Saratov JOURNAL of Medical and Scientific Research

Yaroslavl State Medical Academy

Organizational aspects of conducting of bioequivalence study

Year: 2014, volume 10 Issue: №1 Pages: 203-210
Heading: Parmacology Article type: Original article
Authors: Khokhlov A.L., Kagramanyan I.N., Lileeva E.G., Sinitsina O.A., Miroshnikov A.E., Shitov L.N.
Organization: Ministry of Health of the Russian Federation, Yaroslavl State Medical Academy

Aim: to evaluate the organizational aspects of conducting bioequivalence study in Russia on the example of one of the clinical centers, Yaroslavl. Material and methods. On the basis of the Municipal Autonomous institution of health care of the Yaroslavl region Clinical hospital №2 (CH, clinical base of the Department of clinical pharmacology of YSMA) was held 93 bioequivalence studies and pharmacokinetics in the period from 2011 to 2014, of which 15 studies of foreign sponsors and 78 of domestic producers. Result.: The studies involved 48 volunteers of both sexes from the database of clinical center CH №2. There were 698 females (48.6%) and 739 males (51.4%). The average age of the volunteers was 26,37 years. In each study there were from 18 to 103 volunteers, depending on the design of the research Protocol. At the same time Russian studies ranged about 18-24 volunteers, about 30-103 volunteers abroad. The number of doubles in domestic studies ranged from 2 to 6 persons, and foreign — from 6 to 12 people. 10-15% from the whole number of subjects were not included into the study. Conclusion. In Russia bioequivalence of medicines for more than ten years is the main requirement of medico-biological control generic drugs. Regardless of the manufacturer to the generic drugs are exactly the same as the original drugs, must meet the following requirements: quality efficiency and safety. In connection with the increase in recent years of bioequivalence studies of medicines, require close monitoring of the quality of these studies on the territory of the Russian Federation.

2014_01-01_203-210.pdf370.66 KB

Capabilities of epidural injections for the treatment of chronic discogenic low back pain

Year: 2012, volume 8 Issue: №2 Pages: 502-505
Heading: Neurology Article type: Original article
Authors: Noskov M.S., Kozlova O.G., Lavrukhin V.V.
Organization: Yaroslavl State Medical Academy

The article highlights a comparative effectiveness of conservative therapy and local anesthetic treatment or in conjunction with the glucocorticosteroid agent for low back pain suppression. Low-grade and short-term pain reduction in the treatment of conservative methods was found, especially in comparison with patients for which therapy of minimally invasive technology is used.

201202_502-505.pdf284.85 KB

Hepatic Vessels Condition in Experimental Pulmonary Trunk Stenosis With Different Level of Blood Circulation Compensation

Year: 2009, volume 5 Issue: №2 Pages: 151-155
Heading: Macro- and Micromorphology Article type: Original article
Authors: S.V. Kulikov
Organization: Yaroslavl State Medical Academy

Hepatic changes have been studied in 25 pupies with modeled stenosis with compensation and 8 animals with decompensated stenosis of pulmonary trunk. For controlling we have used liver of 10 dogs of the same age. Material has been tested by hystological, morfometric and stereometric mesurements. We have figured that after pulmanory trunk stenosis and the decrease in circulation of hepatic venous blood tonus of arteries increases, reflectory and resistance to circulation grows. Except venous-arterial reactions in incoming vessels small boundles of oblique intimal muscular system, muscular-elastic sfincters, polipsimillar pillows have been formed and in outcoming vessels muscular structures hypertrophy.has been indicated In case decompensated stenosis with hypoxia relaxation of outcoming and outgoing vessels happens, the quantity of arteries with adapting structures decreases, and muscular formations of hepatic veins atrophy.

200902_151_155.pdf774.52 KB