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(138)
• Posters(42)
• Presentations(65)
• Papers(31)

• Use of Partial AUC to Demonstrate Bioequivalence of Zolpidem Tartrate Extended Release Formulations

  Lionberger, Robert; Raw, Andre; Kim, Stephanie; Zhang, Xinyuan; Yu, Lawrence