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  • Ведомости Научного центра экспертизы средств медицинского применения

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  • Open Access Russian
    Authors: 
    S. I. Kuleshova; T. I. Pshenichnykh; E. P. Simonova;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The article investigates the possibility of using thin-layer chromatography and spectrodensitometer analysis of TLC-chromatograms to determine impurities in ciprofloxacin tablets. HPTLC silica gel 60F254 chromatographic plates and the mobile phase dichloromethane:methan...

  • Open Access Russian
    Authors: 
    V. A. Petrosyants; V. N. Kotikov; E. A. Soloviev; N. A. Korobeynikova;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The article describes the system of electronic document management related to the certification of medicinal immunobiological products (MIBP) in the Scientific Centre for Expert Evaluation of Medicinal Products», as well as historical aspects of its development. It also...

  • Open Access Russian
    Authors: 
    V. K. Lepakhin; Yu. V. Olefir; V. A. Merkulov; N. D. Bunyatyan; B. K. Romanov; A. N. Yavorsky; E. M. Rychihina;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The article describes the landmarks of control and licensing system development for the purpose of drug evaluation, marketing authorization and circulation in Russia. The need for the development of a state institution for performing expert evaluation of medicines was s...

  • Open Access Russian
    Authors: 
    M. N. Makarova; V. G. Makarov; E. V. Shekunova;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The article reviews methodological approaches to the assessment of pharmaceutical substances neurotoxicity. It describes the main battery of animal tests that are conducted prior to clinical trials in order to assess drug effects on the functioning of vital body systems...

  • Open Access
    Authors: 
    K. A. Koshechkin; Yu. V. Olefir;
    Publisher: SCEEMP

    Improvement of drug supply is one of the key factors contributing to the quality of medical services, but it cannot be achieved without introduction of digital technologies. This is a complex task that requires a systematic approach which includes planning, design, deve...

  • Open Access Russian
    Authors: 
    S. V. Moiseev; V. I. Krylov; N. E. Kuz’Mina; V. A. Yashkir; V. A. Merkulov;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The article describes a newly developed procedure of quantitative determination of fluorine which is present in residual trifluoroacetates in glatiramer acetate pharmaceutical substances by19F NMR spectroscopy. Test parameters (the relaxation delay and the number of sca...

  • Open Access Russian
    Authors: 
    Susanne Keitel;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The article describes the history of the European Pharmacopoeia, which is a unique source of pharmacopoeial drug quality standards, not only for the European part of the continent, but for the entire pharmaceutical world. The European Pharmacopoeia has gained the status...

  • Open Access
    Authors: 
    E. V. Gorbunova; D. V. Goryachev; T. E. Gorskaya; A. N. Bogdanov;
    Publisher: SCEEMP

    Evolution of knowledge about pharmacokinetics and pharmacodynamics of locally acting products, and an increase in the number of generics and medicines under development have laid the ground for the development of new scientific approaches to planning and conducting of t...

  • Open Access Russian
    Authors: 
    R. N. Alyautdin; B. K. Romanov; A. P. Pereverzev; A. O. Chikalo; N. D. Bunyatyan; V. A. Merkulov; A. N. Mironov;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    According to EMA, advanced therapy medicinal products include, inter alia, therapeutic systems containing nucleic acids used for replacement or repair of genetic defects. Alipogen tiparvovec, a medicine containing genetic material for treatment of hereditary deficiency ...

  • Open Access Russian
    Authors: 
    A. N. Murashev; V. S. Popov; M. S. Krasilshchikova; T. Yu. Zharmukhamedova; D. I. Rzhevskiy; O. N. Khokhlova;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    The analysis of the international experience in conducting preclinical studies and application of the principle of good laboratory practice was made. The issues associated with the use of laboratory animals for scientific purposes in Russia and abroad were discussed. Th...