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)

• 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

• 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

• Dermal PBPK Model for Psoriatic Skin: Clobetasol Propionate Case Study

  Novakovic, Jasmina; Van Osdol, WW; Spires, J; Le Merdy, M; Tsakalozou, E; Ghosh, P; Lukacova, Viera

• Designing an In Vitro Study to Understand Release of API from the Dispersed Phase of Clobetasol Creams ��� Verification of the Mechanistic Emulsion Model in the MPML MechDermA

  Clarke, James; Murthy, Narasimha; Zhang, Yanling; Paterson, Daniel; Dancik, Yuri; Djehizian, Alexandre; Tsakalozou, Eleftheria; Ghosh, Priyanka; Alam, Khondoker; Polak, Sebastian

• Establishment of Preclinical Mechanistic In Vitro-In Vivo Correlations for Long-Acting Injectable Suspensions

  Silva, D; Bao, Q; Wan, B; Malavia, N; Burgess, D; Lukacova, V

• Development of an In Silico Model of Topical Acyclovir to Explore Formulation Design

  Spires, Jessica; Osdol, William Van; Lukacova, Viera