bridging study
- Guideline or reference source
- ICHE5(R1) Ethnic factors in the acceptability of foreign clinical data
- Definition
- A bridging study is defined as a supplemental study performed in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage and dose regimen in the new region that will allow extrapolation of the foreign clinical data to the new region. Such studies could include additional pharmacokinetic information.
- Related Term
- bridging data package
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