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Communicating the Value of Pharmacodynamic Modelling in Drug ...

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Our purpose is to view and query model-based attributes based on<br />

simulation <strong>of</strong> mean responses.<br />

We can achieve detailed exploration <strong>of</strong> <strong>the</strong> dose-response curve for many<br />

comb<strong>in</strong>ations <strong>of</strong> endpo<strong>in</strong>ts, treatments, covariates, and compet<strong>in</strong>g products<br />

%Change from Basel<strong>in</strong>e <strong>of</strong> <strong>Drug</strong> B<br />

Response Selection<br />

Covariates, Assumptions<br />

Plots Display Trends<br />

Shaded area shows prediction<br />

<strong>in</strong>terval for expected doseresponse<br />

or response as a<br />

function <strong>of</strong> o<strong>the</strong>r explanatory<br />

variables (e.g., dose, time)<br />

Controllable Inputs<br />

(Treatments, Compet<strong>in</strong>g<br />

Therapies & Doses)<br />

Tables Display Details<br />

Dotted horizontal l<strong>in</strong>e(s) show<br />

def<strong>in</strong>ed success ranges, or “cut<br />

po<strong>in</strong>ts” based on product<br />

pr<strong>of</strong>iles<br />

Vertical l<strong>in</strong>es show explanatory<br />

variables <strong>of</strong> <strong>in</strong>terest (e.g., dose,<br />

time)<br />

Output Controls<br />

Tables display quantitative<br />

estimates <strong>of</strong> prediction <strong>in</strong>tervals<br />

or o<strong>the</strong>r <strong>in</strong>formation<br />

slide 35<br />

30 May 2008, ARCS<br />

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