Results for toxicity translation from French to Italian

toxicity
toxicity

developmental toxicity testing
developmental toxicity testing

repeat-dose (90 days) toxicity testing
repeat-dose (90 days) toxicity testing

revised note for guidance on repeated dose toxicity
revised note for guidance on repeated dose toxicity

adjunctive treatment in patients at risk of methotrexate toxicity
adjunctive treatment in patients at risk of methotrexate toxicity

note for guidance on repeated dose toxicity adoptée en juillet 2000
adottate nell’ ottobre 2000

titre du document points to consider on the need for assessment of reproductive toxicity of human insulin analogues
titolo del documento points to consider on the need for assessment of reproductive toxicity of human insulin analogues

la graduation se base sur la version 4.0 de la classification « nci common toxicity criteria ctcae ».
classificazione basata sui “criteri comuni di terminologia per gli eventi avversi v4.0” (ctcae; national cancer institute, nci).

concept paper on the development of a cpmp points to consider on the need for reproduction toxicity studies in the development of human insulin analogues adoptée en décembre 2000
of medicinal products in the treatment of epileptic disorders points to consider on clinical investigation

toxicité non hématologique selon la classification « common toxicity criteria » (ctc) ≤ grade 1
16 può essere continuata durante i 42 giorni di periodo concomitante (fino a un massimo di 49 giorni) se tutte le seguenti condizioni vengono soddisfatte: conta assoluta dei neutrofili (anc) ≥ 1,5 x 109/l − conta trombocitica ≥ 100 x 109/l − − common toxicity criteria (ctc) per tossicità non ematologica ≤ grado 1 (eccetto per alopecia, nausea e vomito).

"risks of environmental dioxins: linking epidemiology with toxicity studies to strengthen accurate risk assessment", février 2000
“risks of environmental dioxins: linking epidemiology with toxicity studies to strengthen accurate risk assessment”, febbraio 2000

un cas d'évolution fatale était associé à une thrombocytopénie de grade 4 selon le common toxicity criteria (ctc).
un caso è stato fatale ed è stato associato a trombocitopenia di grado 4 secondo i comuni criteri di tossicità (ctc).

duration of chronic toxicity testing in animals adoptée en novembre 1998 (rodent and non-rodent toxicity testing) safety studies for gene therapy products.
good manufacturing practice:

pre-approval information for registration of new medicinal products for food producing animals with respect to antimicrobial resistance injection site residues user safety estimation of predicted environmental concentrations, including harmonisation of default values and development of a harmonised computer model toxicity of substances to dung fauna degradation of substances in manure
pre-approval information for registration of new medicinal products for food producing animals with respect antimicrobial resistance injection site residues user safety

environ 8 % des patients ont développé un effet indésirable sévère (common toxicity criteria (ctc), grade 3 ou 4).
circa l’8 % dei pazienti ha riportato una reazione avversa grave (criteri comuni di tossicità, (ctc) grado 3 o 4).

les événements indésirables survenus plus fréquemment (≥ 3%) dans le groupe tarceva que dans le groupe placebo dans l’ étude pivot br.21 et chez au moins 10% des patients du groupe tarceva sont résumés par grade nci-ctc (national cancer institute-common toxicity criteria) dans le tableau 1.
la tabella 1 riassume, in base al grado nci-ctc (criteri comuni di tossicità dell’ istituto nazionale del cancro), gli eventi avversi che si sono verificati con maggiore frequenza (≥ 3%) tra i pazienti trattati con tarceva rispetto al gruppo placebo nello studio registrativo br.21 e almeno nel 10% dei pazienti del gruppo tarceva.