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This document outlines the current evaluation process for the Bridging Data Package (BPA) and includes details on self-evaluation checklists, internal review meetings, and consultant involvement if necessary. It highlights the requirements for supplemental documents and sponsor meetings, as well as the conditions under which Bridging Studies can be waived. Additionally, it provides insights into the Drug Advisory Committee's role and emphasizes the significance of PK/PD properties and clinical properties for assessing ethnic sensitivity through specific working lists and checklists.
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Current Evaluation Process BPA CDE Sponsor • Bridging data package • Summary of self-evaluation Checklist Case registered Internal review meeting Consultants If needed Supplemental documents If needed sponsor meeting Bridging Study waived Drug Advisory committee Bridging Study required
“Working Lists” PK/PD Properties and Clinical Properties for Assessing Ethnic Sensitivity -- PK/PD
“Working Lists” PK/PD Properties and Clinical Properties for Assessing Ethnic Sensitivity -- Clinical
