GDUFA Research Outcomes
PBPK Models
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Physiologically-Based Pharmacokinetic Pediatric Skin Model
Edginton, Andrea; Yun, Esther; Hamadeh, Abdullah
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Development of a CFD PK Nasal Spray Model with In Vivo Human Subject Validation
Dytta, R; Kolanjiyil, A; Golshahi, L; Longest, W
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Model Integrated Equivalence for BE Assessment of Long Acting Injectables: In Silico Continuation to Steady State
Ducharme, Murray
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Model-Integrated BE Approaches for Long-Acting Injectables
Ducharme, Murray
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Development Strategies for Generic Topical Products with Formulation Differences to Reference Listed Drug
Dubey, Vaibhav
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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