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)

• Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions

  Donnelly, Mark; Tsakalozou, Eleftheria; Sharan, Satish; Straubinger, Thomas; Bies, Robert; Zhao, Liang

• Applying a Global Sensitivity Analysis Workflow to Improve the Computational Efficiencies in Physiologically-Based Pharmacokinetic Modeling

  Hsieh, Nanhuang; Reisfeld, Brad; Bois, Frederic; Chiu, Weihsueh

• Leveraging In Vitro Bioequivalence Tests for Locally-Acting Suspension Nasal Sprays with Three Anatomically-Correct Replicas of Human Nasal Airways Representing Intersubject Variability

  Golshahi, L; Alfaifi, A; Hosseini, S; Esmaeili, AR; Hindle, M; Longest, P; Schuman, TA

• Development of Characteristic Upper Tracheobronchial Airway Models for Testing Pharmaceutical Aerosol Delivery

  Walenga, Ross; Tian, Geng; Longest, Worth

• Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report

  Parrott, Neil; Suarez Sharp, Sandra; Kesisoglou, Filippos; Pathak, Shriram; Good, David; Wagner, Christian; Dallmann, Andre; Mullin, James; Patel, Nikunjkumar; Riedmaier, Arian; Mitra, Amitava; Raines, Kimberly; Butler, James; Kakhi, Maziar; Li, Min; Zhao, Yang; Tsakalozou, Eleftheria; Flanagan, Talia; Dressman, Jennifer; Pepin, Xavier

• Differences in Particle Deposition between Members of Imaging-Based Asthma Clusters

  Choi, Jiwoong; Leblanc, Lawrence; Choi, Sanghun; Haghighi, Babak; Hoffman, Eric; O’shaughnessy, Patrick; Wenzel, Sally; Castro, Mario; Fain, Sean; Jarjour, Nizar; Schielbler, Mark; Denlinger, Loren; Delvadia, Renishkumar; Walenga, Ross; Babiskin, Andrew; Lin, Ching-Long

• The Role of Tight Junctions in Skin Barrier Function and Dermal Absorption

  B�_sler, Katja; Bergmann, Sophia; Heisig, Michael; Naegel, Arne; Zorn Kruppa, Michaela; Brandner, Johanna

• Modified Regulatory Pathways to Approve Generic Drugs in the Us and a Systematic Review of Their Outcomes

  Kesselheim, Aaron; Polinski, Jennifer; Fulchino, Lisa; Isaman, Danielle; Gagne, Joshua

• Assessment of Vehicle Volatility and Deposition Layer Thickness in Skin Penetration Models

  Hamadeh, Abdullah; Troutman, John; Edginton, Andrea

• Physiologically Based Pharmacokinetic Modeling of Nanoparticles

  Yuan, Dongfen; He, Hua; Wu, Yun; Fan, Jianghong; Cao, Yanguang