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5 thoradh

  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

    #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)"
  3. 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)"
  4. 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"
  5. 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.