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)

• 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

• 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

• 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

• Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop

  Pal, Arindom; Wu, Fang; Walenga, Ross; Tsakalozou, Eleftheria; Alam, Khondoker; Gong, Yuqing; Liang, Zhao; Fang, Lanyan

• CFD-PK Model for Nasal Suspension Sprays: Validation with Human Adult In Vivo Data for Triamcinolone Acetonide

  Dutta, R; Kolanjiyil, AV; Walenga, R; Chopski, S; Kaviratna, Anubhav; Mohan, Abhinav; Newman, Bryan; Golshahi, L; Longest, Worth

• Anatomically-Detailed Segmented Representative Adult and Pediatric Nasal Models for Assessing Regional Drug Delivery and Bioequivalence with Suspension Nasal Sprays

  Khadka, Prakash; Hejazi, Mohammed; Hindle, Michael; Schuman, Theodore; Longest, Worth; Kaviratna, Anubhav; Chopski, Steven; Walenga, Ross; 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, L; Zhao, Liang

• In Vitro Evaluation of Intersubject Variability in Pediatric Intranasal Drug Delivery using Nasal Spray Suspension Products

  Esmaeili, Amir; Wilkins, John; Hosseini, Sana; Alfaifi, Ali; Hejazi, Mohammed; Hindle, Michael; Longest, Worth; Schuman, Theodore; Dhapare, Sneha; Kaviratna, Anubhav; Walenga, Ross; Newman, Bryan; Golshahi, Laleh