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)

• Quasi-3D Mechanistic Model for Predicting Eye Drop Distribution in the Human Tear Film

  Garimella, Harsha; Norris, Carly; German, Carrie; Przekwas, Andrzej; Walenga, Ross; Babiskin, Andrew; Tan, Ming-Liang

• Impact of Mechanistic Modeling and Simulation Methodologies on Product Specific Guidance Development for Non-Orally Administered Drug Products

  Chopski, Steven; Walenga, Ross; Tan, Ming-Liang; Alam, Khondoker; Babiskin, Andrew; Fang, Lanyan; Tsakalozou, Eleftheria

• Assessment of Ventilation Heterogeneity and Particle Deposition in Asthmatics using Combined SPECT/CT Imaging and Computational Modeling Approaches

  Zhang, Xuan; Rajaraman, Pratish K; Li, Frank; Choi, Sanghun; Comellas, Alejandro P; Hoffman, Eric A; Fain, Sean B; Kaczka, David W; Smith, Benjamin M; Choi, Jiwoong; Castro, Mario; Wenzel, Sally; Jarjour, Nizarn; Schiebler, Mark L; Israel, Elliot; Levy, Bruce D; Fahy, John V; Erzurum, Serpil C; Babiskin, Andrew; Kinjo, Minori; Walenga, Ross; Lin, Ching-Long

• Adopting the Model Master File Framework to Enhance Modeling and Simulations Approaches for Regulatory Use

  Fang, Lanyan; Tsakalozou, Eleftheria; Wu, Fang; Ritterbeck, Daniel; Zhao, Liang; Zhang, Lei; Lionberger, Robert

• Considering Opportunities and Challenges When Implementing the Model Master File Framework – a Meeting Report

  Tsakalozou, Eleftheria; Fang, Lanyan; Skoda, Erin; Nicholas, Timothy; Kollipara, Sivacharan; Ren, Ke; Grosser, Stella; Rege, Bhagwant; Roy, Partha; Zhu, Hao; Zhao, Liang

• Impact of Agglomeration on In Vitro Performance of Long-Acting Injectable Suspensions

  Malavia, Nilesh; Bao, Quanying; Silva, Daniela Amaral; Wang, Yan; Alam, Khondoker; Lukacova, Viera; Burgess, Diane J

• Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products

  Walenga, Ross; Alam, Khondoker; Clarke, James F.; De Backer, J.; Friden, Markus; Hamadeh, Abdullah; Mowli, Jay; Sonti, Sujatha; Spires, Jessica; Tan, Ming-Liang; Musuamba, Flora T; Tsakalozou, Eleftheria

• Leveraging Model Master Files for Long-Acting Injectables

  Gong, Yuqing; Hopefl, Robert; Li, Tonglei; Hooker, Andrew C; Silva, Daniela Amaral; Alam, Khondoker; Ducharme, Murray; Moody, Rebecca; Saha, Pratik; Babiskin, Andrew

• Nasal Absorption of Oxycodone Predicted Using a Novel Computational Fluid Dynamics-Physiologically Based Pharmacokinetic Model

  Walenga, R L; Babiskin, Andrew; Boyce, Heather J; Feng, Xin; Zidan, Ahmed; Kamal, Nahid; Xu, Xiaoming; Kim, Myong-Jin; Zhao, Liang

• Ocular PBPK/PD Modeling to Explore In Vitro Bioequivalence Approach for Brinzolamide Ophthalmic Suspensions

  Tan, Mingliang