GDUFA Research Outcomes
BE Methods & Analyses
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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
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Exploiting Melting Point Depression for Hot Melt Extrusion Processing of Amorphous Solid Dispersions
Taylor, Lynne
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The Application of Temperature-Composition Phase Diagrams for Hot Melt Extrusion Processing of Amorphous Solid Dispersions to Prevent Residual Crystallinity
Taylor, Lynne
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Hot Melt Extrusion Processing Regimes Based on Temperature-Composition Phase Diagrams
Taylor, Lynne
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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
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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
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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
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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
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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
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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