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)

• Emerging 3D Printing Technologies for Solid Oral Dosage Forms: Processes, Materials and Analytical Tools for Real-Time Assessment

  Sierra-Vega, Nobel O; Ashraf, Muhammad; O’Connor, Thomas; Kopcha, Michael; Di Prima, Mathew; Coburn, James; Zidan, Ahmed

• An Ingestible Device for Automated Sampling and Location Tracing in Gastrointestinal Tract

  Li, T; Felton, J; Lewis, J; Cheng, Q; Meredith, R; Lu, HT; Benken, A; Dutta, PP; Liao, J; Zhao, XD; Matvekas, A; Baker, J; Hasler, WL; Babiskin, A; Walenga, R; Fang, L; Lionberger, R; Pal, MP; Sun, D; and Gianchandani, YB

• The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the sixth international EUFEPS/AAPS conference

  Schug, B; Beuerle, G; Bilensoy, E; Cook, J; Fernandes, E; Haertter, S; Kuribayashi, R; Mehta, M; Paixao, P; Seidlitz, A; Tampal, N; Tsang, Y-C; Walstab, J; Wedemeyer, R; Welink, J; Jiang, W

• Bioequivalence of ANDA Data using a Non-Informative Bayesian Procedure (BEST) Compared with the Two One-Sided t-Tests (TOST)

  Wang, Jing; Campbell, Gregory; Lee, Jae H; Hu, Meng; Feng, Karui; Chattopadhyay, Somesh; Zhao, Liang; Peck, Carl C

• Analysis on the Impact of U.S. FDA’s Narrow Therapeutic Index Bioequivalence Criteria on Generic Drug Applications

  Anim Anno, Krista; Mina, Mirette; Zhang, Zhen; Zhang, Lei; Jiang, Wenlei

• Assessing Impact of Food on Oral Drug Bioequivalence Supporting ICH M13A with the Advancements of Physiologically Based Pharmacokinetic Modeling: a Workshop Summary Report

  Pal, Arindom; Alam, Khondoker; Stier, Ethan M; Heimbach, T; Cristofoletti, R; Al-Gousous, Jozef; Langguth, Peter; Zakelj, Rebeka; Ahmed, Tausif; Almeida, Susana; Fan, Jianghong; Kolhatkar, Vidula; Paixao, Paulo; Rayeni, Mohan Krishna; Zhang, Lei K; Wu, Fang

• A Physiologically Based Biopharmaceutics Modeling (PBBM) Framework for Characterizing Formulation-Dependent Food Effects: Paving the Road towards Fed Virtual BE Studies for Itraconazole Amorphous Solid Dispersions

  Rudolph, Niklas; Charbe, Nitin; Plano, David; Al Shoyaib, Abdullah; Pal, Arindom; Boyce, Heather; Zhao, Liang; Wu, Fang; Polli, James; Dressman, Jennifer; Cristofoletti, Rodrigo

• Navigating Complexity: Key Considerations in Developing the Oral Semaglutide Product-Specific Guidance

  Nazzal, Sami

• Navigating the Draft ICH M13B Additional Strengths Biowaiver Guideline

  Zhang, Lei; Tampal, Nilufer; Raines, Kimberly

• ICH M13 Guideline Series

  Zhang, Lei