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55 research outcomes, page 1 of 6
  • publication . Article . 2019
    Open Access Russian
    Authors:
    Talibov, O. B.;
    Persistent Identifiers
    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...

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  • publication . Article . 2020
    Open Access Russian
    Authors:
    article Editorial;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    Neugodova N.P., Stepanyuk E.O., Sapozhnikova G.A., Sakanyan E.I., Ryabtseva M.S. Current approaches to the abnormal toxicity test. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya = The Bulletin of the Scientific Centre for Expert Evaluation of M...

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  • publication . Article . 2019
    Open Access Russian
    Authors:
    Lysikova, I. V.; Basova, O. I.;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    In February 2017 the World Health Organization first published the list of antibiotic-resistant «priority pathogens» — a catalogue of 12 species of bacteria that pose the greatest threat to human health. The list highlights the danger posed by Gramnegative bacteria that...

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  • publication . Article . 2018
    Open Access Russian
    Authors:
    Romodanovsky, D. P.; Goryachev, D. V.; Solovieva, A. P.; Eremenko, N. N.;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The article analyses regulatory documents and requirements for statistical principles of planning and evaluation of results of bioequivalence studies. It describes current statistical approaches to bioequivalence evaluation and relevant recommendations for the planning ...

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  • publication . Article . 2019
    Open Access Russian
    Authors:
    Goryachev, D. V.; Uvarova, N. E.;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The introduction of the «therapeutic equivalence» concept into the Russian legislation is critical for evaluation of medicines interchangeability and for recognising them as generics. It is stipulated by the legislation that therapeutic equivalence has to be evaluated u...

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  • publication . Article . 2019
    Open Access Russian
    Authors:
    Arkhipov, V. V.; Sokova, E. A.; Gorodetskaya, G. I.; Demidova, O. A.; Aleksandrova, T. V.;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    This article looks into interchangeability and therapeutic equivalence of innovator and generic anticonvulsants — the first-generation and new antiepileptic drugs (AEDs). The results of a number of clinical trials assessing therapeutic equivalence of generic AEDs suppor...

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  • publication . Article . 2018
    Open Access Russian
    Authors:
    Bunyatyan, N. D.; Sysuev, B. B.; Sokova, E. A.; Evteev, V. A.;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    Fluconazole – an antifungal agent belonging to the chemical class of triazole derivatives – is represented in the Russian pharmaceutical market by a large number of generic drugs. An important issue of rational pharmacotherapy is the demonstration of the reference and g...

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  • publication . Article . 2019
    Open Access Russian
    Authors:
    Bunyatyan, N. D.; Sysuev, B. B.; Nikolaeva, L. L.;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    A significant share of the hepatoprotectors pharmaceutical market is represented by innovator and generic products containing essential phospholipids. One of the main issues in pharmacotherapy is confirmation of similarity between reference and generic products, which h...

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  • publication . Article . 2018
    Open Access Russian
    Authors:
    Engalycheva, G. N.; Subaev, R. D.; Gorachev, D. V.; Olefir, Yu. V.;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The article dwells upon the results of comparative analysis of the Russian national requirements and EAEU regulations dealing with evaluation of preclinical pharmacological studies. It highlights historical aspects of elaboration of regulatory requirements and scientifi...

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  • publication . Article . 2018
    Open Access Russian
    Authors:
    Uvarova, N. E.; Eremenko, N. N.; Ramenskaya, G. V.; Goryachev, D. V.;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The Government of the Russian Federation approved the State strategy of combating the spread of HIV aimed at prevention of HIV epidemic. One of the goals of the Strategy is to increase the coverage of antiretroviral therapy for people infected with HIV, which includes e...

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55 research outcomes, page 1 of 6