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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Skin in the Game: Mechanistic Modeling of Dermal Drug Absorption
Patel, Nikunkkumar
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Development And Validation Of Dermal Pbpk Model Towards Virtual Bioequivalence Assessment
Patel, Nikunkkumar
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Pbpk Modelling of Dermal Drug Absorption and Population Variability Simcyp Mpml Mechderma Model
Patel, Nikunj; Martins, Frederico; Cristea, Sinziana; Salem, Farzaneh; Abduljalil, Khaled; Jamei, Masoud; Polak, Sebastian
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Mechanistic Modelling of Dermal Drug Absorption Using Simcyp Mpml Mechderma Model Rationale behind Model Development, Its Shape And Performance
Patel, Nikunj; Cristea, Sinziana; Salem, Farzaneh; Jamei, Masoud; Polak, Sebastian
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The Role of Microparticles and Other Excipients in the Complexity of Certain Topical Drug Products
Niu, Mengmeng
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Effect of excipients on the in vitro permeation of drugs from topical products
Murthy, Narasimha
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Microstructural Characterization and In Vitro Permeation Testing of Topical Products
Murthy, Narasimha
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Advanced Characterization Approaches for Topical Formulations
Murthy, Narasimha
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Characterizing the Critical Quality Attributes and In Vitro Bioavailability of Acyclovir and Metronidazole Topical Products
Murthy, Narasimha
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Beyond Q1/Q2-Comparing the Arrangement of Matter (Q3) and Performance
Murthy, Narasimha