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)

• Predicting Human Dermal Drug Concentrations using PBPK Modeling and Simulation: Clobetasol Propionate Case Study

  Van Osdol, William; Novakovic, Jasmina; Le Merdy, Maxime; Tsakalozou, Eleftheria; Ghosh, Priyanka; Spires, Jessica; Lukacova, Viera

• Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary

  Tsakalozou, Eleftheria; Mohamed, Mohamed-Eslam F; Polak, Sebastian; Heimbach, Tycho

• Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products

  Walenga, Ross; Babiskin, Andrew; Bhoopathy, Sid; Clark, James F; De Backer, Jan; Ducharme, Murray; Kelly, Marc; Le Merdy, Maxime; Yoon, Miyoung; Roy, Partha

• RPEM: Randomized Monte Carlo Parametric Expectation Maximization Algorithm

  Chen, Rong; Schumitzky, Alan; Kryshchenko, Alona; Nieforth, Keith; Tomashevskiy, Michael; Hu, Shuhua; Garreau, Romain; Otalvaro, Julian; Yamada, Walter; Neely, Michael N

• Experience Learned and Perspectives on Using Model Integrated Evidence in the Regulatory Context for Generic Drug Products

  Tsakalozou, Eleftheria; Fang, Lanyan; Bi, Youwei; Van Den Heuvel, Michiel; Ahmed, Tausif; Tsang, Yu Chung; Lionberger, Robert; Rostami-Hodjegan, Amin; Zhao, Liang

• Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023

  Tsakalozou, Eleftheria; Gong, Yuqing; Babiskin, Andrew; Hu, Meng; Mousa, Youssef; Walenga, Ross; Wu, Fang; Yoon, Miyoung; Raney, Sam G; Polli, James E.; Schwendeman, Anna; Krishnan, Vishalakshi; Fang, Lanyan; Zhao, Liang

• The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA

  Fang, Lanyan; Gong, Yuqing; Hooker, A; Lukacova, Viera; Rostami-Hodjegan, Amin; Sale, Mark; Grosser, Stella; Jereb, Rebeka; Savic, Rada; Peck, Carl; Zhao, Liang

• Parameterization of Physiologically Based Biopharmaceutics: Workshop Summary Report

  Pepin, Xavier; Arora, Sumit; Borges, Luiza; Cano, Mario; Carducci, Tessa; Chatterjee, Parnali; Chen, Grace; Cristofoletti, Rodrigo; Dallmann, Andre; Delvadia, Poonam; Dressman, Jennifer; Fotaki, Nikoletta; Gray, Elizabeth; Heimbach, Tycho; Holte, Oyvind; Kijima, Shinichi; Kotzagiorgis, Evangelos; Lennernas, Hans; Lindahl, Anders; Loebenberg, Raimar; Mackie, Claire; Malamatari, Maria; Mcallister, Mark; Mitra, Amitava; Moody, Rebecca; Mudie, Deanna; Musuamba, Flora; E, James; Rege, Bhagwant; Ren, Xiaojun; Rullo, Gregory; Scherholz, Megerle; Song, Ivy; Stillhart, Cordula; Saurez, Sandra; Tannergren, Christer; Tsakalozou, Eleftheria; Veerasingham, Shereeni; Wagner, Christian; Seo, Paul

• FDA Recommendations for Alternative Bioequivalence Approaches: Design, Validation, and Use Case for In Silico Studies

  Walenga, Ross

• Clinical Ocular Exposure Extrapolation for a Complex Ophthalmic Suspension Using Physiologically Based Pharmacokinetic Modeling and Simulation

  Le Merdy, M; Spires, J; Tan, M-L; Zhao, Liang; Lukacova, Viera