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)

• Mechanistic Modelling of Lidocaine and Prilocaine Absorption from EMLA Cream upon Topical Application using Physiologically Based Pharmacokinetic Modelling

  Telaprolu, Krishna C; Tsakalozou, Eleftheria; Ghosh, Priyanka; Alam, Khondoker; Grice, Jeffrey E; Roberts, Michael S; Jamei, Masoud; Polak, Sebastian; Clarke, James F

• Mechanistic Modeling of Intramuscular Administration of a Long-acting Injectable Accounting for Tissue Response At the Depot Site

  Silva, Daniela A; Le Merdy, Maxime; Mullin, James; Malavia, Nilesh; Alam, Khondoker; Tsakalozou, Eleftheria; Al Shoyaib, Abdullah; Wang, Yan; Burgess, Diane; Lukacova, Viera

• Using Lung Regional Deposition Modeling as Model-Integrated Evidence for Locally Acting Orally Inhaled Drug Products

  Walenga, Ross L; Chopski, Steven G; Lee, Jae H; Wang, Fenggong; Hu, Meng; Babiskin, Andrew H; Fang, Lanyan; Zhao, Liang

• Modeling Lung Transporters and Their Influence on Inhaled Drug Disposition

  Yeshwante, Shekhar; Mahadevan, Ramya; Sule, Olagoke; Tiley, Jacqueline B; Luterbach, Courtney L; McCann, Sean; Fallon, John K; Smith, Philip C; Tan, Ming-Liang; Walenga, Ross; Newman, Bryan; Zhao, Liang; Gentzsch, Martina; Esther Jr, Charles R; Rao, Gauri G

• Inhaled Aerosol Dosimetry: Models, Implications and Impact. Proceedings of the Conference

  Phalen, R; Asgharian, B; Oberdörster, G; Murray, J; Ritter, D; Benoit, D; Laube, B; Garcia, G; Dzierlenga, M; Golshahi, L; Debjit, K; Su, WC; Hoffman, D; Schroeter, JD; Price, O; Chesnutt, J; Cassee, F; Sayes, C; Kuczaj, A; Oakes, J; McClellan, RO; Yazbeck, C; Xi, J; Schmid, O; Chalupa, D; Wolff, R; Stout, M; Gupta, A; Dey, S; Woo, CG; Bartol, I; Blayac, M; Graffigna, M; Yu, I; Walenga, R; Mate-Kole, EM; Jarabek, AM

• Challenges and Opportunities for Incorporating Physiological Information into Pharmacokinetic Models of Intranasal Drug Delivery to the Brain: A Review of the Current Status and Future Trajectories

  Rezaee, S; Al-Majdoub, ZM; Galetin, A; Rostami-Hodjegan, A; and Ogungbenro, K

• Emerging Perspectives on Leveraging Physiologically Based Biopharmaceutics Modeling (PBBM) for BCS Class III Biowaivers: A Webinar Summary

  Fang, Lanyan (Lucy); Veerasingham, Shereeni; Xu, Yunming; Garcia-Arieta, Alfredo; Kollipara, Sivacharan; Kanagasabathy, Yuvaneshwari; Ahmed, Tausif; Martins, Severino Martins; Suarez-Sharp, Sandra

• An Open-Source Framework for Virtual Bioequivalence Modeling and Clinical Trial Design

  Hamadeh, A; Pellowe, M; Chelle, P; Yeung, CHT; Otalvaro, J; Smith-Roberge, J; Yamada, W; Bartroff, J; Kryshchenko, A; Dallmann, A; Solodenko, J; Lippert, J; Tsakalozou, E; Neely, M; Edginton, A

• Clinical Ocular Exposure Extrapolation for an Ophthalmic Ointment Using PBPK Modeling and Simulation

  Le Merdy, Maxime; Tan, MingLiang; Lukacova, Viera

• Paving the Path for Increased Technological Innovation, Strategic Decision Making and Regulatory Acceptance of Modeling and Simulation Approaches

  Fang, Lanyan; Tsakalozou, Eleftheria; Polli, James