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)

• Are Topical Products Dispensed from Different Packaging Q3 Equivalent and Bioequivalent?

  Mohammed, Yousuf; Namjoshi, Sarika; Jung, Nathalie; Shewan, Heather; Stokes, Jason; Benson, Heather; Grice, Jeffrey; Windbergs, Maike; Raney, Sam; Roberts, Michael

• Water Content and Product Drying Rate as Well as the Amount of Propylene Glycol May Impact the Topical Bioavailability of Acyclovir from Cream Products

  Mohammed, Yousuf; Namjoshi, Sarika; Benson, Heather; Grice, Jeffrey; Raney, Sam; Roberts, Michael

• Simulated “In Use” Conditions To Assess Semisolid Topical Products

  Mohammed, Yousuf; Namjoshi, Sarika; Grice, Jeffrey; Jung, Nathalie; Windbergs, Maike; Raney, Sam; Roberts, Michael

• The pH Of Topical Creams Can Change Rapidly Following Application On The Skin In Vivo

  Maurya, Abhijeet; Srinatha, Anegundha; Raney, Sam; Ghosh, Priyanka; Repka, Michael; Murthy, Narasimha

• Mechanistic Physiologically-Based Pharmacokinetic Modelling for Prediction of Dermal Absorption in Psoriatic Patients

  Martins, Frederico; Patel, Nikunjkumar; Jamei, Masoud; Polak, Sebastian

• Multi-phase Multi-layer MechDermA model: Development, Verification and Application of a PBPK-PD Model of Dermal Absorption for Transdermal Product Assessment

  Martins, Frederico; Patel, Nikunjkumar; Salem, Farzaneh; Jamei, Masoud; Polak, Sebastian

• Multi-phase Multi-layer MechDermA model: Development, Verification and Application of a PBPK-PD Model of Dermal Absorption for Transdermal Product Assessment

  Polak, Sebastian; Patel, Nikunjkumar; Martins, Frederico; Salem, Farzaneh; Jamei, Masoud; Rostami-Hodjegan, Amin

• Development And Validation Of Dermal Pbpk Model Towards Virtual Bioequivalence Assessment: Prediction Of Dermal Drug Absorption Of Various Ibuprofen Formulations Using Simcyp MechdermA model

  Martins, Frederico; Patel, Nikunjkumar; Cristea, Sinziana; Polak, Sebastian

• Raman Spectroscopic Assessment of Topical Drug Bioavailability in the Skin

  Maciel Tabosa, M M; Vitry, P; Belsey, N A; Tsikritsis, D; Woodman, T J; Woodman, T J; bBunge, A L; Charro, Delgado; Guy, R H

• Estimation of In Vivo Percutaneous Permeation (Flux) and Cumulative Amount Input of Metronidazole Formulations in Mini-Pigs’ Dermis

  Kuzma, Benjamin; Senemar, Sharareh; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sam; Stagni, Grazia