GDUFA Research Outcomes
PBPK Models
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Considerations for Using Model Master Files
Babiskin, Andrew
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Regulatory Perspective: Challenges and Opportunities to Enhance Model Sharing upon Regulatory Use
Babiskin, Andrew
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Regulatory Perspective on Modeling Strategies Across Multiple Submissions
Babiskin, Andrew; Yoon, Miyoung
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Use of PBPK Model to Evaluate Impact of Ophthalmic Drug Products Critical Quality Attributes of BA/BE Assessment
Babiskin, Andrew
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Physiologically-based Absorption Modeling and Simulation used in Assessing Bioequivalence for Ophthalmic Products
Babiskin, Andrew
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Novel Model-Integrated Designs for Bioequivalence Studies of LAI Products: A Complete Framework with the MonolixSuite
Ayral, Geraldine
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Modeling Dermal Drug Absorption from Complex Semisolid Formulations: Insights from Multi-Phase, Multi-Layer MechDermA Model
Zhao, Liang (should be Arora S)
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Integrating Topical Drug Product Quality Attributes Within Physiologically-based Pharmacokinetic Models
Zhao, Liang
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Modeling Dermal Drug Absorption from Complex Semisolid Formulations: Insights from Multi-Phase, Multi-Layer MechDermA Model
Zhao, Liang
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Simulating the Effect of Propylene Glycol on Acyclovir (Zovirax® Cream, 5%) Permeation Across the Skin Using a Physiologically Based Pharmacokinetic (PBPK) Model of In Vitro Flow-through Skin Permeation
Arora, S; Patel, N; Polak, S; Jamei, M; Tsakalozou, E; Ghosh, P; Alam, K; Liu, X; Namjoshi, S; Grice, J; Mohammed, Y; Roberts, M