GDUFA Research Outcomes

Generic Substitution

• All(60)
• Posters(13)
• Presentations(16)
• Papers(31)

• Evaluation of Switching Patterns in FDA’s Sentinel System: A New Tool to Assess Generic Drugs

  Gagne, Joshua; Popovic, Jennifer; Nguyen, Michael; Sandhu, Sukhminder; Greene, Patty; Izem, Rima; Jiang, Wenlei; Wang, Zhong; Zhao, Yueqin; Petrone, Andrew; Wagner, Anita; Dutcher, Sarah

• Quantitative Methods and Modeling to Evaluate Alternative Approaches for COVID-19 Interrupted Bioequivalence Studies

  Zhao, Liang

• 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

• 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

• Regulatory and Scientific Considerations on Characterizations of Complex Polymeric Excipients

  Wang, Yan

• 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

• Overview of the Generic Drug Approval Process

  Lionberger, Robert

• Can Clinical Pharmacology Break Down Barriers to Generic Substitution?

  Lionberger, Robert

• Bioequivalence and Clinical Implications of Generic and Brand Bupropion

  Kharasch, Evan

• FDA Bioequivalence Standards

  Jiang, Wenlei