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Role of PKPD Modeling and Simulation in Influencing ... - Pharsight

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… <strong>and</strong> Strategically<br />

Application <strong>of</strong> <strong>in</strong>tegrated drug-disease-trial models to<br />

optimize cl<strong>in</strong>ical development programs with respect to<br />

therapeutic potential, R&D productivity <strong>and</strong> commercial<br />

value.<br />

Trial Data<br />

Disease<br />

Model<br />

Drug<br />

Model<br />

Diverse<br />

Expertise<br />

Physiology<br />

Trial<br />

Model<br />

‣Biology<br />

‣Natural Progression<br />

‣Placebo<br />

‣Biomarker-Outcome<br />

‣Pharmacology<br />

‣Effectiveness<br />

‣Safety<br />

‣Early-Late<br />

‣Precl<strong>in</strong>ical-Healthy-Patient<br />

‣Patient Population<br />

‣Drop-out<br />

‣Compliance<br />

Graphic provided courtesy <strong>of</strong> Dr. Joga Gobburu, OCP/FDA.<br />

Slide 18<br />

© Tripos, L.P. 2011 All Rights Reserved

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