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  1. Article ; Online: International nonproprietary names for monoclonal antibodies: an evolving nomenclature system.

    Guimaraes Koch, Sofia S / Thorpe, Robin / Kawasaki, Nana / Lefranc, Marie-Paule / Malan, Sarel / Martin, Andrew C R / Mignot, Gilles / Plückthun, Andreas / Rizzi, Menico / Shubat, Stephanie / Weisser, Karin / Balocco, Raffaella

    mAbs

    2022  Volume 14, Issue 1, Page(s) 2075078

    Abstract: Appropriate nomenclature for all pharmaceutical substances is important for clinical development, licensing, prescribing, pharmacovigilance, and identification of counterfeits. Nonproprietary names that are unique and globally recognized for all ... ...

    Abstract Appropriate nomenclature for all pharmaceutical substances is important for clinical development, licensing, prescribing, pharmacovigilance, and identification of counterfeits. Nonproprietary names that are unique and globally recognized for all pharmaceutical substances are assigned by the International Nonproprietary Names (INN) Programme of the World Health Organization (WHO). In 1991, the INN Programme implemented the first nomenclature scheme for monoclonal antibodies. To accompany biotechnological development, this nomenclature scheme has evolved over the years; however, since the scheme was introduced, all pharmacological substances that contained an immunoglobulin variable domain were coined with the stem -
    MeSH term(s) Antibodies, Monoclonal ; Pharmaceutical Preparations ; World Health Organization
    Chemical Substances Antibodies, Monoclonal ; Pharmaceutical Preparations
    Language English
    Publishing date 2022-05-18
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2537838-7
    ISSN 1942-0870 ; 1942-0870
    ISSN (online) 1942-0870
    ISSN 1942-0870
    DOI 10.1080/19420862.2022.2075078
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: The INN global nomenclature of biological medicines: A continuous challenge

    Robertson, James S / Chui, Wai-Keung / Genazzani, Armando A / Malan, Sarel F / López de la Rica Manjavacas, Ana / Mignot, Gilles / Thorpe, Robin / Balocco, Raffaella / Rizzi, Menico

    Biologicals. 2019 July, v. 60

    2019  

    Abstract: Medicines are assigned International Nonproprietary Names (INN) by the World Health Organization (WHO), pursuing the aim to increase patient safety. Following scientific developments in drug discovery and biotechnology, the number of biological medicines ...

    Abstract Medicines are assigned International Nonproprietary Names (INN) by the World Health Organization (WHO), pursuing the aim to increase patient safety. Following scientific developments in drug discovery and biotechnology, the number of biological medicines is constantly growing and a surge in INN applications for them has been observed. Pharmacologically active biological substances have a complex structure and mechanism of action posing new challenges in selecting names that appropriately reflect such properties. As a consequence, existing nomenclature naming schemes may need to be revised and new ones developed. This review reports on the recently implemented policies for naming fusion proteins, monoclonal antibodies, advanced therapy substances that cover gene and cell therapy, virus-based therapies as well as vaccines and vaccine-like substances. Different approaches, based on the use of a one-word versus a two-word naming scheme, have been developed for different categories of biological substances highlighting a major and still not completely resolved issue, i.e. how to assign a name that is both informative, short and euphonic.
    Keywords World Health Organization ; biotechnology ; genes ; issues and policy ; mechanism of action ; medicinal properties ; monoclonal antibodies ; patients ; proteins ; therapeutics ; vaccines
    Language English
    Dates of publication 2019-07
    Size p. 15-23.
    Publishing place Elsevier Ltd
    Document type Article
    ZDB-ID 1017370-5
    ISSN 1095-8320 ; 1045-1056
    ISSN (online) 1095-8320
    ISSN 1045-1056
    DOI 10.1016/j.biologicals.2019.05.006
    Database NAL-Catalogue (AGRICOLA)

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  3. Article ; Online: The INN global nomenclature of biological medicines: A continuous challenge.

    Robertson, James S / Chui, Wai-Keung / Genazzani, Armando A / Malan, Sarel F / López de la Rica Manjavacas, Ana / Mignot, Gilles / Thorpe, Robin / Balocco, Raffaella / Rizzi, Menico

    Biologicals : journal of the International Association of Biological Standardization

    2019  Volume 60, Page(s) 15–23

    Abstract: Medicines are assigned International Nonproprietary Names (INN) by the World Health Organization (WHO), pursuing the aim to increase patient safety. Following scientific developments in drug discovery and biotechnology, the number of biological medicines ...

    Abstract Medicines are assigned International Nonproprietary Names (INN) by the World Health Organization (WHO), pursuing the aim to increase patient safety. Following scientific developments in drug discovery and biotechnology, the number of biological medicines is constantly growing and a surge in INN applications for them has been observed. Pharmacologically active biological substances have a complex structure and mechanism of action posing new challenges in selecting names that appropriately reflect such properties. As a consequence, existing nomenclature naming schemes may need to be revised and new ones developed. This review reports on the recently implemented policies for naming fusion proteins, monoclonal antibodies, advanced therapy substances that cover gene and cell therapy, virus-based therapies as well as vaccines and vaccine-like substances. Different approaches, based on the use of a one-word versus a two-word naming scheme, have been developed for different categories of biological substances highlighting a major and still not completely resolved issue, i.e. how to assign a name that is both informative, short and euphonic.
    MeSH term(s) Biological Products ; Humans ; Patient Safety ; Terminology as Topic ; World Health Organization
    Chemical Substances Biological Products
    Language English
    Publishing date 2019-05-23
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 1017370-5
    ISSN 1095-8320 ; 1045-1056
    ISSN (online) 1095-8320
    ISSN 1045-1056
    DOI 10.1016/j.biologicals.2019.05.006
    Database MEDical Literature Analysis and Retrieval System OnLINE

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