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First-in-man clinical trials for high risk products.(Recent Publications, Information and Events)

WHO Drug Information

| March 22, 2007 | COPYRIGHT 1999 World Health Organization. (Hide copyright information)Copyright

European Union -- The Committee for Medicinal Products for Human Use (CHMP) has adapted a draft guideline for first-in-man clinical trials for potential high-risk medicinal products. This guideline has been prepared as one of the measures for minimizing the risk of serious adverse reactions of the nature that occurred during the …

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