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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Example 1. How can precl<strong>in</strong>ical data be used to<br />
support dose selection for a FIM study?<br />
Allometric scal<strong>in</strong>g was used to predict human<br />
pharmacok<strong>in</strong>etics.<br />
Precl<strong>in</strong>ical PK/PD data from cynomolgous monkey, relative<br />
potency <strong>in</strong>formation and literature data was used for<br />
simulation.<br />
A range <strong>of</strong> doses (30-fold), regimens (QD and BID) and<br />
bioavailability fractions (5 to 50%) were used to project<br />
human PK vs. response pr<strong>of</strong>iles The comb<strong>in</strong>ation <strong>of</strong> dose and<br />
bioavailability ranges was chosen to compensate for any<br />
misspecification due to projection method or underly<strong>in</strong>g<br />
assumptions.<br />
Target <strong>the</strong>rapeutic range was determ<strong>in</strong>ed us<strong>in</strong>g publicly<br />
available literature for three comparators.<br />
slide 16<br />
30 May 2008, ARCS<br />
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