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54 research outcomes, page 1 of 6
  • publication . Article . 2019
    Open Access Russian
    Authors:
    Tikhomirova, A. V.;
    Persistent Identifiers
    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 ...

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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 . 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:
    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:
    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 . 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 . 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 . 2019
    Open Access Russian
    Authors:
    Sorokina, A. V.; Alekseeva, S. V.; Eremina, N. V.; Durnev, A. D.;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    Preclinical safety evaluation is an important stage in the development of medicinal products. Clinical laboratory studies, including haematological, biochemical and pathomorphological studies, are an essential part of chronic toxicity studies. A careful choice of method...

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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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54 research outcomes, page 1 of 6