GDUFA Research Outcomes
PBPK Models
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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
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Assessment of Effects of Selective Airway Luminal Expansion on Inhaled Particle Deposition in Severe Asthmatic Human Lungs – A Numerical Study
Choi, Jiwoong; Choi, Sanghun; Hoffman, Eric; O’Shaughenessy, Patrick; Castro, Mario; Delvadia, Renishkumar; Walenga, Ross; Babiskin, Andrew; Lin, Ching-Long
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Cluster-guided Imaging-based CFD Analysis of Airflow and Particle Deposition in Asthmatic Human Lungs
Choi, J; Leblanc, L; Choi, S; Haghighi, B; Hoffman, E; Lin, C
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Characteristics of Inhaled Particle Deposition in the Lungs of Imaging-based Asthma Clusters: a Numerical Study
Choi, J; Leblanc, L; Choi, S; Haghighi, B; Hoffman, E; O’shaughnessy, P; Wenzel, S; Castro, M; Fain, S; Jarjour, N; Schielbler, M; Denlinger, L; Lin, C
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A Population PK Based Model-Integrated BE Platform
Chen, X; Nyberg, H; Assawasuwannakit, P; Ryeznik, Y; Karlsson, M
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Approaches in Establishing BE Safe Space for Oral Solid Dosage Form
Chakraborty, Sumon