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.

• All(374)
• Posters(145)
• Presentations(185)
• Papers(44)

• Open Flow Microperfusion As A Dermal Pharmacokinetic Approach To Evaluate Topical Bioequivalence

  Bodenlenz, Manfred; Tiffner, Katrin; Raml, Reingard; Augustin, Thomas; Dragatin, Christina; Birngruber, Thomas; Schimek, Denise; Schwagerle, Gerd; Pieber, Thomas; Raney, Sam; Kanfer, Isadore; Sinner, Frank

• Application of Confocal Raman Microscopy for the Characterization of Topical Semisolid Formulations and their Penetration into Human Skin Ex Vivo

  Jung, N; Namjoshi, S; Mohammed, Y; Grice, J E; Benson, H A E; Raney, S G; Roberts, M S; Windbergs, M

• Evaluation of Local Bioavailability of Metronidazole from Topical Formulations Using Dermal Microdialysis: Preliminary Study in a Yucatan Mini-pig Model

  Kuzma, Benjamin; Senemar, Sharareh; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sam; Stagni, Grazia

• Identification of critical formulation parameters affecting the in vitro release, permeation, and rheological properties of the acyclovir topical cream

  Kamal, Nahid; Krishnaiah, Yellela; Xu, Xiaoming; Zidan, Ahmed; Raney, Sam; Cruz, Celia; Ashraf, Muhammad

• Determining Equivalence for Generic Locally Acting Drug Products

  Grosser, Stella; Park, Misook; Raney, Sam; Rantou, Elena

• Cutaneous Pharmacokinetic Approaches to Compare Bioavailability and/or Bioequivalence for Topical Drug Products

  Raney, Sam; Ghosh, Priyanka; Ramezanli, Tannaz; Lehman, Paul; Franz, Thomas

• Comparative In Vitro Release Testing (IVRT) of Acyclovir Products

  Tiffner, Katrin; Kanfer, Isadore; Augustin, Thomas; Raml, Reingard; Raney, Sam; Sinner, Frank

• The Dose-Duration Effect on Cutaneous Pharmacokinetics of Metronidazole from Topical Dermatological Formulations in Yucatan Mini-Pigs

  Kuzma, Benjamin; Senemar, Sharareh; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sam G; Stagni, Grazia

• Physicochemical and Structural Evaluation of Microparticles in Tretinoin Topical Gels

  Elfakhri, K H; Niu, M; Ghosh, P; Ramezanli, T; Raney, S G; Ahmed, S; Willett, D R; Yilmaz, H; Ashraf, M; Zidan, A S

• Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products

  Yacobi, Avraham; Shah, Vinod; Bashaw, Edward; Benfeldt, Eva; Davit, Barbara; Ganes, Derek; Ghosh, Tapash; Kanfer, Isadore; Kasting, Gerald; Katz, Lindsey; Lionberger, Robert; Lu, Guangwei; Maibach, Howard; Pershing, Lynn; Rackley, Russell; Raw, Andre; Shukla, Chinmay; Thakker, Tailas; Wagner, Nathalie; Zovko, Elizabeta; Lane, Majella