Are acute toxicity studies required to support overdose for new medicines?

Abstract

Dear Dr. Gori, Our recent evidence-based review of the requirement for acute toxicity studies in pharmaceutical drug development demonstrated that acute toxicity studies are not useful to support the first clinical trial in humans (Robinson et al., 2008). Additional analysis of our data highlighted that the information obtained from acute toxicity studies… (More)
DOI: 10.1016/j.yrtph.2009.06.012

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