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(452)
• Posters(198)
• Presentations(229)
• Papers(25)

• Method Development for the Evaluation of In Vitro Skin Permeation of Clascoterone from Clascoterone Topical Cream, 1%

  Yang, Yang; Wang, Jiang; Wanasathop, Apipa; Zidan, Ahmed; Niu, Mengmeng; Ghosh, Priyanka; Faustino, Patrick; Ashraf, Muhammad; Xu, Xiaoming

• Recommendations Related to In Vitro Permeation Test Studies in Product-Specific Guidances for Topical Drug Products

  Niu, Mengmeng; Ghosh, Priyanka; Ramezanli, Tannaz; Luke, Markham; Raney, Sam G.

• Dermal OFM Indicates Differences in Acyclovir Skin Permeation between Males and Females

  Bodenlenz, Manfred; Augustin, Thomas; Teles Barbosa, Felipe; Birngruber, Thomas; Tiffner, Katrin; Raml, Reingard; Ramezanli, Tannaz; Raney, Sam G.; Sinner, Frank

• Impact of Fatty Acids on In Vitro Performance of Clindamycin Phosphate Vaginal Creams

  Yue, Weizhou; Xie, Lingxiao; Kelchen, Megan; Ghosh, Priyanka; Niu, Mengmeng; Raney, Sam G.; Shen, Jie

• Assessment of Bio(in)Equivalence of Metronidazole Topical Formulations using Stimulated Raman Scattering Microscopy

  Zarmpi, P; Tsikritsis, D; Watson, AC; Vorng, JL; Tyagi, V; Belsey, N; Woodman, TJ; White, KAJ; Ghosh, P; Bunge, AL; Delgado-Charro, MB; Guy, RH

• Current Methods for Assessing Bioequivalence of Drug Products Applied to the Skin ��� a US FDA Perspective

  Kelchen, Megan; Xie, Lingxiao; Luke, Markham; Ghosh, Priyanka

• In vitro-In vivo Comparison of Cooling Sensation in Topical Gel Products

  Phan, Khanh; Liu, David; Panchal, Bhavesh; Namjoshi, Sarika; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sam G.; Luke, Markham; Roberts, Michael; Mohammed, Yousuf

• Facilitating Drug Development Through GDUFA Regulatory Science and Research Opportunities for Collaboration with FDA

  Ghosh, Priyanka; Ramezanli, Tannaz; Luke, Markham

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

  Bodenlenz, M; Tiffner, K; Raml, R; Tschapeller, B; Augustin, T; Dragatin, C; Birngruber, T; Kainz, S; Schwagerle, G; Korsatko, S; Raney, S; Sinner, F

• Evaluation of Metronidazole Bioavailability from Dermal Products Using an In Vitro Permeation Test (IVPT) Across Human Skin

  Zhang, Qingzhao; Ghosh, Priyanka; Rantou, Elena; Raney, Sam; Hammell, Dana; Stinchcomb, Audra