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14 research outcomes, page 1 of 2
  • 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 . 2021
    Open Access
    Authors:
    D. P. Romodanovsky; A. L. Khokhlov; D. V. Goryachev;
    Persistent Identifiers
    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...

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  • publication . Article . 2021
    Open Access Russian
    Authors:
    O. V. Evdokimova; A. V. Beketova; M. N. Lyakina;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The relevance of this study stems from the need for alignment of test methods used for identification and assay of anthracene derivatives in herbal preparations and herbal medicinal products. The aim of the study was to analyse Russian and international quality standard...

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  • publication . Article . 2021
    Open Access
    Authors:
    P. V. Shadrin; T. A. Batuashvili; L. V. Simutenko; N. P. Neugodova;
    Persistent Identifiers
    Publisher: SCEEMP

    The median lethal dose (LD50) and low lethal dose (LD10) are calculated in acute toxicity studies, as well as during specific activity assessment of some medicines. The aim of the study was to develop a procedure for using CombiStats to calculate LD50 and LD10. The auth...

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  • publication . Article . 2021
    Open Access
    Authors:
    A. I. Belanova; E. L. Kovaleva; L. I. Mit’kina;
    Persistent Identifiers
    Publisher: SCEEMP

    Stability testing gives necessary data on the effect of such factors as temperature, light, humidity, etc. on the medicinal product quality. The results of these studies help to select suitable primary and secondary packaging and to determine storage conditions and shel...

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  • publication . Article . 2021
    Open Access
    Authors:
    N. E. Kuz'mina; S. V. Moiseev; B. K. Romanov;
    Persistent Identifiers
    Publisher: SCEEMP

    Near-infrared spectrometry (NIRS) is a new pharmacopoeial method. It is widely used in the pharmaceutical industry for quality control of medicinal products at various production stages (control of raw materials and finished products), and for detection of substandard a...

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  • publication . Article . 2021
    Open Access
    Authors:
    O. I. Basova; I. V. Lysikova; O. Yu. Ivanova;
    Persistent Identifiers
    Publisher: SCEEMP

    Patient subgroup analysis plays an important role in interpretation of confirmatory clinical trial results and is mandatory in most cases. The purpose of subgroup analysis is to assess the consistency (heterogeneity) of the treatment effect in subgroups of patients iden...

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  • publication . Article . 2021
    Open Access Russian
    Authors:
    N. P. Antonova; S. S. Prokhvatilova; E. P. Shefer; A. M. Kalinin; I. M. Morgunov; T. A. Golomazova; U. S. Legon’kova;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    Arbutin is the main active ingredient in many herbal medicinal products that have diuretic, antimicrobial, bactericidal, and antioxidant effects. Many of these products are mixtures of different herbal substances. Therefore, the approaches to quality control of HMPs can...

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  • publication . Article . 2021
    Open Access Russian
    Authors:
    N. P. Antonova; I. M. Morgunov; S. S. Prokhvatilova; E. P. Shefer; O. V. Evdokimova; A. V. Beketova; M. N. Lyakina;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    Abstract. Identification of hellebore (Veratrum Lobelianum Bernh.) herbal substance, as well as hellebore-based herbal preparation and herbal medicinal product by the same group of biologically active substances using the same test method is in line with the so-called “...

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  • publication . Article . 2021
    Open Access Russian
    Authors:
    N. P. Neugodova; O. V. Shapovalova; G. A. Sapozhnikova; E. O. Stepanyuk;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    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 ...

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14 research outcomes, page 1 of 2