Clinical trials in animals provide the supporting science necessary to meet regulatory requirements and ensure your product complies with the appropriate regulations. Clinical trials can be as simple as a proof of concept, or as extensive as an efficacy trial with client-owned animals. Nutrasource can help you determine what type of study will be needed to allow you to make the claims you need to set your product apart.
Clinical trials in animals can take place in client-owned animals through a veterinary care center or colony animals in a research facility. Nutrasource can assist with you with choosing which population would best serve your needs.
Proof of Concept
A proof of concept study will generally use a small group of the target species of animal to determine essential information such as the amount of your ingredient needed to produce the desired effect.
A trial designed to support the safety of your ingredient will provide scientific evidence that your product does not cause any harm at the intended use levels.
An efficacy trial will provide scientific evidence that your product has a beneficial effect. It is important to keep in mind the regulatory aspects of claims that can be made about a product and the evidence needed to support those claims.
Studies in production animals typically take place on research farms. Clinical studies in production animals evaluate safety in the target species and may also determine if there are any residues that could impact humans who consume the meat/dairy/egg products.
Not sure which study is needed for your product? Nutrasource can help you determine what type of study will be needed to allow you to make the claims you need to set your product apart.