GDUFA Research Outcomes

Human Subject Saftey

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to the safety of human subjects in bioequivalence studies for generic products.

• All(16)
• Posters(3)
• Presentations(12)
• Papers(1)

• Summary of 2nd GBHI Worshop Session IV: Exclusion of Pharmacokinetic Data is Bioequivalence Assessment

  Jiang, Wenlei

• Equivalence Criteria for In Vitro BE Tests for Locally Acting Drug Products: The Earth Mover’s Distance Approach

  Hu, Meng

• Potential Impact of Gastric pH on Generic Drug Bioequivalence Evaluation

  Fan, Jianghong

• 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

• 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

• Evaluation of U.S. FDA Approved Generic Oral Solution Products

  Hakeem, Susan; Huang, Yih-Chain; Jiang, Wenlei