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(374)
• Posters(145)
• Presentations(185)
• Papers(44)

• Estimating Maximal In Vitro Skin Permeation Flux from Studies Using Non-Sink Receptor Phase Conditions

  Yousef, Shereen; Liu, Xin; Mostafa, Ahmed; Mohammed, Yousuf; Grice, Jeffrey; Anissimov, Yuri; Sakran, Wedad; Roberts, Michael

• Topical Drug Delivery: History, Percutaneous Absorption, and Product Development

  Roberts, Michael; Cheruvu, Manumanth; Mangion, Sean; Alinaghi, Azadeh; Benson, Heather; Mohammed, Yousef; Holmes, Amy; Van Der Hoek, John; Pastore, Michael; Grice, Jeffrey

• Mechanistic Modeling of In Vitro Skin Permeation and Extrapolation to In Vivo for Topically Applied Metronidazole Drug Products Using a Physiologically Based Pharmacokinetic Model

  Arora, Sumit; Clarke, James; Tsakalozou, Eleftheria; Ghosh, Priyanka; Alam, Khondoker; Grice, Jeffery E; Roberts, Michael S; Jamei, Masoud; Polak, Sebastian

• Mechanistic Evaluation of Hydration Effects on the Human Epidermal Permeation of Salicylate Esters

  Yousef, Shereen; Mohammed, Yousuf; Namjoshi, Sarika; Grice, Jeffrey; Sakran, Wedad; Roberts, Michael

• Physiologically-based pharmacokinetic modeling to support determination of bioequivalence for dermatological drug products: scientific and regulatory considerations

  Tsakalozou, Eleftheria; Alam, Khondoker; Babiskin, Andrew; Zhao, Liang

• Mechanistic Modeling of Drug Products Applied to the Skin: A Workshop Summary Report

  Tsakalozou, Eleftheria; Alam, Khondoker; Ghosh, Priyanka; Spires, Jessica; Polak, Sebasitan; Fang, Lanyan; Sammeta, Srinivasa; Zhao, Ping; Arora, Sumit; Raney, Sam G

• Stratum Corneum Sampling to Assess Bioequivalence between Topical Acyclovir Products

  Pensado Lopez, Andrea; Chiu, Wingsin; Cordery, Sarah; Rantou, Elena; Bunge, Annette; Delgado Charro, Maria; Guy, Richard

• The Tritiated Water Skin Barrier Integrity Test: Considerations for Acceptance Criteria with and without 14C-Octanol

  Lehman, Paul; Beatch, Kacie; Raney, Sam; Franz, Thomas

• Visualizing topical drug uptake with conventional fluorescence microscopy and deep learning

  Evans, Conor; Hermsmeier, Maiko; Yamamoto, Akira; Chan, Kin

• Variability of Skin Pharmacokinetic Data: Insights from a Topical Bioequivalence Study Using Dermal Open Flow Microperfusion

  Bodenlenz, Manfred; Augustin, Thomas; Birngruber, Thomas; Tiffner, Katrin; Boulgaropoulos, Beate; Schwingenschuh, Simon; Raney, Sam; Rantou, Elena; Sinner, Frank