GDUFA Research Outcomes

Generic Substitution

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

• Examination of Metoprolol Pharmacokinetics and Pharmacodynamics across CYP2D6 Genotype-Derived Activity Scores

  Thomas, Cameron; Mosley, Scott; Kim, Sarah; Lingineni, Karthik; Rouby, Nihal; Langaee, Taimour; Gong, Yan; Wang, Danxin; Schmidt, Siegfried; Binkley, Philip; Estores, David; Feng, Kairui; Kim, Hyewon; Kinjo, Minori; Li, Zhichuan; Fang, Lanyan; Chapman, Arlene; Cooper-Dehoff, Rhonda; Gums, John; Hamadeh, Issam; Zhao, Liang; Schmidt, Stephan; Frye, Reginald; Johnson, Julie; Cavallari, Larisa

• 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

• 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

• 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

• 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