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| Content Provider | OECD iLibrary |
|---|---|
| Organization | OECD |
| Abstract | Cette Ligne directrice décrit des études « in vivo » qui fournissent des informations sur le bilan massique, l’absorption, la biodisponibilité, la distribution tissulaire, le métabolisme, l’excrétion, et les principaux paramètres toxicocinétiques (par exemple AUC), ainsi que des approches supplémentaires qui peuvent fournir des informations utiles sur la toxicocinétique. Les informations sur la toxicocinétique aident à relier la concentration ou la dose à la toxicité observée et à comprendre son mécanisme de toxicité. La substance d’essai (radiomarquée ou non) est normalement administrée par voie orale, mais d’autres voies d’administration sont possibles. L’administration de doses uniques de la substance (de préférence un minimum de deux niveaux de doses) peut convenir, mais des doses répétées peuvent être nécessaires dans certaines circonstances. Les études utilisent de préférence la même espèce que celle utilisée dans d’autres études toxicologiques faites avec la substance (normalement le rat, un minimum de 4 animaux d’un même sexe pour chaque dose). Une estimation initiale de l’absorption peut être obtenue par la détermination du bilan massique; mais il est possible que d’autres études, telles que les études avec administration en intraveineuse (IV) et excrétion biliaire, soient nécessaires. La biodisponibilité peut être déterminée à partir des cinétiques plasma/sang des groupes oraux et IV. Le pourcentage de la dose totale dans les tissus est au moins mesuré à la fin de l’essai, mais des mesures à d’autres moments peuvent s’avérer nécessaires. Les métabolites présents à 5 % ou plus de la dose administrée sont identifiés. Le taux et l’importance de l’excrétion de la dose administrée sont déterminés par la mesure du pourcentage de dose récupéré dans l’urine, les fèces et l’air expiré. |
| Page Count | 22 |
| ISSN | 20745842 |
| e-ISBN | 9789264070899 |
| Language | French |
| Publisher | OECD Publishing |
| Publisher Date | 2010-07-23 |
| Access Restriction | Open |
| Subject Keyword | Environment |
| Content Type | Text |
| Resource Type | Book |
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