Nedocromil sodium preclinical safety evaluation studies: a preliminary report

The preclinical safety evaluation programme for nedocromil sodium was conducted to examine the toxicity potential of the compound in animals and to support its chronic use in man by the inhalation route. Tests, from single-dose to 'lifetime' studies, were conducted in mouse, rat, rabbit and dog at high doses and by various routes of administration. This programme evaluated nedocromil sodium in terms of its general and reproductive toxicology, mutagenic and carcinogenic potential and other areas of interest. Nedocromil sodium proved to be safe, with a low order of toxicity and high safety margins. The results of the preclinical safety programme support the chronic use of nedocromil sodium in humans.