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

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.