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Communicating the Value of Pharmacodynamic Modelling in Drug ...

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…. And What Can Be Done About It?<br />

Model-Based <strong>Drug</strong> Development (MBDD)<br />

● Ra<strong>the</strong>r than fill<strong>in</strong>g <strong>in</strong> gaps <strong>in</strong> knowledge, M&S is now<br />

be<strong>in</strong>g used to better design future studies and drug<br />

development programs:<br />

• Optimize cl<strong>in</strong>ical drug development focus on<br />

establish<strong>in</strong>g exposure-response relationships to allow<br />

correct choice <strong>of</strong> dose(s)<br />

• Establish <strong>the</strong> use <strong>of</strong> drug-disease models and<br />

advanced pharmacometric concepts <strong>in</strong> early drug<br />

development<br />

• Promote <strong>the</strong> use <strong>of</strong> <strong>in</strong>novative cl<strong>in</strong>ical designs early <strong>in</strong><br />

cl<strong>in</strong>ical development to establish pro<strong>of</strong> <strong>of</strong> concept<br />

and exposure-response relationships<br />

slide 5<br />

30 May 2008, ARCS<br />

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