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ethnobridging studies

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Journal Article
East Asian Science, Technology and Society (1 September 2012) 6 (3): 379–399.
Published: 01 September 2012
... termed “bridging.” In particular, the ICH E5 focused on a type of study termed “ethnobridging,” studies conducted on a drug-by-drug basis to look at the sensitivities of a drug to “ethnic factors.” Ethnobridging studies are drug trials specific to ethnic populations to assure safety, effectiveness, and...
Journal Article
East Asian Science, Technology and Society (1 September 2012) 6 (3): 347–354.
Published: 01 September 2012
... drug approval process shorter, as Japan requires additional studies called ethnobridging studies to look at specific “ethnic factors” to assure safety, effectiveness, and dose specificity for a specific ethnic population, the Japanese. Despite protests by Western and Japanese critics, including...