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)

• Influence of Quantitative Differences in Propylene Glycol on the Performance of Diclofenac Sodium Topical Gels

  Rangappa, S; Phan, K; AL-Smadi, K; Zhu, J; Jiang, Y; Ghosh, P; Ramezanli, T; Raney, SG; Roberts, M; Mohammed, Y; Narasimha Murthy, S

• Critical Quality Attributes Enhance Understanding of Skin Sensory Perceptions

  Phan, Khanh; Leite-Silva, Vania R; Prakash, Sangeeta; Liu, David; Ramezanli, Tannaz; Ghosh, Priyanka; Natarajan, Karthika; Raney, Sam G.; Luke, Markham; Roberts, Michael; Mohammed, Yousuf

• Mapping Skin Properties in Psoriasis for Improved Understanding of Topical Absorption

  Mangion, SE; Dalton, JK; Mackenzie, L; Tsakalozou, Eleftheria; Clarke, JF; Polak, Sebastian; Roberts, Michael

• Development of In Vitro Skin Permeation Testing Method to Assess Bioequivalence of Topical Roflumilast Cream Formulations

  Kamal, Nahid; Sultana, Tasmin Ara; Ali, Muhammad; Russo, Jackson; Jiang, Ying; Ghosh, Priyanka; Zidan, Ahmed; Ashraf, Muhammad

• Understanding Critical Quality Attributes of Gelatin Coated Miconazole Nitrate Vaginal Inserts and Suppositories

  Chauhan, Anjali; Xie, Lingxiao; Kelchen, Megan; Ghosh, Priyanka; Shen, Jie

• Bioequivalence Approaches Utilized in Generic Drug Applications for Topical Drug Products Applied to the Skin

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

• Comparing the Performance of Metronidazole Topical Gels with Variant Concentrations of Polyethylene Glycol (PEG) 400 in the Formulation

  Rangappa, S; Phan, K; AL-Smadi, K; Zhu, J; Jiang, Y; Ghosh, P; Ramezanli, T; Raney, SG; Roberts, M; Mohammed, Y; Narasimha Murthy, S

• Assessment of In Vitro Skin Permeation of Ruxolitinib of OPZELURA (Ruxolitinib Phosphate) Topical Cream, EQ 1.5% Base to Support a Demonstration of Bioequivalence

  Kamal, Nahid; Ali, Muhammad; Sultana, Tasmin Ara; Srinivasan, Priyanka; Russo, Jackson; Jiang, Ying; Ghosh, Priyanka; Ashraf, Muhammad; Zidan, Ahmed

• Irritation and Sensitization Potential of Approved Topical and Transdermal Delivery Systems ��� A Retrospective Study

  Russo, Jackson; Jiang, Ying; Ghosh, Priyanka; Luke, Markham C

• Current Bioequivalence Approaches Utilized in Generic Drug Applications for Topical Drug Products Applied to the Skin

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