Population PKPD Mode.. - Pharsight Corporation
Population PKPD Mode.. - Pharsight Corporation
Population PKPD Mode.. - Pharsight Corporation
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PK/PD Expertise to Support Drug Development<br />
3) <strong>Population</strong> PK/PD Analysis<br />
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<strong>Mode</strong>ling and Simulation Analysis Plan<br />
PK/PD Analysis using NONMEM and Supporting Figures with S-Plus<br />
• <strong>Mode</strong>l build-up Process<br />
• Covariate Analysis and <strong>Mode</strong>l Validation (bootstrap, case-deletion diagnostic, predictive check)<br />
• 100% QC’d (Dataset, Programs, & Outputs) by two scientists (Auth. and Reviewer)<br />
<strong>Population</strong> PK Report or ICHE3 Clinical Study Report<br />
<strong>Mode</strong>l Build-Up<br />
Covariate Analysis<br />
and <strong>Mode</strong>l Validation<br />
Simulations<br />
slide 16<br />
© <strong>Pharsight</strong> <strong>Corporation</strong> All Rights Reserved
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