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24 Research products, page 1 of 3

  • Publications
  • 2012-2021
  • Open Access
  • 03 medical and health sciences
  • Ведомости Научного центра экспертизы средств медицинского применения

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  • Open Access Russian
    Authors: 
    O. B. Talibov;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The article describes specific aspects of biosimilars research and development. The aim of the study was to analyse the ways to conduct comparative studies of biotechnological medicinal products and the main approaches to the assessment of the obtained data. The paper h...

  • Open Access Russian
    Authors: 
    A. V. Rybakova; M. N. Makarova; A. E. Kukharenko; A. S. Vichare; F. R. Rueffer;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    Today, within the context of harmonisation of requirements in the international pharmaceutical market, there is a trend towards development of common standards, including in the field of preclinical studies. The reliability and reproducibility of experimental data obtai...

  • Open Access Russian
    Authors: 
    D. P. Romodanovsky; A. L. Khokhlov; D. V. Goryachev;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The coronavirus (COVID-19) pandemic, which began in 2020, has affected all spheres of life, including clinical trial processes. Health authorities around the world issued recommendations aimed at minimising the risks of virus spreading and ensuring the safety of study p...

  • Open Access
    Authors: 
    N. S. Tereshina; M. N. Lyakina; O. A. Naumova;
    Publisher: SCEEMP

    Sea water and sea salt obtained from it are widely used as substances in the production of medicinal products. Complex chemical composition of sea water which contains various salts, calls for the development of a common quality standard for sea water-based medicines. T...

  • Open Access Russian
    Authors: 
    A. V. Tikhomirova;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    Criteria for evaluation of clinical efficacy make it possible to assess the risk-benefit ratio of anticancer medicines that patients receive, in particular, for the treatment of solid malignant tumors. A medicine’s efficacy is assessed using special criteria called the ...

  • Open Access
    Authors: 
    T. A. Batuashvili; L. V. Simutenko; P. V. Shadrin; N. P. Neugodova;
    Publisher: SCEEMP

    The paper considers insulin’s specific action on the patient’s body, types of insulin preparations and insulin analogues which are used for the treatment of diabetes, as well as applicable requirements for these products. It was demonstrated that determination of biolog...

  • Open Access
    Authors: 
    G. I. Gorodetskaya; V. V. Arkhipov; E. S. Melnikov; T. A. Rodina;
    Publisher: SCEEMP

    Rational use of glybenclamide products in the treatment of patients with type 2 diabetes remains a high-priority task. The paper offers a summary of the main groups of glibenclamide drugs and describes pharmacogenetics of glybenclamide. Glibenclamide is metabolized by t...

  • Open Access
    Authors: 
    N. V. Eremina; L. G. Kolik; R. U. Ostrovskaya; A. D. Durnev;
    Publisher: SCEEMP

    Neurotoxic effects are one of the common reasons for discontinuation of preclinical and/or clinical studies. Preclinical evaluation of neurotoxic effects is complicated due to a wide range of manifestations and degrees of severity. Current experimental approaches to neu...

  • Open Access
    Authors: 
    E. V. Shekunova; M. A. Kovaleva; M. N. Makarova; V. G. Makarov;
    Publisher: SCEEMP

    One of the major obstacles to effective translational medicine is the challenge of translating animal research results into clinical studies. Scientific literature mainly addresses the selection of the drug dose at initiation of clinical trials (Phase 1). Appropriate se...

  • Open Access
    Authors: 
    G. E. Kodina; A. O. Malysheva;
    Publisher: SCEEMP

    One of the prerequisites for successful application of nuclear medicine technologies is the production and clinical use of radiopharmaceuticals (RPs) of a reliably high quality. The aim of the review is to discuss specific properties of RPs, which stipulate specific app...