GDUFA Research Outcomes
Generic Substitution
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to considerations impacting substitution with generic products.
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Quantitative Methods and Modeling to Evaluate Alternative Approaches for COVID-19 Interrupted Bioequivalence Studies
Zhao, Liang
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Comparison Of The Effects Of Brand Name Versus Generic Immunosuppressants On Long-Term Graft Failure Risk Among U.S. Liver Transplant Recipients: Analysis Of Srtr And Medicare Claims Data
Zee, Jarcy; Bello, Ghalib; Oguntimein, Murewa; Beil, Charlotte; Liu, Qian; Smith, Abigail; Park, Jeong; Saulles, Adam; Goel, Sangeeta; Balkrishnan, Rajesh; Fava, Melissa; Sharma, Pratima; Merion, Robert; Leichtman, Alan
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Comparison Of The Effects Of Brand Name Versus Generic Immunosuppressants On Long-Term Graft Failure Risk Among U.S. Kidney Transplant Recipients: Analysis Of Srtr And Medicare Claims Data
Zee, Jarcy; Bello, Ghalib; Oguntimein, Murewa; Beil, Charlotte; Liu, Qian; Smith, Abigail; Park, Jeong; Saulles, Adam; Goel, Sangeeta; Balkrishnan, Rajesh; Fava, Melissa; Sharma, Pratima; Merion, Robert; Leichtman, Alan
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Model Integrated Evidence for Bioequivalence Evaluation to Support Generic Drug Development and Regulatory Approval
Fang, Lanyan (Lucy)
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Regulatory and Scientific Considerations on Characterizations of Complex Polymeric Excipients
Wang, Yan
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Towards Building a Dermal Model for BE Assessment: The Role of Drug Product Characterization and Performance Data
Ghosh, Priyanka
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Comparative, Crossover PD Study of d|Different Formulations of Extended Release MPH
Spencer, Thomas; Biederman, Joseph; Faraone, SV; Childress, Ann; Gomeni, Roberto; Babiskin, Andrew; Fang, Lucy
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FDA Bioequivalence Standards
Jiang, Wenlei
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Can Clinical Pharmacology Break Down Barriers to Generic Substitution?
Lionberger, Robert
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Bioequivalence and Clinical Implications of Generic and Brand Bupropion
Kharasch, Evan