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)

• Introduction and Overview of the Model Master File

  Fang, Lanyan

• Considerations for CFD-DEM Predictions of Regional Deposition Following Dry Powder Inhalation Administration

  Lee, Jae(Mike)

• Pirana–Simcyp Virtual Bioequivalence (VBE) Workflow: Software Demonstration and Case Study on Paliperidone Palmitate Long-Acting Injectables.

  Craig, J; Morris, NM; McNally, K; Corpstein, C; Telaprolu, KC; Bogdanovich, P; Turner, DB; Rostami-Hodjegan, A; Jamei, M; and Bois, FY

• Impact of Polyethylene Glycol Polymer in the Development of Long-Acting Injectable Suspensions

  Malavia, Nilesh; Bao, Quanying; Silva, Daniela Amaral; Lukacova, Viera; Alam, Khondoker; Wang, Yan; Burgess, Diane J

• Modeling Metamorphosis: Advancing Dermal PBPK Modeling – A Metronidazole Case Study

  Pettarin, Maximo; Spires, Jessica; Lukacova, Viera; Sharkawy, Asma; Williams, Adrian; Bunge, Annette L; Guy, Richard H; Ghosh, Priyanka; Tsakalozou, Eleftheria; Delgado-Charro, M Begona

• Quantitative Studies to Inform PSG Development for Tiotropium Bromide Inhalation Spray, Metered

  Chopski, Steven; Babiskin, Andrew; Newman, Bryan; Dhapare, Sneha; Boc, Susan; Kakhi, Maziar; Walenga, Ross

• Effect of Inflammation on Drug Transporter Concentrations in Human Airway Epithelia Measured by Quantitative Targeted Absolute Proteomics

  Fallon, John K.; Cholon, Deborah M.; Boyles, Susan E.; Tiley, Jacqueline B.; Smith, Philip C.; Rao, Gauri; Gentzsch, Martina; Tan, Ming-Liang; Zhao, Liang; and Esther Jr, Charles R

• Pirana–Simcyp Virtual Bioequivalence (VBE) Workflow: Software Demonstration and Case Study on Paliperidone Palmitate Long-Acting Injectables

  Craig, J; Morris, NM; McNally, K; Corpstein, C; Telaprolu, KC; Bogdanovich, P; Turner, DB; Rostami-Hodjegan, A; Jamei, M; and Bois, FY

• Physiologically Based Pharmacokinetic Modeling and Mechanistic In Vitro-In Vivo Correlation for Long-Acting Injectable Suspension

  Silva, Daniela Amaral; Lukacova, Viera; Alam, Khondoker; Tsakalozou, Eleftheria; Al Shoyaib, Abdullah

• Impact of Topical Product Metamorphosis on Absorption of Metronidazole

  Sharkawy, A; Jamaledin, R; Williams, A C; Bunge, A L; Guy, R H; Pettarin, M; Spires, J; Ghosh, P; Tsakalozou, E; Delgado-Charro, M B