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)

• Formulation Drug Product Quality Attributes Additions in Dermal PBPK Model

  Babiskin, Andrew

• Mechanistic Modeling of Complex Injectables: Recommendations to Navigate Regulatory Challenges

  Andre, Kris

• Research Overview and Regulatory Experience on Mechanistic Modeling for Generic Dermatological Drug Products

  Alam, Khondoker

• Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products, Part 2

  Arora, Sumit

• Excipient Safety Assessment in Generic Drug Formulations: An Overview

  Agarwal, Stuti

• Expectations and Common Deficiencies for IVRT Studies Submitted in ANDAs for Ophthalmic Emulsion Products

  Abuznait, Alaa

• 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