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.
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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, Sameersingh; Roberts, Michael
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Simulated “In Use” Conditions To Assess Semisolid Topical Products
Mohammed, Yousuf; Namjoshi, Sarika; Grice, Jeffrey; Jung, Nathalie; Windbergs, Maike; Raney, Sameersingh; Roberts, Michael
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The pH Of Topical Creams Can Change Rapidly Following Application On The Skin In Vivo
Maurya, Abhijeet; Srinatha, Anegundha; Raney, Sameersingh; Ghosh, Priyanka; Repka, Michael; Murthy, Narasimha
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Mechanistic Physiologically-Based Pharmacokinetic Modelling for Prediction of Dermal Absorption in Psoriatic Patients
Martins, Frederico; Patel, Nikunjkumar; Jamei, Masoud; Polak, Sebastian
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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
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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
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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
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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
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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, Sameersingh; Stagni, Grazia
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Estimation of In Vivo Skin Permeation (Flux) and Cumulative Amount Input of Metronidazole Formulations in Mini-Pigs’ Dermis
Kuzma, Benjamin; Senemar, Sharareh; Stagni, Grazia