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(57)
• Posters(10)
• Presentations(44)
• Papers(3)

• 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

• iBCS: 3. A Biopharmaceutics Classification System for Orally Inhaled Drug Products

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

• Understanding Syringeability and Injectability of High Molecular Weight PEO Solution through Time-Dependent Force-Distance Profiles

  Feng, Xin; Wu, Kai-Wei; Balajee, V; Leissa, Jesse; Ashraf, Muhammad; Xu, Xiaoming

• The Development and Framework of MMF as a Regulatory Initiative

  Zhao, Liang

• The Development and Framework of MMF as a Regulatory Initiative

  Zhao, Liang

• When Modeling & Simulation Meets AI

  Zhao, Liang

• Model-Integrated Evidence (MIE) Industry Meeting Pilot Between FDA and Generic Drug Applicants

  Zhao, Liang

• Applying Modeling & Simulation to Support Drug Lifecycle Management

  Zhao, Liang

• Introduction: Statistical Approaches to establishing Bioequivalence

  Zhao, Liang

• M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Implementing the Final Guidance

  Zhang, Lei; Tampal, Nilufer; Kim, Myong Jin