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2004 Workshop Presentations
Session 1: Model Qualification
Fiedler-Kelly:
Introduction to Workshop: Session I Content and Terms
Gastonguay:
Brief Overview of Model Qualification and Validation Methodologies
Case Study 1:
PopPK Analysis of a High-Dose Antineoplastic for Bone Marrow Transplant in Adults and Children
Case Study 2:
PopPK Analysis of an Intravenous Dose Ranging Study Evaluating an Antineoplastic Agent in Adults and Children
Case Study 3:
Drug X PK-PD Modeling/Simulation
Case Study 4:
Model Qualifications in Industrial Applications
Duffull:
Selecting The Right Model Across Modeling Platforms � A Pop PK/PD Perspective
Session 2: Software Validation
Mould:
Introduction to Workshop: Session II Content and Terms
Gobburu:
Population Analysis Software Validation: Good Practices
Fiedler-Kelly:
Example Documentation of Population Software Validation Efforts
2004 Scientific Meeting Presentations
Booth:
"Population Pharmacokinetic Modeling and Simulation-Derived Dosing of Intravenous Busulfan in Pediatric Patients"
Gopalakrishnon:
"A Pharmacokinetic-Pharmacodynamic Model for Insulin to Guide Optimal Drug Delivery"
Jadhav:
"Mixed Effects Model Qualification Using Predictive Check"
Duan:
"Population Pharmacokinetics in Assessing Drug-Drug Interactions: Consideration During Regulatory Review"
Guzy:
"Application of the Monte Carlo Parametric Expectation Maximization (MCPEM) Algorithm for Analyzing Population Pharmacokinetic/Pharmacodynamic (PK/PD) Data"
Li:
"Impact of Mis-specified Residual Model on Parameter Estimates in Population Pharmacokinetic Analysis"
Nedelman:
"Diagnostics for Confounding in a PK/PD Model"
Madabushi:
"Mixed Effects Modeling of Sparse Data: A Comparison of Three Software Packages"
Tornoe:
"Stochastic Differential Equations in NONMEM: A Diagnostic Tool for Pinpointing Model Deficiencies"
Lee:
"Population Pharmacokinetics of Troxacitabine"