GDUFA Research Outcomes
Human Subject Saftey
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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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Potential Impact of Gastric pH on Generic Drug Bioequivalence Evaluation
Fan, Jianghong
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FDA and EMA Regulatory Recommendations on Fed Bioequivalence Study in Healthy Subjects vs. Patients for Generic Drug Development
Bae, Jihyun; Tran, Tony; Nguyen, Duyen; Borges, Silvana; Kim, Myong-Jin.; Shon, Jihong; Li, Karen
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A Comparative Review of Study Population and Dose Recommendations for In Vivo Bioequivalence Studies with Pharmacokinetic Endpoints between FDA and EMA Guidances
Tran, Tony; Bae, Jihyun; Nguyen, Duyen; Borges, Silvana; Kim, Myong Jin; Li, Karen; Shon, Jihong
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Evaluation of U.S. FDA Approved Generic Oral Solution Products
Hakeem, Susan; Huang, Yih-Chain; Jiang, Wenlei