Animal toxicity test set to be scrapped
pharmafile | January 9, 2008 | News story | Research and Development |Â Â Â
The pharmaceutical industry has made a major reduction in the number of rodents used in pre-clinical drug testing after an industry wide review, and is set to scrap an outdated toxicity test.
Eighteen pharmaceutical companies took part in the review, which was co-ordinated by the UK's NC3Rs – the National Centre for the Replacement, Refinement and Reduction of Animals – and with support from European pharma body EFPIA.
The single dose acute toxicity test is traditionally conducted before the first clinical trial in humans and is required to identify the dose of a medicine that causes major toxic effects.
But the review, published in Regulatory Toxicology and Pharmacology, shows that this toxicity test, which can harm animals, is now redundant.
The review has already led to a reduction in animal use of more than 70% in the acute toxicity tests carried out by the companies involved, and the NC3Rs says there remains even greater scope to reduce use of the test worldwide.
Companies who have participated in the review include AstraZeneca, Roche, Lilly, Pfizer, Novartis, Sanofi-Aventis, GlaxoSmithKline and Huntingdon Life Sciences.
The leader of the review, AstraZeneca's Dr Sally Robinson, said animals testing in many cases still provides the best prediction of what might happen in people, but where it does not, its use should be reviewed.
"In light of our desire to replace, refine and reduce animal use wherever possible, we were keen to examine whether there was a better way to conduct this type of test.
"While we recognize that this reduction represents a small proportion of the total, it is an important step in the right direction."
Dr Kathryn Chapman, co-ordinator of the project at the NC3Rs, said the next step will be to change the regulations that require the test to be carried out, and pledged that the NC3Rs and the industry would work with worldwide regulatory bodies to achieve this.
The FDA, EMEA and Japan's regulator have raised no objections to the plans, paving the way for the international guidelines to be revised and the ending of the tests globally within two years.
