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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Quantitative Analysis to Discriminate Cutaneous Pharmacokinetic Profiles for Topical Drug Products
Shukla, Sagar; Ramezanli, Tannaz; Rantou, Elena; Tiffner, Katrin; Birngruber, Thomas; Sinner, Frank; Raney, Sam G.
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In-Silico and Experimental Investigation of the Thermodynamic Change of Topical Formulations due to Evaporation and the Impact on Skin Permeation
Silva, Samadhi R; Mohammad, Yousuf; Roberts, Michael; Ramezanli, Tannaz; Lian, Guoping; Chen, Tao
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Quantitative Discrimination of Cutaneous Pharmacokinetic Profiles for Topical Drug Products
Shukla, Sagar; Ramezanli, Tannaz; Rantou, Eleni; Tiffner, Katrin; Birngruber, Thomas; Sinner, Frank; Raney, Sam G
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Impact of Operator Variability on the Reproducibility of Tape Stripping Results
Shukla, Sagar; Thomas, Sherin; Hammell, Dana; Bunge, Annette; Hassan, Hazem; Stinchcomb, Audra
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Assessment of Local and Systemic Bioavailability of Lidocaine from Two Lidocaine Topical Delivery Systems using Pharmacokinetic and Skin (Tape) Stripping Analyses
Shukla, Sagar; Thomas, Sherin; Hammell, Dana; Bunge, Annette; Hassan, Hazem; Stinchcomb, Audra
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Assessment of Bioavailabilty of Diclofenac from Two Topical Drug Products using Pharmacokinetic and Skin (Tape) Stripping Analyses
Shukla, Sagar; Thomas, Sherin; Yu, Mingming; Shin, Soohyeon; Hammell, Dana; Bunge, Annette; Hassan, Hazem; Stinchcomb, Audra
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In Vivo Evaluation of Lidocaine Bioavailability from Two Topical Patch Products by Pharmacokinetic and Skin (Tape) Stripping Analyses
Shukla, Sagar; Thomas, Sherin; Hammell, Dana; Bunge, Annette; Hassan, Hazem; Stinchcomb, Audra
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In Vivo Evaluation of Lidocaine Bioavailability from Two Topical Patch Products by Pharmacokinetic and Skin (Tape) Stripping Analyses
Shukla, Sagar; Thomas, Sherin; Hammell, Dana; Bunge, Annette; Hassan, Hazem; Stinchcomb, Audra
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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, Sam; 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, Sam; Newman, Bryan; Ghosh, Priyanka; Bunge, Annette; Stinchcomb, Audra