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63 research outcomes, page 1 of 7
  • 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 . 2021
    Open Access Russian
    Authors:
    O. A. Vaganova;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    ‘Identification. Peptide mapping’ is a necessary part of manufacturers’ product specification files for therapeutic proteins (active ingredients and final products of monoclonal antibodies, filgrastims, erythropoietins). The expert of the Federal State Budgetary Institu...

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  • 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 . 2018
    Open Access Russian
    Authors:
    E. V. Yakovleva;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The article describes the main stages of introduction of the Good Distribution Practice (GDP) in Russia following the adoption of new laws making it mandatory for wholesalers to comply with requirements for storage and transportation of medicinal products. The article c...

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  • publication . Article . 2018
    Open Access Russian
    Authors:
    A. S. Osipov; O. A. Popova; S. E. Milkina; T. N. Gretskaya; A. I. Sulimenkova;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The article investigates the applicability of the amino column XBridge Amide 150×4.6 mm for separation of 4-hydroxybenzoic acid esters (parabens) — based on experience with hydrophilic interaction liquid chromatography used for analysis of various compounds. The study a...

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

    The review compares individual case safety reports (ICSRs) for hydroxychloroquine, favipiravir, and the lopinavir/ ritonavir combination registered in the VigiBase global database during 6 months in 2019 and the same period in 2020 which coincides with the global “first...

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  • publication . Article . 2021
    Open Access Russian
    Authors:
    E. S. Petrova; D. V. Goryachev; A. D. Kuznetsova;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The need for development of a clinical trial guidance for medicines for bronchial asthma is brought about by the improvement of requirements for research programmmes for new medicines. The aim of the study was to develop a methodological approach to conducting clinical ...

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

    Expansion of the range of new medicines leads to a significant increase in healthcare spending and, consequently, to the appearance of more affordable generic drugs. A drug can be recognised as generic if there is sufficient evidence of equivalent structural characteris...

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

    Open borders of the present-day pharmaceutical market call for improvement and harmonisation of the legal basis underlying drug circulation. Part of the overall process of harmonisation of regulatory requirements is the alignment of the terminological systems used in Ru...

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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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63 research outcomes, page 1 of 7