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55 research outcomes, page 4 of 6
  • publication . Article . 2021
    Open Access Russian
    Authors:
    D. P. Romodanovsky; A. L. Khokhlov; D. V. Goryachev;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    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 . 2018
    Open Access Russian
    Authors:
    A. V. Tikhomirova; D. V. Goryachev; V. A. Merkulov; I. V. Lysikova; A. I. Gubenko; A. I. Zebrev; А. P. Solovieva; D. P. Romodanovsky; E. V. Melnikova;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The article reviews literature data on development and clinical use of biomedical cell products (BCPs) — a new class of medicines which could be approved for distribution and use only after their specific activity and safety have been thoroughly examined at the stage of...

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  • publication . Article . 2018
    Open Access Russian
    Authors:
    D. P. Andreev; E. M. Rychikhina; A. V. Kozlovich; B. K. Romanov;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The article dwells upon the development and implementation of a computerised information system for automation of expert work related to evaluation of medicines interchangeability parameters. The article analyses the results of application of a process-oriented approach...

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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 . 2021
    Open Access Russian
    Authors:
    N. E. Kuz'mina; S. V. Moiseev; B. K. Romanov;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    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 Russian
    Authors:
    A. I. Belanova; E. L. Kovaleva; L. I. Mit’kina;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    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 . 2020
    Open Access Russian
    Authors:
    T. A. Batuashvili; L. V. Simutenko; N. P. Neugodova; P. V. Shadrin;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    In order to harmonise national and foreign requirements for quality control of medicinal products, a second variant of the test method, which complies with the requirements of the European Pharmacopoeia, was included into the general monograph OFS.1.2.4.0008.18 “Test fo...

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  • publication . Article . 2018
    Open Access Russian
    Authors:
    N. G. Olenina; N. S. Mikheeva; N. M. Krutikova;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The use of medicinal plants for therapeutic purposes (herbal medicine) is still popular nowadays. The aim of the present paper was to analyse registration dossiers for herbal medicines submitted for expert evaluation in accordance with the current national legal require...

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  • publication . Article . 2020
    Open Access Russian
    Authors:
    E. V. Shekunova; M. A. Kovaleva; M. N. Makarova; V. G. Makarov;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    One of the major obstacles to effective translational medicine is the challenge of translating animal research results into clinical studies. Scientific literature mainly addresses the selection of the drug dose at initiation of clinical trials (Phase 1). Appropriate se...

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  • publication . Article . 2020
    Open Access Russian
    Authors:
    Yu. V. Olefir; A. Yu. Khubieva; E. L. Kovaleva; L. I. Mit’kina; A. A. Struzhkova; E. V. Savin;
    Persistent Identifiers
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The manufacturing process, the source (raw materials), and primary packaging materials dictate requirements for the quality of ethyl alcohol used in the pharmaceutical industry.The aim of the paper was to analyse how the quality of ethyl alcohol used as a component of m...

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55 research outcomes, page 4 of 6