Modeling and Simulation in Drug Development

4/16/01


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Table of Contents

Modeling and Simulation in Drug Development

Knowledge Generation Cycle

Modeling & Simulation

Why Modeling & Simulation?

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Primary Areas of Use

Pre-Clinical & Non-Clinical

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“Early” Clinical Development

Basic Concept: A Sample “Chaining” of Models

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Evaluation of Dose & Drug t1/2 for Effect

“Late” Clinical Development

Example: Simulation comparing therapeutic drug monitoring with fixed dosing

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Why Not Simulate?

Premises (Two Classes)

Premises (Two Classes)

Implementation

Towards Confidence in Implementation

Interpretation

Summary: Why Not Simulate?

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Recent Clinical References

Relevant (?) FDA Guidance

Effectiveness Guidance, pt 2

Do we currently combine premise, data, & analysis for regulatory approval?

Conclusions

Author: Michael Hale