Table of Contents
Modeling and Simulation in Drug Development
Knowledge Generation Cycle
Modeling & Simulation
Why Modeling & Simulation?
PPT Slide
Primary Areas of Use
Pre-Clinical & Non-Clinical
PPT Slide
“Early” Clinical Development
Basic Concept: A Sample “Chaining” of Models
PPT Slide
Evaluation of Dose & Drug t1/2 for Effect
“Late” Clinical Development
Example: Simulation comparing therapeutic drug monitoring with fixed dosing
PPT Slide
Why Not Simulate?
Premises (Two Classes)
Premises (Two Classes)
Implementation
Towards Confidence in Implementation
Interpretation
Summary: Why Not Simulate?
PPT Slide
Recent Clinical References
Relevant (?) FDA Guidance
Effectiveness Guidance, pt 2
Do we currently combine premise, data, & analysis for regulatory approval?
Conclusions
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