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8 Research products, page 1 of 1

  • Publications
  • 2012-2021
  • Open Access
  • 0301 basic medicine
  • Ведомости Научного центра экспертизы средств медицинского применения

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  • Open Access
    Authors: 
    D. P. Romodanovsky; A. L. Khokhlov; D. V. Goryachev;
    Publisher: SCEEMP

    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: 
    A. V. Rybakova; M. N. Makarova; A. E. Kukharenko; A. S. Vichare; F. R. Rueffer;
    Publisher: SCEEMP

    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: 
    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: 
    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: 
    S. V Moiseev; N. E. Kuz’mina; A. I. Luttseva;
    Publisher: SCEEMP

    The work is a continuation of the research on the use of NMR spectroscopy in the quality control of natural peptide hormone-based active substances and their synthetic analogues.The aimof the paper was to develop identification test methods for triptorelin acetate and g...

  • Open Access
    Authors: 
    N. P. Neugodova; O. V. Shapovalova; G. A. Sapozhnikova; E. O. Stepanyuk;
    Publisher: SCEEMP

    The State Pharmacopoeia of the Russian Federation, 14th edition states that implants are a sterile dosage form, and have to be tested for pyrogens. However, it does not provide details on how the test should be performed for this dosage form.The aim of the study was to ...

  • Open Access Russian
    Authors: 
    O. A. Goroshko; L. M. Krasnykh; V. G. Kukes; V. I. Zozina;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The article examines the role of ubiquinone as a redox molecule whose functions consist in electron transport in the mitochondrial respiratory chain and regeneration of endogenous antioxidants. Changes in electron redox pathways cause uncontrolled release of reactive ox...

  • Open Access Russian
    Authors: 
    O, A. Bezborodova; A. A. Pankratov; E. R. Nemtsova; Yu. B. Venediktova; M. S. Vorontsova; G. N. Engalycheva; R. D. Syubaev;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The decoding of the DNA structure and development of new molecular methods of its analysis, as well as identification of specific genomic changes responsible for malignant transformation, have become the turning points in elaboration of novel anti-tumour drugs directed ...