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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Development and Application of a Dermal PBPK Modeling for Ethinyl Estradiol-Containing Transdermal Delivery Systems to Predict Exposure for Different Application Sites
Tsakalozou, Eleftheria; Alam, Khondoker; Babiskin, Andrew; Fang, Lanyan (Lucy); Zhao, Liang
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PBPK Modeling of Percutaneous Pharmacokinetics for Tazarotene and Tretinoin Creams: Applicability and Challenges
Tsakalozou, Eleftheria; Alam, Khondoker; Babiskin, Andrew; Zhao, Liang
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Development of a Dermal PBPK Modeling for an Ethinyl Estradiol-Containing Transdermal Delivery System
Tsakalozou, Eleftheria; Alam, Khondoker; Babiskin, Andrew; Fang, Lanyan; Zhao, Liang
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Clinical Study to Assess the Cutaneous Bioequivalence of Topically Applied Lidocaine and Prilocaine Products Using Dermal Open Flow Microperfusion
Tiffner, Katrin; Ramezanli, Tannaz; Birngruber, Thomas; Bodenlenz, Manfred; Lackner, Bettina; Raml, Reingard; Raney, Sam G; Sinner, Frank
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A Clinical Study to Assess the Bioequivalence of Lidocaine and Prilocaine Topical Drug Products Using Dermal Open Flow Microperfusion
Tiffner, Katrin; Ramezanli, Tannaz; Birngruber, Thomas; Bodenlenz, Manfred; Lackner, Bettina; Raml, Reingard; Schwagerle, Gerd; Kainz, Sonja; Gander, Edgar; Raney, Sam; Sinner, Frank
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A Clinical Study Design to Evaluate Whether the Systemic Bioavailability of Topical Drugs May Influence the Assessment of Local Dermal Pharmacokinetics by Dermal Open Flow Microperfusion (dOFM)
Tiffner, Katrin; Birngruber, Thomas; Schwagerle, Gerd; Ramezanli, Tannaz; Bodenlenz, Manfred; Lackner, B; Augustin, Thomas; Raml, Reingard; Kanfer, Isadore; Raney, Sam; Sinner, Frank
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Dermal Pharmacokinetic Endpoint Studies to Evaluate Bioequivalence of Topically Applied Lidocaine and Prilocaine Drug Products
Tiffner, Katrin; Birngruber, Thomas; Schwagerle, Gerd; Bodenlenz, Manfred; Augustin, Thomas; Raml, Reingard; Kanfer, Isadore; Sinner, Frank
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In Vitro Release Test (IVRT) Comparisons of Six Acyclovir Cream, 5% Products to Evaluate the Impact of Compositional Differences on Product Performance
Tiffner, Katrin; Kanfer, Isadore; Augustin, Thomas; Raml, Reingard; Raney, Sam; Sinner, Frank
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Reference-Scaled Average Bio-Equivalence (SABE): A Promising Statistical Approach to Analyze Cutaneous Pharmacokinetic Results for Topically Applied Drug Products
Tiffner, Katrin; Rantou, Elena; Bodenlenz, Manfred; Augustin, Thomas; Reisnegger, Peter; Raml, Reingard; Raney, Sam; Sinner, Frank
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Evaluation of Dermal Open Flow Microperfusion (dOFM) as a General Methodology to Assess the Bioequivalence of Hydrophobic, Protein-Bound Topical Drug Products
Tiffner, Katrin; Birngruber, Thomas; Schwagerle, Gerd; Bodenlenz, Manfred; Augustin, Thomas; Raml, Reingard; Kanfer, Isadore; Raney, Sam; Sinner, Frank