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)

• Solubility-Physicochemical-Thermodynamic Theory of Penetration Enhancer Mechanism of Action

  Haq, Anika; Chandler, Mark; Michniak-Kohn, Bozena

• Evaluation of In Vitro Performance Attributes of Imvexxy® (Estradiol) Vaginal Insert

  Hamad, Ghaled; Kelchen, Megan; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sam G; Ashraf, Muhammad; Zidan, Ahmed

• A Mechanistic Evaluation of Drug Availability from Imvexxy® (Estradiol) Vaginal Inserts

  Hamad, Ghaled; Bolla, Pradeep; Kelchen, Megan; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sam; Ashraf, Muhammad; Zidan, Ahmed

• Interaction Studies of Tretinoin with Microspheres in Tretinoin Topical Gel

  Hamad, Ghaled; Niu, Mengmeng; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sam; Ashraf, Muhammad; Zidan, Ahmed

• Preparation, Characterization and In Vitro Release Test (IVRT) Study of Tretinoin-Loaded Microspheres in a Topical Gel Product

  Hamad, Ghaled; Niu, Mengmeng; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sameersingh; Ashraf, Muhammad; Zidan, Ahmed

• Evaluation of U.S. FDA Approved Generic Oral Solution Products

  Hakeem, Susan; Huang, Yih-Chain; Jiang, Wenlei

• Tribological Response of Hydroxyethylcellulose Gels as a Function of Isopropyl Alcohol Concentration and Angular Velocity Profile

  Dick, Arianna; Panchal, Bhavesh; Prakash, Sangeet; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sam; Roberts, Michael; Mohammed, Yousuf

• Deciphering the Effects of Microstructure on Lidocaine-Prilocaine Topical Product Performance

  Dabbaghi, M; Mohammed, Y; Namjoshi, S; K, Telaprolu; Rantou, E; Ramezanli, T; Raney, S; Roberts, M; Grice, J

• In Vitro-In Vivo Correlation (Ivivc) Of Diclofenac Bioavailability From Three Topical Drug Products

  Cordery, Sarah; Chiu, Wingsin; Shehab, Zaher; Bunge, Annette; Delgado-Charro, Begona; Guy, Richard

• Feasibility of In Vitro Permeation Testing for Cleocin T® (Clindamycin Phosphate) Topical Lotion to Support a Demonstration of Bioequivalence

  Bolla, Pradeep; Hamad, Ghaled; Jiang, Ying; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sam