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European Medicines Agency trials guidelines

FTIH trials are discussed in the Guideline on strategies to identify and mitigate risks for first-in human clinical trials with investigational medicinal products, EMEA/CHMP/SWP/28367/07issued by the European Medicines Agency (EMEA), in 2007. [Pg.512]

European Medicines Agency—Committee for Medicinal Products for Human Use (CHMP). Guideline on Strategies to Identify and Mitigate Risks for First-in-Man Human Clinical Trials with Investigational Medicinal Products. EMEA/CHMP/ SWP/2836707/2007. 19 July 2007. http //www.emea.europa.eu/pdfs/human/swp/ 2836707enfin.pdf... [Pg.91]

European Medicines Agency (2004) CPMP/CHMP/QWP185401 Draft guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials. (http //www.emea.eu.int/Inspections/docs/18540104en.pdf)... [Pg.171]

See other pages where European Medicines Agency trials guidelines is mentioned: [Pg.4]    [Pg.70]    [Pg.579]    [Pg.68]    [Pg.165]    [Pg.166]    [Pg.129]    [Pg.172]    [Pg.27]    [Pg.98]    [Pg.22]    [Pg.262]    [Pg.56]    [Pg.2339]    [Pg.157]    [Pg.353]    [Pg.5]   
See also in sourсe #XX -- [ Pg.975 ]



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