GDUFA Research Outcomes
QCP Methods
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to quantitative clinical pharmacology assessments of oral absorption to support generic product development and assessment.
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Application of Modeling and Simulation in Establishing Appropriate Bioequivalence Limits for Complex Formulations
Sharan, Satish
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Evaluation Of Residual Levonorgestrel As Potential Bioequivalence Metric For A Long Acting Intrauterine System Using Quantitative Modeling And Simulation Approach
Sharan, Satish
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Model-Integrated Methods and Innovative Study Designs for Generic LAI Product Development and Regulatory Assessment
Hooker, Andrew
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Batch-to-Batch Pharmacokinetic Variability of Orally Inhaled Drug Products
Li, Matt (Zhichuan)
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Dose-Scale (Emax) Modeling in Pharmacodynamic Bioequivalence Studies – FDA Perspective
Li, Matt
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Predictive Performance of PBPK Dose Estimates for Pediatric Trials
Dallmann, Andre
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Development and Comparison of Model-based Bioequivalence Analysis Methods on Sparse Data
Hooker, Andrew; Nyberg, Henrik; Karlsson, Mats; Chen, Xiaomei
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Model-based Approaches as Guidance to Bioequivalence Decision Making: Design and Analysis Considerations
Hooker, Andrew
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Correlating The In Vitro Dissolution Behavior Of Inhalation And Nasal Drug Products With In Vivo Performance: Pitfalls And Potential Solutions Using The Transwell System
Hochhaus, Guenther
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Mechanistic in Silico Inference of Dermal Absorption for Chemical Risk Assessment
Troutman, John