Role of PKPD Modeling and Simulation in Influencing ... - Pharsight
Role of PKPD Modeling and Simulation in Influencing ... - Pharsight
Role of PKPD Modeling and Simulation in Influencing ... - Pharsight
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Case Study 1: Transition<strong>in</strong>g from Precl<strong>in</strong>ical to FIH<br />
• Integration <strong>of</strong> animal data <strong>and</strong> public literature allowed human PK-<br />
PD to be projected under certa<strong>in</strong> plausible assumptions <strong>and</strong><br />
scenarios.<br />
• Human projections for CS-3030 identified dos<strong>in</strong>g regimens which<br />
provided similar efficacy <strong>and</strong> safety pr<strong>of</strong>iles to that <strong>of</strong> comparators<br />
• This example illustrates the application <strong>of</strong> M&S to guide drug<br />
development <strong>and</strong> <strong>in</strong>form the design <strong>of</strong> cl<strong>in</strong>ical trials.<br />
Slide 25<br />
© Tripos, L.P. 2011 All Rights Reserved
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