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)

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

  Wu, Fang

• EMA Discussion on Levothyroxine NTI Classification and BE Approach

  Donnelly, Mark

• Partial Area Under Curve (pAUC): Product-Specific Guidance Development

  Fang, Lanyan (Lucy)

• Applications and Lessons Learned for Conducting Adaptive Designs in Generic Drug Development

  Feng, Kairui

• 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

• Application of Quantitative Clinical Pharmacology (QCP) in Development of Long Acting Injectable Products

  Sharan, Satish

• Application of Modeling and Simulation in Establishing Appropriate Bioequivalence Limits for Complex Formulations

  Sharan, Satish

• Evaluation Of Residual Levonorgestrel As Potential Bioequivalence Metric For A Long Acting Intrauterine System Using Quantitative Modeling And Simulation Approach

  Sharan, Satish

• Model-Integrated Methods and Innovative Study Designs for Generic LAI Product Development and Regulatory Assessment

  Hooker, Andrew