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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Simulating the Effect of Propylene Glycol on Acyclovir (Zovirax® Cream, 5%) Permeation Across the Skin Using a Physiologically Based Pharmacokinetic (PBPK) Model of In Vitro Flow-through Skin Permeation
Arora, Sumit; Patel, Nikunjkumar; Polak, Sebastian; Jamei; Roberts, Michael
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Evaluation Of Water Activity (Aw) As A Critical Quality Attribute Of Topical Dosage Forms
Murthy, Narasimha
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In Vitro-In Vivo Relationships (IVIVR) For Transdermal Delivery Of Nicotine From Patches
Alinaghi, Azadeh; Cheruvu, Hanumanth; Liu, Xin; Anissimov, Yuri; Kuswahyuning, Rina; Ghosh, Priyanka; Grice, Jeffrey; Raney, Sam; Roberts, Michael
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Does Vehicle Evaporation Affect Drug Distribution within Different Phases of Topically Applied Emulsion? A Modeling Case Study with Clindamycin Phosphate Lotion
Alam, Khondoker; Tsakalozou, Eleftheria; Babiskin, Andrew; Ghosh, Priyanka; Ramezanli, Tannaz; Jiang, Ying; Niu, Mengmeng; Zhao, Liang
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Development of an In Vitro Release Method for Mechlorethamine Hydrochloride Topical Gel
Ako Adounvo, Ann Marie; Niu, Mengmeng; Ghosh, Priyanka; Ashraf, Muhammad; Zidan, Ahmed
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A Mechanistic Evaluation of How Metamorphosis of a Topical Dosage Form Impacts Permeation
Ajjarapu, S; Rangappa, S; Ghosh, Priyanka; Kelchen, Megan; Raney, Sam; Urena-Benavides, EE; Maibach, H; Narasimha Murthy, S
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A Mechanistic Evaluation of the Impact of Formulation Viscosity and Fractional Solubility on Drug Release and Permeation
Ajjarapu, S; Rangappa, S; Ghosh, Priyanka; Kelchen, Megan; Raney, Sam; Urena-Benavides, EE; Maibach, H; Narasimha Murthy, S
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The Impact of the Metamorphosis of Topical Formulations on Bioavailability
Ajjarapu, S; Rangappa, S; Ghosh, Priyanka; Kelchen, Megan; Raney, Sameersingh; Repka, M A; Maibach, H; Narasimha Murthy, S
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Method Development and Optimization of an In Vitro Permeation Test (IVPT) to Compare the Rate and Extent of Drug Permeation from Topical Drug Products
Ajjarapu, S; Rangappa, S; Raney, S G; Repka, M A; Murthy, S N
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A Novel Strategy for the Efficient Modulation of Topical Drug Delivery to Validate the Sensitivity of an In Vitro Permeation Test (IVPT)
Ajjarapu, S; Rangappa, S; Ghosh, P; Raney, S G; Murthy, S N