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)

• Physiologically Based Pharmacokinetic Modeling to Evaluate Formulation Factors Influencing Bioequivalence of Metoprolol Extended-Release Products

  Basu, Sumit; Yang, Haitao; Fang, Lanyan; Gonzalez Sales, Mario; Zhao, Liang; Trame, Mirjam; Lesko, Lawrence; Schmidt, Stephan

• An Integrated Bioinformatics and Quantitative Modeling Approach to Investigate Potential Claims of Oral Generic Drug Product Bioinequivalence: Introduction

  Lesko, Lawrence; Fang, Lanyan; Schmidt, Stephan; Trame, Mirjam

• Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness

  Gagne, Joshua

• Generic Escitalopram Initiation and Substitution among Medicare Beneficiaries: A New User Cohort Study

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

• Disclosure Of Industry Payments To Prescribers: Industry Payments Might Be A Factor Impacting Generic Drug Prescribing

  Qian, Jingjing; Hansen, Richard; Surry, Daniel; Howard, Jennifer; Kiptanui, Zippora; Harris, Ilene

• Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop

  Fang, Lanyan; Kim, Myongjin; Li, Zhichuan; Wang, Yaning; Diliberti, Charles; Au, Jessie; Hooker, Andrew; Ducharme, Murray; Lionberger, Robert; Zhao, Liang

• Comment on: “Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs”

  Suggs, Courtney; Levin, Robert; Mosholder, Andrew; Swain, Richard; Zhao, Liang

• Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence

  Gagne, Joshua; Polinski, Jennifer; Jiang, Wenlei; Dutcher, Sarah; Xie, Jing; Lii, Joyce; Fulchino, Lisa; Kesselheim, Aaron

• Role of Authorized Generics in Postapproval Surveillance of Generic Drug Products

  Gagne, Joshua; Sarpatwari, Ameet; Desai, Rishi

• Dissolution Failure of Solid Oral Drug Products in Field Alert Reports

  Sun, Dajun; Hu, Meng; Browning, Mark; Friedman, Rick L; Jiang, Wenlei; Zhao, Liang; Wen, Hong