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(251)
• Posters(64)
• Presentations(67)
• Papers(120)

• Laser Directed Infrared (LDIR) Imaging to Track the Evolution of Polymorphic Transformation During Stability Studies on Ritonavir Tablets

  Zaker, Y; Yilmaz, H; Willett, D

• Laser Directed Infrared (LDIR) Imaging to Track the Evolution of Polymorphic Transformation During Stability Studies on Ritonavir Tablets

  Zaker, Y; Yilmaz, H; Willett, D

• Evaluation of Near Infrared (NIR) for the Quantification of Low Dose Drugs

  Krull, S; Ding ,T; Xu, X

• Impact of Risk Evaluation and Mitigation Strategy Programs on Product-Specific Guidance for Generic Drug Development

  Moore, A; Li, K; Shon, J; Kim, MJ; Nguyen, D

• 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