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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

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