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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Application and Validation of Mechanistic Modeling for Generic Drug Products at the U.S. Food and Drug Administration (FDA)
Walenga, Ross; Tan, Ming-Lian; Wu, Fang
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Modeling and Simulation to Support Development and Approval of Generic Orally Inhaled Drug Products
Walenga, Ross
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Complex Nasal Suspensions: Utilization of In Silico Studies to Support Development and Approval
Walenga, Ross
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Mechanistic Modeling and Realistic In Vitro Models to Facilitate Development of Generic Nasal Drug Products
Walenga, Ross
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Utilizing In Vitro and In Silico Methods to Accelerate Product Development for Generic Nasal Drug Products
Walenga, Ross
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Modeling of CNS Delivery for Nose-to-Brain Targeted Drug Products
Walenga, Ross
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ANDA and Pre-ANDA Experience with OIDP Modeling
Walenga, Ross
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Abbreviated New Drug Application (ANDA) and Pre-ANDA Experience with Orally Inhaled Drug Product (OIDP) Modeling
Walenga, Ross
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In Silico and Experimental Methods to Support Generic Nasal Drug Product (NDP) Development
Walenga, Ross
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Bridging the Gap Between Regional Deposition and Systemic Pharmacokinetic Data of OINDPs with Modeling and Simulation
Walenga, Ross