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)

• A General Framework for Assessing IVIVC as a Tool for Maximizing the Benefit-Risk Ratio of a Treatment Using a Convolution-Based Modeling Approach

  Gomeni, Roberto; Fang, Lanyan; Gomeni, Francoise; Spencer, Thomas; Faraone, Stephen; Babiskin, Andrew

• Considerations for Generic-to-Generic Levothyroxine Switching-Reply

  Brito, Juan P; Wang, Zhong; Lipska, Kasia

• Quantification of Lamotrigine in Patient Plasma Utilizing a Fast Liquid Chromatography-Tandem Mass Spectrometry Method with Backflush Technology

  Wong, Jessica; Jones, Jace; Jiang, Wenlei; Polli, James; Maureen, Kane

• Biopharmaceutic Risk Assessment of Brand and Generic Lamotrigine Tablets

  Soundarya, Vaithianathan; Raman, Siddarth; Jiang, Wenlei; Ying, Tricia; Kane, Maureen; Polli, James

• Relationship of Antiepileptic Drugs to Generic Brittleness in Patients with Epilepsy

  Das, Sharmila; Jiang, Xiaohui; Jiang, Wenlei; Ting, Tricia; Polli, James

• Comparative Effectiveness of Generic vs Brand-name Levothyroxine in Achieving Normal Thyrotropin Levels

  Brito, Juan; Ross, Joseph; Sangaralingham, Lindsey; Dutcher, Sarah; Graham, David; Wang, Zhong; Wu, Yute; Yao, Xiaoxi; Smallridge, Robert; Bernet, Victor; Shah, Nilay; Lipska, Kasia

• Development and Validation of a High-Throughput Stereoselective LC-MS/MS Assay for Bupropion, Hydroxybupropion, Erythrohydrobupropion, and Threohydrobupropion in Human Plasma

  Teitelbaum, Aaron; Flaker, Alicia; Kharasch, Evan

• Generic Lamotrigine Versus Brand-Name Lamictal Bioequivalence in Patients with Epilepsy: A Field Test of the FDA Bioequivalence Standard

  Ting, Tricia; Jiang, Wenlei; Lionberger, Robert; Wong, Jessica; Jones, Jace; Kane, Maureen; Krumholz, Allan; Temple, Robert; Polli, James

• Generic-to-Generic Lamotrigine Switches in People with Epilepsy: the Randomised Controlled EQUIGEN Trial

  Privitera, Michael; Welty, Timothy; Gidal, Barry; Diaz, Francisco; Krebill, Ron; Szaflarski, Jerzy; Dworetzky, Barbara; Pollard, John; Elder Jr, Edmund; Jiang, Wenlei; Jiang, Xiaohus, Berg, Michel

• Cardiovascular Outcomes and Rates of Fractures and Falls among Patients with Brand-name Versus Generic L-thyroxine Use

  Brito, Juan; Ross, Joseph; Deng, Yihong; Sangaralingham, Lindsey; Graham, David; Qiang, Yandong; Wang, Zhong; Yao, Xiaoxi; Zhao, Liang; Smallridge, Robert; Bernet, Victor; Shah, Nilay; Lipska, Kasia