主页 > 医学动态 >
【medical-news】开发新药革新: 真的可以不做动物急
By Andrew Jack
Published: January 9 2008 02:05 | Last updated: January 9 2008 02:05
Many thousands fewer mice and rats will be killed each year in tests to develop medicines because of streamlined procedures made public on Tuesday by European researchers and pharmaceutical companies.
A group of 18 leading European pharmaceutical companies and clinical research organisations backed the scrapping of “acute toxicity tests”, which have long been conducted in rodents to identify the minimal lethal dose of an experimental drug.While universally applied in the past to win regulatory approval, the companies concluded that the tests, first introduced in 1927, had been superseded by others that were more accurate and were therefore no longer needed as a precondition for launching drug tests in humans.
The move ís the first significant success for the UK’s National Centre for the Replacement, Refinement and Reduction of Animals in Research, which has co-ordinated the work.
It also reflects a growing number of recent initiatives to re-examine clinical research in order to speed up development of drugs, reduce failure rates and rising costs, and identify side-effects and problems more quickly.
Animal testing is also an emotive subject, particularly in Britain, where protesters have conducted sometimes violent campaigns against companies and individuals involved in animal experimentation.
Regulators in the EU, US and Japan have already been informed of the initiative and have raised no objections.
The scrapping of the tests is likely to be included in revised international guidelines due to be drawn up within two years.
The companies involved in the study have already stopped carrying out most acute toxicity tests, resulting in an annual reduction between them of 15,000 mice and rats killed in drug development.
“This is a very good first step in the right direction,” said Sally Robinson from AstraZeneca, the Anglo-Swedish pharmaceutical company, which headed the review. Other participants included Roche, Eli Lilly, Pfizer, Novartis, Sanofi-Aventis, GlaxoSmithKline and Huntingdon Life Sciences.
Use of thousands of animals avoided as test proved redundant
Important step taken to reduce animals used in specific safety test for new medicines
Thousands of rodents per year are no longer being used in a particular test needed to develop new medicines. This outcome follows an extensive review by 18 pharmaceutical companies and the NC3Rs with the support of EFPIA. The review, published in Regulatory Toxicology and Pharmacology , shows that this particular toxicity test, which can cause substantial effects to animals, is now redundant. In fact, the review has already led to more than a 70% reduction in animal use in acute toxicity tests by the companies involved, and there clearly is even greater potential for reducing animal use for this test worldwide.
Toxicity testing of new medicines for humans and animals accounts for 4% of all animal use in Europe, which means just under half a million rats and mice are used for this purpose each year. The estimated reduction of 15,000 in animal use following this review equates to around 3.5% of the rats and mice used in testing new human or veterinary medicines or dentistry products.
Given recent changes in the process for developing medicines, the review's authors questioned the need for a particular animal test that has been required in the safety testing of new medicines. The evidence they gathered showed that the information obtained had little or no value in assessing the risk to humans. The review focussed on the single dose acute toxicity test, which is usually conducted prior to the first clinical trial in humans. It is traditionally required to identify the dose of a medicine that causes major toxic effects.
The leader of the review, Dr Sally Robinson AstraZeneca, said: "Appropriate safety testing with animals is a worldwide regulatory requirement, providing protection to the public and providing doctors with important information on how to administer new medicines. Before new medicines are administered to humans, their safety is evaluated by screening for potentially harmful effects. This screening is mostly done using animals since these currently provide the best prediction of what might happen in people.
"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. We continuously shared and reviewed information between 2003 and 2007, which provided the evidence to reduce animal use by demonstrating that this acute toxicity test is no longer needed before a new medicine is tested in humans. 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, NC3Rs said: "The next step has to be changing the regulations that require this test to be carried out and the NC3Rs and the companies are working hard to achieve this with worldwide regulatory bodies.
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-05-05 17:49
医学,生命科学网