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)

• Association Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults

  Brito, Juan P; Deng, Yihong; Ross, Joseph S; Choi, Nam Hee; Graham, David J; Qiang, Yandong; Rantou, Eleni; Wang, Zhong; Zhao, Liang; Shah, Nilay D; Lipska, Kasia J

• A Theoretical Physiologically-Based Pharmacokinetic Approach to Ascertain Covariates Explaining the Large Interpatient Variability in Tacrolimus Disposition

  Emoto, Chie; Johnson, Trevor; Hahn, David; Christians, Uwe; Alloway, Rita; Vinks, Alexander; Fukuda, Tsuyoshi

• Generic and Brand-Name Thyroid Hormone Drug Use among Commercially Insured and Medicare Beneficiaries

  Ross, Joseph; Rohde, Stefanie; Sangaralingham, Linsey; Brito, Juan; Choi, Lauren; Dutcher, Sarah; Graham, David; Jenkins, Marjorie; Lipska, Kasia; Mendoza, Martin; Qiang, Yandong; Wang, Zhong; Wu, Yute; Yao, Xiaoxi; Shah, Nilay

• Assessment of Tacrolimus Intrapatient Variability in Stable Adherent Transplant Recipients: Establishing Baseline Values

  Leino, Abbie; King, Eileen; Jiang, Wenlei; Vinks, Alexander; Klawitter, Jost; Christians, Uwe; Woodle, Steve; Alloway, Rita; Rohan, Jennifer

• Confidence in Generic Drug Substitution

  Lionberger, Robert; Jiang, Wenlei; Huang, Shiewmei; Geba, Gregory

• Development, Validation and Application of a Comprehensive Stereoselective LC-MS/MS Assay for Bupropion and Oxidative, Reductive, and Glucuronide Metabolites in Human Urine

  Teitelbaum, Aaron; Flaker, Alicia; Kharasch, Evan

• Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA

  Wang, Zhong; Ahluwalia, Sharon; Newman, Bryan; Dhapare, Sneha; Zhao, Liang; Luke, Markham

• A Randomized, Cross-over Trial of Metoprolol Succinate Formulations to Evaluate PK and PD Endpoints for Therapeutic Equivalence

  Mosley, Scott; Kim, Sarah; Rouby, Nihal; Lingineni, Karthik; Vozmediano, Valvanera; Gong, Yan; Chen, Yiqing; Estores, David; Feng, Kairui; Kim, Hyewon; Kinjo, Minori; Langaee, Taimour; Li, Zhichuan; Schmidt, Siegfried; Johnson, Julie; Frye, Reginald; Fang, Lanyan; Zhao, Liang; Binkley, Philip; Schmidt, Stephan; Cavallari, Larisa

• Lack of Association of Generic Brittle Status with Genetics and Physiologic Measures in Patients with Epilepsy

  Das, Sharmila; Guo, Dong; Jiang, Xiaohui; Jiang, Wenlei; Shu, Yan; Ting, Tricia; Polli, James

• Examination of Metoprolol Pharmacokinetics and Pharmacodynamics across CYP2D6 Genotype-Derived Activity Scores

  Thomas, Cameron; Mosley, Scott; Kim, Sarah; Lingineni, Karthik; Rouby, Nihal; Langaee, Taimour; Gong, Yan; Wang, Danxin; Schmidt, Siegfried; Binkley, Philip; Estores, David; Feng, Kairui; Kim, Hyewon; Kinjo, Minori; Li, Zhichuan; Fang, Lanyan; Chapman, Arlene; Cooper-Dehoff, Rhonda; Gums, John; Hamadeh, Issam; Zhao, Liang; Schmidt, Stephan; Frye, Reginald; Johnson, Julie; Cavallari, Larisa