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European Medicines Agency Committees

Christians U, First MR, Benet LZ (2000) Recommendations for bioequivalence testing of cyclosporine generics revisited. Ther Drug Monit 22 330-335 CPMP (2000) European Medicines Agency. Committee for Proprietary Medicinal Products. Note for guidance on the investigation on bioavailability and bioequivalence. CPMP/EWP/QWP/1401/98.http //www.emea.europa.eu/pdfs/human/qwp/140198en.pdf. Cited 30 Dec 2008... [Pg.110]

European Medicines Agency. Committee for Human Medicinal Products Guideline on the Specification Limits for Residues of Metal Catalysts, http //www.ema.europa.eu/ docs/en GB/document library/Scientific guideline/ 2009/09/WC500003586.pdf (accessed October 2012). [Pg.356]

European Medicines Agency—Committee for Proprietary Medicinal Products. Guideline on the Evaluation of Control Samples In Nonclincial Safety Studies Checking for Contamination with the Test Substance. CPMP/SWP/1094/04. 17 March 2005. http //www.emea.europa.eu/pdfs/human/swp/109404en.pdf... [Pg.90]

European Medicines Agency—Committee for Proprietary Medicinal Products. Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products. CPMP/BWP/3088/99. London, 24 April 2001. http //www. emea.eu.int/pdfs/human/bwp/308899en.pdf... [Pg.91]

European Medicines Agency—Committee for Proprietary Medicinal Products. Guideline on the Comparability of Medicinal Products Containing Biotechnology-... [Pg.91]

European Medicines Agency—Committee for Medicinal Products for human use. Guideline on Similar Biological Medicinal Products. CHMP/437/04, 30 October... [Pg.92]

European Medicines Agency—Committee for Medicinal Products for Human Use. Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance Nonclinical and Clinical Issues. EMEA/ CHMP/42832/05. 22 February 2006. http //www.emea.europa.eu/pdfs/human/ biosimilar/4283205en.pdf... [Pg.92]

EMEA (European Medicines Agency, Committee for Human Medicinal Products). Guideline on the need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications (Draft). 2005. EMEA/CHMP/SWP/169215/ 2005. [Pg.293]

EMEA. 2008. Community herbal monograph on Solidago virgaurea L., heiba. London European Medicines Agency, Committee on Herbal Medicinal Products. [Pg.821]

See other pages where European Medicines Agency Committees is mentioned: [Pg.232]    [Pg.444]    [Pg.92]    [Pg.92]    [Pg.64]   


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