Gaois

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2 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry · PRODUCTION, TECHNOLOGY AND RESEARCH|technology and technical regulations|biotechnology

    #687726

    IATE #3637160
    staidéar bithdháileacháin Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    biodistribution study | BD study | nonclinical BD study | non-clinical BD study | bio-distribution study | bio-distribution studies
    en
    Definition assessment of adverse events arising from the risk factors specific to cell therapies (survival/engraftment, proliferation, differentiation, migration, and tumorigenicity, and the efficacy of the products) as well as of the doses and the method (route) of administration Reference "COM-Terminology Coordination, based on: Kamiyama Y, Naritomi Y, Moriya Y, Yamamoto S, Kitahashi T, Maekawa T, Yahata M, Hanada T, Uchiyama A, Noumaru A, Koga Y, Higuchi T, Ito M, Komatsu H, Miyoshi S, Kimura S, Umeda N, Fujita E, Tanaka N, Sugita T, Takayama S, Kurogi A, Yasuda S, Sato Y. 'Biodistribution studies for cell therapy products: Current status and issues' (24.2.2023). Regenerative Therapy 2021 Jul 12;18:202-216. doi: 10.1016/j.reth.2021.06.005. PMID: 34307798; PMCID: PMC8282960."
    Comment BD studies can be conducted as stand-alone BD studies or in conjunction with nonclinical pharmacology and toxicology studies.
  2. SOCIAL QUESTIONS|health|pharmaceutical industry · PRODUCTION, TECHNOLOGY AND RESEARCH|technology and technical regulations|biotechnology

    #687725

    IATE #3637159
    bithdháileadh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'I gcás nach bhfuil gnáthstaidéir chógaschinéiteacha ábhartha maidir le táirgí a gineadh de thoradh innealtóireacht fíocháin, tabharfar aghaidh ar bhithdháileadh, marthanacht agus díghrádú chomhpháirteanna an táirge a gineadh de thoradh innealtóireacht fíocháin le linn na forbartha cliniciúla.' Reference "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA"
    biodistribution | bio-distribution
    en
    Definition in vivo distribution, persistence and clearance of a gene therapy product at the site of administration and in target and non-target tissues, including biofluids (e.g. blood, cerebrospinal fluid, vitreous fluid), in biologically relevant animal species Reference "COM-Terminology Coordination, based on: EMA. 'ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products Step 2b' (24.2.2023). EMA/CHMP/ICH/318372/2021. 24 June 2021"