GDUFA Research Outcomes
Complex Oral Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the oral route, including buccal and locally-acting gastrointestinal products.
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Bioequivalence Assessment for Long-Acting Injectables (LAIs) – FDA Regulatory Perspectives
Jiang, Wenlei
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Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices
Jiang, Wenlei
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In Vivo Relevance of Dissolution
Jiang, Wenlei
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Summary of 2nd GBHI Worshop Session IV: Exclusion of Pharmacokinetic Data is Bioequivalence Assessment
Jiang, Wenlei
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Equivalence Criteria for In Vitro BE Tests for Locally Acting Drug Products: The Earth Mover’s Distance Approach
Hu, Meng
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Bioequivalence of Polymeric Long Acting Drugs
Wang, Yan
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Model-informed Drug Development for Long-acting Injectable Products
Fang, Lanyan (Lucy)
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Potential Impact of Gastric pH on Generic Drug Bioequivalence Evaluation
Fan, Jianghong