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- W2035378380 abstract "Resume Des recommandations de validation des techniques analytiques utilisees dans l'industrie pharmaceutique ont ete etablies par des experts issus notamment de la Food and Drug Administration (Etats-Unis) et du Comite des specialites pharmaceutiques (Union europeenne). Les criteres a satisfaire sont : la specificite, l'exactitude, la linearite, la fidelite et l'estimation des limites de detection et de quantification. Appliquee aux medicaments, l'immunoanalyse offre des avantages en terme de sensibilite mais pose des problemes particuliers de validation. Ceux-ci concernent tout particulierement la specificite des anticorps vis-a-vis de metabolites ou de substances endogenes ou la necessite de validation dans plusieurs fluides biologiques de differents especes. Au travers des recommandations exigees pour les dosages de medicaments en milieu biologique, le but de cette presentation est d'exposer les contraintes particulieres a l'immunoanalyse et de proposer certaines solutions pour satisfaire aux criteres de validation." @default.
- W2035378380 created "2016-06-24" @default.
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- W2035378380 date "1994-01-01" @default.
- W2035378380 modified "2023-10-18" @default.
- W2035378380 title "Problèmes posés par la validation de l'immunoanalyse de médicaments" @default.
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