GDUFA Research Outcomes
QCP Models
-
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
-
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
-
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