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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Effect on aPTT is Concentration Dependent<br />
Concentration-aPTT relationship is similar between<br />
adults (healthy) and pediatrics (patients)<br />
200<br />
Healthy Adults<br />
Pediatric Patients<br />
Population Mean<br />
aPTT (seconds)<br />
150<br />
100<br />
50<br />
E =<br />
E<br />
0<br />
+<br />
E<br />
EC<br />
max<br />
50<br />
⋅C<br />
+ C<br />
0<br />
0.1 1 10 100 1000 10000<br />
Plasma Argatroban (ng/mL)<br />
September 24-25, 2009 OCP Ambassador Program Nit<strong>in</strong>.Mehrotra@fda.hhs.gov 20