title: Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors.
authors.affiliation: Office of New Drugs III, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Ichimaru
authors.forename: S
authors.initials: S
authors.lastname: Toyoshima
authors.forename: Y
authors.initials: Y
authors.lastname: Uyama
mesh_terms: D054316:Biomarkers, Pharmacological / Q000032:analysis; D002986:Clinical Trials as Topic / Q000379:methods / Q000639:trends; D017277:Drug Approval / Q000379:methods*; D055808:Drug Discovery / Q000379:methods* / Q000639:trends*; D064420:Drug-Related Side Effects and Adverse Reactions; D005006:Ethnicity / Q000208:ethnology*; D006801:Humans; D038622:Internationality; D007564:Japan; D004364:Pharmaceutical Preparations / Q000008:administration & dosage
chemical_list: D054316:Biomarkers, Pharmacological; D004364:Pharmaceutical Preparations