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)

• Theoretical Principles and Best Practices In Vitro Release Testing (IVRT)

  Ramezanli, Tannaz

• SRS Microscopy and Deep Learning: Novel Approach for Evaluation of Topical Bioequivalence

  Iliopoulos, Fotis

• Topical Dermatological Drug Products Complex Generic Drug Products (CGDPs) with a locally-acting route of delivery

  Ramezanli, Tannaz; Simamora, Pahala; Babiskin, Andrew; Luke, Markham

• Use of Q3 Characterization Tests for Topical Semisolid Drug Products

  Raney, Sam

• In Vitro Permeation Test (IVPT) Fundamentals: Scientific and Practical Considerations

  Raney, Sam

• Statistical Considerations in Assessing BE of IVPT Data

  Rantou, Elena

• Precilinical Models for Pulmonary Delivery

  Hochhaus, Guenther

• New developments in the Assessment of Cutaneous Bioavailability and Bioequivalence of Topical Dermatological Drug Products Using Dermal Microdialysis

  Senemar, Sharareh

• Mathematical Models of Skin Penetration

  Heisig, Michael; Nagel, Arne; Wittum, Gabriel

• Parameter Sensitivity Analysis of a Two-Dimensional Skin Diffusion Model

  Heisig, Michael; Nagel, Arne; Wittum, Gabriel