GDUFA Research Outcomes

Other Generics Research

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to other research relevant to generic products.

• All(66)
• Posters(11)
• Presentations(47)
• Papers(8)

• Expanding Global Access to Complex Generics: The Case for Regulatory Convergence

  Pribulda, Victor; Koduri, Chaitanya; Ibrahim, Sarah; Blake, Kevin

• 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

• In Vitro Oral Cavity Permeability Assessment to Enable Simulation of Drug Absorption

  Dwivedi, Pankaj; Kalra, Priyata; Zhou, Haiying; Alam, Khondoker; Tsakalozou, Eleftheria; Al-Ghabeish, Manar; Kelchen, Megan; Pauletti, Giovanni

• 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

• iBCS: 4. Application of the Inhalation Biopharmaceutics Classification System to the Development of Orally Inhaled Drug Products

  Forbes, Ben; Backman, Per; Cabal, Antonio; Clark, Andy; Ehrhardt, Carsten; Hastedt, Jayne E; Hickey, Anthony J; Hochhaus, Guenther; Jiang, Wenlei; Kassinos, Stavros; Kuehl, Philip J; Olsson, Bo; Prime, David; Son, Yoen-Ju; Teague, Simon; Tehler, Ulrika; Wylie, Jennifer

• Perspectives on Current Quality and Bioequivalence Challenges for Complex Products

  O’Reilly Beringhs, Andre; Delvadia, Renishkumar

• ICH M13 Guideline Series

  Zhang, Lei

• Mastering Controlled Correspondences: What, When, and How

  Wang, Yan

• From In Vitro Dissolution Testing to In Vivo Clinical Pharmacokinetic Prediction Using PBPK Models for Oral Cavity Drug Products

  Plait, Fiona; Kalra, Priyata; Le Merdy, Maxime; Subhami, Saima; Lukacova, Viera; Dwivedi, Pankaj; Alam, Khondoker; Tsakalozou, Eleftheria; Pauletti, Giovanni; Zhou, Haiying

• Progress in Clinical Pharmacology in China: A Randomized Controlled Study to Advance Genotype-Guided Precision Medicine

  Zhao, Liang; Giacomini, KM; Van Der Graaf, Piet H