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49 research outcomes, page 1 of 5
  • publication . Article . 2019
    Open Access Russian
    Authors:
    V. V. Arkhipov; E. A. Sokova; G. I. Gorodetskaya; O. A. Demidova; T. V. Aleksandrova;
    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 . 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 . 2018
    Open Access Russian
    Authors:
    Kuzmin, V. S.; Chernyshev, V. V.; Luttseva, A. I.;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    X-ray powder diffraction is one of the methods used for detection and analysis of polymorphic forms of pharmaceutical substances. The article elucidates the concept of polymorphism, briefly explains physical characteristics of this phenomenon, conditions of polymorphic ...

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  • publication . Article . 2018
    Open Access Russian
    Authors:
    Sakanyan, E. I.; Kovaleva, E. L.; Frolova, L. N.; Shelestova, V. V.;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The article provides the results of a comparative analysis of requirements laid out in the State Pharmacopoeia of the USSR, XI ed. (SPh XI) and the State Pharmacopoeia of the Russian Federation, XIII ed. (SPh XIII) concerning quality evaluation and standardization of he...

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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:
    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:
    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 . 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:
    Mit'kina, L. I.; Ericheva, Anastasiya K.;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    Labeling is an important source of information about a medicinal product. The completeness and accuracy of labeling ensures correct identification, as well as safe and efficacious use of the product. The aim of the present paper was to perform comparative analysis of re...

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  • publication . Article . 2019
    Open Access Russian
    Authors:
    Kodina, G. E.; Malysheva, A. O.;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    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...

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49 research outcomes, page 1 of 5