Preclinical Development of Low Toxicity DrugsFocus on Zanamivir, an Anti-Influenza Drug

Developing novel compounds with low toxicity may present more difficulties for pharmaceutical companies than developing compounds with known class-related effects. The absence of clearly identified toxicity may be a consequence either of an inadequate or poorly designed toxicity programme or of the very low toxicity of the novel compound. To enable an informed risk assessment to be undertaken prior to registration, regulatory authorities must satisfy themselves that all efforts to fully evaluate the toxicity profile of a novel compound have been made.