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Opportunities to minimise animal use in pharmaceutical regulatory general toxicology: a cross-company review.
Regul Toxicol Pharmacol ; 61(2): 222-9, 2011 Nov.
Article en En | MEDLINE | ID: mdl-21855593
ABSTRACT
Toxicity studies in animals are carried out to identify the intrinsic hazard of a substance to support risk assessment for humans. In order to identify opportunities to minimise animal use in regulatory toxicology studies, a review of current study designs was carried out. Pharmaceutical companies and contract research organisations in the UK shared data and experience of standard toxicology studies (ranging from one to nine months duration) in rodents and non-rodents; and carcinogenicity studies in the rat and mouse. The data show that variation in study designs was primarily due to (i) the number of animals used in the main study groups, (ii) the use of animals in toxicokinetic (TK) satellite groups, and (iii) the use of animals in off-treatment recovery groups. The information has been used to propose a series of experimental designs where small adjustments could reduce animal use in practice, while maintaining the scientific objectives.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pruebas de Toxicidad / Alternativas al Uso de Animales / Experimentación Animal Tipo de estudio: Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Animals / Humans Idioma: En Revista: Regul Toxicol Pharmacol Año: 2011 Tipo del documento: Article País de afiliación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pruebas de Toxicidad / Alternativas al Uso de Animales / Experimentación Animal Tipo de estudio: Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Animals / Humans Idioma: En Revista: Regul Toxicol Pharmacol Año: 2011 Tipo del documento: Article País de afiliación: Reino Unido
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