GDUFA Research Outcomes
Other Generics Research
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to other research relevant to generic products.
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Deep Dive into Generic Drug Applications to Seek Data-Driven Harmonization of Bioequivalence Criteria for Narrow Therapeutic Index Drugs
Mina, Mirette; Amin Anno, Krista; Zhang, Zhen; Sun, Wanjie; Zhang, Lei; Jiang, Wenlei
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A Survey on Recommendation of Food Conditions in Bioequivalence Studies with Pharmacokinetic Endpoints for Generic Oral Antineoplastic Drug Development
Kim, Myong-Jin; Li, Karen; Shon, Jihong
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Safety Considerations of Subject Population Selection in Bioequivalence Studies for Generic Drug Development
Tran, Tony; Bae, Jungeun; Nguyen, Duyen; Shon, Jihong; Kim, Myong-Jin; Borges, Silvana; Li, Karen
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Ensuring Therapeutic Equivalence for Drugs to be Used in Pregnant Patients: A Literature Review and Modeling Exercise to Extrapolate BE Results from Non-pregnant Individuals to Pregnant Individuals
Xin, Ellen; Babiskin, Andrew; Shoyaib, Abdullah Al
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Survey of Bioequivalence Data of Abbreviated New Drug Applications of Narrow Therapeutic Index Drug Products
Anno, Krista; Mina, Mirette; Zhang, Zhen; Zhang, Lei; Jiang, Wenlei
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Exploration of Food Conditions and Study Population in Bioequivalence Studies with Pharmacokinetic Endpoints for Oral Antineoplastic Drugs in Generic Drug Development
Bae, Jihyun; Tran, Tony; Shon, Jihong; Kim, Myong – Jin; Li, Karen
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Exploration for Exclusion of Males of Reproductive Potential as a Bioequivalence Study Population in Product-Specific Guidances for Generic Drug Development
Park, Se Jin; Nguyen, Duyen; Tran, Tony; Li, Karen; Kim, Myong – Jin; Shon, Jihong