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)

• 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

• PoPKAT: A Framework for Bayesian Population PBPK Analysis

  Reisfeld, Brad; Chiu, Weihsueh; Hsieh, Nanhung; Olschanowsky, Catherine; Bois, Frederic; Ghosh, Sudipto

• 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

• 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

• Qualitative Analysis of Generic and Reference LAI Drug PK Profiles Using Multivariate Score Space

  Paul, Prokash; Handelman, Garry; Kim, Jaeyeon; Yoon, Seongkyu

• 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

• Development of the Dermal Absorption Model for the Ketoprofen Local and Systemic Exposure Prediction

  Patel, Nikunjkumar

• 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, Sam; Zhang, Xinyuan; Lin, Hopi; Newman, Bryan; Chow, Edwin; Ghosh, Priyanka; Fan, Jianghong; Fang, Lanyan; Jamei, M

• Population Pharmacokinetic/Pharmacodynamic (PKPD) Modeling for Long Acting Injectable(LAI) Products and Statistical Analysis for Bioequivalence(BE) Assessment

  Paul, Prokash; Yoon, Seongkyu; Kim, Namjoon; Trunfio, Nicholas; Handelman, Garry; Kim, Jaeyeon

• Qualitative Analysis of Generic and Reference LAI Drug PK Profiles Using Multivariate Score Space

  Paul, Prokash; Handelman, Garry; Kim, Jaeyeon; Yoon, Seongkyu