GDUFA Research Outcomes
Topical Product
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Variability of Skin Pharmacokinetic Data: Insights from a Topical Bioequivalence Study Using Dermal Open Flow Microperfusion
Bodenlenz, Manfred; Augustin, Thomas; Birngruber, Thomas; Tiffner, Katrin; Boulgaropoulos, Beate; Schwingenschuh, Simon; Raney, Sam; Rantou, Elena; Sinner, Frank
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Bioequivalence Methodologies for Topical Drug Products: In Vitro and Ex Vivo Studies with a Corticosteroid and an Anti-Fungal Drug
Leal, Leila; Cordery, Sarah; Delgado Charro, Begona; Bunge, Annette; Guy, Richard
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Relating Transdermal Delivery Plasma Pharmacokinetics with In Vitro Permeation Test (IVPT) Findings Using Diffusion and Compartment-In-Series Models
Liu, Xin; Anissimov, Yuri; Grice, Jeffrey; Cheruvu, Hanumanth; Ghosh, Priyanka; Raney, Sam; Maibach, Howard; Roberts, Michael