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(114)
• Posters(34)
• Presentations(59)
• Papers(21)

• U.S. FDA Recommendation on Bioequivalence Demonstration of Topical Drug Products

  Jiang, Wenlei

• Bioequivalence Evaluation of Narrow Therapeutic Index Drugs – Rationales for the Current Regulatory Approach by U.S. FDA

  Jiang, Wenlei

• Non-Invasive Raman Spectroscopy-Based Bioequivalence Approaches

  Ghosh, Priyanka

• Bioequivalence of Generic Topical Dermatological Drug Products

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

• 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