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

• 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