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Role of Quantitative Clinical Pharmacology in Guiding Drug

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Agenda<br />

• What is Pharmacometrics?<br />

• Pharmacometrics: Concept, Application<br />

and Communication<br />

• Pediatrics: History <strong>of</strong> Legislation<br />

• Pediatric Case Studies:<br />

- Dos<strong>in</strong>g Recommendations<br />

- Trial Design<br />

• Tra<strong>in</strong><strong>in</strong>g needs for Pharmacometrics<br />

success<br />

Provid<strong>in</strong>g technical tra<strong>in</strong><strong>in</strong>g is not a goal <strong>of</strong> this presentation<br />

September 24-25, 2009 OCP Ambassador Program Nit<strong>in</strong>.Mehrotra@fda.hhs.gov 2

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