Roberts, Michael

• Validating CFD Predictions of Pharmaceutical Aerosol Deposition with In Vivo Data

  Tian, Geng; Hindle, Michael; Lee, Sau; Longest, Worth

• In Vivo Predictive Dissolution: Transport Analysis of the CO2 , Bicarbonate in Vivo Buffer System

  Krieg, Brian; Taghavi, Seyed; Amidon, Gordon; Amidon, Gregory

• Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation

  Le Merdy, Maxime; Alqaraghuli, Farah; Tan, Ming Liang; Walenga, Ross; Babiskin, Andrew; Zhao, Liang; Lukacova, Viera

• Recent Developments in the Computational Simulation of Dry Powder Inhalers

  Capecelatro, Jesse; Longest, Worth; Boerman, Connor; Sulaiman, Mostafa; Sundaresan, Sankaran