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)

• Challenges and Opportunities in Data Access and Methodology Development for Post-Market Generic Drug Monitoring

  Zhao, Liang

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

  Schmidt, Stephan

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

  Schmidt, Stephan

• Changing Physician and Patient Perceptions about Generic Drugs

  Sarpatwari, Ameet

• Provider-Level Variation And Determinants Of Outpatient Generic Prescribing In A Mixed-Payer Healthcare System

  Romanelli, Robert; Nimbal, Vani; Segal, Jodi

• Machine Learning For Adverse Drug Event Detection

  Page, David

• Can Clinical Pharmacology Break Down Barriers to Generic Substitution?

  Lionberger, Robert

• A Signal to Noise Ratio Classification System of Drugs to Investigate Generic Drug Ineffectiveness Claims

  Kitabi, Eliford

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

  Jiang, Wenlei

• Predictors of Generic Thyroid Hormone Utilization among the Commercially Insured

  Daubresse, Matthew