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.
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Development of In Vitro Release Testing and In Vitro Permeation Testing Methods to Study the Impact of Quantitative Differences in Carbomer on the Performance of Diclofenac Sodium Topical Gels
Rath, Seeprarani; Niu, Mengmeng; Ghosh, Priyanka; Michniak-Kohn, Bozena
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Investigating the Impact of Variation in Carbomer Homopolymer Type C (Carbopol® 980) Concentration on Diclofenac Sodium Gels’ Microstructure and Skin Permeation
Dey, Anuradha; Viswaroopan, Nethra; Karve, Tanvi; Shrestha, Nisha; Miu, Mengmeng; Ghosh, Priyanka; Banga, Ajay K
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Quantitative Differences in Carbomer Homopolymer Type B and Its Effect on the Structural and Permeation Characteristics of Diclofenac Sodium Topical Gels
Viswaroopan, Nethra; Dey, Anuradha; Ghosh, Meheli; Radmard, Ariana; Niu, Mengmeng; Ghosh, Priyanka; Banga, Ajay K
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Modeling Metamorphosis: Advancing Dermal PBPK Modeling – A Metronidazole Case Study
Pettarin, Maximo; Spires, Jessica; Lukacova, Viera; Sharkawy, Asma; Williams, Adrian; Bunge, Annette L; Guy, Richard H; Ghosh, Priyanka; Tsakalozou, Eleftheria; Delgado-Charro, M Begona
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Systematic Evaluation of Topical Dosage Form Types and Approved Indications for Dermatologic Use
Jiang, Ying; Ghosh, Priyanka; Luke, Markham C
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Impact of Quantitative Differences in Carbomer on Drug Release from Diclofenac Sodium Topical Gels
Rath, Seeprarani; Abdulhafid, Khadija; Niu, Mengmeng; Ghosh, Priyanka; Michniak-Kohn, Bozena
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Topical Creams Sensorial Perception: Correlation with Product Critical Quality Attributes
Phan, Khanh; Leite-Silva, Vania R; Prakash, Sangeeta; Liu, David; Ramezanli, Tannaz; Ghosh, Priyanka; Natarajan, Karthika; Jiang, Ying; Raney, Sam G; Luke, Markham C; Roberts, Michael; Mohammed, Yousuf
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Impact of Formulation Differences on Performance of Topical Gels
Ramezanli, T; Rangappa, S; Phan, K; Jiang, Y; Raney, Sam G.; Mohammed, Y; Murthy Narasimha, S; Luke, Markham C; Ghosh, Priyanka
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Optimization of Manufacturing Method for Development of Crystal-Free Diclofenac Topical Gels
Rath, Seeprarani; Abdulhafid, Khadija; Michniak-Kohn, Bozena
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Impact of Quantitative Differences in Carbomer on Drug Release from Diclofenac Sodium Topical Gels
Rath, Seeprarani; Abdulhafid, Khadija; Niu, Mengmeng; Ghosh, Priyanka; Michniak-Kohn, Bozena