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.
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Communicating Benefits and Risks of Generic Drugs to Consumers: Patient and Caregiver Opinions of two FDA-Developed Educational Materials
Hohmann, Natalie; Garza, Kimberly; Surry, Daniel; Hansen, Richard; Harris, Ilene; Kiptanui, Zippora; Oguntimein, Oluwamurewa; Frost, Mitchell; Qian, Jingjing
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Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA
Wang, Zhong; Ahluwalia, Sharon; Newman, Bryan; Dhapare, Sneha; Zhao, Liang; Luke, Markham
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Correction to: 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
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Random-Effects Linear Modeling and Sample Size Tables for Two Special Cross-over Designs of Average Bioequivalence Studies: the 4-Period, 2-Sequence, 2 Formulation and 6-Period, 3-Sequence, 3-Formulation Designs
Diaz, Francisco; Berg, Michael; Krebill, Ron; Welty, Timothy; Gidal, Barry; Alloway, Rita; Privitera, Michael
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Predicting Tacrolimus Concentrations in Children Receiving a Heart Transplant Using a Population Pharmacokinetic Model
Rower, Joseph; Stockmann, Chris; Linakis, Matthew; Kumar, Shaun; Liu, Xiaoxi; Korgenski, Kent; Sherwin, Catherine
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Association between Higher Generic Drug Use and Medicare Part D Star Ratings: An Observational Analysis
Hohmann, Natalie; Hansen, Richard; Garza, Kimberly; Harris, Ilene; Kiptanui, Zippora; Qian, Jingjing
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Model-Based Assessment Using Conventional Bioequivalence Limits to Ensure Safety and Efficacy of Rivaroxaban in Patients Undergoing Hip or Knee Replacement
Gonzalez-Sales, Mario; Fang, Lanyan; Kim, Myong Jin; Zhao, Liang
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Erratum to: Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products
Chang, Rong-Kun; Raw, Andre; Lionberger, Robert; Yu, Lawrence
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Variations in Patients’ Perceptions and Use of Generic Drugs: Results of a National Survey
Kesselheim, Aaron; Gagne, Joshua; Franklin, Jessica; Eddings, Wesley; Fulchino, Lisa; Avorn, Jerry; Campbell, Eric
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Physiologically Based Pharmacokinetics Modeling to Investigate Formulation Factors Influencing the Generic Substitution of Dabigatran Etexilate
Farhan, Nashid; Cristofoletti, Rodrigo; Basu, Sumit; Kim, Sarah; Lingineni, Karthik; Jiang, Sibo; Brown, Joshua; Fang, Lanyan; Lesko, Lawrence; Schmidt, Stephan