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.
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Physiologically-based Pharmacokinetic Modeling for the Development of Dermatological Drug Products and its Regulatory Impact
Tsakalozou, Eleftheria
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Physiologically-based pharmacokinetic modeling and simulation used in assessing bioequivalence for generic dermatological products
Tsakalozou, Eleftheria
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Continuous Skin Sampling Methods for the Assessment of Cutaneous PK-Based Bioequivalence
Tiffner, Katrin; Boulgaropoulos, Beate; Birngruber, Thomas; Bodenlenz, Manfred; Lackner, Bettina; Raml, Reingard; Sinner, Frank
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Integration of Biopredictive Dissolution and PBPK Models for Evaluation of GI Locally Acting Products: PART I
Thomas, Sherin
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IVRT Studies During Topical Product Development: Challenges in Method Development and Transfer
Thakker, Kailas
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GDUFA Research Update on Mechanistic Modeling Approaches for Generic Ophthalmic, Nasal, Implant and Injectable Drug Products
Tan, Mingliang
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Physiologically-based Pharmacokinetic Modeling to Support Generic Ophthalmic Product Development and Regulatory Decision Making
Tan, Mingliang
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Powder Fluidization in Dry Powder Inhalers
Sulaiman, Mostafa; Liu, Xiaoyu; Kolehmainen, Jari; Ozel, Ali; Sundaresan, Sankaran
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IVPT Studies with Topical and Transdermal Products
Stinchcomb, Audra
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PBPK Modeling of Dermal Penetration from Topical Formulations
Spires, Jessica