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)

• Mechanistic Modelling of Lidocaine and Prilocaine Absorption from EMLA Cream upon Topical Application using Physiologically Based Pharmacokinetic Modelling

  Telaprolu, Krishna C; Tsakalozou, Eleftheria; Ghosh, Priyanka; Alam, Khondoker; Grice, Jeffrey E; Roberts, Michael S; Jamei, Masoud; Polak, Sebastian; Clarke, James F

• Development and Validation of an In Vitro Release Test (IVRT) Method for a Locally Acting Mesalamine Suppository

  Xie, Lingxiao; Kelchen, Megan; Ghosh, Priyanka; Raney, Sam G; Shen, Jie

• Improved Dual-Modality Bioequivalence Evaluation of Topical Formulations Within Human Skin Using Stimulated Raman Scattering Microscopy

  Tu, Dandan; Lemberger, Nick-Sidney; Wallmeier, Kristin; Riseman, Jackson; Kuzma, Benjamin; Wei, Yuxiao; Khoo, Ting Chean; Ghosh, Priyanka; Luke, Markham; Raney, Sam; Fallnich, Carsten; Evans, Conor

• Raman Spectroscopy as a Tool to Accelerate Development of Complex Medicinal Products

  Zarmpi, Panagiota; Tsikritsis, Dimitrios; Watson, Andrew C; Vorng, Jean-Luc; Tyagi, Vasundhara; Belsey, Natalie A; Rantou, Elena; Ghosh, Priyanka; Bunge, Annette L; Woodman, Timothy J; Delgado-Charro, M Begona; Guy, Richard H

• Impact of Mechanistic Modeling and Simulation Methodologies on Product Specific Guidance Development for Non-Orally Administered Drug Products

  Chopski, Steven; Walenga, Ross; Tan, Ming-Liang; Alam, Khondoker; Babiskin, Andrew; Fang, Lanyan; Tsakalozou, Eleftheria

• 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

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

  Luke, Markham

• 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