Target Animal Safety

Veterinary products that are administered to specific animals have to be shown to be safe in those animals. Target animal studies are not based on generating a toxic response but are related to the maximum intended dose in commercial use. The aim of these studies is to establish safety or tolerance in animals dosed at low multiples of the intended dose level of the veterinary product.

Studies are generally designed to comply with the requirements of existing target animal safety guidelines:

• EU Volume 7, ‘Guidelines for the testing of veterinary medicinal products’
• Current draft VICH guideline, ‘Target animal safety guidance for veterinary pharmaceutical products’
• FDA CVM guideline 33, ‘Target animal safety guidelines for new animal drugs’

The experimental treatments applied and the range and type of observations and investigations for specific study protocols, will depend upon the type of compound under investigation, its pharmacological effects and its intended veterinary application.

Testing is carried out using the intended final market formulation according to the intended route of administration and dosing regime in veterinary use, since changes in formulation and administration can significantly affect absorption / exposure and consequently adverse effects and levels of tolerance. In particular, local tolerance of the formulated product must be addressed.

An integrated approach from all scientists involved, present on the one Research Centre site, allows fast study conduct and reporting.