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)

• A quasi-3D model of the whole lung: airway extension to the tracheobronchial limit using the constrained constructive optimization and alveolar modeling, using a sac–trumpet model

  Kannan, Ravishekar; Singh, Narender; Przekwas, Andrzej; Zhou, Xianlian; Walenga, Ross; Babiskin, Andrew

• Validating CFD Predictions of Nasal Spray Deposition: Inclusion of Cloud Motion Effects for Two Spray Pump Designs

  Kolanjiyil, Arun V; Hosseini, Sana; Alfaifi, Ali; Farkas, Dale; Walenga, Ross; Babiskin, Andrew; Hindle, Michael; Golshahi, Laleh; Longest, P Worth

• Estimating Maximal In Vitro Skin Permeation Flux from Studies Using Non-Sink Receptor Phase Conditions

  Yousef, Shereen; Liu, Xin; Mostafa, Ahmed; Mohammed, Yousuf; Grice, Jeffrey; Anissimov, Yuri; Sakran, Wedad; Roberts, Michael

• A Compartment-Quasi-3D Multiscale Approach for Drug Absorption, Transport, and Retention in the Human Lungs

  Kannan, Ravishekar; Singh, Narender; Przekwas, Andrzej

• Validating Whole-Airway CFD Predictions of DPI Aerosol Deposition at Multiple Flow Rates

  Longest, Worth; Tian, Geng; Khajeh Hosseini Dalasm, Nawab; Hindle, Michael

• In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products

  Walenga, Ross; Babiskin, Andrew; Zhao, Liang

• Importance of Spray-Wall Interaction and Post-Deposition Liquid Motion in the Transport and Delivery of Pharmaceutical Nasal Sprays

  Kolanjiyil, Arun V; Alfaifi, Ali; Aladwani, Ghali; Golshahi, Laleh; Longest, Worth

• Topical Drug Delivery: History, Percutaneous Absorption, and Product Development

  Roberts, Michael; Cheruvu, Manumanth; Mangion, Sean; Alinaghi, Azadeh; Benson, Heather; Mohammed, Yousef; Holmes, Amy; Van Der Hoek, John; Pastore, Michael; Grice, Jeffrey

• Mechanistic Modeling of Generic Orally Inhaled Drug Products: A Workshop Summary Report

  Walenga, Ross; Butler, Clare; Craven, Brent; Longest, P Worth; Mohamed, Raja; Newman, Bryan; Olsson, Bo; Hochhaus, Gunther; Li, Bing; Luke, Markham; Zhao, Liang; Przekwas, Andrzej; Lionberge, Robert

• Mechanistic Modeling of In Vitro Skin Permeation and Extrapolation to In Vivo for Topically Applied Metronidazole Drug Products Using a Physiologically Based Pharmacokinetic Model

  Arora, Sumit; Clarke, James; Tsakalozou, Eleftheria; Ghosh, Priyanka; Alam, Khondoker; Grice, Jeffery E; Roberts, Michael S; Jamei, Masoud; Polak, Sebastian