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)

• Association of Authorized Generic Marketing with Prescription Drug Spending on Antidepressants from 2000 to 2011

  Cheng, Ning; Banerjee, Tannista; Qian, Jingjing; Hansen, Richard

• Post-marketing Surveillance of Generic Drug Usage and Substitution Patterns

  Zuckerman, Ilene; Pradel, Francoise; Palumbo, Francis; Shen, Xian; Kiptanui, Zippora; Polli, James; Gardner, Jim; Franey, Christine; Malik, Sana

• Development of a Physiologically Based Pharmacokinetic Model of Tacrolimus in Adult Organ Transplant Patients.

  Yu, Tian; Rower, Joseph; Liu, Xiaoxi; Balch, Alfred; Halford, Zachery; Korgenski, E. Kent; Sherwin, Catherine

• Population Pharmacokinetics Of Tacrolimus In Pediatric Heart Transplant Patients.

  Yu, Tian; Liu, Xiaoxi; Balch, Alfred; Molina, Kimberly; Constance, Jonathan; Prevedel, Jamie; Korgenski, E.Kent; Spigarelli, Michael; Sherwin, Catherine

• Determinants Of Generic Drug Substitution In The United States

  Segal, Jodi; Daubresse, Matthew; Onasanya, Olukayode

• Therapeutic Class Differences In Generic Usage

  Segal, Jodi; Daubresse, Matthew; Lee, Chiaying; Dutcher, Sarah; Jiang, Wenlei; Moechtar, Mischka; Romanelli, Robert

• Use Of Physiologically Based Pharmacokinetic Modeling As A Computational And Mathematical Tool To Evaluate Switchability Of Generic And Brand Name Products

  Samant, Tanay; Schmidt, Stephan; Fang, Lanyan; Chow, Edwin; Trame, Mirjam; Lesko, Lawrence

• Generic Substitution Patterns of Levothyroxine and Escitalopram in Subgroups of U.S. Medicare Beneficiaries

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

• Comparing Clinical Outcomes Of Brand And Generic Drugs: Systematic Literature Review Of Acarbose, Calcitonin Nasal Spray And Venlafaxine Er Tablets

  Park, Jina-Yujin; Kiptanui, Zippora; Palumbo, Francis; Zuckerman, Ilene; Pradel, Francoise; Khokhar, Bilal; Jiang, Wenlei; Cai, Wendy; Dutcher, Sarah

• Clinical Practice Patterns and Potential Barriers to Generic Drug Use in Special Populations

  Ogbenna, Bethany; Kiptanui, Zippora; Harris, Ilene; Dyrmishi, Jola; Dowell, Paul; Qian, Jingjing; Hansen, Richard