bridging data package
- Guideline or reference source
- ICHE5(R1) Ethnic factors in the acceptability of foreign clinical data
- Definition
- Selected information from the Complete Clinical Data Package that is relevant to the population of the new region, including pharmacokinetic data, and any preliminary pharmacodynamic and dose-response data and, if needed, supplemental data obtained from a bridging study in the new region that will allow extrapolation of the foreign safety and efficacy data to the population of the new region.
- Related Term
- bridging study
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