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)

• 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

• 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

• 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

• 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

• Designing an In Vitro Study to Understand Release of API from the Dispersed Phase of Clobetasol Creams ��� Verification of the Mechanistic Emulsion Model in the MPML MechDermA

  Clarke, James; Murthy, Narasimha; Zhang, Yanling; Paterson, Daniel; Dancik, Yuri; Djehizian, Alexandre; Tsakalozou, Eleftheria; Ghosh, Priyanka; Alam, Khondoker; Polak, Sebastian

• How Comparative Clinical Endpoint Bioequivalence Studies Facilitate the Development of Generic Topical Drug Products

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

• Development of an In Silico Model of Topical Acyclovir to Explore Formulation Design

  Spires, Jessica; Osdol, William Van; Lukacova, Viera