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.

• All(360)
• Posters(77)
• Presentations(193)
• Papers(90)

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

• Qualitative Analysis of Generic and Reference LAI Drug PK Profiles Using Multivariate Score Space

  Paul, Prokash; Handelman, Garry; Kim, Jaeyeon; Yoon, Seongkyu

• 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

• 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

• 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

• Modelling and Simulation of Corneocyte Swelling: A Theoretical Contribution on the Barrier Properties of the Skin

  Nagel, Arne; Scherer, Martin; Wittum, Gabriel

• Simulation of in vitro Dissolution and Degradation of Orntide-loaded PLGA Microspheres

  Mullin, James; Van Osdol, William; Lukacova, Viera; Woltosz, Walter; Bolger, Michael

• 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