GDUFA Research Outcomes
PBPK Models
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Accelerating LAI Generic Development Using Model-Integrated Bioequivalence
Gobburu, Joga
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In Vitro Bioequivalence Testing of Nasal Sprays Using Multiple AnatomicallyCorrect Nasal Airway Models
Golshahi, L; Manniello, M; Hosseini, S; Alfaifi, A; Schuman, T; Hindle, M; Longest, W; Sandell, D
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General Approach to the Safety Review of Pediatric Excipients
Ghosh, Amrita
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A Model-Integrated Pathway to Explore Bioequivalence of LAI Products: Studies Using Paliperidone Palmitate
Gajjar, Parmesh
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Industry Perspective: Incorporation of BE Modeling and LAI Development Challenges
Fitzgerald, Michael
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Physiologically Based Pharmacokinetic Absorption Modeling to Support Bioequivalence Assessment for BCS Class III Drug Products
Fang, Lanyan
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Leveraging Modeling and Simulation to Streamline Generic Drug Development and Assessment
Fang, Lanyan
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Regulatory Applications and Research of Absorption Modeling for Pediatric Products
Fang, Lanyan
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PK and Statistical Considerations for Steady State Bioequivalence Studies – FDA Perspective
Fang, Lanyan (Lucy)
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In Vitro Evaluation of Regional Drug Deposition in Nasal Airways of Children Using Realistic Anatomical Replicas
Esmaeili, A; Hosseini, S; Wilkins, J; Alfaifi, A; Dhapare, S; Walenga, R; Newman, B; Schuman, T; Edwards, D; Longest, W; Hindle, M; Golshahi, L