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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Evaluation Of Two Lidocaine Topical Patch 5% Products By Cutaneous Pharmacokinetic Methods: In Vitro Tape Stripping And In Vitro Permeation Testing
Shukla, Sagar; Raney, Sameersingh; Ghosh, Priyanka; Hassan, Hazem; Bunge, Annette; Stinchcomb, Audra
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Evaluation Of Flector And Lidoderm Topical Formulations By Dermal Pharmacokinetic Methods: In Vitro Tape Stripping And In Vitro Permeation Testing (Ivpt)
Shukla, Sagar; Hassan, Hazem; Raney, Sameersingh; Newman, Bryan; Ghosh, Priyanka; Bunge, Annette; Stinchcomb, Audra
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Assessing Bioavailability And Estimating Bioequivalence Of Acyclovir Creams By In Vitro Permeation Tests With Excised Human Skin
Shin, Soohyeon; Raney, Sameersingh; Rantou, Elena; Newman, Bryan; Ghosh, Priyanka; Hassan, Hazem; Stinchcomb, Audra
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Low Volume And High Shear Rheology On A Conventional Rheometer: A Tool For Characterising Pharmaceutical Skin Creams
Shewan, Heather; Boehm, Michael; Suvanmani, Vilaiwan; Mohammed, Yousuf; Namjoshi, Sarika; Raney, Sameersingh; Roberts, Michael; Stokes, Jason
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The Systematic Influence of Changes in Manufacturing Process Variables on the Microstructure and Performance of Topical Emulsions
Sharma, Purnendukumar; Srinatha, Anegundha; Raney, Sameersingh; Ghosh, Priyanka; Hashemnejad, Seyed-Meysam; Kundu, Santanu; Repka, Michael; Murthy, Narasimha
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Determination Of Ph For An Oil-In-Water Based Semisolid Cream: Method Development And Standardization
Sharma, Purnendukumar; Srinatha, Anegundha; Angamuthu, Muralikrishnan; Raney, Sameersingh; Ghosh, Priyanka; Repka, Michael; Murthy, Narasimha
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Investigation of the Relationship Between Product-Dose and Dermal Exposure of Lidocaine and Prilocaine from a Topical Cream Product Using Dermal Microdialysis
Senemar, Sharareh; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sam; Kuzma, Benjamin; Stagni, Grazia
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Dermal Clearance, Elimination Half-life, and Apparent Volume of Distribution of Lidocaine And Prilocaine Are Independent of the Dose Delivered Directly in Dermis Using a Dermal Infusion Technique
Senemar, S; Kuzma, B A; Ramezanli, T; Ghosh, P; Raney, S G; Stagni, G
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A Cross-Species Retrospective Percutaneous IVIVR for Topical Dermatological Products Containing Metronidazole
Senemar, Sharareh; Kuzma, Benjamin; Stagni, Grazia
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Comparison of Metronidazole Dermal Pharmacokinetics Between Mini-pig and Rabbit
Senemar, Sharareh; Kuzma, Benjamin; Stagni, Grazia