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)

• Research and Education Needs for Complex Generics

  Stern, Sydney; Coghlin, Jill; Krishnan, Vishalakshi; Raney, Sam G; Babiskin, Andrew; Jiang, Wenlei; Lionberger, Robert; Xu, Xiaoming; Schwendeman, Anna; Polli, James E.

• Mechanistic Evaluation of Hydration Effects on the Human Epidermal Permeation of Salicylate Esters

  Yousef, Shereen; Mohammed, Yousuf; Namjoshi, Sarika; Grice, Jeffrey; Sakran, Wedad; Roberts, Michael

• Physiologically-based pharmacokinetic modeling to support determination of bioequivalence for dermatological drug products: scientific and regulatory considerations

  Tsakalozou, Eleftheria; Alam, Khondoker; Babiskin, Andrew; Zhao, Liang

• Mechanistic Modeling of Drug Products Applied to the Skin: A Workshop Summary Report

  Tsakalozou, Eleftheria; Alam, Khondoker; Ghosh, Priyanka; Spires, Jessica; Polak, Sebasitan; Fang, Lanyan; Sammeta, Srinivasa; Zhao, Ping; Arora, Sumit; Raney, Sam G

• In Silico Models of Aerosol Delivery to the Respiratory Tract – Development and Applications

  Holbrook, Landon

• Effect of Spray Momentum on Nasal Spray Droplet Transport and Deposition

  Kolanjiyil, Arun; Manniello, Michele; Alfaifi, Ali; Farkas, Dale; Hosseini, Sana; Hindle, Michael; Golshahi, Laleh; Longest, Worth

• Effect of an Upstream Grid on the Fluidization of Pharmaceutical Carrier Powders

  Elserfy, Khalid; Kourmatzis, Agisilaos; Chan, Hak Kim; Walenga, Ross; Cheng, Shaokoon

• 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

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

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

• Metabolism of Bupropion by Carbonyl Reductases in Liver and Intestine

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