GDUFA Research Outcomes

BE Methods & Analyses

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to bioequivalence methods and analyses for generic drug products.

• All(237)
• Posters(60)
• Presentations(64)
• Papers(113)

• Influence Of Fluid Shear Rate On The Dissolution Rate Of Poorly Soluble Drug Particles; Implications For In Vivo Predictive In Vitro Dissolution Methodologies And Mechanistic Computational Modeling.

  Mudie, Deanna; Brasseur, James; Mansfield, Joel; Wang, Yanxing; Jayaraman, Balaji; Amidon, Gregory

• The Application of Temperature-Composition Phase Diagrams for Hot Melt Extrusion Processing of Amorphous Solid Dispersions to Prevent Residual Crystallinity

  Taylor, Lynne

• Hot Melt Extrusion Processing Regimes Based on Temperature-Composition Phase Diagrams

  Taylor, Lynne

• Exploiting Melting Point Depression for Hot Melt Extrusion Processing of Amorphous Solid Dispersions

  Taylor, Lynne

• Using a Physiologically-based Pharmacokinetic Absorption Model to Establish Clinically Relevant Dissolution Safe Space for Oseltamivir in Adult and Pediatrics

  Miao, Lei; Wu, Fang; Zhao, Liang; Raines, Kimberly; Seo, Paul

• Application of Physiologically-based Pharmacokinetic Absorption Modeling and Simulations for Biopharmaceutics: Risk Assessment and Control of Critical Quality Attributes for Medical Countermeasure Drug Products

  Miao, Lei; Wu, Fang; Moldthan, Huong; Xu, Da; Zhao, Liang; Raines, Kimberly; Seo, Paul

• Fasted and Fed Motility of the Undisturbed Small Bowel: Development of Novel MRI Methods to Advance In Vivo Predictive Dissolution Studies

  Khalaf, Asseel; Hoad, Caroline; Menys, Alex; Mudie, Deanna; Wright, Jeff; Heissam, Khaled; Abrehart, Nichola; Gowland, Penny; Amidon, Gregory; Spiller, Robin; Amidon, Gordon; Marciani, Luca

• A new Particle Population Balance Model (PPB) for PBPK Modelling of Orally Dosed Drugs Accounting for Two Solid States

  Liu, Dan; Jamei, Masoud; Turner, David

• Using In Vivo Flow Rates In Usp Apparatus 4 To Develop A More In Vivo Relevant Hydrodynamic Dissolution Test.

  Krieg, Brian; Amidon, Gorgon; Amidon, Gregory

• Fasted and Fed Motility of the Undisturbed Small Bowel: Development of Novel MRI Methods to Advance In Vivo Predictive Dissolution Studies

  Khalaf, Asseel; Hoad, Caroline; Menys, Alex; Mudie, Deanna; Wright, Jeff; Heissam, Khaled; Abrehart, Nichola; Gowland, Penny; Amidon, Gregory; Spiller, Robin; Amidon, Gordon; Marciani, Luca