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Experimental designs for the preclinic toxicology studies in the Finlay Institute

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Author(s): Mildrey Fariñas Medina | Daniel Francisco Arencibia Arrebola | Yulieé López Feria | Daiyana Díaz Rivero | Sergio Sifontes Rodríguez | Juan Francisco Infante Bourzac

Journal: RETEL : Revista de Toxicología en Línea
ISSN 1668-091X

Volume: 24;
Start page: 40;
Date: 2009;
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Keywords: Toxicology | preclinic | rats | vaccine-toxicology-study

ABSTRACT
The preclinic studies achieve the approval of the clinical assays. Some vaccines conceive a toxicity assay for unique dose, for repeated dose and local tolerance, as well as studies of reproduction toxicology. These studies constitute a fundamental link in the chain of regulatory requirements of the preclinic toxicologic studies since they allow to make an through the animals behaviour during a time predetermined to register the generated lesions by the vaccine composition of the chronologically where the adjuvant and the preserve many times they carry out the toxic effect of the same one or for their reaction with the immune system, giving a better information with respect to the products in the preclinic phase of their development. The rats, and in particular those of the Sprague Dawley line, is the species used in the toxicologic assays. To consider an excellent animal model for the preclinical toxicologic evaluation of vaccines it is indispensable that it is sensitive inmunological to the assay product. The objective of the present work is to know the experimental designs for the studies of candidates' preclinic toxicology of the vaccine or vaccine candidates to study that allow a better evaluation of the possible adverse effects provoked and evolution of these in the Finlay Institute.
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