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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A Physiologically-Based Pharmacokinetic Model Framework To Estimate Systemic Bioavailability Of Fluticasone Propionate Nasal Spray
Schroeter, Jeffry; Stricklin, Daniela; Kimbell, Julia; Delvadia, Renishkumar; Zhang, Xinyuan
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The Impact Of Actuation Force On Droplet Size Distribution And Spray Duration Of Three Commercially Available Nasal Sprays
Schroeter, Jeffry; Kimbell, Julia; Saluja, Bhawana; Delvadia, Renishkumar; Vallorz-III, Ernest; Sheth, Poonam
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PoPKAT: A Framework for Bayesian Population PBPK Analysis
Reisfeld, Brad; Chiu, Weihsueh; Hsieh, Nanhung; Olschanowsky, Catherine; Bois, Frederic; Ghosh, Sudipto
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Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Gatifloxacin Solution Case Study
Qaraghuli, Farah Al; Tan, Ming Liang; Walenga, Ross; Babiskin, Andrew; Zhao, Liang; Lukacova, Viera; Lemerdy, Maxime
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Evaluation of Methamphetamine and Amphetamine Disposition Discrepancy upon Selegiline Transdermal patch Administration in Healthy volunteers versus Special populations using PBPK modelling
Puttrevu, Santoshkumar; Arora, Sumit; Polak, Sebastian; Patel, Nikunjkumar
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Qualitative Analysis of Generic and Reference LAI Drug PK Profiles Using Multivariate Score Space
Paul, Prokash; Handelman, Garry; Kim, Jaeyeon; Yoon, Seongkyu
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Development of the Dermal Absorption Model for the Ketoprofen Local and Systemic Exposure Prediction
Patel, Nikunjkumar
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Predicting Diclofenac Systemic and Synovial Fluid Concentrations after Dermal Application using the Multi-Phase Multi-Layer MechDermA PBPK model
Polak, Sebastian; Patel, Nikunjkumar; Martins, Frederico; Salem, Farzaneh; Jamei, Masoud; Rostami-Hodjegan, Amin
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Towards Mechanistic Simulation And Prediction Of Bioequivalence Studies Of Topical Formulations Case Study With Two Diclofenac Formulations
Polak, Sebastian; Patel, Nikunjkumar; Cristea, Sinziana; Rose, Rachel; Salem, Farzaneh; Abduljalil, Khaled; Johnson, Trevor; Raney, Sameersingh; Zhang, Xinyuan; Lin, Hopi; Newman, Bryan; Chow, Edwin; Ghosh, Priyanka; Fan, Jianghong; Fang, Lanyan; Jamei, M
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Qualitative Analysis of Generic and Reference LAI Drug PK Profiles Using Multivariate Score Space
Paul, Prokash; Handelman, Garry; Kim, Jaeyeon; Yoon, Seongkyu