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How should ethnicity‐related information be included on drug labels? Considerations based on comparison of multiregional clinical trial data on the label between Japan and the United States
Author(s) -
Tanaka A,
Asano K,
Uyama Y
Publication year - 2015
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.197
Subject(s) - ethnic group , clinical trial , drug , drug development , medicine , drug trial , alternative medicine , family medicine , pharmacology , political science , pathology , law
Clinical data on various ethnicities collected in multiregional clinical trials (MRCTs) have increased in regulatory review for drug approval. However, how such data should be included on the drug labels has not been discussed. We compared information related to ethnicities on the labels of drugs that were approved in both Japan and the United States, and discussed the issues to be considered for providing better information to healthcare professionals in this era of globalized drug development.