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7 dtoradh

  1. INDUSTRY|chemistry · SOCIAL QUESTIONS|health|pharmaceutical industry

    #678923

    IATE #1330633
    eisíontas Tagairt "Rialachán (AE) 2022/1439 lena leasaítear Rialachán (AE) Uimh. 283/2013 a mhéid a bhaineann leis an bhfaisnéis a bheidh le cur isteach maidir le substaintí gníomhacha agus na ceanglais shonracha sonraí i ndáil le miocrorgánaigh, CELEX:32022R1439/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    impurity
    en
    Sainmhíniú any unwanted chemical that is present in a manufactured product or that develops during formulation or upon ageing of that product Tagairt "COM-Terminology Coordination, based on: PharmTech.com. 'Evaluating Impurities in Drugs (Part III of III)' (17.2.2023)"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #682216

    IATE #3510060
    genotoxic impurity | DNA reactive impurity | mutagenic impurity
    en
    Sainmhíniú impurity - for which there are test data or sufficient evidence - that has the potential to damage DNA at any level of exposure, with such damage possibly leading/contributing to tumour development Tagairt "COM-Terminology Coordination, based on:: EMEA. CHMP. 'Guideline on the limits of genotoxic impurities' (10.12.2024). London, 28 June 2006 CPMP/SWP/5199/02 EMEA/CHMP/QWP/251344/2006"
    Nóta "This type of mutagenic carcinogen is usually detected in a bacterial reverse mutation (mutagenicity) assay. Other types of genotoxicants that are non-mutagenic typically have threshold mechanisms and usually do not pose carcinogenic risk in humans at the level ordinarily present as impurities. Therefore to limit a possible human cancer risk associated with the exposure to potentially mutagenic impurities, the bacterial mutagenicity assay is used to assess the mutagenic potential and the need for controls. Structure-based assessments are useful for predicting bacterial mutagenicity outcomes based upon the established knowledge."
  3. SOCIAL QUESTIONS|health|pharmaceutical industry

    #680004

    IATE #1554037
    próifíl eisíontais Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs 'Is le foirmliú dáileoige béil soladach tobscaoilte nó le tuaslagán béil amháin a bhainfidh an t-athrú agus ní spreagfar athrú díobhálach ar phróifíl eisíontais cáilíochta ná ar phróifíl eisíontais cainníochta ná ar airíonna fisiciceimiceacha.' Tagairt "Rialachán Cur Chun Feidhme (AE) 2021/17 lena mbunaítear liosta modhnuithe nach n-éilíonn measúnú i gcomhréir le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0017/GA"
    impurity profile
    en
    Sainmhíniú "identity of impurities, quantity of impurities and source of impurities as well as description of unidentified impurities present" Tagairt "COM-Terminology Coordination, based on: - EMA. 'ICH Topic Q 3 B (R2) Impurities in New Drug Products' (17.2.2023). June 2006 CPMP/ICH/2738/99- PharmTech.com. 'Evaluating Impurities in Drugs (Part III of III)' (17.2.2023)"
    Nóta Concerning pharmaceutical products, there are synthesis-related impurities, formulation-related impurities, dosage form-related impurities, method-related impurities, environmental-related impurities, impurities on aging, metabolite impurities.
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #664636

    IATE #3592472
    eisíontas a bhaineann le próiseas Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    process-related impurity | process-related impurities
    en
    Sainmhíniú impurity that is derived from the manufacturing process Tagairt "European Medicines Agency (EMA). 'ICH Topic Q 6 B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Step 5. NOTE FOR GUIDANCE ON SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS (CPMP/ICH/365/96)' (21.1.2021)"
  5. SOCIAL QUESTIONS|health|pharmaceutical industry

    #664637

    IATE #3592473
    eisíontas a bhaineann le táirgí Tagairt "Rialachán Tarmligthe (AE) 2021/805 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    product-related impurity
    en
    Sainmhíniú molecular variant of the desired product (e.g. precursors, certain degradation products arising during manufacture and/or storage) which does not have properties comparable to those of the desired product with respect to activity, efficacy, and safety Tagairt "European Medicines Agency (EMA). 'ICH Topic Q 6 B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Step 5. NOTE FOR GUIDANCE ON SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS (CPMP/ICH/365/96)' (21.1.2021)"
  6. AGRICULTURE, FORESTRY AND FISHERIES|means of agricultural production|means of agricultural production|plant health product

    #602093

    IATE #150111
    eisíontas ábhartha Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs 'Sainaithníodh an t-eisíontas hiodraisín, ar ábhar tosaigh é, mar eisíontas ábhartha, le linn an mheasúnaithe, ós rud é gur aimsíodh é sna baisceanna plandaí píolótacha ar a ndearnadh athmheasúnú agus sna baisceanna plandaí ó na láithreáin tráchtála.' Tagairt "Rialachán Cur Chun Feidhme (AE) 2021/459 lena leasaítear Rialachán Cur Chun Feidhme (AE) Uimh. 540/2011 maidir le coinníollacha formheasa na substainte gníomhaí feinpiorasaimín, CELEX:32021R0459/GA"
    relevant impurity
    en
    Sainmhíniú impurity that is particularly undesirable because of its toxicological, ecotoxicological or environmental properties Tagairt "COM-Terminology Coordination, based on: Regulation (EU) No 283/2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market"
  7. SOCIAL QUESTIONS|health|pharmaceutical industry

    #690707

    IATE #3648708
    unqualifizierte Verunreinigung
    de
    Sainmhíniú Verunreinigung, deren biologische Sicherheit unbekannt ist Tagairt COM-DE aufgrund der EN Definition
    unqualified impurity
    en
    Sainmhíniú "impurity (substance that is not the active substance or an excipient in a medicinal product) whose biological safety is unknown" Tagairt "COM-Terminology Coordination and COM-EN, based on: EMA. ICH Topic Q 3 B (R2) Impurities in New Drug Products. Step 5. NOTE FOR GUIDANCE ON IMPURITIES IN NEW DRUG PRODUCTS (CPMP/ICH/2738/99) (9.12.2024), CPMP/ICH/2738/99, June 2006."
    Nóta "An impurity can result from a chemical change in the active substance brought about during manufacture and/or storage of the new medicinal product by the effect of, for example, light, temperature, pH, water, or by reaction with an excipient and/or the immediate container closure system. In this case the impurity is a degradation product and its biological safety must also be known. The biological safety of metabolites of a medicinal product (which are also degradation products) must also be known and relevant data are normally included in safety and/or clinical studies."
    impureté non qualifiée
    fr
    Sainmhíniú composant présent dans l'intermédiaire ou la substance active et qui n'est pas l’entité désirée, dont la sécurité biologique n’est pas connue Tagairt "COM-FR, d'après:Agence nationale de sécurité du médicament et des produits de santé (ANSM), Guide des bonnes pratiques de fabrication (19.12.2024), Glossaire, 2019"