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)

• Heat Effects and IVIVC in Transdermal and Topical Drug Delivery

  Stinchcomb, Audra

• Bioavailability And Bioequivalence Of Products Applied To The Skin

  Stinchcomb, Audra

• IVIVC In Transdermal Drug Delivery: Streamlining The Drug Approval Process

  Stinchcomb, Audra

• Evaluating Topical Bioavailability In Vivo by Skin Stripping and In Vitro by IVPT

  Stinchcomb, Audra

• Challenges In The Development Of Bioequivalent Topically Applied Drug Products

  Stinchcomb, Audra

• In Vivo Evaluation of Lidocaine Bioavailability from Two Topical Patch Products by Pharmacokinetic and Skin (Tape) Stripping Analyses

  Shukla, Sagar

• Evaluation of Level A In Vitro In Vivo Correlations (IVIVC) for Nicotine and Fentanyl Transdermal Delivery Systems (TDS) with Transient Heat Exposure by Using Multiple Approaches

  Shin, Soo Hyeon

• In Vitro and In Vivo Evaluation of Three Fentanyl Transdermal Delivery Systems In Conjunction With Transient Heat Exposure

  Shin, Soo Hyeon

• Statistical Issues with Aberrant IVRT/IVPT Data- FDA Perspective

  Rantou, Elena

• Physicochemical, Structural, and Performance Characterization of Topical Semisolid Products

  Raney, Sam