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

• Mechanistic Modeling of Intramuscular Administration of Long-acting Injectable Suspensions Accounting for Fibrosis at the Depot Site

  Silva, Daniela Amaral; Malavia, Nilesh; Burgess, Daine J; Khondoker, Alam; Wang, Yan; Lukacova, Viera

• In Silico Predictive Modeling of the Pharmacokinetic (PK) Profiles of Nasal Sprays in Adults and Children

  Kaviratna, Anubhav; Mohan, Abhinav R; Newman, Bryan; Walenga, Ross; Dutta, Rabijit; Kolanjiyil, Arun; Longest, P Worth; Golshahi, Laleh

• Enabling Formulation Development of LAIs Thorough Understanding Critical Formulation Parameters

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

• Physiologically Based Pharmacokinetic (PBPK) Model of Drug Delivery in the Female Reproductive Tract

  Li, Xinnong; Straubinger, Thomas; Valicherla, Guru R; Zhang, Zhongfang; Achilles, Sharon L; Donnelly, Mark; Zhao, Liang; Tsakalozou, Eleftheria; Chen, Beatrice A; Rohan, Lisa; Bies, Robert

• A Hybrid CFD-PBPK Approach to Simulate Deposition, Absorption, and Bioavailability of Corticosteroid Nasal Sprays

  Schroeter, Jeffry; Garcia, Guilherme; Rose, Morgan; Kimbell, Julia; Walenga, Ross

• Formulation Insights into Long-Acting Hormonal Contraceptives for Advancing Generic Product Development

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

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

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

• Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Ofloxacin Ointment Case Study

  Alqaraghuli, Farah; Le Merdy, Maxime; Tan, Ming-Liang; Lukacova, V

• Mapping Skin Properties in Psoriasis for Improved Understanding of Topical Absorption

  Mangion, SE; Dalton, JK; Mackenzie, L; Tsakalozou, Eleftheria; Clarke, JF; Polak, Sebastian; Roberts, Michael

• Understanding the Impact of Disease on Pediatric Regional Intranasal Drug Delivery with Nasal Sprays

  Hejazi, Mohammad; Owen, Xiomara; Wilkins, John; Schuman, Theodore; Hindle, Michael; Longest, Worth; Walenga, Ross; Kaviratna, Anubhav; Newman, Bryan; Golshahi, Laleh