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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Evaluation of Different Dose Application Techniques on the In Vitro Cutaneous Pharmacokinetics of Metronidazole from Topical Gel and Cream Products
Rangappa, Srinath; Ajjarapu, Srinivas; Ghosh, Priyanka; Raney, Sameersingh; Murthy, Narasimha
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Correlation of Physical and Structural (Q3) Properties of Lidocaine/Prilocaine Topical Products with Product Performance In Vitro and In Vivo
Ramezanli, Tannaz; Jiang, Ying; Dabbaghi, Maryam; Tiffner, Katrin; Mohammed, Yousuf; Namjoshi, Sarika; Birngruber, Thomas; Bodenlenz, Manfred; Raney, Sam; Roberts, Michael; Sinner, Frank
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Correlation of Physico-Structural (Q3) Properties of Lidocaine/Prilocaine Topical Products with Product Performance In Vitro and In Vivo
Ramezanli, Tannaz; Jiang, Ying; Ghosh, Priyanka; Dabbaghi, Maryam; Tiffner, Katrin; Mohammed, Yousuf; Namjoshi, Sarika; Birngruber, Thomas; Bodenlenz, Manfred; Roberts, Michael; Sinner, Frank; Raney, Sam
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Development of the Dermal Absorption Model for the Ketoprofen Local and Systemic Exposure Prediction
Patel, Nikunjkumar
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Predicting Diclofenac Systemic and Synovial Fluid Concentrations after Dermal Application using the Multi-Phase Multi-Layer MechDermA PBPK model
Polak, Sebastian; Patel, Nikunjkumar; Martins, Frederico; Salem, Farzaneh; Jamei, Masoud; Rostami-Hodjegan, Amin
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Towards Mechanistic Simulation And Prediction Of Bioequivalence Studies Of Topical Formulations Case Study With Two Diclofenac Formulations
Polak, Sebastian; Patel, Nikunjkumar; Cristea, Sinziana; Rose, Rachel; Salem, Farzaneh; Abduljalil, Khaled; Johnson, Trevor; Raney, Sameersingh; Zhang, Xinyuan; Lin, Hopi; Newman, Bryan; Chow, Edwin; Ghosh, Priyanka; Fan, Jianghong; Fang, Lanyan; Jamei, M
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Dermatopharmacokinetics As A Tool For Bioequivalence Testing: A Case Study Comparing Acyclovir Creams From The Us And Uk
Pensado, Andea; Chiu, Wingsin; Cordery, Sarah; Bunge, Annette; Delgado-Charro, Begona; Guy, Richard
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Integration of Physicochemical Product Characteristics within a Mechanistic Dermal PBPK Model to Support Virtual Bioequivalence Evaluation of Topical Drug Products: A Case Study with Acyclovir Topical Creams
Martins, Frederico; Patel, Nikunjkumar; Salem, Farzaneh; Jamei, Masoud; Polak, Sebastian
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Towards Development And Validation Of The Dermal Pbpk Model For Virtual Bioequivalence -Model Description And Validation Case Studies
Patel, Nikunjkumar; Cristea, Sinziana; Polak, Sebastian
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Mechanistic Modelling Of Dermal Drug Absorption Using The Simcyp Multi-Phase Multi-Layer Mechderma Model: Case Study Of A Transdermal Patch Formulation Of Weak Base Drug Timolol
Patel, Nikunjkumar; Cristea, Sinziana; Rose, Rachel; Salem, Farzaneh; Abduljalil, Khaled; Johnson, Trevor; Jamei, Masoud; Raney, Sameersingh; Zhang, Xinyuan; Lin, Hopi; Newman, Bryan; Chow, Edwin; Ghosh, Priyanka; Fan, Jianghong; Fang, Lanyan; Polak, Se