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(415)
• Posters(179)
• Presentations(216)
• Papers(20)

• Rheological Characterization of Topical Pharmaceutical Foam Products

  Varadarajan, A; Ajjarapu, S; Rangappa, S; Ghosh, Priyanka; Raney, Sam; Maibach, H; Repka, M A; Narasimha Murthy, S; Kundu, S

• Simulating the Dermal Permeation of Clobetasol-17 Propionate from a Topical Formulation

  Van Osdol, W; Dong, J; Spires, J

• Development and Application of a Dermal PBPK Modeling for Ethinyl Estradiol-Containing Transdermal Delivery Systems to Predict Exposure for Different Application Sites

  Tsakalozou, Eleftheria; Alam, Khondoker; Babiskin, Andrew; Fang, Lanyan (Lucy); Zhao, Liang

• PBPK Modeling of Percutaneous Pharmacokinetics for Tazarotene and Tretinoin Creams: Applicability and Challenges

  Tsakalozou, Eleftheria; Alam, Khondoker; Babiskin, Andrew; Zhao, Liang

• Development of a Dermal PBPK Modeling for an Ethinyl Estradiol-Containing Transdermal Delivery System

  Tsakalozou, Eleftheria; Alam, Khondoker; Babiskin, Andrew; Fang, Lanyan; Zhao, Liang

• Clinical Study to Assess the Cutaneous Bioequivalence of Topically Applied Lidocaine and Prilocaine Products Using Dermal Open Flow Microperfusion

  Tiffner, Katrin; Ramezanli, Tannaz; Birngruber, Thomas; Bodenlenz, Manfred; Lackner, Bettina; Raml, Reingard; Raney, Sam G; Sinner, Frank

• A Clinical Study to Assess the Bioequivalence of Lidocaine and Prilocaine Topical Drug Products Using Dermal Open Flow Microperfusion

  Tiffner, Katrin; Ramezanli, Tannaz; Birngruber, Thomas; Bodenlenz, Manfred; Lackner, Bettina; Raml, Reingard; Schwagerle, Gerd; Kainz, Sonja; Gander, Edgar; Raney, Sam; Sinner, Frank

• A Clinical Study Design to Evaluate Whether the Systemic Bioavailability of Topical Drugs May Influence the Assessment of Local Dermal Pharmacokinetics by Dermal Open Flow Microperfusion (dOFM)

  Tiffner, Katrin; Birngruber, Thomas; Schwagerle, Gerd; Ramezanli, Tannaz; Bodenlenz, Manfred; Lackner, B; Augustin, Thomas; Raml, Reingard; Kanfer, Isadore; Raney, Sam; Sinner, Frank

• Dermal Pharmacokinetic Endpoint Studies to Evaluate Bioequivalence of Topically Applied Lidocaine and Prilocaine Drug Products

  Tiffner, Katrin; Birngruber, Thomas; Schwagerle, Gerd; Bodenlenz, Manfred; Augustin, Thomas; Raml, Reingard; Kanfer, Isadore; Sinner, Frank

• In Vitro Release Test (IVRT) Comparisons of Six Acyclovir Cream, 5% Products to Evaluate the Impact of Compositional Differences on Product Performance

  Tiffner, Katrin; Kanfer, Isadore; Augustin, Thomas; Raml, Reingard; Raney, Sam; Sinner, Frank