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.
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Discussion with EMA PKWG and CVSWP: Levothyroxine NTI Classification and BE Approach
Donnelly, Michael; Fang, Lanyan(Lucy)
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Demonstrating Bioequivalence with Inhalation Spray Drug Products
Dhapare, Sneha
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Integrating Biopharmaceutic Data and Gastrointestinal Physiology Using Mechanistic Modeling
Cristofoletti, Rodrigo
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ASME V&V 40 for Establishing Credibility of CFD Models
Craven, Brent
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Opening Remarks to the FDA and the Center for Research on Complex Generics (CRCG) Workshop: Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches
Corrigan-Curay, Jacqueline
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Utilizing Mechanistic Dermal Absorption Models to Assess Virtual BE
Clarke, James
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Predicting Dermal Absorption in Diseased or Damaged Skin Using PBPK Modelling
Clarke, James; Roberts, Michael
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Formulation Drug Product Quality Attributes Additions in Dermal PBPK Model
Clarke, James
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Physiologically Based Pharmacokinetic Modeling of Naloxone Hydrochloride Nasal Sprays
Chopski, Steven; Al Ghabeish, Manar; Babiskin, Andrew; Zhao, Liang; Walenga, Ross
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Innovative Technology: Particle Image Velocimetry (PIV) and High Speed Imaging to Support Approval of Generic Orally Inhaled Drug Products
Chopski, Steven