Scientific Center for Expertise of Medical Products

Petrovskiy, Russia

Scientific Center for Expertise of Medical Products

Petrovskiy, Russia

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Volkova E.A.,Moscow State University | Ramenskaya G.V.,Moscow State University | Shohin I.E.,Moscow State University | Vasilenko G.F.,Scientific Center for Expertise of Medical Products | Savchenko A.Y.,Scientific Center for Biomedical Technologies
Russian Journal of Biopharmaceuticals | Year: 2011

The article is devoted to dissolution kinetics studies of preparations containing low-soluble substance (nifedipine) in biorelevant media (media modeling physiological gastrointestinal conditions). Dissolution profiles of two nifedipine IR drug products in fasted state simulate intestinal fluid (FaSSIF), and sodium lauryl sulphate solutions (0.05 and 0.1 %) are provided. It was shown that 0.05 % sodium lauryl sulphate solution provides the same dissolution rate and discriminatory power as FaSSIF, and could be used as low-cost alternative.


Pirozhkov A.P.,Central Scientific Research Institute N 48 | Timofeev M.A.,Central Scientific Research Institute N 48 | Borisevich I.V.,Scientific Center for Expertise of Medical Products | Syromlatnlkova S.I.,Central Scientific Research Institute N 48 | And 4 more authors.
Voprosy Virusologii | Year: 2015

The goal of this work was to describe methodological approaches to determination of sensitivity and specificity of the enzyme-linked immunosorbent assay kit (ELISA Kit) for detection of the specific anti-Junin virus (JV) antibody. Comparison of ELISA to plaque reduction neutralization test (PRNT) showed direct relationship between antibody titers in the samples of serum of immunized animals, determined by either PRNT or ELISA methods. The obtained results provided an opportunity to form the panels of positive and negative serum samples to determine the sensitivity and specificity of the ELISA Kit Sensitivity of the ELISA Kit was at least 98% when studying the samples of serum of immunized Guinea pigs and rabbits (determined as positive in PRNT). The sensitivity of the ELISA Kit was at least 68% when studying the samples determined by PNRT as uncertain positive. The specificity was 98%. The specificity of the ELISA Kit was 98%.


Kuz'mina N.E.,Scientific Center for Expertise of Medical Products | Moiseev S.V.,Scientific Center for Expertise of Medical Products | Krylov V.I.,Scientific Center for Expertise of Medical Products | Yashkir V.A.,Scientific Center for Expertise of Medical Products | Merkulov V.A.,Scientific Center for Expertise of Medical Products
Journal of Analytical Chemistry | Year: 2015

The possibility of the application of diffusion-ordered NMR spectroscopy to the study of the molecular-weight distribution of hydroxyethyl starch is investigated. The use of regression equations relating these parameters to the coefficients of the self-diffusion of polymer macromolecules as a whole, namely, the average coefficient of self-diffusion Ds and the coefficient of self-diffusion at the peak maximum Dp, is proposed for the quantitative assessment of weight-average (Mw) and number-averaged (Mn) molecular weights and molecular weight at the peak maximum (Mp). It is shown that the determination of Mw, Mn, Mp based on the data on Ds gives the best results. It was found that the values of polydispersity indexes found using diffusion-ordered NMR spectroscopy are independent of the choice of diffusion parameter Ds or Dp. © 2015, Pleiades Publishing, Ltd.


Kuz'mina N.E.,Scientific Center for Expertise of Medical Products | Moiseev S.V.,Scientific Center for Expertise of Medical Products | Krylov V.I.,Scientific Center for Expertise of Medical Products | Yashkir V.A.,Scientific Center for Expertise of Medical Products | Merkulov V.A.,Scientific Center for Expertise of Medical Products
Journal of Analytical Chemistry | Year: 2015

A correlation equation is obtained for the evaluation of the average molecular weight (MW) of hydroxyethyl starches from the self-diffusion coefficient D measured using diffusion-ordered NMR spectroscopy. Correlation equations MW = cD−αare compared for hydroxyethyl starches, dextrans, and pullulans. It has been demonstrated that different MWs correspond to constant D values of uncharged polysaccharides with the similar type of nonvalent interactions and different degrees of branching. © 2015, Pleiades Publishing, Ltd.


Kuz'mina N.E.,Scientific Center for Expertise of Medical Products | Moiseev S.V.,Scientific Center for Expertise of Medical Products | Krylov V.I.,Scientific Center for Expertise of Medical Products | Yashkir V.A.,Scientific Center for Expertise of Medical Products | Merkulov V.A.,Scientific Center for Expertise of Medical Products
Journal of Analytical Chemistry | Year: 2014

The possibility of using nuclear magnetic resonance (NMR) spectrometry for the determination of trace components in mixtures in the concentration range 1 × 10−5–5 × 10−4 M is shown. The conditions of NMR experiments at which the measurement error attains a minimum are standardized and the precision of NMR spectrometry in determining trace components of mixtures within the analytical range is estimated. © 2014, Pleiades Publishing, Ltd.


Ramenskaya G.V.,Moscow State University | Shohin I.E.,Moscow State University | Savchenko A.Y.,Scientific Center for Expertise of Medical Products | Volkova E.A.,Moscow State University
Biomeditsinskaya Khimiya | Year: 2011

The review deals with the modern tool for modeling of drug behavior in vivo, - the dissolution test in biorelevant media, imitating gastrointestinal fluids. The formulations and preparation methods of fasted state simulation intestinal fluid, FaSSIF and fed state simulation intestinal fluid, FeSSIF, are defined. In addition, the dissolution characteristics of APIs from different BCS classes in biorelevant media are described. Possible applications of biorelevant media in regulatory practice and science are also shown.


Gavrishina E.V.,Scientific Center for Expertise of Medical Products | Dobrovolskii A.V.,Scientific Center for Expertise of Medical Products | Niyazov R.R.,Scientific Center for Expertise of Medical Products | Romodanovskii D.P.,Scientific Center for Expertise of Medical Products | Vasil'ev A.N.,Scientific Center for Expertise of Medical Products
Eksperimental'naya i Klinicheskaya Farmakologiya | Year: 2015

General principles of appropriate strategies for preclinical and clinical development of unfractionated and low-molecular-weight heparins and demonstration of their biosimilarity to corresponding reference medicinal products are provided. Demonstration of the biosimilarity of heparin-containing medicinal products constitutes the basis for their efficacy and safety during anticoagulation therapy. Hie main quality, safety, and efficacy characteristics of heparin products are described and the extent of non-clinical and clinical investigations necessary prior to drug marketing authorization are considered.

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