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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Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Moxifloxacin Solution Case Study
Le Merdy, Maxime; Lukacova, Viera; Tan, Ming-Liang; Babiskin, Andrew; Zhao, Liang
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Impact of Changes in Ophthalmic Emulsion Globule Size Distribution and Viscosity on Tear Film Thickness and Menisci Characteristics
Kumar, Sandeep; Cook, Nicholas; Gum, Glenwood; Manza, Linda; Naageshwaran, Vatsala; Lyulkin, Mathew; Xu, Xiaoming; Patel, Deval; Qu, Haiou; Walenga, Ross; Tan, Ming Liang; Babiskin, Andrew; Kaisar, Mohmmad Abul
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On the Importance of Liquid Motion in Nasal Spray Delivery
Kolanjiyil, A; Golshahi, L; Longest, W
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How Spray Metric Variability Impacts the Initial Deposition of Nasal Sprays
Kolanjiyil, Arun; Hosseini, Sana; Alfaifi, Ali; Golshahi, Laleh; Hindle, Michael; Longest, Worth
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Effect of Spray Momentum on Nasal Spray Droplet Transport and Deposition
Kolanjiyil, Arun; Hosseini, Sana; Manniello, Michele; Alfaifi, Ali; Farkas, Dale; Golshahi, Laleh; Longest, Worth
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The Effect of PLGA Molecular Weight on Drug Release from Microspheres
Kohno, Moe; Andhariya, Janki; Rothstein, Sam; Wang, Yan; Qin, Bin; Burgess, Diane
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Estimating Size-specific Numbers of Active Pharmaceutical Ingredient Particles in the Regional Deposition of a Nasal Spray
Kimbell, Julia; Schroeter, Jeffry; Tian, Geng; Walenga, Ross; Babiskin, Andrew; Delvadia, Renishkumar
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Effect of Actuation Force on Simulated Regional Nasal Spray Deposition in a Healthy Nasal Cavity
Kimbell, Julia; Schroeter, Jeffry; Sheth, Poonam; Tian, Geng; Delvadia, Renishkumar; Saluja, Bhawana; Walenga, Ross
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Simulating Nasal Spray Deposition: Effects of Spray Nozzle Presence in the Nasal Vestibule
Kimbell, Julia; Stricklin, Daniela; Schroeter, Jeffry
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A Multiscale Modeling Approach To Optimize Pulmonary Drug Delivery
Kannan, Ravi; Singh, Narender; Przekwas, Andrzej; Delvadia, Renishkumar; Tian, Geng; Walenga, Ross