Institute for Medical Research and Occupational Health
Abstract
Despite the lack of formal immunotoxicity testing guidelines, the assessment of immune function has been a routine component of toxicity testing for over twenty years. The European Agency for the Evaluation of Medicinal Products (EMEA) and The US Food and Drug Administration (FDA) have recently adopted new guidelines for immunotoxicity testing of new medicinal products. These two guidelines are compared in this article.Iako donedavno nisu postojale službene smjernice o ispitivanju imunotoksičnosti lijekova, ispitivanja utjecaja lijekova na imunosni sustav dio su rutinskih ispitivanja toksičnosti lijekova već više od 20 godina. U proteklih nekoliko godina i Europska agencija za evaluaciju lijekova i Američka agencija za hranu i lijekove objavile su smjernice o ispitivanju imunotoksičnosti lijekova koje su u ovom radu uspoređene
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