A Framework of Modeling and Simulation in Regulatory Decisions

4/16/01


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Table of Contents

A Framework of Modeling and Simulation in Regulatory Decisions

Terminology

Topics for Discussion

How good is the current drug development process?

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Simulation - a rapidly emerging technology

Current Environment

Number of CTS

Past Experience in M&S

New Experience in CTS

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Study Design/Conduct Factors

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Utilities of Simulation

Additional (Potential) Utilities of Simulations

Key Factors to Successful Simulation Projects

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Questions To ACPS Committee

Questions To ACPS Committee (cont.)

Author: CDER USER