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)

• Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches: A Workshop Overview

  Babiskin, Andrew; Wu, Fang; Mousa, Youssef; Tan, Ming-Liang; Tsakalozou, Eleftheria; Walenga, Ross; Yoon, Miyoung; Raney, Sam G; Polli, James E; Schwendeman, Anna; Krishnan, Vishalakshi; Fang, Lanyan; Zhao, Liang

• Validating CFD Predictions of Highly Localized Aerosol Deposition in Airway Models: In Vitro Data and Effects of Surface Properties

  Longest, Worth

• Effects of Subject-Variability on Nasally Inhaled Drug Deposition, Uptake, and Clearance

  Chari, Sriram; Sridhar, Karthik; Kleinstreuer, Clement

• 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