Gaois

Cóip statach de shonraí a easpórtáiltear ó IATE ó am go chéile atá sa chnuasach seo. Níor cheart glacadh leis gurb ionann i gcónaí an t-eolas a thugtar faoi iontráil anseo agus a bhfuil sa leagan reatha den iontráil ar IATE. Is féidir an leagan reatha sin a cheadú ach cliceáil ar an nasc atá ar thaobh na láimhe deise ag barr gach iontrála. Breis eolais »

2 thoradh

  1. 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)"
  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)"