Communicating the Value of Pharmacodynamic Modelling in Drug ...
Communicating the Value of Pharmacodynamic Modelling in Drug ...
Communicating the Value of Pharmacodynamic Modelling in Drug ...
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Models provide answers to important cl<strong>in</strong>ical<br />
questions.<br />
What is <strong>the</strong> expected cl<strong>in</strong>ical response for a treatment <strong>in</strong> a particular<br />
patient population?<br />
What is <strong>the</strong> level <strong>of</strong> certa<strong>in</strong>ty surround<strong>in</strong>g predicted response?<br />
How do different treatment strategies and target patient sub-populations<br />
impact response?<br />
But <strong>of</strong>ten <strong>the</strong> challenge is <strong>in</strong> communicat<strong>in</strong>g this<br />
<strong>in</strong>formation to nonmodellers<br />
What is <strong>the</strong> probability that response is less or greater than a specific<br />
target?<br />
who lack familiarity with <strong>the</strong> models,<br />
What dose is required to achieve a target response?<br />
but who need to be <strong>in</strong>formed <strong>of</strong> <strong>the</strong> drugs key<br />
attributes <strong>in</strong> order to make cl<strong>in</strong>ical development<br />
decisions.<br />
What is <strong>the</strong> probability <strong>of</strong> achiev<strong>in</strong>g a specific efficacy target while keep<strong>in</strong>g<br />
probability for adverse events below a certa<strong>in</strong> level?<br />
How do <strong>the</strong> attributes for <strong>the</strong> compound compare to competitors?<br />
What is optimal position<strong>in</strong>g strategy versus competitors to balance safety<br />
and efficacy?<br />
slide 33<br />
30 May 2008, ARCS<br />
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