GDUFA Research Outcomes

Transdermal Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the transdermal route, including transdermal delivery systems.

• All(111)
• Posters(33)
• Presentations(58)
• Papers(20)

• Bioequivalence of Generic Topical Dermatological Drug Products

  Ghosh, Priyanka; Luke, Markham; Tsakalozou, Eleftheria; Simamora, Pahala

• Non-Invasive Raman Spectroscopy-Based Bioequivalence Approaches

  Ghosh, Priyanka

• Innovation and Harmonization of Bioequivalence Standards for Generic Topical and Transdermal Products

  Ghosh, Priyanka

• Bioequivalence Fundamentals for Generic Topical Dermatological Drug Products

  Ghosh, Priyanka

• FDA Initiatives to Stimulate Innovation and Imporve Patient Access to Generic Topical & Transdermal Products Part lI

  Ghosh, Priyanka

• CGDPs with Drug and Device Consituents: Transdermal Delivery Systems (TDS)

  Ghosh, Priyanka

• In Vitro Data Analysis Issues: IVPT Analyses and Other Challenges

  Ghosh, Priyanka

• Overview of Complex Generic Inhalation, Nasal and Auto-Injector Drug-Device Combination Products

  Conti, Denise

• Evaluation Of Heat Effects On Transdermal Delivery Systems Using An In Vitro Permeation Test (Ivpt) Strategy

  Zhang, Q; Murawsky, M K; Lacount, T; Hao, J; Raney, S G; Ghosh, P; Kasting, G; Li, S

• A Fully Validated LC MS/MS Method For Simultaneous Determination Of Oxybutynin And Its Metabolite N-desethyloxybutynin In Human Serum

  Yu, Mingming; Thomas, Sherin; Hammell, Dana; Hassan, Hazem; Stinchcomb, Audra