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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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
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Mechanistic Physiologically-Based Pharmacokinetic Modelling for Prediction of Dermal Absorption in Psoriatic Patients
Martins, Frederico; Patel, Nikunjkumar; Jamei, Masoud; Polak, Sebastian
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Multi-phase Multi-layer MechDermA model: Development, Verification and Application of a PBPK-PD Model of Dermal Absorption for Transdermal Product Assessment
Martins, Frederico; Patel, Nikunjkumar; Salem, Farzaneh; Jamei, Masoud; Polak, Sebastian
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Multi-phase Multi-layer MechDermA model: Development, Verification and Application of a PBPK-PD Model of Dermal Absorption for Transdermal Product Assessment
Polak, Sebastian; Patel, Nikunjkumar; Martins, Frederico; Salem, Farzaneh; Jamei, Masoud; Rostami-Hodjegan, Amin
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Development And Validation Of Dermal Pbpk Model Towards Virtual Bioequivalence Assessment: Prediction Of Dermal Drug Absorption Of Various Ibuprofen Formulations Using Simcyp MechdermA model
Martins, Frederico; Patel, Nikunjkumar; Cristea, Sinziana; Polak, Sebastian
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Dissolution Testing of Diltiazem HCI Extended-Release Capsule Products
Li, Min; Gao, Zongming; Tang, Fuxing; Choi, Stephanie; Toth, Roxana; Rodriguez, Jason
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Assessment of the Impact of Drug Dissolution on Pharmacokinetics of Diltiazem Extended Release Drug Products Using Physiologically Based Pharmacokinetic Analysis
Li, Min; Gao, Zongming; Tang, Fuxing; Choi, Stephanie; Toth, Roxana; Rodriguez, Jason
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Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Levofloxacin Solution Case Study
Le Merdy, Maxime; Zheng, Yujuan; Lukacova, Viera; Tan, Ming Liang; Babiskin, Andrew; Zhao, Liang