GDUFA Research Outcomes
PBPK Models
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to physiologically-based pharmacokinetics (PBPK) computational modeling to support generic product development and assessment.
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Population Pharmacokinetic/Pharmacodynamic (PKPD) Modeling for Long Acting Injectable(LAI) Products and Statistical Analysis for Bioequivalence(BE) Assessment
Paul, Prokash; Yoon, Seongkyu; Kim, Namjoon; Trunfio, Nicholas; Handelman, Garry; Kim, Jaeyeon
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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
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Modelling and Simulation of Corneocyte Swelling: A Theoretical Contribution on the Barrier Properties of the Skin
Nagel, Arne; Scherer, Martin; Wittum, Gabriel
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Simulation of in vitro Dissolution and Degradation of Orntide-loaded PLGA Microspheres
Mullin, James; Van Osdol, William; Lukacova, Viera; Woltosz, Walter; Bolger, Michael
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Development Of An In Vitro Mechanistic Model That Describes Drug Release From Risperidone Long-Acting Injectable Microspheres
Mullin, James; Lukacova, Viera; Woltosz, Walter; Bolger, Michael
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Determination of CYP2D6 Phenotyping for Metoprolol using the Genotype-derived Activity Score
Mosley, Scott; Frye, Reginald; Langaee, Taimour; Schmidt, Siegfried; Schmidt, Stephen; Gong, Yan; Binkley, Philip; Johnson, Julie; Cavallari, Larisa
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Using a Physiologically-based Pharmacokinetic Absorption Model for Biopharmaceutics to Establish Clinically Relevant Dissolution Safe Space for Oseltamivir in Adult and Pediatric Populations
Miao, Lei; Wu, Fang; Zhao, Liang; Raines, Kimberly; Seo, Paul
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Cellular Pharmacokinetic/Pharmacodynamic Of Doxorubicin In A Wide Array Of Cell Lines.
LeMerdy, Maxime; Hendriks, Bart; Cao, Yanguang