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)

• 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

• 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

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

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

• Recent Developments in the Computational Simulation of Dry Powder Inhalers

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

• Deposition of Particles in the Alveolar Airways: Inhalation and Breath-Hold with Pharmaceutical Aerosols

  Longest, Worth

• Well-Tempered MCMC Simulations for Population Pharmacokinetic Models

  Bois, Frederic; Hsieh, Nan-Hung; Gao, Wang; Chiu, Weihsueh; Reisfeld, Brad