Safety of biological preparations. Report 1. Terminology and classification issues
Adverse drug reactions (ADR) are injuries caused by taking a medication. For the purpose of an objective analysis of the reasons and mechanisms of ADR, with a view to developing the methods for their relief and prevention, one should use standard criteria for the characterization of ADR. Typically,...
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-02-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
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| Online Access: | https://www.biopreparations.ru/jour/article/view/37 |
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| author | A. A. Soldatov Zh. I. Avdeeva Yu. V. Olefir V. A. Merkulov V. P. Bondarev |
| author_facet | A. A. Soldatov Zh. I. Avdeeva Yu. V. Olefir V. A. Merkulov V. P. Bondarev |
| author_sort | A. A. Soldatov |
| collection | DOAJ |
| description | Adverse drug reactions (ADR) are injuries caused by taking a medication. For the purpose of an objective analysis of the reasons and mechanisms of ADR, with a view to developing the methods for their relief and prevention, one should use standard criteria for the characterization of ADR. Typically, the description of ADR includes information about the damaged organ or tissue and the frequency of ADR occurrence. To characterize ADRs caused by low molecular weight chemicals proposed, an A/B classification and its modifications have been proposed, based on the possible mechanisms of ADR. Biological preparations differ from chemicals by a number of characteristics, including the mechanism of action. Considering the nature of biological/biotechnological preparations, several types of ADR classifications, related to the mentioned drug group, have been suggested. The most popular classification for ADR related to biological preparations have been suggested by W. J. Pichler. It is based on the involvement of immunological mechanisms in ADR occurrence. This classification divides ADR related to biologicals into 5 types: type α (reactions caused by high level of cytokines), type β (hypersensitivity reaction), type γ (reactions caused by the imbalance of immune factors), type δ (cross-reactivity reactions) and type ε (reactions caused by non-immunological mechanisms). The mentioned classification method has certain disadvantages: it does not cover all biological preparations, but only drugs, containing cytokines, hormones and monoclonal antibodies preparations; and it does not consider ADR occurring without immune mechanisms (such as increased blood pressure when administering preparations of recombinant erythropoietins). |
| format | Article |
| id | doaj-art-cfc67d053a8749eaa5bf8fb9229fed98 |
| institution | Matheson Library |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| publishDate | 2018-02-01 |
| publisher | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Биопрепараты: Профилактика, диагностика, лечение |
| spelling | doaj-art-cfc67d053a8749eaa5bf8fb9229fed982025-08-04T10:16:00ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562018-02-01161142637Safety of biological preparations. Report 1. Terminology and classification issuesA. A. Soldatov0Zh. I. Avdeeva1Yu. V. Olefir2V. A. Merkulov3V. P. Bondarev4Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsAdverse drug reactions (ADR) are injuries caused by taking a medication. For the purpose of an objective analysis of the reasons and mechanisms of ADR, with a view to developing the methods for their relief and prevention, one should use standard criteria for the characterization of ADR. Typically, the description of ADR includes information about the damaged organ or tissue and the frequency of ADR occurrence. To characterize ADRs caused by low molecular weight chemicals proposed, an A/B classification and its modifications have been proposed, based on the possible mechanisms of ADR. Biological preparations differ from chemicals by a number of characteristics, including the mechanism of action. Considering the nature of biological/biotechnological preparations, several types of ADR classifications, related to the mentioned drug group, have been suggested. The most popular classification for ADR related to biological preparations have been suggested by W. J. Pichler. It is based on the involvement of immunological mechanisms in ADR occurrence. This classification divides ADR related to biologicals into 5 types: type α (reactions caused by high level of cytokines), type β (hypersensitivity reaction), type γ (reactions caused by the imbalance of immune factors), type δ (cross-reactivity reactions) and type ε (reactions caused by non-immunological mechanisms). The mentioned classification method has certain disadvantages: it does not cover all biological preparations, but only drugs, containing cytokines, hormones and monoclonal antibodies preparations; and it does not consider ADR occurring without immune mechanisms (such as increased blood pressure when administering preparations of recombinant erythropoietins).https://www.biopreparations.ru/jour/article/view/37побочные реакции на препаратынежелательные явления на препаратыклассификация побочных реакцийаллергические реакции на препаратылекарственная аллергияреакции гиперчувствительности на препаратыбиологические препаратыбиотехнологические препаратыadverse drug reactionsadverse drug effectsadverse drug reactions classificationdrug allergic reactionsdrug allergydrug hypersensitivity reactionsbiological preparationsbiotechnological preparations |
| spellingShingle | A. A. Soldatov Zh. I. Avdeeva Yu. V. Olefir V. A. Merkulov V. P. Bondarev Safety of biological preparations. Report 1. Terminology and classification issues Биопрепараты: Профилактика, диагностика, лечение побочные реакции на препараты нежелательные явления на препараты классификация побочных реакций аллергические реакции на препараты лекарственная аллергия реакции гиперчувствительности на препараты биологические препараты биотехнологические препараты adverse drug reactions adverse drug effects adverse drug reactions classification drug allergic reactions drug allergy drug hypersensitivity reactions biological preparations biotechnological preparations |
| title | Safety of biological preparations. Report 1. Terminology and classification issues |
| title_full | Safety of biological preparations. Report 1. Terminology and classification issues |
| title_fullStr | Safety of biological preparations. Report 1. Terminology and classification issues |
| title_full_unstemmed | Safety of biological preparations. Report 1. Terminology and classification issues |
| title_short | Safety of biological preparations. Report 1. Terminology and classification issues |
| title_sort | safety of biological preparations report 1 terminology and classification issues |
| topic | побочные реакции на препараты нежелательные явления на препараты классификация побочных реакций аллергические реакции на препараты лекарственная аллергия реакции гиперчувствительности на препараты биологические препараты биотехнологические препараты adverse drug reactions adverse drug effects adverse drug reactions classification drug allergic reactions drug allergy drug hypersensitivity reactions biological preparations biotechnological preparations |
| url | https://www.biopreparations.ru/jour/article/view/37 |
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