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(415)
• Posters(179)
• Presentations(216)
• Papers(20)

• 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

• 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

• Evaluation of In Vitro Skin Permeation of Clascoterone from Clascoterone Topical Cream, 1% (w/w)

  Yang, Yang; Wang, Jiang; Wanasathop, Apipa; Niu, Mengmeng; Ghosh, Priyanka; Zidan, Ahmed; Gu, Jianghong; Hunt, Robert; Faustino, Patrick; Ashraf, Muhammad; Xu, Xiaoming

• 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

• Effect of “In Use” Administration on Topical Product Metamorphosis and Skin Permeation of Acyclovir Creams: Implications for Bioequivalence

  Namjoshi, Sarika; Telaprolu, K C; Grice, Jeffrey; Benson, H.A.E; Raney, S G; Roberts, Michael S; Mohammed, Yousuf H

• Cutaneous Pharmacokinetics-based Bioequivalence: A Clinical Dermal Open Flow Microperfusion Verification Study using Lidocaine and Prilocaine Combination Topical Products

  Tiffner, Katrin; Ramezanli, Tannaz; Boulgaropoulos, Beate; Birngruber, Thomas; Bodenlenz, M; Lackner, Bettina C; Raml, Reingard; Jiang, Ying; Raney, Sam; Sinner, Frank

• Locally Acting Dermatology Drug Products: Pharmaco-analytic Considerations for Bioequivalence

  Luke, Markham

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

  Kim, Donggyu; Ahn, Joongho; Kim, Donghyun; Kim, J V; Yoo, Seungah; Lee, Ji Hyun; Ghosh, Priyanka; Luke, Markham; Kim, Chulhong

• Reverse Iontophoresis: Noninvasive Assessment of Topical Drug Bioavailability

  Moore, Kieran; Gregorie, Sebastien; Eilstein, Joan; Begona Delgado-Charro, M; Guy, R H

• Impact of Different Packaging Configurations on a Topical Cream Product

  Mohammed, Yousuf; Namjoshi, Sarika; Telaprolu, Krishna; Jung, N; Shewan, HM; Stokes, JR; Benson, HAE; Grice, Jeffery E; Raney, Sam G; Rantou, Eleni; Windbergs, Maike; Roberts, Michael S