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(430)
• Posters(94)
• Presentations(218)
• Papers(118)

• Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop

  Pal, Arindom; Wu, Fang; Walenga, Ross; Tsakalozou, Eleftheria; Alam, Khondoker; Gong, Yuqing; Liang, Zhao; Fang, Lanyan

• Anatomically-Detailed Segmented Representative Adult and Pediatric Nasal Models for Assessing Regional Drug Delivery and Bioequivalence with Suspension Nasal Sprays

  Khadka, Prakash; Hejazi, Mohammed; Hindle, Michael; Schuman, Theodore; Longest, Worth; Kaviratna, Anubhav; Chopski, Steven; Walenga, Ross; Newman, Bryan; Golshahi, Laleh

• CFD-PK Model for Nasal Suspension Sprays: Validation with Human Adult In Vivo Data for Triamcinolone Acetonide

  Dutta, R; Kolanjiyil, AV; Walenga, R; Chopski, S; Kaviratna, Anubhav; Mohan, Abhinav; Newman, Bryan; Golshahi, L; Longest, Worth

• Sensitivity of Charcoal Block PK Metrics to Differences in Regional Deposition for Budesonide and Formoterol Fumarate Dihydrate

  Walenga, Ross; Tsakalozou, Eleftheria; Chopski, Steven; Fang, L; Zhao, Liang

• In Vitro Evaluation of Intersubject Variability in Pediatric Intranasal Drug Delivery using Nasal Spray Suspension Products

  Esmaeili, Amir; Wilkins, John; Hosseini, Sana; Alfaifi, Ali; Hejazi, Mohammed; Hindle, Michael; Longest, Worth; Schuman, Theodore; Dhapare, Sneha; Kaviratna, Anubhav; Walenga, Ross; Newman, Bryan; Golshahi, Laleh

• Development of Mechanistic In Vitro-In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables

  Silva, Daniela A; Le Merdy, Maxime; Alam, Khondoker; Wang, Yan; Bao, Quanying; Malavia, Nilesh; Burgess, Diane; Lukacova, Viera

• CFD-DEM Investigation of the Effects of Aperture Size for a Capsule-based Dry Powder Inhaler

  Zhu, Qixuan; Kakhi, Maziar; Jayasundara, Chandana; Walenga, Ross; Behara, Srinivas; Chan, Hak Kim; Yang, Runyu

• Development of an In Vitro Method for In Vivo Prediction of Regional Deposition of Nasal Powders

  Holtgrewe, Nicholas; Walenga, Ross; Bielski, Elizabeth; Guo, C

• Nasal Steroid Spray Simulations Using Measured Spray Characteristics in Healthy and Rhinitic Nasal Passages

  Kimbell, J S; Garcia, G J M; Schroeter, J D; Sheth, P; Vallorz-III, E L; Saluja, B; Babiskin, A H; Tian, G; Walenga, R L

• Transport and Deposition of Beclomethasone Dipropionate Drug Aerosols with Varying Ethanol Concentration in Severe Asthmatic Subjects

  Rajaraman, Prathish; Choi, Jiwoong; Babiskin, Andrew; Walenga, Ross; Lin, Chinglong