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)

• Development of Mechanistic In Vitro-In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables

  Silva, Daniela A; Le Merdy, Maxime; Alam, Khondoker; Wang, Yan; Bao, Quanying; Malavia, Nilesh; Burgess, Diane; Lukacova, Viera

• CFD-DEM Investigation of the Effects of Aperture Size for a Capsule-based Dry Powder Inhaler

  Zhu, Qixuan; Kakhi, Maziar; Jayasundara, Chandana; Walenga, Ross; Behara, Srinivas; Chan, Hak Kim; Yang, Runyu

• Development of an In Vitro Method for In Vivo Prediction of Regional Deposition of Nasal Powders

  Holtgrewe, Nicholas; Walenga, Ross; Bielski, Elizabeth; Guo, C

• Nasal Steroid Spray Simulations Using Measured Spray Characteristics in Healthy and Rhinitic Nasal Passages

  Kimbell, J S; Garcia, G J M; Schroeter, J D; Sheth, P; Vallorz-III, E L; Saluja, B; Babiskin, A H; Tian, G; Walenga, R L

• Transport and Deposition of Beclomethasone Dipropionate Drug Aerosols with Varying Ethanol Concentration in Severe Asthmatic Subjects

  Rajaraman, Prathish; Choi, Jiwoong; Babiskin, Andrew; Walenga, Ross; Lin, Chinglong

• Regulatory Utility of Physiologically Based Pharmacokinetic Modeling to Support Alternative Bioequivalence Approaches and Risk Assessment: A Workshop Summary Report

  Wu, F; Mousa, Y; Raines, K; Bode, C; Tsang, YC; Cristofoletti, R; Zhang, H; Heimbach, T; Fang, L; Kesisoglou, F; Mitra, A; Polli, J; Kim, MJ; Fan, J; Zolnik, BS; Sun, D; Zhang, Y; Zhao, L

• Mechanistic Modeling of Ophthalmic, Nasal, Injectable, and Implant Generic Drug Products: a Workshop Summary Report.

  Tan, Ming-Liang; Chandran, Sajeev; Jereb, Rebeka; Alam, Khondoker; Bies, Robert; Kozak, Darby; Walenga, Ross; Le Merdy, Maxime; Babiskin, Andrew

• Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation

  Le Merdy, Maxime; Alqaraghuli, Farah; Tan, Ming Liang; Walenga, Ross; Babiskin, Andrew; Zhao, Liang; Lukacova, Viera

• The Role of Capsule Aperture Size on the Dispersion of Carrier-based Formulation at Different Air Flowrates

  Tang, Patricia; Kakhi, Maziar; Albariqi, Ahmed; Behara, Srinivas; Walenga, Ross; Yang, Runyu; Chan, Hak-Kim

• Increasing Impact of Quantitative Methods and Modeling in Establishment of Bioequivalence and Characterization of Drug Delivery

  Yoon, Miyoung; Babiskin, Andrew; Hu, Meng; Wu, Fang; Raney, Sam G.; Fang, Lanyan; Zhao, Liang