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)

• Generic Antiepileptic Drug (AED) Research Leading to Changes in Clinical Practices

  Jiang, Wenlei

• Drug-Disease Modeling Approach to Describe the Relationship Between Long-Acting Methlyphenidate Exposure and Clinical Response

  Gomeni, Roberto

• Frequency Of Generic Brittleness In Epilepsy Patients

  Das, Sharmila; Pu, Xia; Jiang, Xiaohui; Tung, Renee; Ting, Tricia; Polli, James

• Real-World Data Approaches for Early Detection of Potential Safety and Effectiveness Signals for Generic Substitution: A Metoprolol ExtendedRelease Case Study

  Brown, Joshua

• Assessing Bioequivalence for Generic Extended Release Formulations

  Babiskin, Andrew

• Determination of CYP2D6 Phenotyping for Metoprolol using CYP2D6 Genotype-derived Activity Score: Results from a Prospective, Clinical Trial

  Thomas, C D; Monsely, S A; El Rouby, N; Kim, S; Lingineni, K; Langaee, T; Langaee, T; Gong, Y; Johnson, J A; Schmidit, S O; Fyre, R F; Cavallari, L H

• Assessing The Association Of Four Measurements Of Adherence To Tacrolimus For Organ Transplant Recipients

  Peipert, John; Waterman, Amy; Tsai, Eileen; Morisky, Donald; Zonana, Moses; Bunnapradist, Suphamai

• Evaluation of Clinical and Safety Outcomes Following Uncontrolled Tacrolimus Conversion in Adult Renal Transplant Recipients

  Lichvar, Alicia; Tremblay, Simon; Naik, Devanshi; Lipscomb, Jessi; King, Eileen; Vinks, Alexander; Christians, Uwe; Alloway, Rita

• Evaluation of Clinical and Safety Outcomes Following Uncontrolled Tacrolimus Conversion in Adult Renal Transplant Recipients

  Lichvar, Alicia; Tremblay, Simon; Naik, Devanshi; King, Eileen; Vinks, Alexander; Christians, Uwe; Alloway, Rita

• Bioequivalence Assessment of Brand and Generic Lamotrigine Extended-Release Tablets

  Li, Zhichuan; Zheng, Nan; Wen, Hong; Fang, Lanyan; Zhang, Xinyuan; Sun, Dajun; Kinjo, Minori; Zhao, Liang; Jiang, Wenlei; Lionberger, Robert