FSFI “VGNKI” HAS CONCLUDED 27 CONTRACTS FOR PRE-CLINICAL STUDIES OF MEDICINES FOR VETERINARY USE
From January 10 to March 11, 2024, The Russian State Center for Animal Feed and Drug Standardization and Quality (FSFI “VGNKI”) entered into agreements with applicants for the provision of services for conducting 27 preclinical studies of veterinary drugs of Russian and foreign origin.
It is worth noting that as of March 11, 2024, FSFI “VGNKI” had already concluded 27 contracts for preclinical studies, some of which are already in the process of implementation. The study will primarily focus on the general toxicity of antibiotics, the tolerance of hormones, anthelmintics, non-steroidal anti-inflammatory drugs, antibiotics and muscle relaxants for domestic and farm animals. In addition, pharmacokinetic studies will be conducted, including bioequivalence studies of antiparasitic and anti-inflammatory drugs, as well as anthelmintics and antibiotics for pets.
It can be observed that, due to import substitution, research on drugs for cats and dogs will be in high demand in 2023 and 2024. The range of studies includes the study of general toxic properties, tolerability and pharmacokinetics.
Preclinical research is one of the main stages of introducing a drug for veterinary use into practice, which makes it possible to study its toxic and pharmacological properties, as well as evaluate its safety and effectiveness.
Reports on preclinical studies are an essential part of the registration dossier for a medicinal product and are necessary for its state registration.
It is especially important to highlight that, unlike organizations conducting preclinical studies of medical products, it is FSFI “VGNKI” that has the necessary material and technical base and provides a full range of appropriate preclinical studies for registration of drugs for veterinary use.
When conducting research at FSFI “VGNKI”, all the subtleties of interpreting the results obtained and the nuances of using drugs are taken into account. For example, such as studying the timing of removal of residual amounts of the active substance or its metabolites from the body of target productive animals in order to ensure the safety of products of animal origin. One of the main objectives of the study is to establish, the terms of safe use of livestock products for food, based on experimental and calculated data.
In turn, FSFI “VGNKI” conducts research on domestic and foreign vaccines as part of the introduction into civil circulation of immunobiological medicinal products for veterinary use.
Examination of the quality of drugs is carried out in accordance with control methods established by regulatory documents.
FSFI “VGNKI” has the technical capabilities to reproduce original methods for monitoring foreign drugs, such as studying the quantitative content of antigens in inactivated vaccines, various options for enzyme immunoassay to detect antibodies in laboratory and target animals when studying the antigenic activity of foreign vaccines.
FSFI “VGNKI” test reports must be submitted by the applicant to Rosselkhoznadzor to obtain permission to introduce immunobiological medicinal products into civil circulation.
