Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Scientific guideline

This document provide 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.

Keywords: Antimicrobial, pharmacokinetic/pharmacodynamic (PK/PD) relationship, clinical study, summary of product characteristics (SPC), veterinary medicinal product (VMP)

Document history - Revision 1 (current version)


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