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)

• Assessment of In Vitro Skin Permeation of Ruxolitinib of OPZELURA (Ruxolitinib Phosphate) Topical Cream, EQ 1.5% Base to Support a Demonstration of Bioequivalence

  Kamal, Nahid; Ali, Muhammad; Sultana, Tasmin Ara; Srinivasan, Priyanka; Russo, Jackson; Jiang, Ying; Ghosh, Priyanka; Ashraf, Muhammad; Zidan, Ahmed

• Irritation and Sensitization Potential of Approved Topical and Transdermal Delivery Systems – A Retrospective Study

  Russo, Jackson; Jiang, Ying; Ghosh, Priyanka; Luke, Markham C

• Current Bioequivalence Approaches Utilized in Generic Drug Applications for Topical Drug Products Applied to the Skin

  Xie, Lingxiao; Kelchen, Megan; Luke, Markham; Ghosh, Priyanka

• Bioequivalence Recommendations for Tretinoin-Containing Topical Products

  Niu, Mengmeng; Luke, Markham C; Ghosh, Priyanka

• Development of an In Vitro Release Test Method for Miconazole Nitrate (MN) Vaginal Suppositories

  Chauhan, Anjali; Xie, Lingxiao; Kelchen, Megan; Ghosh, Priyanka; Raney, Sam G.; Shen, Jie

• Topical Product Metamorphosis: Impact on Metronidazole In Vitro Skin Permeation Post-Application of Binary Mixture Formulations

  Sharkawy, Asma; Williams, Adrian; Bunge, Annette; Guy, Richard; Ghosh, Priyanka; Van Osdol, William; Novakovic, Jasmina; Pettarin, Maximo; Spires, Jessica; Le Merdy, Maxime; Tsakalozou, Eleftheria; Delgado-Charro, M B

• Dermal PBPK Model for Psoriatic Skin: Clobetasol Propionate Case Study

  Novakovic, Jasmina; Van Osdol, WW; Spires, J; Le Merdy, M; Tsakalozou, E; Ghosh, P; Lukacova, Viera

• Assessing the Influence of Quantitative Differences in Propylene Glycol on the Performance of Metronidazole Topical Gels

  Rangappa, S; Phan, K; AL-Smadi, K; Zhu, J; Jiang, Y; Ghosh, P; Ramezanli, T; Raney, S G; Roberts, M; Mohammed, Y; Narasimha Murthy, S

• A Clinical Dermal Open Flow Microperfusion Study to Assess Bioequivalence of Topically Applied Diclofenac Products Using Cutaneous Pharmacokinetic Endpoints

  Tiffner, K; Ramezanli, Tannaz; Birngruber, T; Bodenlenz, Manfred; Teles, Felipe; Schwagerle, G; Raml, Reingard; Kainz, S; Raney, Sam G.; Sinner, F

• Stimulated Raman Scattering (SRS) Microscopy and Deep Learning: Novel Pharmacokinetic Approach for Evaluation of Topical Bioequivalence

  Iliopoulos, Fotis; Pence, I; Ghosh, Priyanka; Raney, Sam G.; Luke, Markham; Evans, Edith