Tolerance studies of medicinal products in target animal species
A tolerance study shows how the target animal species tolerate the product at the recommended dose and at overdose. It is a mandatory part of proving the safety of a veterinary medicinal product before registration.
What is assessed
- General tolerance: clinical condition, behaviour, feed and water intake, body weight dynamics.
- Margin of safety: the animals' response to the product at the recommended dose and at multiples of it, as well as with an extended course.
- Laboratory parameters: haematological and biochemical blood parameters before, during and after treatment.
- Local reactions: condition of the tissues at the injection site for injectable and topical forms.
- Special groups: where required, young animals, pregnant and lactating animals, breeding stock.
Why a tolerance study is needed
The study results define the contraindications, adverse reactions and special warnings in the instructions for use. Without these data the registration authority cannot assess the safety of the product for the target species.
How we work
- Development of the study plan taking into account the species, age and physiological condition of the animals.
- Formation of test and control groups and conduct of the study at a research centre or on a farm.
- Clinical observation, collection of biological samples and laboratory testing.
- Statistical analysis and preparation of a report suitable for the registration dossier.
What the client receives
- A tolerance study plan.
- A report with individual observation data, laboratory results and safety conclusions.
- Proposed wording for the adverse reactions and contraindications sections of the instructions.
Timing and cost
The duration depends on the treatment regimen and the observation period after the last administration. The cost is calculated individually and depends on the species and number of animals, the number of doses tested and the scope of laboratory testing.
Why choose us
- Experience: more than 20 years of work with veterinary medicinal products and feed additives and over 10,000 completed studies.
- In-house laboratory: 170 units of analytical and test equipment, including chromatography–mass spectrometry.
- Full cycle: studies, laboratory analysis and registration dossier preparation in one company, with no time lost passing data between contractors.
- Transparency: an agreed plan and timeline, with interim results as the work progresses.
How to order
To get a quote and agree on the study design, contact Neurometrix specialists by phone at +7 903 613-00-79 or send a request to info@neirometrix.ru. We prepare a commercial proposal within two business days.
Frequently asked questions
How does a tolerance study differ from a toxicology study?
Toxicology studies are performed in laboratory animals and define the safety margins of a substance. A tolerance study is performed in the target species, the animals the product is intended for, and shows how they respond to the recommended and increased doses.
By how much is the dose exceeded in the study?
The multiple is set by the requirements for the specific product type and is usually several times the recommended dose. We agree the scheme at the planning stage.
Can the study be carried out on the client's farm?
Yes, if the housing conditions and record-keeping allow the requirements of the study plan to be met. Our specialists organise observation, sampling and documentation on site.
What happens if the animals show adverse reactions?
All reactions are recorded and analysed, as they are part of an objective safety picture. Based on the results, contraindications and precautions are formulated and, if necessary, the recommended dose is adjusted.