GDUFA Research Outcomes

PBPK Models

• All(430)
• Posters(94)
• Presentations(218)
• Papers(118)

• Development And Validation Of Dermal Pbpk Model Towards Virtual Bioequivalence Assessment: Prediction Of Dermal Drug Absorption Of Various Ibuprofen Formulations Using Simcyp MechdermA model

  Martins, Frederico; Patel, Nikunjkumar; Cristea, Sinziana; Polak, Sebastian

• Multi-phase Multi-layer MechDermA model: Development, Verification and Application of a PBPK-PD Model of Dermal Absorption for Transdermal Product Assessment

  Polak, Sebastian; Patel, Nikunjkumar; Martins, Frederico; Salem, Farzaneh; Jamei, Masoud; Rostami-Hodjegan, Amin

• Assessment of the Impact of Drug Dissolution on Pharmacokinetics of Diltiazem Extended Release Drug Products Using Physiologically Based Pharmacokinetic Analysis

  Li, Min; Gao, Zongming; Tang, Fuxing; Choi, Stephanie; Toth, Roxana; Rodriguez, Jason

• Dissolution Testing of Diltiazem HCI Extended-Release Capsule Products

  Li, Min; Gao, Zongming; Tang, Fuxing; Choi, Stephanie; Toth, Roxana; Rodriguez, Jason

• Physiologically-based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development

  Le Merdy, Maxime; Fan, Jianghong; Babiskin, Andrew; Zhao, Liang

• Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Levofloxacin Solution Case Study

  Le Merdy, Maxime; Zheng, Yujuan; Lukacova, Viera; Tan, Ming Liang; Babiskin, Andrew; Zhao, Liang

• Physiologically-based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development

  LeMerdy, Maxime; Fan, Jianghong; Babiskin, Andrew; Zhao, Liang

• Application of Ocular Physiologically Based Pharmacokinetic Modeling to Understand the Impact of Particle Size and Viscosity on Ophthalmic Bioavailability of Tobradex ST Suspension in Rabbits

  Lemerdy, Maxime; Tsakalozou, Eleftheria; Choi, Stephanie; Kim, Myongjin; Xu, Lin; Stewart, Sharron; Chockalingam, Ashok; Rouse, Rodney; Matta, Murali; Zhao, Liang; Lionberger, Robert; Fan, Jianghong

• 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

• 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