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)

• Correlation between the Quality Attributes and Performance Characteristics of Metronidazole Gels and Creams: Implications for the Evaluation of Bioequivalence

  Rangappa, Srinath; Ajjarapu, Srinivas; Hashemnejad, Seyed-Meysam; Prado, Rosa-Maria-Badani; Ghosh, Priyanka; Raney, Sam; Kundu, Santanu; Murthy, Narasimha

• 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, Sam; Murthy, Narasimha

• 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

• 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

• Development of the Dermal Absorption Model for the Ketoprofen Local and Systemic Exposure Prediction

  Patel, Nikunjkumar

• 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

• 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, Sam; Zhang, Xinyuan; Lin, Hopi; Newman, Bryan; Chow, Edwin; Ghosh, Priyanka; Fan, Jianghong; Fang, Lanyan; Jamei, M

• 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

• 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

• Towards Development And Validation Of The Dermal Pbpk Model For Virtual Bioequivalence -Model Description And Validation Case Studies

  Patel, Nikunjkumar; Cristea, Sinziana; Polak, Sebastian