Nonclinical evaluation of immunological safety in Göttingen Minipigs: The CONFIRM initiative

Autor: Peter Vestbjerg, Claire Friry-Santini, Philippe Ancian, Hollie Skaggs, Jacques Descotes, Antonio Iglesias, Henrik Duelund Pedersen, Tina Rubic-Schneider, Linda Allais
Rok vydání: 2018
Předmět:
Zdroj: Regulatory Toxicology and Pharmacology. 94:271-275
ISSN: 0273-2300
DOI: 10.1016/j.yrtph.2018.02.015
Popis: 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 Gottingen 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 Gottingen 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.
Databáze: OpenAIRE
Externí odkaz: