ABSTRACT
The ICH E5 guideline suggests that a bridging study (BS) be conducted in the new region to generate additional information to bridge the foreign clinical data, when this data contained in the complete clinical data package (CCDP) cannot provide
sufficient bridging evidence. According to the ICH E5 guideline, a BS is therefore defined as a supplementary study conducted in the new region to provide pharmacodynamic or clinical data on the efficacy, safety, dosage, and dose regimen to allow extrapolation of the foreign clinical data to the population of the new region. Recently, interest has developed in assessing the similarity based on the additional information from the BS and the foreign clinical data in the CCDP.
