Is it Safe & Effective? Clinical Studies Evaluating Veterinary Medicines: Increasing Focus on High Quality and Representativeness
This is the third article in the “From Molecule to Market” series, where the challenges to successfully run a clinical program for the registration of new veterinary medicinal products shall be described. While traditionally all safety and efficacy studies conducted in the target animal species are considered “clinical studies”, the European Union (EU), lately, has introduced a more restricted definition of “clinical” studies being the pivotal field efficacy and safety studies only. In this article, we will focus on the field studies, while providing some considerations for preclinical studies as defined now in the EU.
DATE » 18.10.2022
AUTHORS » Dr. Klaus Hellmann; Dr. Stephen Bienhoff