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)

• How Does the Food and Drug Administration Approve Topical Generic Drugs Applied to the Skin?

  Ghosh, Priyanka; Raney, Sam; Luke, Markham C

• Bioequivalence Methodologies for Topical Drug Products: In Vitro and Ex Vivo Studies with a Corticosteroid and an Anti-Fungal Drug

  Leal, Leila; Cordery, Sarah; Delgado Charro, Begona; Bunge, Annette; Guy, Richard

• Relating Transdermal Delivery Plasma Pharmacokinetics with In Vitro Permeation Test (IVPT) Findings Using Diffusion and Compartment-In-Series Models

  Liu, Xin; Anissimov, Yuri; Grice, Jeffrey; Cheruvu, Hanumanth; Ghosh, Priyanka; Raney, Sam; Maibach, Howard; Roberts, Michael

• Near-Infrared Spectrometry for the Quantification of Dermal Absorption of Econazole Nitrate and 4-Cyanophenol

  Medendorp, Joseph; Yedluri, Jhansi; Hammell, Dana; Ji, Tao; Lodder, Robert; Stinchcomb, Audra

• Diffusion Cell Apparatus: Scientific Principles and Practical Challenges I

  Zidan, Ahmed

• Imaging Formulated Product Performance Using Optical Spectroscopy

  Belsey, Natalie

• Recent Advances on Topical, Transdermal and Nail Drug Delivery

  Charro, M.B.Delgado

• Sampling the Stratum Corneum to Quantify Drug Uptake from Topical Products

  Cordery, SF; Shehab, MZ; Bunge, AL; Delgado-Charro, MB; Guy, RH

• Introduction to Q3

  Yu, Lawrence

• Bioequivalence of Topical Products

  Yu, Lawrence