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Libraries scientific

ICH (2011) ICH guideKne S6 (Rl)— preclinical safety evaluation of biotechnology-derived pharmaceuticals, http //www.ema. europa.eu/docs/en GB / document library/ Scientific guideline / 2 0 09 / 09 / WC500002828.pdf Accessed 24 Aug 2011... [Pg.36]

EMEA (1997) Note for guidance on preclini-cal pharmacological and toxicological testing of vaccines. CPMP/SWP/465/95. http //www. ema.europa.eu/docs/en GB/document library/Scientific guideline/2 00 9/09/ WC500003102.pdf. Accessed 16 Sept 2011... [Pg.89]

ICH (2009) Harmonised Tripartite Guideline M3(R2). Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. http //www.ema.europa.eu/docs/en GB/ document library/Scientific guide-line/2009/09/WC500002941. pdf. [Pg.156]

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]

Committee for Medicinal Products for Human Use (CHMP). Points to consider on the choice of non-inferiority margin, 2005. http //www.ema.europa.eu/docs/ en GB/document library/Scientific guideline/2009/09/WC500003636.pdf... [Pg.51]

ICH. 2005. ICH topic E14 CHMP/IC/2/04. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Available from http //www.ema.europa.eu/docs/en GB/document library/ Scientific guideline/2009/09/WC500002879.pdf. Accessed March 5,2013. [Pg.336]

EMA (2006) Reflection paper formulations of choice for the paediatric population. http //www.ema.enropa.en/docs/en GB/doc nment library/Scientific guideline 009/09/WC500003782.pdf... [Pg.98]

EM A (2012) Guideline on the clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus. Effective November 2012. Available at. http //www.emtLeuropa. eu/docs/en GB/document library/Scientific guidelme 012/06/WC500129256.pdf Accessed 2 Jan 2016... [Pg.269]

EMA (2010) Guideline on the investigation of bioequivalence, appendix I dissolution testing and similarity of dissolution EMA 2010 profiles CPMP/EWP/QWP/1401/98 Rev. 1/ Corn http //www.ema.europa.eu/docs/en GB/document library/Scientific guideline/2010/01/... [Pg.511]

CHMP/SWP/169215/2005. www.ema.europa.eij/docs/en GB/docuinent library/Scientific guideline/2009/09/WC500003305.pdf... [Pg.374]

See other pages where Libraries scientific is mentioned: [Pg.65]    [Pg.193]    [Pg.11]    [Pg.105]    [Pg.105]    [Pg.20]    [Pg.47]    [Pg.249]    [Pg.348]    [Pg.150]    [Pg.54]   


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