GDUFA Research Outcomes

QCP Methods

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to quantitative clinical pharmacology assessments of oral absorption to support generic product development and assessment.

• All(110)
• Posters(37)
• Presentations(56)
• Papers(17)

• Regulatory Challenges with Pharmacokinetic (PK) Bioequivalence (BE) Studies for Drugs Containing Endogenous Compounds

  Donnelly, Mark

• Model-Integrated Evidence for Bioequivalence Assessment of Long-Acting Injectables from a Generic Drug Perspective

  Yoon, Miyoung

• Model-Integrated Evidence for BE Assessment of Complex Generic Drugs

  Yoon, Miyoung

• Pharmacometric Approach To Define Narrow Therapeutic Index (NTI) Drugs & Evaluate Bioequivalence (BE) Criteria for NTI Drugs

  Dahmane, Elyes; Gobburu, Joga; Ivaturi, Vijay

• Use of Clinical Practice Data and PK/PD Modeling to Aid Classification of Narrow Therapeutic Index Drugs

  Cohen-Wolkowiez, Michael

• Clinical Practice Data to Aid Narrow Therapeutic Index Drug Classification

  Cohen-Wolkowiez, Michael

• Levetiracetam Characterization: Is it an NTI Drug?

  Clarke, William

• Model-based Bioequivalence Evaluation for Ophthalmic Products Using Model Averaging Approaches

  Chen, Xiaomei; Hooker, Andrew; Nyberg, Henrik; Karlsson, Mats

• Real-World Data Approaches for Early Detection of Potential Safety and Effectiveness Signals for Generic Substitution: A Metoprolol ExtendedRelease Case Study

  Brown, Joshua

• Best Practices to Leverage Model-Integrated Evidence and Model Master File Packages to Bring Complex Generics to Market

  Ghosh, Priyanka