GDUFA Research Outcomes

QCP Models

• All(7)
• Posters(0)
• Presentations(5)
• Papers(2)

• pyDarwin Machine Learning Algorithms Application and Comparison in Nonlinear Mixed-effect Model Selection and Optimization

  Li, Xinnong; Sale, Mark; Nieforth, Keith; Craig, James; Wang, Fenggong; Solit, David; Feng, Kairui; Hu, Meng; Bies, Robert; Zhao, Liang

• pyDarwin: A Machine Learning Enhanced Automated Nonlinear Mixed-Effect Model Selection Toolbox

  Li, Xinnong; Sale, Mark; Nieforth, Keith; Bigos, Kristin L; Craig, James; Wang, Fenggong; Feng, Kairui; Hu, Meng; Bies, Robert; Zhao, Liang

• Introduction & Overview: Current Regulatory Horizon of Narrow Therapeutic Index Drugs & ICH Guideline Development for Bioequivalence Assessment

  Zhang, Lei

• Considerations for FEV1-based Comparative Clinical Endpoint or Pharmacodynamic Bioequivalence Studies for Orally Inhaled Drug Products

  Gong, Yuqing

• ANDA Challenges Related to Vasoconstrictor Studies

  Feng, Kairui

• Acceptability Of Using Alternative Pk Metrics From Systemic Pharmacokinetic (Pk) Data To Inform Regional Deposition For Orally Inhaled Drug Products

  Feng, Kairui

• User Friendly Tools for Population PK and PBPK modeling

  Bies, Robert S