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)

• Leveraging Quantitative Methods and Modeling to Modernize

  Zhao, Liang

• Application of Quantitative Methods and Modeling to Generic Drug Development

  Zhao, Liang

• Foundations of PK Comparisons of Generic Opioids to RLDs with Labeling Describing Abuse-deterrent Properties

  Zhao, Liang

• 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

• Model-Integrated Bioequivalence Establishment: Long-Acting Injectable Drug Products

  Yoon, Miyoung

• Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations

  Wu, Fang

• Recommendation of Partial Area Under the Curve (pAUC) Metrics in Product-Specific Guidance for Long-Acting Injectable (LAI) Drug Products

  Thomas, Sherin

• Comparative, Crossover PD Study of d|Different Formulations of Extended Release MPH

  Spencer, Thomas; Biederman, Joseph; Faraone, SV; Childress, Ann; Gomeni, Roberto; Babiskin, Andrew; Fang, Lucy

• Virtual Bioequivalence Workflow

  Pellowe, M