The Center of Pre-clinical and Clinical Studies
The Center of Pre-clinical and Clinical Studies was created at BelSU in 2011.
The Center is included in list of enterprises and organizations, conducting preclinical research of pharmaceutical products by Federal Service for the Supervision of Public Health and Social Development. The Center was certified against the ISO 9001-2008 standard at 12/29/2011, and, 04/27/2012 BelSU was credentialed for the conducting of clinical studies by the order of PHM RF №274.
The staff of the Center consists of 8 doctors of science, 5 assistant professors – Candidates of Sciences. 3 laboratory assistants, 2 dieners and more than ten postgraduates and doctoral candidates with broad experience in preclinical studies. The staff underwent special courses at Scientific Center for Evaluation of Medical Products of Federal Service for the Supervision of Public Health and Social Development. They have certificates for the preclinical studies of general toxical action of pharmaceutical products, the preclinical studies of specific toxicity of pharmaceutical products, preclinical material inspection, clinical pathology, certificates of advanced training in HELC.
The Center continues to be the ground for the forming common use center as a basic infrastructural object of Belgorod Biopharmaceutical cluster. The Center created unique scientific complex for the research of bioequivalence of pharmaceutical products, including clinical research for 24 volunteers with intensive care ward and pharmacokinetics laboratory.
The field of work
Up to this moment, the Center has conducted near 40 preclinical research projects of general toxical action, specific activities, pharmacokinetics and bioequivalence of new pharmaceutical products ordered by the largest national and foreign pharmaceutical companies. The Center completed an agreement with the leading producers of pharmaceutical products: «TEVA» (Israel), «Advanced Pharmaceuticals» (India), «Farmstandard» (RF). The Center also works at experimental cardiac pharmacology, experimental osteology, the research of pharmacological correction of endothelial dysfunction of heart-vascular system, diabetes, gestational toxicosis and other nosologies, pharmacological correction of chronic limb ischemia, research of the usage of distant ischemic and pharmacological preconditioning in surgery, tocoginecology, cardiology.
For the effectiveness of the work, the Center organized the following research groups:
- general toxical,
- solated organ pharmacology,
- behavioral pharmacology,
- Cardiac Pharmacology,
- controlled clinical study.
General toxical research group conducts the research of pharmacological
products' toxicological safety. Research work is conducted according to the modern standards of experimental pets' keeping and assessment of the impact of the pharmaceutical products on its vital characteristics.
The Center conducts following research:
- acute toxicity,
- subchronic toxicity,
- chronic toxicity,
- chronic toxicity on impuberal animals
- chronic toxicity of pregnant animals
- fertility research,
- allergenic effect
The electrophysiology research group conducts following research:
- event-related potentials,
- impendance resistography.
The isolated organ pharmacology research group conducts following research:
- ischemia/reperfusion-induced injury of Langendorf-perfused rat hearts,
- mechanical activity of isolated vessel's segments (portal vein, aorta),
- mechanical activity of intestine’s isolated segment,
- mechanical activity of isolated uterine horn.
Address: 308034 Belgorod ul. Studencheskaya, 14, korp. 3,
Director: Prof. Mikhail Pokrovskiy
Phone/Fax: 8 (4722) 30-18-59
E-mail: [email protected]