Transcription of Guideline on Repeated Dose Toxicity Corr - Europa
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Guideline on Repeated Dose Toxicity Corr - Europa
7 Westferry Circus Canary Wharf London E14 4HB United KingdomTelephone+44 (0)20 7418 8400 Facsimile +44 (0)20 7418 agency of the European Union European Medicines Agency, 2010. Reproduction is authorised provided the source is March 2010 CPMP/SWP/1042/99 Rev 1 Corr*Committee for Human Medicinal Products(CHMP) Guideline on Repeated dose toxicityDraft Agreed by Safety Working PartyMay - December 2007 Adoption by CHMP for release for consultation24 January 2008 End of consultation (deadline for comments)30 May 2008 Agreed by Safety Working PartyFebruary 2010 Adoption by CHMPM arch 2010 Date for coming into effect01 September 2010 Keywordsrepeated dose Toxicity , study design, choice of species, list of tissues * Reference to OECD Guidance Document 19 has been included in page 6, Section ; the section References has been updated accordingly.
data generated. However, ethical considerations as well as practical aspects are also of importance. The following should be considered: Background knowledge concerning the ranges of variables to be studied in the species and strains used …
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