GDUFA Research Outcomes

BE Methods & Analyses

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

• Utilizing PBPK Absorption Modeling to Evaluate Impact of Single-Sex on Bioequivalence Evaluation of Atorvastatin Immediate Release Tablets

  Cheng, Yi Hsien; Wu, Fang; Zhao, Liang; Fang, Lanyan (Lucy)

• Comparing a t-Distribution-Based Bayesian Approach with the Two One-Sided t-Test (TOST) for Bioequivalence Studies in Real-World Datasets

  Wang, Jing; Campbell, Gregory; Hu, Meng; Feng, Kairui; Chattopadhyay, Somesh; Zhao, Liang; Peck, Carl

• Assessment of Male Infertility Risks to Support Product-Specific Guidance Development for Generic Oral Products

  Park, Se Jin; Nguyen, Duyen; Tran, Tony; Li, Karen; Kim, Myong – Jin; Borges, Silvana; Shon, Jihong

• 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