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Role of PKPD Modeling and Simulation in Influencing ... - Pharsight

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Event Probability (%)<br />

0 10 20 30 40 50 60 70<br />

Case Study 1: Transition<strong>in</strong>g from Precl<strong>in</strong>ical to FIH<br />

Comparison across drugs showed favorable projected response pr<strong>of</strong>ile<br />

for CS-3030, comparable to observed responses for comparator drugs.<br />

QD regimen, VTE, Hip<br />

BID regimen, VTE, Hip<br />

QD regimen, Bleed, Hip<br />

BID regimen, Bleed, Hip<br />

Warfar<strong>in</strong> (INR=2.5), VTE, Hip<br />

Warfar<strong>in</strong> (INR=2.5), Bleed, Hip<br />

0.75 1.5 2.5 3 6 8 0 10 40 60 10 20 40<br />

Fondapar<strong>in</strong>ux Dose Enoxapar<strong>in</strong> Dose CS3030 Dose<br />

(mg/day) (mg/day) (mg/day)<br />

S Rohatagi et al., Model based development <strong>of</strong> a direct Factor Xa <strong>in</strong>hibitor, ACoP Meet<strong>in</strong>g, Tucson AZ, Mar 2008<br />

Slide 23<br />

© Tripos, L.P. 2011 All Rights Reserved

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