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)

• Estimating Generic Drug Utilization With Electronic Health Records From A Mixed-Payer Ambulatory Healthcare Delivery System

  Nimbal, Vani; Segal, Jodi; Romanelli, Robert

• Generic Competition And Authorized Generics In The Us

  Moon, Jungyoon; Nkurunziza, Joseph; Jambi, Aseel; Seoane-Vazquez, Enrique; Qian, Jingjing; Hansen, Richard

• Patient Relevant Outcomes Associated With Generic Drugs In Fda’S Adverse Event Reporting System

  Marimuthu, Sathiya; Iyer, Geetha; Segal, Jodi; Singh, Sonal

• Population Pharmacokinetics Of Tacrolimus In Pediatric Patients With Kidney Transplant.

  Liu, Xiaoxi; Yu, Tian; Balch, Alfred; Sherbotie, Joseph; Korgenski, Kent; Spigarelli,Michael; Sherwin, Catherine

• A Model- and Systems-Based Approach to Efficacy and Safety Questions Related to Generic Substitution

  Lesko, Lawrence; Biliouris, Konstantinos; Samant, Tanay; Combes, Francois; Fang, Lanyan; Schmidt, Stephan; Trame, Mirjam

• A Tool For Priorization of Investigation Of Generic Drug Ineffectiveness Complaints

  Kitabi, Eliford; Ivaturi, Vijay; Zhao, Liang; Fang, Lanyan; Gobburu, Joga; Gopalakrishnan, Mathangi

• Consistency of Publicy-Accessible Generic Drug Labels with Reference Listed Drug Labels in DailyMed: A Case Analysis for the Special Populations

  Kiptanui, Z; Dowell, P; Ogbenna, B; Desai, K; Zenilman, D; Harris, I; Qian, J J; Hansen, R

• Consistency of Publicy-Accessible Generic Drug Labels with Reference Listed Drug Labels in DailyMed: A Case Analysis for the Special Populations

  Kiptanui, Z; Dowell, P; Ogbenna, B; Desai, K; Zenilman, D; Harris, I; Qian, J J; Hansen, R

• A Systematic Review of Generic Drug Substitution in Special Populations

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

• A Model- and Systems-Based Approach to Assess Impact of Potential Pharmacokinetic Differences on Pharmacodynamics and Questions Regarding Generic Substitution

  Kim, Sarah; Sharma, Vishnu; Lingineni, Karthik; Farhan, Nashid; Fang, Lanyan; Zhao, Liang; Brown, Joshua; Cristofoletti, Rodrigo; Vozmediano, Valvanera; Ait-Oudhia, Sihem; Lesko, Lawrence; Trame, Mirjam; Schmidt, Stephan