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- Title
Effective Global Drug Development Strategy for Obtaining Regulatory Approval in Japan in the Context of Ethnicity-Related Drug Response Factors.
- Authors
Ichimaru, K.; Toyoshima, S.; Uyama, Y.
- Abstract
In recent years, drug development has become dramatically globalized, and global clinical trials (GCTs) are being conducted in both International Conference on Harmonisation (ICH) and non-ICH regions.1 To ensure the success of global drug development, ethnicity-related factors must be taken into consideration. In this article, the experiences and initiatives of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan are described, and the contours of an effective global drug development strategy are discussed.
- Subjects
DRUG development; STRATEGIC planning; GLOBALIZATION; CLINICAL trials; ETHNICITY
- Publication
Clinical Pharmacology & Therapeutics, 2010, Vol 87, Issue 3, p362
- ISSN
0009-9236
- Publication type
Article
- DOI
10.1038/clpt.2009.285