What is Target Animal Safety?

Target Animal Safety (TAS) is an important aspect that helps to identify effects of an animal medicinal product and determine what its safety margin is for its labeled dose. It ensures that the drug in question is safe for the specific animal that it is intended to treat. Information from TAS studies is integral for the registration of veterinary products, especially for regions that fall under the Veterinary International Conference on Harmonization (VICH). It helps evaluate the drug’s effect on the health and well-being of target animal species (minor species, companion animals, or livestock).

What is the importance of Target Animal Safety studies?

Target Animal Safety (TAS) studies provide information on the safety of an Investigational Veterinary Pharmaceutical Product (IVPP) under proposed conditions of use in intended animal species. Indeed, TAS studies are crucial in protecting animal welfare and making sure that veterinary medicines provide benefits without posing undue harm. TAS studies help in assessing potential toxicity, impact of overdosing, and other side effects that could occur under various conditions. Such TAS studies also help to maintain consumer confidence in veterinary pharmaceuticals, especially for drugs used in livestock which could enter the human food chain.

What are some of the challenges associated with conducting Target Animal Safety studies?

Designing an appropriate TAS study requires careful planning as it must mimic realistic usage conditions in order to provide the required & meaningful data. This could necessitate a complex study design (depending on the animal's physiology, environment, and interactions with the drug).

Another challenge is the ethical consideration of animal welfare during testing. It is important to balance the collection of comprehensive data with minimizing animal suffering. This requires strict adherence to ethical and legal guidelines, increasing the complexity of study protocols.

Minor species and rare diseases can also complicate TAS studies, as there may be limited data on the appropriate safety parameters or baseline health conditions for these species. Scarcity of this information makes it difficult to determine the standard dosing or predict possible side effects, leading to a longer and more complicated study process.

DDReg’s Capabilities

As part of its diverse pharmaceutical portfolio, DDReg provides comprehensive regulatory services and tailored solutions for animal product development. The team helps clients navigate complex approval pathways to bring safe and effective products to the markets, including providing tailored strategies that streamline approval processes for animal drugs.