GDUFA Research Outcomes

IR Oral Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to immediate release generic drug products.

• All(19)
• Posters(4)
• Presentations(12)
• Papers(3)

• Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices

  Jiang, Wenlei

• In Vivo Relevance of Dissolution

  Jiang, Wenlei

• 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

• Identifying High Drug Load Solid Oral Products with Swallowing-Related Adverse Events for In Vitro Swallowability Testing

  Nguyen, Duyen; Shon, Jihong; Frost, Mitchell; Kim, Myong-Jin; Natarajan, Karthika

• The Impact of Cyclodextrin on Fasting and Fed Bioequivalence Studies in Solid Oral Immediate-Release Drug Products

  Kotsybar, Joseph; Zhang, Lei; Jiang, Wenlei

• Solid Oral Immediate-Release Drug Product Landscape and Bioequivalence Recommendations

  Kotsybar, Joseph; Hakeem, Susan; Zhang, Lei; Jiang, Wenlei

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

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