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)

• Impact of Formulation and Manufacturing on Drug Delivery from Topical Drug Products Applied to the Skin

  Kelchen, Megan; Xie, Lingxiao; Ramezanli, Tannaz; Jiang, Ying; Luke, Markham; Ghosh, Priyanka

• Mechanistic Evaluation of Microstructure and Performance Attributes of Medicated Topical Shampoos

  Liyanage, Ishanka; Kelchen, Megan; Ramezanli, Tannaz; Ghosh, Priyanka; Ashraf, Muhammad; Zidan, Ahmed

• Enhanced Understanding of Structure Performance Relationship Using Modeling and Simulation- A Case Study with Dapsone Topical Gel

  Tsakalozou, Eleftheria; Ramezanli, Tannaz; Raney, Sam G; Zhao, Liang; Luke, Markham C; Ghosh, Priyanka

• 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