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)

• A Physiologically-Based Pharmacokinetic Model to Estimate Absorption and Bioavailability of Corticosteroid Nasal Sprays

  Schroeter, JD; Rose, M; Kimbell, JS; Chopski, S; Walenga, RL

• Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug Administration for New Drugs

  Wu, Fang; Shah, Heta; Li, Min; Duan, Peng; Zhao, Ping; Suarez, Sandra; Raines, Kimberly; Zhao, Yang; Wang, Meng; Lin, Ho-Pi; Duan, John; Yu, Lawrence; Seo, Paul

• Metabolism of Bupropion by Carbonyl Reductases in Liver and Intestine

  Connarn, Jamie; Zhang, Xinyuan; Babiskin, Andrew; Sun, Duxin

• Relating Transdermal Delivery Plasma Pharmacokinetics with In Vitro Permeation Test (IVPT) Findings Using Diffusion and Compartment-In-Series Models

  Liu, Xin; Anissimov, Yuri; Grice, Jeffrey; Cheruvu, Hanumanth; Ghosh, Priyanka; Raney, Sam; Maibach, Howard; Roberts, Michael

• A Bayesian Population Physiologically Based Pharmacokinetic Absorption Modeling Approach to Support Generic Drug Development: Application to Bupropion Hydrochloride Oral Dosage Forms

  Hsieh, Nan-Hung; Bois, Frederic; Tsakalozou, Eleftheria; Ni, Zhanglin; Yoon, Miyoung; Sun, Wanjie; Klein, Martin; Reisfeld, Brad; Chiu, Weihsueh

• Pharmaceutical Aerosols Deposition Patterns from a Dry Powder Inhaler: Euler Lagrangian Prediction and Validation

  Kannan, Ravishekar; Chen, Zhijian; Singh, Narender; Przekwas, Andrzej; Delvadia, Renishkumar; Tian, Geng; Walenga, Ross

• In Vitro Evaluation of Regional Nasal Drug Delivery Using Multiple Anatomical Nasal Replicas of Adult Human Subjects and Two Nasal Sprays

  Manniello, Michele; Hosseini, Sana; Alfaifi, Ali; Esmaeili, Amir; Kolanjiyil, Arun; Walenga, Ross; Babiskin, Andrew; Sandell, Dennis; Mohammadi, Reza; Schuman, Theodore; Hindle, Michael; Golshahi, Laleh

• A Quasi-3D Wire Approach to Model Pulmonary Airflow in Human Airways

  Kannan, Ravishekar; Chen, Zhijian; Singh, Narender; Przekwas, Andrzej; Delvadia, Renishkumar; Tian, Geng; Walenga, Ross

• Importance of Cloud Motion and Two-way Momentum Coupling in the Transport of Pharmaceutical Nasal Sprays

  Kolanjiyil, Arun; Hosseini, Sana; Alfaifi, Ali; Hindle, Michael; Golshahi, Laleh; Longest, Worth

• Anatomically Realistic Nasal Replicas Capturing the Range of Nasal Spray Drug Delivery in Adults

  Alfaifi, A; Hosseini, S; Esmaeili, A; Walenga, R; Babiskin, A; Schuman, T; Longest, W; Hindle, M; Golshahi, L