GDUFA Research Outcomes

Post-Approval Monitoring

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to post-approval monitoring of generic products.

• All(91)
• Posters(30)
• Presentations(12)
• Papers(49)

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

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

• Healthy User Bias in Comparative Safety Studies for Brand-Name vs. Generic Products: The Example of Warfarin

  Bird, Steven; Flowers, Natasha; Zhao, Yueqin; Mckean, Stephen; Izem, Rima; Wernecke, Michael; Kozlowski, Steven; Macurdy, Thomas; Kelman, Jeffrey; Graham, David

• 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

• 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

• Determinants Of Generic Drug Substitution In The United States

  Segal, Jodi; Onasanya, Oluwadamilola; Daubresse, Matthew; Lee, Chia Ying; Moechtar, Mischka; Pu, Xia; Dutcher, Sarah; Romanelli, Robert

• Genotype-Guided Dosing of Warfarin through Modeling and Simulation

  Deng, Jiexin; Vozmediano, Valvanera; Rodriguez, Monica; Cavallari, Larisa; Schmidt, Stephan

• Differences in Rates of Switchbacks after Switching from Branded to Authorized Generic and Branded to Generic Drug Products: Cohort Study

  Desai, Rishi; Sarpatwari, Ameet; Dejene, Sara; Khan, Nazleen; Lii, Joyce; Rogers, James; Dutcher, Sarah; Raofi, Saeid; Bohn, Justin; Connolly, John; Fischer, Michael; Kesselheim, Aaron; Gagne, Joshua

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

  Brown, Joshua; Henriksen, Carl; Vozmediano, Valvanera; Schmidt, Stephan

• Oral Generic Tacrolimus Initiation and Substitution in the Medicaid Population: A New User Cohort Study

  Chen, Li; Li, Chao; Huo, Nan; Mishuk, Ahmed; Hansen, Richard; Harris, Ilene; Kiptanui, Zippora; Qian, Jingjing

• A Model- & Systems-based Approach to Assess & Ensure Generic Substitution

  Zhao, Liang