Population PKPD Mode.. - Pharsight Corporation
Population PKPD Mode.. - Pharsight Corporation
Population PKPD Mode.. - Pharsight Corporation
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RAS Regulatory PK-PD <strong>Mode</strong>ling<br />
RAS scientists use state of the art software and methods to perform<br />
regulatory-oriented population PK-PD data analysis.<br />
Regulatory <strong>Population</strong> PK-PD <strong>Mode</strong>ling & Simulation Activities<br />
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Dataset construction including QC and QA activities<br />
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<strong>Mode</strong>l Build-Up and Discrimination for Regulatory <strong>Population</strong> PK/PD Analysis<br />
Covariate Analysis<br />
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<strong>Mode</strong>l Validation (Bootstrap, Predictive Checks, Case-Deletion Diagnostics…)<br />
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<strong>Population</strong> PK Report & ICHE3 Clinical Study Report<br />
• Compliant with <strong>Population</strong> PK Guidances (FDA and EMEA)<br />
• Quality Controlled and Quality Assured<br />
slide 19<br />
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