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)

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

  Kim, Sarah; Lingineni, Karthik; Meng, Amy; Sharma, Vishnu; Miller, Raymond; Trame, Mirjam; Brown, Joshua; Lesko, Lawrence; Schmidt, Stephan

• Identification Of Generic Drugs In The Fda Adverse Event Reporting System

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

• Comparison Of Generic-To-Brand Switchback Patterns For Authorized Generic Vs. Independent Generic Drugs

  Hansen, Richard; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah; Raofi, Saeid; Page, David; Peissig, Peggy

• Comparison of Clinical Outcomes Following a Switch From a Brand to an Authorized vs. Independent Generic Drug

  Hansen, Richard; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah; Raofi, Saeid; Page, David; Peissig, Peggy

• Application of Physiologically-Based Oral Absorption & Pharmacokinetic Modeling to Investigate Formulation Factors Influencing the Pharmacokinetics of Novel Oral Anticoagulants

  Farhan, Nashid; Basu, Sumit; Kim, Sarah; Lingineni, Karthik; Vozmediano, Valvanera; Ait-Oudhia, Sihem; Fang, Lanyan; Zhao, Liang; Lesko, Lawrence; Schmidt, Stephan

• Development of a Universal Pharmacogenetics-Guided Warfarin Dosing Nomogram

  Deng, Jiexin; Arwood, Meghan; Duarte, Julio; Cavallari, Larisa; Schmidt, Stephan

• Integrated Data Mining And Systems Pharmacology To Explore The Comparative Safety Of Brand-Name And Generic Drugs

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

• Integrated Data Mining And Systems Pharmacology To Explore The Comparative Safety Of Brand-Name And Generic Drugs

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

• Physiologically Based Absorption Modeling as a Tool to Evaluate the Bioequivalence of Metoprolol ER Products

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

• Clinical Implementation of Warfarin Pharmacogenetics In A Real-World Setting: A Proposal For A New Pharmacogenetic Dosing Approach For Diverse Patient Populations

  Arwood, Meghan; Deng, Jiexin; Drozda, Katarzyna; Nutescu, Edith; Schmidt, Stephan; Duarte, Julio; Cavallari, Larisa