GDUFA Research Outcomes

QCP Methods

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

• 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

• Performance of Machine Learning Algorithms for Model Selection

  Sale, Mark

• Clearing the Path for Modeling and Simulation in Drug Applications

  Lionberger, Robert

• Quantitative Medicine Innovations in the Generic Drug Program

  Lionberger, Robert

• Batch-to-Batch Pharmacokinetic Variability of Orally Inhaled Drug Products

  Li, Matt (Zhichuan)

• Dose-Scale (Emax) Modeling in Pharmacodynamic Bioequivalence Studies – FDA Perspective

  Li, Matt

• Data-driven & Science-based Recommendation on Harmonization of Bioequivalence Standards for Narrow Therapeutic Index Drugs

  Jiang, Wenlei

• Predictive Performance of PBPK Dose Estimates for Pediatric Trials

  Dallmann, Andre