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

• Streamlining Recommendations for Topical Products Applied to the Skin and Mucosa

  Kelchen, Megan

• Science-Based Advancements in Assessing Performance of Topical Generic Products

  Ramezanli, Tannaz

• Designing IVPT Methods: Practical Insights for Integrating the IVPT GuDesigning IVPT Methods: Practical Insights for Integrating the IVPT Guidance recommendationsdance recommendations

  Zidan, Ahmed

• Formulations in Flux: Simulating the Effect of Dynamic Formulation Composition Changes Following Application of Complex Topical Drug Products

  Clarke, James

• FDA-CRCG Workshop on Implementing FDA’s IVPT Guidance Recommendations: A Step-By-Step Illustration

  Ramezanli, Tannaz