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(415)
• Posters(179)
• Presentations(216)
• Papers(20)

• Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary

  Tsakalozou, Eleftheria; Mohamed, Mohamed-Eslam F; Polak, Sebastian; Heimbach, Tycho

• Predicting Human Dermal Drug Concentrations using PBPK Modeling and Simulation: Clobetasol Propionate Case Study

  Van Osdol, William; Novakovic, Jasmina; Le Merdy, Maxime; Tsakalozou, Eleftheria; Ghosh, Priyanka; Spires, Jessica; Lukacova, Viera

• Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop

  Pal, Arindom; Wu, Fang; Walenga, Ross; Tsakalozou, Eleftheria; Alam, Khondoker; Gong, Yuqing; Liang, Zhao; Fang, Lanyan

• Determining Topical Product Bioequivalence with Stimulated Raman Scattering Microscopy

  Iliopoulos, Fotis; Tu, Dandan; Pence, Isaac J; Li, Xiaolei; Ghosh, Priyanka; Luke, Markham; Raney, Sam G.; Rantou, Eleni; Evans, Conor L

• Evaluation of Chemical Disposition in Skin by Stimulated Raman Scattering Microscopy

  Zarmpi, P; Tsikritis, D; Vorng, J-L; Belsey, NA; Bunge, AL; Woodman, TJ; Begona Delgado-Charro, M; Guy, R H

• Confocal Raman Spectroscopic Characterization of Dermatopharmacokinetics Ex Vivo

  Zarmpi, Panagiota; Maciel-Tabosa, MA; Vitry, Pauline; Bunge, Annette; Belsey, Natalie; Tsikritsis, Dimitrios; Woodman, Timothy; Delgado-Charro, M Begona; Guy, Richard

• In Vitro-In Vivo Correlation of Buprenorphine Transdermal Systems Under Normal and Elevated Skin Temperature

  Stinchcomb, A; Thomas, Sherin

• Quantification of Chemical Uptake into the Skin by Vibrational Spectroscopies and Stratum Corneum Sampling

  Maciel-Tabosa, MA; Vitry, P; Zarmpi, P; Bunge, AL; Belsey, NA; Tsikritsis, D; Woodman, TJ; Jane White, KA; Begona Delgado-Charro, M; Guy, R H

• Bioequivalence Evaluation of Topical Metronidazole Products Using Dermal Microdialysis in New Zealand Rabbits

  Senemar, Sharareh; Kuzma, B A; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sam G.; Rantou, Elena; Stagni, Grazia

• Near-Infrared Spectrometry for the Quantification of Dermal Absorption of Econazole Nitrate and 4-Cyanophenol

  Medendorp, Joseph; Yedluri, Jhansi; Hammell, Dana; Ji, Tao; Lodder, Robert; Stinchcomb, Audra