GDUFA Research Outcomes

Generic Substitution

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

• 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

• Towards Building a Dermal Model for BE Assessment: The Role of Drug Product Characterization and Performance Data

  Ghosh, Priyanka

• Model Integrated Evidence for Bioequivalence Evaluation to Support Generic Drug Development and Regulatory Approval

  Fang, Lanyan (Lucy)

• 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

• A Generic Tacrolimus Capsule Shown Not to Be Bioequivalent to the Brand Tacrolimus Capsule in a Post-approval Pharmacokinetic Bioequivalence Study in Healthy Subjects

  Sun, Wei-Jhe; Mahjabeen, Sanjida; Kinjo, Minori; Thomas, Sherin; Wu, Fang; Ni, Zhanglin; Frost, Mitchell; Markollari, Artan; Best, Ryan; Le, Sunny; Kim, Myong-Jin; Zhao, Liang

• 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