Protein biomarkers for in vitro testing of developmental...

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G01N 33/50 (2006.01)

Patent

CA 2726563

Presently, the toxicological assessment of chemicals is mainly performed in vivo using a variety of animal species and in addition taking into account human clinical, biochemical, pathological and morphological data. Over the past years it be-came increasingly clear that some substances are particularly harmful for children and thus there is a focus on the special vulnerability of the developing human brain. Meanwhile there is a recommendation to test substances with a known neurotoxic or teratogenic (in particular a neuroteratogenic) risk additionally for embryotoxicity. Moreover the US Environmental Protection Agency (EPA) requires embryotoxicity tests for pesticides. Further tests are required if substances shall be used as medicaments (S7A Safety Pharmacology Studies for Human Pharmaceuticals, Guidelines of the International Conference on Harmonization, ICH, 2001).

Selon linvention, l'évaluation toxicologique de produits chimiques est à présent principalement effectuée in vivo à l'aide d'une diversité d'espèces animales et de plus en prenant en compte des données cliniques, biochimiques, pathologiques et morphologiques humaines. Au cours des dernières années, il est devenu de plus en plus clair que certaines substances sont particulièrement nuisibles aux enfants, et ainsi il y a une focalisation sur la vulnérabilité spéciale du cerveau humain en développement. Cependant, il y a une recommandation pour tester des substances avec un risque neurotoxique ou tératogène (en particulier, neurotératogène) connu de plus pour l'embryotoxicité. De plus, l'agence de protection environnementale américaine (EPA) demande des tests d'embryotoxicité pour les pesticides. D'autres tests sont requis si les substances doivent être utilisées en tant que médicaments (études de pharmacologie de sécurité S7A pour les produits pharmaceutiques humains, Directives de la Conférence internationale sur l'harmonisation, ICH, 2001).

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