Role of Quantitative Clinical Pharmacology in Guiding Drug
Role of Quantitative Clinical Pharmacology in Guiding Drug
Role of Quantitative Clinical Pharmacology in Guiding Drug
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Simulations to Explore Optimum Dos<strong>in</strong>g<br />
Models<br />
PKPD<br />
Demographics<br />
Dos<strong>in</strong>g<br />
0.25-3 ug/kg/m<strong>in</strong><br />
<strong>in</strong> <strong>in</strong>crements <strong>of</strong><br />
0.25 ug/kg/m<strong>in</strong><br />
Start<strong>in</strong>g Dose<br />
Simulations<br />
Generate conc. &<br />
aPTT data <strong>in</strong><br />
5000 peds at<br />
each dose<br />
Analysis<br />
Count % patients:<br />
< Target<br />
Achiev<strong>in</strong>g Target<br />
Exceed<strong>in</strong>g Target<br />
Target: 1.5-3 times basel<strong>in</strong>e aPTT and < 100 seconds.<br />
September 24-25, 2009 OCP Ambassador Program Nit<strong>in</strong>.Mehrotra@fda.hhs.gov 21
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