Analysis of Global Drug Development Pathways and Postmarketing Safety in Japan: Local Studies May Reduce Drug‐Related Deaths
Recent International Conference on Harmonization (ICH) guidelines provide pharmaceutical companies with regulatory justifications to pursue various global drug‐development pathways, in some of which "local" dose‐ranging and/or pivotal phase III studies are skipped. We examined the associat...
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Wiley,
2019-07-01T00:00:00Z.
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