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(452)
• Posters(198)
• Presentations(229)
• Papers(25)

• Challenges In The Development Of Bioequivalent Topically Applied Drug Products

  Stinchcomb, Audra

• Computational Modeling of Absorption from Complex Topical Formulations

  Spires, Jessica

• Use of Skin Pharmacokinetics (PK) & Pharmacodynamics (PD) in Drug Development

  Sinner, Frank

• In-Vivo Skin PK Testing for New and Generic Topical Dermatological Drug Development

  Sinner, Frank

• Clinical Pharmacokinetic Evaluation of Dermal Bioavailability and Bioequivalence

  Sinner, Frank

• In Vivo Dermal Open Flow Microperfusion: A Novel Approach to Evaluating Topical Bioavailability and Bioequivalence

  Sinner, Frank

• Dermal Open Flow Microperfusion (Dofm) For The Bioequivalence Assessment Of Topical Products Based On Skin Pk

  Sinner, Frank

• Innovative Dermal PK and PD: In Vivo Proof-of-Mechanism to Clinical Dermal Bioequivalence using Open Flow Microperfusion

  Sinner, Frank

• Evaluating Topical Bioavailability In Vivo By Dermal Open Flow Microperfusion And Equivalence By Ivrt

  Sinner, Frank

• Tissue Specific Pk And Pd Enabled By Open Flow Microperfusion: From Bioequivalence To Mechanism Of Drug Action Poc Studies

  Sinner, Frank