Comparison of global versus Asian clinical trial strategies supportive of registration of drugs in Japan
Author:
Affiliation:
1. Department of Drug Development and Regulatory Science of Pharmacy; Keio University; Tokyo Japan
2. Laboratory of Clinical Pharmacology; Yokohama College of Pharmacy; Kanagawa Japan
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1002/jcph.273/fullpdf
Reference24 articles.
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2. Globalization of sponsored clinical trials;Karlberg;Nature Rev. Drug Discov,2008
3. Ethical and scientific implications of the globalization of clinical research;Glickman;N. Engl. J. Med,2009
4. http://csdd.tufts.edu/files/uploads/outlook-2012.pdf
5. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/11/WC500013468.pdf
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