Draft concept paper on guidance on statistical principles for clinical trials for immunological veterinary medicinal products

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Download document Draft concept paper on guidance on statistical principles for clinical trials for immunological veterinary medicinal products
Reference number EMA/CVMP/IWP/309514/2015
Status draft: consultation open
First published 18/12/2015
Last updated 15/01/2016
Consultation start date 18/12/2015
Consultation end date 31/03/2016
Email address for submissions vet-guidelines@ema.europa.eu

Summary

A guideline on statistical principles for veterinary clinical trials for veterinary medicinal products (pharmaceuticals) (EMA/CVMP/EWP/81976/2010) was adopted in 2012. This guideline provides guidance on the statistical principles to be considered in the design, conduct, analysis and evaluation of clinical trials to demonstrate efficacy and/or safety of an investigational veterinary pharmaceutical product in animals.