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.

• All(475)
• Posters(107)
• Presentations(231)
• Papers(137)

• 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

• How Spray Metric Variability Impacts the Initial Deposition of Nasal Sprays

  Kolanjiyil, Arun; Hosseini, Sana; Alfaifi, Ali; Golshahi, Laleh; Hindle, Michael; Longest, Worth

• On the Importance of Liquid Motion in Nasal Spray Delivery

  Kolanjiyil, A; Golshahi, L; Longest, W

• The Effect of PLGA Molecular Weight on Drug Release from Microspheres

  Kohno, Moe; Andhariya, Janki; Rothstein, Sam; Wang, Yan; Qin, Bin; Burgess, Diane

• 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

• 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

• Simulating Nasal Spray Deposition: Effects of Spray Nozzle Presence in the Nasal Vestibule

  Kimbell, Julia; Stricklin, Daniela; Schroeter, Jeffry

• 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

• A Multiscale Modeling Approach To Optimize Pulmonary Drug Delivery

  Kannan, Ravi; Singh, Narender; Przekwas, Andrzej; Delvadia, Renishkumar; Tian, Geng; Walenga, Ross

• A Bayesian Population Compartmental Absorption and Transit Modeling Approach to Support Generic Drug Development and Regulation – Application to Bupropion

  Hsieh, Nan Hung; Bois, Frederic; Tsakalozou, Eleftheria; Yoon, Miyoung; Reisfeld, Brad; Chiu, Weihsheh