Nonclinical evaluation of immunological safety in Göttingen Minipigs: The CONFIRM initiative.
Regul Toxicol Pharmacol
; 94: 271-275, 2018 Apr.
Article
em En
| MEDLINE
| ID: mdl-29481836
ABSTRACT
There is a growing need to consider non-rodent species for the immunological safety evaluation of drug candidates. The EU Framework-6 RETHINK Project demonstrated that the Göttingen Minipig is a relevant animal model for regulatory toxicology studies. Extensive knowledge on the immune system of domestic pigs is available and fewer differences from humans have been identified as compared to other species, such as mice or non-human primates. Minipig data are too scarce to allow for claiming full immunological comparability with domestic pigs. Another gap limiting minipig use for immunological safety evaluation is the lack of a qualified and validated database. However, available data lend support to the use of minipigs. The need for a COllaborative Network For Immunological safety Research in Minipigs (the CONFIRM Initiative) was obvious. It is intended to trigger immunological safety research in Göttingen Minipigs, to assist and synergize fundamental, translational and regulatory investigative efforts relevant to the immunological safety evaluation of pharmaceuticals and biologics, and to spread current knowledge and new findings to the scientific and regulatory toxicology community.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Porco Miniatura
/
Testes de Toxicidade
/
Avaliação Pré-Clínica de Medicamentos
Tipo de estudo:
Prognostic_studies
Limite:
Animals
Idioma:
En
Revista:
Regul Toxicol Pharmacol
Ano de publicação:
2018
Tipo de documento:
Article