Animal health holds significant importance for the sustainability of both agriculture and the food industry, as well as for public health. However, substantiating the efficacy and safety of veterinary medicinal products necessitates their rigorous testing prior to market introduction. In this regard, in-vivo tests, performed within the framework of Good Laboratory Practice (GLP), constitute an indispensable element in the development of veterinary medicinal products.
What constitutes in-vivo testing for veterinary medicinal products?
In-vivo tests involve studies where veterinary medicinal products are administered to living animals to assess parameters such as efficacy, safety, and bioavailability. These tests ascertain whether the medicinal product elicits the intended effect and identify any potential adverse reactions.
What is GLP and why is it important?
GLP (Good Laboratory Practice)) represents an international quality standard governing the planning, execution, monitoring, recording, reporting, and archiving of laboratory studies. GLP ensures transparency and precision, especially in critical assessments such as safety evaluations.
Veterinary medicinal product tests conducted according to GLP standards:
- Ensure scientific validity
- They are recognized by national and international regulatory authorities
- They accelerate approval processes
- They minimize risks to animal health and public health
Key in-vivo tests for veterinary medicinal products
In the development process of veterinary medicinal products, various in-vivo tests are conducted for different purposes:
🔬 Efficacy Tests: The efficacy of the medicinal product against the target disease or infection is measured.
🔬 Toxicity Tests: By evaluating acute, subchronic, or chronic toxicity, the safety profile of the medicinal product is determined.
🔬 Pharmacokinetic and Bioavailability Studies: The absorption, distribution, metabolism, and excretion of the medicinal product in the body are investigated.
🔬 Target Animal Safety Tests: The potential adverse effects of the medicinal product in the target animal species are evaluated.
🔬 Environmental Impact Assessments: The potential negative effects of the medicinal product on the environment are investigated.
Conducting all these tests in accordance with GLP standards increases the reliability and legal acceptance of the data obtained.
Why are in-vivo tests required?
Unlike human medicinal products, veterinary medicinal products have impacts not only on animal health but also on food safety, environmental health, and zoonotic diseases.
- Prevention of unexpected adverse effects in animals
- Prevention of serious issues such as antibiotic resistance
- Safety of animal products such as meat, milk, and eggs
- Identification of potential negative impacts on the environment
- Adherence to regulatory requirements during the approval and market launch phases
GLP Standards for Safe Veterinary Medicinal Products
In-vivo tests conducted under GLP are a scientific and legal obligation that indirectly serves human health. Reliable data obtained from GLP-compliant tests are the most crucial evidence for product efficacy and safety.
If you wish to have reliable in-vivo tests conducted for your veterinary medicinal products as part of the approval procedures, you can rely on our expert laboratory services.