GDUFA Research Outcomes
PBPK Models
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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
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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
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Development of an In Vitro Method for In Vivo Prediction of Regional Deposition of Nasal Powders
Holtgrewe, Nicholas; Walenga, Ross; Bielski, Elizabeth; Guo, Changning
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Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Ofloxacin Ointment Case Study
Alqaraghuli, Farah; Le Merdy, Maxime; Tan, Ming-Liang; Lukacova, V
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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
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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
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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
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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
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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
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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