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)

• Computational Studies of Drug Release, Transport, and Absorption in the Human Intestines

  Gong, Yuqing

• Screening Oral Excipients against P-glycoprotein

  Bajaj, Ruchika

• Biopharmaceutic In Vitro In Vivo Extrapolation (IVIV_E) Informed Physiologically-Based Pharmacokinetic Model of Ritonavir Norvir Tablet Absorption in Humans Under Fasted and Fed State Conditions

  Arora, Sumit

• Advancing the Science of Oral Solid Dosage Form Development and Performance

  Amidon, G

• In Vivo Predictive Dissolution (iPD) to Advance Oral Drug Product Development

  Amidon, Gordon

• New Scientific Directions in Oral Bioequivalence(BE)

  Amidon, Gordon

• Role of Biopredictive Dissolution and Oral PBPK to Evaluate the Impact of Food on Drug Absorption

  Al-Gousous, Jozef; Langguth, P

• 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