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.

• All(57)
• Posters(12)
• Presentations(15)
• Papers(30)

• Bioequivalence between Innovator and Generic Tacrolimus in Liver and Kidney Transplant Recipients: A Randomized, Crossover Clinical Trial

  Alloway, Rita; Vinks, Alexander; Fukuda, Tsuyoshi; Mizuno, Tomoyuki; King, Eileen; Zou, Yuanshu; Jiang, Wenlei; Woodle, Steve; Tremblay, Simon; Klawitter, Jelena; Klawitter, Jost; Christians, Uwe

• Secular Trends in the Cost of Immunosuppressants after Solid Organ Transplantation in the United States

  Helmuth, Margaret; Liu, Qian; Turenne, Marc; Park, Jeong; Qguntimein, Murewa; Dutcher, Sarah; Balkrishnan, Rajesh; Sharma, Pratima; Zee, Jarcy; Leichtman, Alan; Smith, Abigail

• The Adoption of Generic Immunosuppressant Medications in Kidney, Liver, and Heart Transplantation Among Recipients in Colorado or Nationally with Medicare part D

  Liu, Qian; Smith, Abigail; Park, Jeong; Oguntimein, Murewa; Dutcher, Sarah; Bello, Ghalib; Helmuth, Margaret; Turenne, Marc; Balkrishnan, Rajesh; Fava, Melissa; Beil, Charlotte; Saulles, Adam; Goel, Sangeeta; Sharma, Pratima; Leichtman, Alan; Zee, Jarcy

• Release of Levetiracetam from Extended-Release Tablets that Appear Intact in Patient Stool

  Vaithianathan, Soundarya; Ting, Tricia; Jiang, Wenlei; Polli, James

• Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MSMS

  Shokati, Touraj; Bodenberger, Nicholas; Gadpaille, Holly; Schniedewind, Bjorn; Vinks, Alexander; Jiang, Wenlei; Alloway, Rita; Christians, Uwe

• Novel and Rapid LC-MS/MS Method for Quantitative Analysis of Methylphenidate in Dried Blood Spots

  Gandhi, Adarsh; Beekman, Christopher; Parker, Robert; Fang, Lanyan; Babiskin, Andrew; Matta, Murali

• Bioequivalance and Therapeutic Equivalence of Generic and Brand Bupropion in Adults with Major Depression: A Randomized Clinical Trial

  Kharasch, Evan; Neiner, Alicia; Kraus, Kristin; Blood, Jane; Stevens, Angela; Schweiger, Julia; Miller, Philip; Lenze, Eric

• Model-Based Approach for Optimizing Study Design and Clinical Drug Performances of Extended-Release Formulations of Methylphenidate for the Treatment of Attention-Deficit Hyperactivity Disorder

  Gomeni, Roberto; Lucy, Fang; Bressolle Gomeni, Françoise; Spencer, Thomas; Faraone, Stephen; Babiskin, Andrew

• Comparison of Brand Versus Generic Antiepileptic Drug Adverse Event Reporting Rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS)

  Rahman, Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Plotkina, Annya; Peissig, Peggy; Berg, Richard; Page, David; Hansen, Richard

• 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