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(452)
• Posters(198)
• Presentations(229)
• Papers(25)

• Application of PBPK Modelling to Optimize IVPT Study Design and Predict the Impact of Formulation Changes on Skin Permeation

  Zhang, Y; Murthy, N; Rangappa, S; Paterson, D; Polak, S; Dancik, Y; Tsakalozou, E; Ghosh, P; Clarke, J

• Raman-Assessed Microstructure, Dermatopharmacokinetics & Bioequivalence of Doxepin Topical Products

  Zarmpi, Panagiota; Tsikritsis, Dimitrios; Belsey, Natalie A; Rantou, Elena; Ghosh, Priyanka; Bunge, Annette L; Delgado-Charro, M Begona; Guy, Richard H

• Impact of Topical Product Metamorphosis on Absorption of Metronidazole

  Sharkawy, A; Jamaledin, R; Williams, A C; Bunge, A L; Guy, R H; Pettarin, M; Spires, J; Ghosh, P; Tsakalozou, E; Delgado-Charro, M B

• Mechanistic Physiologically-Based Pharmacokinetic Modelling of Skin Permeation of Propylene Glycol from Clobetasol Propionate Cream Formulations with variable Propylene Glycol Content

  Maciel Tabosa, A; Dancik, Y; Thakur, K; Zhang, Y; Rangappa, S; Murthy, N; Tsakalozou, E; Ghosh, P; Polak, S; Clarke, J

• Dermal Drug Distribution in Normal and Psoriatic Skin Assessed in Silico via PBPK Modeling and Simulations

  Novakovic, J; van Osdol, WW; Spires, J; Le Merdy, M; Tsakalozou; E; Ghosh, P; Lukacova V

• Evaluation of Critical Microstructural and Performance Attributes of Azelaic Acid Topical Gels

  Ashraf-Uz-Zaman, Md; Ako-Adounvo, Ann-Marie; Kelchen, Megan; Ghosh, Priyanka; Ashraf, Muhammad; Zidan, Ahmed

• A Clinical Dermal Open Flow Microperfusion (dOFM) Study to Assess Bioequivalence (BE) of Different Topically Applied Diclofenac Products

  Tiffner, Katrin; Ramezanli, Tannaz; Birngruber, Thomas; Bodenlenz, Manfred; Lackner, Bettina; Raml, Reingard; Raney, Sam G.; Sinner, Frank

• Advances in Product Quality and Performance Tests for Topical and Transdermal Products: View of the USP Expert Panel

  Raney, Sam; Senemar, Sharareh; Burke, Matt; Lee, Christina; Shah, Jaimin; Li, Kevin; Anand, O; Warner, Kevin

• Quantitative Volumetric Photoacoustic Assessment of Vasoconstriction by Topical Corticosteroid Application in Mice Skin

  Kim, Donggyu; Ahn, Joongho; Kim, Donghyun; Kim, Jin Young; Yoo, Seungah; Lee, Ji Hyun; Ghosh, Priyanka; Luke, Markham C; Kim, Chulhong

• Understanding the Impact of Formulation Design on Microstructure and Drug Release from Porous Microparticle-Based Tretinoin Topical Gels

  Elfakhri, K H; Niu, Mengmeng; Ghosh, Priyanka; Ramezanli, Tannaz; Raney, Sam G; Kamal, Nahid; Ashraf, Muhammad; Zidan, Ahmed