GDUFA Research Outcomes
Transdermal Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the transdermal route, including transdermal delivery systems.
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Statistical Considerations and Impact of the FDA Draft Guidance for Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs
Sun, Wanjie; Grosser, Stella; Kim, Carol; Raney, Sam
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Introduction to Q3
Yu, Lawrence
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Bioequivalence of Topical Products
Yu, Lawrence
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Comparative Analyses: Device and User Interface Considerations
Witzmann, Kimberly
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Overview of Regulatory and User-Interface Considerations, and the Role of Comparative Analyses, in Developing a Generic Drug-Device Combination Product in an ANDA
Witzmann, Kimberly
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Overcoming Barriers to Entry for Complex Generic Oral Inhalation Drug Products
Witzmann, Kimberly
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The Role of Comparative Analyses for Evaluation of Generic Drug-Device Combinations in an ANDA
Witzmann, Kimberly
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The Pursuit of Alternative Methodologies for Demonstrating Bioequivalence for Generic Topical Dermatologic Drug Products
Wilkin, Jonathan
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In Vitro Evaluation of a Buprenorphine Transdermal Delivery System with Transient Heat Exposure and the Correlation of In Vitro Results with Existing In Vivo Results
Thomas, Sherin
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Scientific Challenges for Generic Transdermal Products: Recent Advances and Future Research
Stinchcomb, Audra