GDUFA Research Outcomes
Generic Substitution
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Landscape Analysis of Generic Availability for Oncologic Drugs
Kumar, Vaibhav; Wang, Fenggong; Hu, Meng; Kluetz, Paul; Liang, Zhao
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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
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Considerations for Generic-to-Generic Levothyroxine Switching-Reply
Brito, Juan P; Wang, Zhong; Lipska, Kasia
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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
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Biopharmaceutic Risk Assessment of Brand and Generic Lamotrigine Tablets
Soundarya, Vaithianathan; Raman, Siddarth; Jiang, Wenlei; Ying, Tricia; Kane, Maureen; Polli, James
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Relationship of Antiepileptic Drugs to Generic Brittleness in Patients with Epilepsy
Das, Sharmila; Jiang, Xiaohui; Jiang, Wenlei; Ting, Tricia; Polli, James
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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
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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
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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
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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