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)

• Evaluating the Bioequivalence of Topical Dermatological Drug Products Containing Metronidazole Using Dermal Microdialysis: Preliminary Studies in Rabbits

  Senemar, Sharareh; Kuzma, Benjamin; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sameersingh; Stagni, G

• Influence of Varying Amount of an Inactive Ingredient on the Microstructure and Performance of Metronidazole Topical Gels

  Rangappa, Srinath; Ghosh, Priyanka; Jiang, Ying; Raney, Sam G; Murthy, S Narasimha

• Comparative Evaluation of the Permeation of Metronidazole Using Static Diffusion Cells and Flow-Through Diffusion Cells

  Rangappa, S; Ajjarapu, S; Ghosh, Priyanka; Kelchen, Megan; Raney, Sam; Repka, M; Maibach, H; Narasimha Murthy, S

• Critical Quality Attributes of Topical Clobetasol Propionate Foams

  Rangappa, S; Ajjarapu, S; Ghosh, Priyanka; Kelchen, Megan; Raney, Sam; Repka, M; Maibach, H; Narasimha Murthy, S

• Critical Quality Attributes of Topical Pharmaceutical Foams

  Rangappa, Srinath; Ajjarapu, Srinivas; Ghosh, Priyanka; Kelchen, Megan; Raney, Sameersingh; Repka, Michael; Maibach, Howard; Murthy, Narasimha

• Influence of Relative Humidity on Time to Break Analysis of Pharmaceutical Foams

  Rangappa, Srinath; Ajjarapu, Srinivas; Ghosh, Priyanka; Kelchen, Megan; Raney, Sameersingh; Repka, Michael; Maibach, Howard; Murthy, Narasimha

• Comparative Assessment of the Physical and Structural Similarity of Topical Drug Products Containing Lidocaine and Prilocaine

  Rangappa, Srinath; Ajjarapu, Srinivas; Varadarajan, Anandavalli; Prado, Rosa-Maria-Badani; Ghosh, Priyanka; Raney, Sameersingh; Kundu, Santanu; Repka, Michael; Murthy, Narasimha

• Evaluation of Bioavailability of Lidocaine and Prilocaine from Topical Drug Products Using an In Vitro Permeation Test (IVPT)

  Rangappa, Srinath; Ajjarapu, Srinivas; Ghosh, Priyanka; Rantou, Elena; Raney, Sameersingh; Repka, Michael; Murthy, Narasimha

• Correlation between the Quality Attributes and Performance Characteristics of Metronidazole Gels and Creams: Implications for the Evaluation of Bioequivalence

  Rangappa, Srinath; Ajjarapu, Srinivas; Hashemnejad, Seyed-Meysam; Prado, Rosa-Maria-Badani; Ghosh, Priyanka; Raney, Sameersingh; Kundu, Santanu; Murthy, Narasimha

• Evaluation of Different Dose Application Techniques on the In Vitro Cutaneous Pharmacokinetics of Metronidazole from Topical Gel and Cream Products

  Rangappa, Srinath; Ajjarapu, Srinivas; Ghosh, Priyanka; Raney, Sameersingh; Murthy, Narasimha