GDUFA Research Outcomes
Drug-Device Combo Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to considerations impacting the device constituent of generic drug-device combination products.
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Emerging Technologies for Bioequivalence of Generic Complex Drug-Device Combination Products
Conti, Denise
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Mechanistic Drug Delivery Models
Zhao, Liang
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Pre – ANDA Evaluation of Drug Delivery Device Constituents
Zhao, Liang
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Device Considerations from User Interface Perspective: Comparative Analyses
Zhao, Liang