GDUFA Research Outcomes
Topical Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the topical route, including topical dermatological products.
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Theoretical Principles and Best Practices In Vitro Permeation Testing (IVPT)
Ghosh, Priyanka
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Promising Technologies: Continuous Skin Sampling Methods for Cutaneous PK-Based Bioequivalence Assessment
Tiffner, Katrin; Boulgaropoulos, Beate; Birngruber, Thomas; Bodenlenz, Manfred; Lackner, Bettina; Raml, Reingard; Sinner, Frank
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IVPT Data Challenges and Statistical Analysis
Ghosh, Priyanka
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Evaluation of Cutaneous Pharmacokinetics The Past, The Present, and The Future
Ghosh, Priyanka
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Scientific Challenges for Generic Transdermal Products: Recent Advances and Future Research
Stinchcomb, Audra
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Characterizing In Vitro Bioavailability of Acyclovir and Metronidazole Topical Products, and In Vitro-In Vivo Correlation Results with Transdermal Systems
Stinchcomb, Audra
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Bioavailability And Bioequivalence Of Products Applied To The Skin
Stinchcomb, Audra
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Evaluating Topical Bioavailability In Vivo by Skin Stripping and In Vitro by IVPT
Stinchcomb, Audra
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Challenges In The Development Of Bioequivalent Topically Applied Drug Products
Stinchcomb, Audra
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Computational Modeling of Absorption from Complex Topical Formulations
Spires, Jessica