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EMEA 2001 Reproduction and/or distribution of this document is authorised This Note for guidance concerns the conduct of repeated dose toxicity studies of E-mail: mail@emea.europa.eu www.emea.europa.eu repeated dose toxicity, study design, choice of species, list of tissues .. This Guideline concerns the conduct of repeated dose toxicity studies of active substances intended for. 6 Sep 2013 In addition to the well-established procedures for the EMA's scientific . The organs listed in the guideline on repeated dose toxicity should beDescription, This document applies to the conduct of repeated dose toxicity studies of active substances intended for human use. It provides guidance on the 20 Jul 2017 Send a question via our website www.ema.europa.eu/contact .. Pharmacokinetics: Guidance for repeated dose tissue distribution studies (ICH S3B). . The non-clinical data in PD, PK and toxicology and their translation to. The European Medicines Agency's scientific guidelines currently open for consultation, see Single and repeat-dose toxicity; Genotoxicity; Carcinogenicity 23 Sep 2010 E-mail info@ema.europa.eu Website www.ema.europa.eu. An agency of the scope to similar guidelines already issued by OECD and FDA, is far less detailed. CMPM Note of Guidance on Repeated Dose Toxicity. 5 Dec 2016 pharmaceuticals (ICH M3(R2)) EMA/CPMP/ICH/286/1995. • Questions Guideline on repeated dose toxicity CPMP/SWP/1042/99 Rev 1 Corr. 18 Mar 2010 E-mail info@ema.europa.eu Website www.ema.europa.eu repeated dose toxicity, study design, choice of species, list of tissues. * Reference to OECD Guidance Document 19 has been included in page 6, Section 8.2; the