GDUFA Research Outcomes

BE Methods & Analyses

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to bioequivalence methods and analyses for generic drug products.

• All(237)
• Posters(60)
• Presentations(64)
• Papers(113)

• 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

• Identify Biopredictive Dissolution for Predicting In Vivo Performance of a BCS II Drug Product Under Fed Conditions

  Du, Ping; Fang, Lanyan; Zhao, Liang; Wu, Fang

• 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

• 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

• Effect of Medium Viscosity on Swelling and Disintegration of Immediate Release Solid Oral Tablet

  Doole, Fatima T; Don, Ranganath W; Poudel, Ishwor; Zhang, Lei; Jiang, Wenlei; Gao, Zongming

• Global Harmonization of Immediate-Release Solid Oral Drug Product Bioequivalence Recommendations and the Impact on Generic Drug Development

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

• 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

• FDA Perspective on Dissolution Testing for Development of High-Risk Oral Drug Products Containing Amorphous Solid Dispersions

  Zhao, Gang; Wei, Kevin; Nguyen, Duyen; Lim, Hye-Lim; Rege, Bhagwant; Lu, Dongmei; Zhang, Qi

• 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

• A Generic Tacrolimus Capsule Shown Not to Be Bioequivalent to the Brand Tacrolimus Capsule in a Post-approval Pharmacokinetic Bioequivalence Study in Healthy Subjects

  Sun, Wei-Jhe; Mahjabeen, Sanjida; Kinjo, Minori; Thomas, Sherin; Wu, Fang; Ni, Zhanglin; Frost, Mitchell; Markollari, Artan; Best, Ryan; Le, Sunny; Kim, Myong-Jin; Zhao, Liang