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)

• Effect of Formulation Wipe-Off Time on Topical Bioavailability of Metronidazole Using Dermal Microdialysis

  Kuzma, Benjamin; Senemar, Sharareh; Stagni, Grazia

• Evaluation of Local Bioavailability of Metronidazole from Topical Formulations Using Dermal Microdialysis: Preliminary Studies in Yucatan Mini-Pig

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

• LC/MS/MS Method for the Quantification of Metronidazole in Skin Dialysate

  Kuzma, Benjamin; Senemar, Sharareh; DePinto, Richard; Stagni, Grazia

• Developing Efficient Bioequivalence Approaches for Generic Vaginal Drug Products

  Kelchen, Megan; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sam G.

• Strategic analysis of the Roadmap for Implementing Characterization-Based Bioequivalence Approaches in Product-Specific Guidances for Generic Topical Dermatological Drug Products

  Kelchen, Megan; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sameersingh

• Strategic analysis of the Roadmap for Implementing Characterization-Based Bioequivalence Approaches in Product-Specific Guidances for Generic Topical Dermatological Drug Products

  Kelchen, Megan; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sameersingh

• Evaluation of Penetration Kinetics of Commercial Topical Formulations in Human Skin using Non-invasive Confocal Raman Microscopy

  Jung, Nathalie; Namjoshi, Sarika; Mohammed, Yousuf; Grice, Jeffrey; Raney, Sameersingh; Roberts, Michael; Windbergs, Maike

• Visualizing the Penetration of Semisolid Topical Formulations in Excised Human Skin by non-Invasive Confocal Raman Microscopy

  Jung, Nathalie; Namjoshi, Sarika; Mohammed, Yousuf; Grice, Jeffrey; Raney, Sameersingh; Roberts, Michael; Windbergs, Maike

• Factors Influencing Transepidermal Water Loss Measurements Used to Test Skin Barrier Integrity In Vitro: A Literature Review

  Jiang, Ying; Simamora, Matteo; Ramezanli, Tannaz; Raney, Sam

• Stimulated Raman Scattering (SRS) Microscopy and Deep Learning: Novel Pharmacokinetic Approach for Evaluation of Topical Bioequivalence

  Iliopoulos, Fotis; Pence, Isaac J; Ghosh, Priyanka; Raney, Sam G; Luke, Markham C; Evans, Conor L