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)

• A Hybrid CFD-PBPK Approach to Simulate Deposition, Absorption, and Bioavailability of Corticosteroid Nasal Sprays

  Schroeter, Jeffry; Garcia, Guilherme; Rose, Morgan; Kimbell, Julia; Walenga, Ross

• Formulation Insights into Long-Acting Hormonal Contraceptives for Advancing Generic Product Development

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

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

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

• Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Ofloxacin Ointment Case Study

  Alqaraghuli, Farah; Le Merdy, Maxime; Tan, Ming-Liang; Lukacova, V

• Mapping Skin Properties in Psoriasis for Improved Understanding of Topical Absorption

  Mangion, SE; Dalton, JK; Mackenzie, L; Tsakalozou, Eleftheria; Clarke, JF; Polak, Sebastian; Roberts, Michael

• Understanding the Impact of Disease on Pediatric Regional Intranasal Drug Delivery with Nasal Sprays

  Hejazi, Mohammad; Owen, Xiomara; Wilkins, John; Schuman, Theodore; Hindle, Michael; Longest, Worth; Walenga, Ross; Kaviratna, Anubhav; Newman, Bryan; Golshahi, Laleh

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

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

• Enhanced PBPK-Based In Vitro to In Vivo Extrapolation Method to Support the Development of Pulmonary Drug Products

  Mullin, J M; Le Merdy, Maxime; Chopski, Steven; Walenga, Ross; Bielski, Elizabeth; Boc, Susan; Clerman, Andrew; Newman, Bryan; Pineiro-Llanes, Janny; Eltanameli, Bassma; Cristofoletti, R

• Development of Graphical Interface in R Shiny for PBPK Model-based Prediction and Simulation of Drug Delivery in the Female Reproductive Tract

  Straubinger, Thomas; Li, Xinnong; Valicherla, Guru R; Zhang, Zhongfang; Achilles, Sharon L; Donnelly, Mark; Zhao, Liang; Tsakalozou, Eleftheria; Chen, Beatrice A; Rohan, Lisa C; Bies, Robert

• Topical Product Metamorphosis: Impact on Metronidazole In Vitro Skin Permeation Post-Application of Binary Mixture Formulations

  Sharkawy, Asma; Williams, Adrian; Bunge, Annette; Guy, Richard; Ghosh, Priyanka; Van Osdol, William; Novakovic, Jasmina; Pettarin, Maximo; Spires, Jessica; Le Merdy, Maxime; Tsakalozou, Eleftheria; Delgado-Charro, M B