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)

• Development of Performance Matrix for Generic Product Equivalence of Acyclovir Topical Creams

  Krishnaiah, Yellela; Xu, Xiaoming; Rahman, Ziyaur; Yang, Yang; Katragadda, Usha; Lionberger, Robert; Peters, John; Uhl, Kathleen; Khan, Mansoor

• Multi-Phase Multi-Layer Mechanistic Dermal Absorption (MPML MechDermA) Model to Predict Local and Systemic Exposure of Drug Products Applied on Skin

  Patel, N; Clarke, J F; Salem, F; Abdulla, T; Martins, F; Arora, S; Tsakalozou, E; Hodgkinson, A; Arjmandi-Tash, O; Cristea, S; Gosh, P; Alam, K; Raney, Sam G; Jamei, M; Polak, S

• Quantification of Acyclovir in Dermal Interstitial Fluid and Human Serum by Ultra-High-Performance Liquid Chromatography-High Resolution Tandem Mass Spectrometry for Topical Bioequivalence Evaluation

  Schimek, Denise; Raml, Reingard; Francesconi, Kevin; Bodenlenz, Manfred; Sinner, Frank

• The Role of Tight Junctions in Skin Barrier Function and Dermal Absorption

  Bäsler, Katja; Bergmann, Sophia; Heisig, Michael; Naegel, Arne; Zorn Kruppa, Michaela; Brandner, Johanna

• Modified Regulatory Pathways to Approve Generic Drugs in the Us and a Systematic Review of Their Outcomes

  Kesselheim, Aaron; Polinski, Jennifer; Fulchino, Lisa; Isaman, Danielle; Gagne, Joshua

• The History of Dermatology and Dermatologists at the US Food and Drug Administration

  Luke, Markham

• A New Paradigm for Topical Generic Drug Products: Impact on Therapeutic Access

  Luke, Markham

• Low-Frequency Raman Mapping and Multivariate Image Analysis for Complex Drug Products

  Willett, Daniel; Yilmaz, Huzeyfe; Wokovich, Anna; Rodriguez, Jason

• Mathematical Modelling of the Viable Epidermis: Impact of the Cell Shape and Vertical Arrangement

  Wittum, Rebecca; Naegel, Arne; Heisig, Michael; Wittum, Gabriel

• Percutaneous absorption of steroids from finite doses: Predicting urinary excretion from in vitro skin permeation testing

  Liu, Xin; Cheruvu, Hanumanth; Anissimov, Yuri; Van Der Hoek, John; Tsakalozou, Eleftheria; Ni, Zhanglin; Ghosh, Priyanka; Grice, Jeffrey; Roberts, Michael