GDUFA Research Outcomes
Other Generics Research
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to other research relevant to generic products.
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Scientific Harmonization of Bioequivalence Standards for Generic Drugs
Zhang, Lei
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Harmonization of Bioequivalence FDA Perspective
Zhang, Lei
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Drug-Drug Interactions and Generic Drugs
Zhang, Lei
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Newly Approved Complex Drug Products and Potential Challenges to Generic Drug Development
Zhang, Lei
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Role of Regulatory Science in Reducing Barries to Generic Drug Product Development
Zhang, Lei
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ICH Reflection Paper: Further Opportunities for Harmonization of Standards for Generic Drugs
Zhang, Lei
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U.S. FDA Reflection Paper: Further Opportunities for Harmonization of Standards for Generic Drugs -Update-
Zhang, Lei
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Bioquivalence for Immediate-Release Solid Oral Dosage Forms Category
Zhang, Lei
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Bioequivalence Evaluation For Generic Drug Products -Discussion with PKWP-
Zhang, Lei
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Complex Generic Drug Products Challenges in Development
Zhang, Lei