Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors

Clin Pharmacol Ther. 2010 Mar;87(3):362-6. doi: 10.1038/clpt.2009.285. Epub 2010 Jan 27.

Authors

K Ichimaru¹, S Toyoshima, Y Uyama

Affiliation

¹ Office of New Drugs III, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

PMID: 20107436
DOI: 10.1038/clpt.2009.285

No abstract available

Publication types

Review

MeSH terms

Biomarkers, Pharmacological / analysis
Clinical Trials as Topic / methods
Clinical Trials as Topic / trends
Drug Approval / methods*
Drug Discovery / methods*
Drug Discovery / trends*
Drug-Related Side Effects and Adverse Reactions*
Ethnicity / ethnology*
Humans
Internationality
Japan
Pharmaceutical Preparations / administration & dosage

Substances

Biomarkers, Pharmacological
Pharmaceutical Preparations