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)

• Designing an In Vitro Study to Understand Release of API from the Dispersed Phase of Clobetasol Creams – Verification of the Mechanistic Emulsion Model in the MPML MechDermA

  Clarke, James; Murthy, Narasimha; Zhang, Yanling; Paterson, Daniel; Dancik, Yuri; Djehizian, Alexandre; Tsakalozou, Eleftheria; Ghosh, Priyanka; Alam, Khondoker; Polak, Sebastian

• How Comparative Clinical Endpoint Bioequivalence Studies Facilitate the Development of Generic Topical Drug Products

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

• Development of an In Silico Model of Topical Acyclovir to Explore Formulation Design

  Spires, Jessica; Osdol, William Van; Lukacova, Viera

• 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